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Americaâ&#x20AC;&#x2122;s Leading Menopause Magazine

HT Is it for me? Making informed decisions about hormone therapy

In transition Everything you need to know on the journey through menopause

Menopausal

moments! What to do when the heat is on

Apples or Pears? Follow our tailored exercise plan to suit your body shape

Naturally does it

Your expert guide to tried and tested complimentary and alternative therapies

No Pills, No Patch—Just Cool Relief Divigel® is a discreet, quick-drying, prescription transdermal gel that relieves moderate to severe hot flashes, including night sweats associated with menopause1  Lowest FDA-approved dose of estradiol (0.25 mg) in a gel, lotion, or spray available to effectively treat these symptoms of menopause1-5  Plant-derived bioidentical estradiol, identical to the body’s own natural hormone1  Convenient, easy-to-use gel1

To learn more and to try a nonmedicated gel sample, visit www.divigel.com. Divigel® is not for everyone. Ask your healthcare professional if it’s right for you. For proven relief of moderate to severe hot flashes associated with menopause.1

www.divigel.com

Important Safety Information About Divigel® The following are not all the possible risks for Divigel®. Please read the product brief summary on the adjacent page and talk to your healthcare provider. Estrogens increase the chance of getting cancer of the uterus. Report any unusual vaginal bleeding right away while you are taking estrogens. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to ﬁnd out the cause. In general, the addition of a progestin is recommended for women with a uterus to reduce the chance of getting cancer of the uterus. Do not use estrogens, with or without progestins, to prevent heart disease, heart attacks, or strokes. Using estrogens, with or without progestins, may increase your chance of getting heart attacks, strokes, breast cancer, and blood clots. Do not use estrogens, with or without progestins, to prevent dementia. Using estrogens, with or without progestins, may increase your risk of dementia. Do not use estrogen products, including Divigel®, if you have unusual vaginal bleeding, currently have or have had certain cancers, had a stroke or heart attack in the past year, currently have or have had blood clots, currently have or have had liver problems, are allergic to any Divigel® ingredients, or think you may be pregnant. The most common side effects for all estrogen products are headache, breast pain, irregular vaginal bleeding or spotting, stomach/abdominal cramps and bloating, nausea and vomiting, and hair loss. The less common but serious side effects include breast cancer, cancer of the uterus, stroke, heart attack, blood clots, dementia, gallbladder disease, and ovarian cancer. In Divigel® clinical trials, the most common side effects were inﬂammation of the nasal passages and pharynx, upper respiratory tract infection, vaginal yeast infection, breast tenderness and vaginal bleeding. Call your healthcare provider right away if you have any symptoms that concern you. Estrogen products should be used at the lowest dose possible for your treatment and only as long as needed. You and your healthcare provider should talk regularly about whether you still need treatment with Divigel®. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. For more information, call 1-800-654-2299. Divigel® is a registered trademark of Upsher-Smith Laboratories, Inc. All other trademarks are property of the respective trademark holders.

Do not alter log Tagline may be to Application g Black and PMS No CMYK use

Divigel® (estradiol gel) 0.1% Rx only ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is no evidence that the use of "natural" estrogens results in a different endometrial risk profile than synthetic estrogens at equivalent estrogen doses. (See WARNINGS, Malignant neoplasms, Endometrial cancer.) CARDIOVASCULAR AND OTHER RISKS Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia. (See CLINICAL STUDIES and WARNINGS, Cardiovascular disorders and Dementia.) The estrogen-alone substudy of the Women's Health Initiative (WHI) reported increased risks of stroke and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 6.8 years and 7.1 years, respectively, of treatment with oral conjugated estrogens (CE 0.625 mg) alone per day, relative to placebo. (See WARNINGS, Cardiovascular disorders.) The estrogen-plus-progestin substudy of the WHI reported increased risk of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) per day, relative to placebo. (See WARNINGS, Cardiovascular disorders and Malignant neoplasms, Breast cancer.) The Women’s Health Initiative Memory Study (WHIMS), a substudy of the WHI, reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with CE 0.625 mg alone and during 4 years of treatment with CE 0.625 mg combined with MPA 2.5 mg, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. (See WARNINGS, Dementia, and PRECAUTIONS, Geriatric Use.) Other doses of oral conjugated estrogens with medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman. CONTRAINDICATIONS: Estrogen products, including Divigel® (estradiol gel) 0.1% should not be used in women with any of the following conditions: 1. Undiagnosed abnormal genital bleeding. 2. Known, suspected, or history of cancer of the breast. 3. Known or suspected estrogen-dependent neoplasia. 4. Active deep vein thrombosis, pulmonary embolism, or history of these conditions. 5. Active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction). 6. Liver dysfunction or disease. 7. Known hypersensitivity to the ingredients of Divigel®. 8. Known or suspected pregnancy. There is no indication for Divigel® in pregnancy. There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins from oral contraceptives inadvertently during early pregnancy. (See PRECAUTIONS.) WARNINGS (See BOXED WARNINGS.) 1. Cardiovascular Disorders: Estrogen-alone therapy has been associated with an increased risk of stroke and deep vein thrombosis (DVT). Estrogen-plus-progestin therapy has been associated with an increased risk of myocardial infarction as well as stroke, venous thrombosis and pulmonary embolism. Should any of these occur or be suspected, estrogens should be discontinued immediately. Risk factors for arterial vascular disease (e.g., hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (e.g., personal history or family history of VTE, obesity, and systemic lupus erythematosus) should be managed appropriately. a. Stroke: In the estrogen-alone substudy of the Women’s Health Initiative (WHI), a statistically significant increased risk of stroke was observed in women receiving CE 0.625 mg daily compared to placebo (44 versus 32 per 10,000 women-years). The increase in risk was observed in year 1 and persisted. In the estrogen-plus-progestin substudy of the WHI study, a statistically significant increased risk of stroke was reported in women receiving CE/MPA 0.625 mg/2.5 mg daily compared to women receiving placebo (31 versus 24 per 10,000 women-years). The increase in risk was demonstrated after the first year and persisted. b. Coronary heart disease: In the estrogen-alone substudy of WHI, no overall effect on coronary heart disease (CHD) events (defined as non-fatal MI, silent MI, or death, due to CHD) was reported in women receiving estrogen-alone compared to placebo. In the estrogen-plus-progestin substudy of WHI, no statistically significant increase of CHD events was reported in women receiving CE/MPA compared to women receiving placebo (39 vs. 33 per 10,000 women-years). An increase in relative risk was demonstrated in year one and a trend toward decreasing relative risk was reported in years 2 through 5. In postmenopausal women with documented heart disease (n=2,763, average age 66.7 years), a controlled clinical trial of secondary prevention of cardiovascular disease (Heart and Estrogen/Progestin Replacement Study (HERS)) treatment with CE/MPA (0.625 mg/2.5 mg per day) demonstrated no cardiovascular benefit. During an average follow-up of 4.1 years, treatment with CE/MPA did not reduce the overall rate of CHD events in postmenopausal women with established coronary heart disease. There were more CHD events in the CE/MPA-treated group than in the placebo group in year 1, but not during the subsequent years. Participation in an open label extension of the original HERS trial (HERS II) was agreed to by 2,321 women. Average follow-up in HERS II was an additional 2.7 years, for a total of 6.8 years overall. Rates of CHD events were comparable among women in the CE/MPA group and the placebo group in HERS, HERS II, and overall. Large doses of estrogen (5 mg conjugated estrogens per day), comparable to those used to treat cancer of the prostate and breast, have been shown in a large prospective clinical trial in men to increase the risks of non-fatal myocardial infarction, pulmonary embolism, and thrombophlebitis. c. Venous Thromboembolism: In the estrogen-alone substudy of WHI the risk of VTE (DVT and pulmonary embolism [PE]), was reported to be increased for women taking conjugated estrogens compared to placebo (30 versus 22 per 10,000 women-years), although only the increased risk of DVT reached statistical significance (23 vs. 15 per 10,000 women-years). The increase in VTE risk was demonstrated during the first two years. In the estrogen-plus-progestin substudy of WHI, a statistically significant two-fold greater rate of VTE, was reported in women receiving CE/MPA compared to women receiving placebo (35 vs. 17 per 10,000 women-years). Statistically significant increases in risk for both DVT (26 vs. 13 per 10,000 women-years) and PE (18 vs. 8 per 10,000 women-years) were also demonstrated. The increase in VTE risk was demonstrated during the first year and persisted. If feasible, estrogens should be discontinued at least 4 to 6 weeks before surgery of the type associated with an increased risk of thromboembolism, or during periods of prolonged immobilization. 2. Malignant Neoplasms, a. Endometrial Cancer : The use of unopposed estrogens in women with intact uteri has been associated with an increased risk of endometrial cancer. The reported endometrial cancer risk among unopposed estrogen users is about 2 to 12 times greater than in nonusers, and appears dependent on duration of treatment and on estrogen dose. Most studies show no significant increased risk associated with use of estrogens for less than 1 year. The greatest risk appears associated with prolonged use, with increased risk of 15- to 24-fold for 5 to 10 years or more. This risk has been shown to persist for at least 8 to 15 years after estrogen therapy is discontinued. Clinical surveillance of all women taking estrogen/progestin combinations is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is no evidence that the use of natural estrogens results in a different endometrial risk profile than synthetic estrogens of equivalent estrogen dose. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. b. Breast Cancer : In some studies, the use of estrogens and progestins by postmenopausal women has been reported to increase the risk of breast cancer. The most important randomized clinical trial providing information about this issue is the Women’s Health Initiative (WHI). The results from observational studies are generally consistent with those of the WHI clinical trial. Observational studies have also reported an increased risk of breast cancer for estrogen-plusprogestin combination therapy, and a smaller increased risk for estrogen-alone therapy, after several years of use. For both findings, the excess risk increased with duration of use, and appeared to return to baseline over about five years after stopping treatment (only the observational studies have substantial data on risk after stopping). In these studies, the risk of breast cancer was greater, and became apparent earlier, with estrogen-plus-progestin combination therapy as compared to estrogenalone therapy. However, these studies have not found significant variation in the risk of breast cancer among different estrogens or among different estrogen-plus-progestin combinations, doses, or routes of administration.

In the estrogen-alone substudy of WHI, after an average of 7.1 years of follow-up, CE (0.625 mg daily) was not associated with an increased risk of invasive breast cancer (RR 0.80, 95% nCI 0.62-1.04). In the estrogen-plus-progestin substudy, after a mean follow-up of 5.6 years, the WHI substudy reported an increased risk of breast cancer. In this substudy, prior use of estrogen-alone or estrogen/progestin combination hormone therapy was reported by 26% of the women. The relative risk of invasive breast cancer was 1.24 (95% nCI, 1.01-1.54), and the absolute risk was 41 versus 33 cases per 10,000 women-years, for estrogen-plusprogestin compared with placebo, respectively. Among women who reported prior use of hormone therapy, the relative risk of invasive breast cancer was 1.86, and the absolute risk was 46 versus 25 cases per 10,000 women-years, for estrogen-plus-progestin compared with placebo. Among women who reported no prior use of hormone therapy, the relative risk of invasive breast cancer was 1.09, and the absolute risk was 40 versus 36 cases per 10,000 women-years for estrogen-plus-progestin compared with placebo. In the WHI trial, invasive breast cancers were larger and diagnosed at a more advanced stage in the estrogen-plusprogestin group compared with the placebo group. Metastatic disease was rare with no apparent difference between the two groups. Other prognostic factors such as histologic subtype, grade and hormone receptor status did not differ between the groups. The use of estrogen-alone and estrogen-plus-progestin has been reported to result in an increase in abnormal mammograms requiring further evaluation. All women should receive yearly breast examinations by a healthcare provider and perform monthly breast self-examinations. In addition, mammography examinations should be scheduled based on patient age, risk factors, and prior mammogram results. 3. Dementia: In the estrogen-alone Women's Health Initiative Memory Study (WHIMS), a substudy of WHI, a population of 2,947 hysterectomized women aged 65 to 79 years was randomized to CE (0.625 mg daily) or placebo. In the estrogen-plus-progestin WHIMS, a population of 4,532 postmenopausal women aged 65 to 79 years was randomized to CE/MPA (0.625 mg/2.5 mg daily) or placebo. In the estrogen-alone substudy, after an average follow-up of 5.2 years, 28 women in the estrogen-alone group and 19 women in the placebo group were diagnosed with probable dementia. The relative risk of probable dementia for CE alone versus placebo was 1.49 (95% CI, 0.83-2.66). The absolute risk of probable dementia for CE alone versus placebo was 37 versus 25 cases per 10,000 women-years. In the estrogen-plus-progestin substudy, after an average follow-up of 4 years, 40 women in the estrogen-plus-progestin group and 21 women in the placebo group were diagnosed with probable dementia. The relative risk of probable dementia for estrogen-plus-progestin versus placebo was 2.05 (95% CI, 1.21-3.48). The absolute risk of probable dementia for CE/MPA versus placebo was 45 versus 22 cases per 10,000 women-years. When data from the two populations were pooled as planned in the WHIMS protocol, the reported overall relative risk for probable dementia was 1.76 (95% CI 1.19-2.60). Since both substudies were conducted in women aged 65 to 79 years, it is unknown whether these findings apply to younger postmenopausal women. (See BOXED WARNINGS and PRECAUTIONS, and Geriatric Use.) 4. Gallbladder Disease: A two- to four-fold increase in the risk of gallbladder disease requiring surgery in postmenopausal women receiving estrogens has been reported. 5. Hypercalcemia: Estrogen administration may lead to severe hypercalcemia in patients with breast cancer and bone metastases. If hypercalcemia occurs, use of the drug should be stopped and appropriate measures taken to reduce the serum calcium level. 6. Visual Abnormalities: Retinal vascular thrombosis has been reported in patients receiving estrogens. Discontinue medication pending examination if there is sudden partial or complete loss of vision, or a sudden onset of proptosis, diplopia, or migraine. If examination reveals papilledema or retinal vascular lesions, estrogens should be permanently discontinued. PRECAUTIONS, A. General, 1. Addition of a progestin when a woman has not had a hysterectomy: Studies of the addition of a progestin for 10 or more days of a cycle of estrogen administration, or daily with estrogen in a continuous regimen, have reported a lowered incidence of endometrial hyperplasia than would be induced by estrogen treatment alone. Endometrial hyperplasia may be a precursor to endometrial cancer. There are, however, possible risks that may be associated with the use of progestins with estrogens compared to estrogen-alone regimens. These include a possible increased risk of breast cancer, adverse effects on lipoprotein metabolism (e.g., lowering HDL, raising LDL), and impairment of glucose tolerance. 2. Elevated blood pressure: In a small number of case reports, substantial increases in blood pressure have been attributed to idiosyncratic reactions to estrogens. In a large, randomized, placebocontrolled clinical trial, a generalized effect of estrogens on blood pressure was not seen. Blood pressure should be monitored at regular intervals with estrogen use. 3. Hypertriglyceridemia: In patients with pre-existing hypertriglyceridemia, estrogen therapy may be associated with elevations of plasma triglycerides leading to pancreatitis and other complications. 4. Impaired liver function and past history of cholestatic jaundice: Estrogens may be poorly metabolized in patients with impaired liver function. For patients with a history of cholestatic jaundice associated with past estrogen use or with pregnancy, caution should be exercised, and in the case of recurrence, medication should be discontinued. 5. Hypothyroidism: Estrogen administration leads to increased thyroid-binding globulin (TBG) levels. Patients with normal thyroid function can compensate for the increased TBG by making more thyroid hormone, thus maintaining free T4 and T3 serum concentrations in the normal range. Patients dependent on thyroid hormone replacement therapy who are also receiving estrogens may require increased doses of their thyroid replacement therapy. These patients should have their thyroid function monitored to maintain their free thyroid hormone levels in an acceptable range. 6. Fluid retention: Estrogens may cause some degree of fluid retention. Because of this, patients who have conditions that might be influenced by this factor, such as a cardiac or renal dysfunction, warrant careful observation when estrogens are prescribed. 7. Hypocalcemia: Estrogens should be used with caution in individuals with severe hypocalcemia. 8. Ovarian cancer: The estrogen-plus-progestin substudy of the WHI reported that after an average follow-up of 5.6 years, the relative risk for ovarian cancer for estrogen-plusprogestin versus placebo was 1.58 (95% nCI, 0.77-3.24), but was not statistically significant. The absolute risk for estrogen-plus-progestin versus placebo was 4.2 versus 2.7 cases per 10,000 women-years. In some epidemiologic studies, the use of estrogen only products in particular for 10 or more years, has been associated with an increased risk of ovarian cancer. Other epidemiologic studies have not found these associations. 9. Exacerbation of endometriosis: Endometriosis may be exacerbated with administration of estrogens. Malignant transformation of residual endometrial implants have been reported in women treated post-hysterectomy with estrogen-alone therapy. For patients known to have residual endometriosis post-hysterectomy, the addition of progestin should be considered. 10. Exacerbation of other conditions: Estrogens may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine or porphyria, systemic lupus erythematosus, and hepatic hemangiomas and should be used with caution in women with these conditions. 11. Photosensitivity/Photoallergy: The effects of direct sun exposure to Divigel® (estradiol gel) 0.1% application sites have not been evaluated in clinical trials. Nonclinical studies in guinea pigs showed no phototoxicity or photosensitivity. In addition, Divigel® has been shown to absorb light primarily at wavelengths below 290 nm. Therefore, Divigel® is not considered to have photosensitizing potential. 12. Sunscreen application: Studies conducted using other approved topical estrogen gel products have shown that sunscreens have the potential for changing the systemic exposure of topically applied estrogen gels. The effect of concomitant application of sunscreen and Divigel® to the same application site has not been clinically evaluated. 13. Miscellaneous: Alcohol based gels are flammable. Avoid fire, flame, or smoking until the gel has dried. Occlusion of the area where the topical drug product is applied with clothing or other barriers is not recommended until the gel is completely dried. 14. Potential for Estradiol Transfer and Effects of Washing: There is a potential for drug transfer from one individual to the other following physical contact of Divigel® application sites. In a study to evaluate transferability to males from their female contacts, there was some elevation of estradiol levels over baseline in the male subjects, however, the degree of transferability in this study was inconclusive. Patients are advised to avoid skin contact with other subjects until the gel is completely dried. The site of application should be covered (clothed) after drying. Washing the application site with soap and water 1 hour after application resulted in a 30 to 38% decrease in the mean total 24-hour exposure to estradiol. Therefore, patients should refrain from washing the application site for at least one hour after application. B. Information for Patients: Physicians and pharmacists are advised to discuss the PATIENT INFORMATION leaflet with patients for whom they prescribe or dispense Divigel®.

C. Laboratory Tests: Estrogen administration should be initiated at the lowest dose approved for the treatment of moderate-to-severe vasomotor symptoms associated with menopause and then guided by clinical response rather than by serum hormone levels (e.g., estradiol, FSH). D. Drug and Laboratory Test Interactions: 1. Accelerated prothrombin time, partial thromboplastin time, and platelet aggregation time; increased platelet count; increased factors II, VII antigen, VIII antigen, VIII coagulant activity, IX, X, XII, VII-X complex, II-VII-X complex, and beta-thromboglobulin; decreased levels of anti-factor Xa and antithrombin III, decreased antithrombin III activity; increased levels of fibrinogen and fibrinogen activity; increased plasminogen antigen and activity. 2. Increased thyroid binding globulin (TBG) levels leading to increased circulating total thyroid hormone levels, as measured by proteinbound iodine (PBI), T4 levels (by column or by radioimmunoassay) or T3 levels by radioimmunoassay. T3 resin uptake is decreased, reflecting the elevated TBG. Free T4 and free T3 concentrations are unaltered. Patients on thyroid replacement therapy may require higher doses of thyroid hormone. 3. Other binding proteins may be elevated in serum (i.e., corticosteroid binding globulin (CBG), sex hormone binding globulin (SHBG) leading to increased total circulating corticosteroids and sex steroids, respectively. Free hormone concentrations may be decreased. Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-1-antitrypsin, ceruloplasmin). 4. Increased plasma HDL and HDL2 cholesterol subfraction concentrations, reduced LDL cholesterol concentration, increased triglyceride levels. 5. Impaired glucose tolerance. 6. Reduced response to metyrapone test. E. Carcinogenesis, Mutagenesis, Impairment of Fertility (See BOXED WARNINGS, WARNINGS and PRECAUTIONS.) Long-term continuous administration of natural and synthetic estrogens in certain animal species increases the frequency of carcinomas of the breast, uterus, cervix, vagina, testis and liver. F. Pregnancy: Estrogen products, including Divigel® (estradiol gel) 0.1%, should not be used in pregnancy. (See CONTRAINDICATIONS.) G. Nursing Mothers: Estrogen administration to nursing mothers has been shown to decrease the quantity and quality of the milk. Detectable amounts of estrogens have been identified in the milk of mothers receiving estrogen therapy. Caution should be exercised when estrogen products, including Divigel®, are administered to a nursing woman. H. Pediatric Use: Safety and efficacy of Divigel® in pediatric patients has not been established. I. Geriatric Use: There have not been sufficient numbers of geriatric patients involved in studies utilizing Divigel® to determine whether those over 65 years of age differ from younger subjects in their response to Divigel®. Of the total number of subjects in the estrogen-alone substudy of the Women’s Health Initiative (WHI), 46% (n=4,943) were 65 years and older, while 7.1% (n=767) were 75 years and older. There was a higher relative risk (CE versus placebo) of stroke in women less than 75 years of age compared to women 75 years and older. In the estrogen-alone substudy of the Women’s Health Initiative Memory Study (WHIMS), a substudy of WHI, a population of 2,947 hysterectomized women, aged 65 to 79 years, was randomized to CE (0.625 mg per day) or placebo. After an average follow-up of 5.2 years, the relative risk (CE versus placebo) of probable dementia was 1.49 (95% CI, 0.83-2.66). The absolute risk of developing probable dementia with estrogen alone was 37 vs. 25 cases per 10,000 womenyears with placebo. Of the total number of subjects in the estrogen-plus-progestin substudy of the WHI, 44% (n=7,320) were 65 years and older, while 6.6% (n=1,095) were 75 years and older. There was a higher relative risk (CE/MPA versus placebo) of stroke and invasive breast cancer in women 75 and older compared to women less than 75 years of age. In women greater than 75, the increased risk of non-fatal stroke and invasive breast cancer observed in the estrogen-plus-progestin combination group compared to the placebo group was 75 vs. 24 per 10,000 women-years and 52 vs. 12 per 10,000 women years, respectively. In the estrogenplus-progestin substudy of WHIMS, a population of 4,532 postmenopausal women, aged 65 to 79 years, was randomized to CE/MPA (CE 0.625 mg/2.5 mg daily) or placebo. In the estrogenplus-progestin group, after an average follow-up of 4 years, the relative risk (CE/MPA versus placebo) of probable dementia was 2.05 (95% CI, 1.21-3.48). The absolute risk of developing probable dementia with CE/MPA was 45 vs. 22 cases per 10,000 women-years with placebo. Seventy-nine percent of the cases of probable dementia occurred in women that were older than 70 for the CE group, and 82 percent of the cases of probable dementia occurred in women who were older than 70 in the CE/MPA group. The most common classification of probable dementia in both the treatment groups and placebo groups was Alzheimer’s disease. When data from the two populations were pooled as planned in the WHIMS protocol, the reported overall risk of probable dementia was 1.76 (95% CI, 1.19-2.60). Since both substudies were conducted in women aged 65 to 79 years, it is unknown whether these findings apply to younger postmenopausal women. (See BOXED WARNINGS, and WARNINGS, Dementia.) ADVERSE REACTIONS (See BOXED WARNINGS, WARNINGS and PRECAUTIONS.) Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. Divigel® was studied in a 12-week, double-blind, placebo-controlled study that included a total of 495 postmenopausal women (86.5% Caucasian). The following adverse events were reported by ≥5% of patients in any treatment group, listed as occurrences (%), for 0.25 g/day (n=122), 0.5 g/day (n=123), 1.0 g/day (n=125) and placebo (n=125), respectively: nasopharyngitis – 7 (5.7%), 5 (4.1%), 6 (4.8%), 5 (4.0%); upper respiratory tract infection – 7 (5.7%), 3 (2.4%), 2 (1.6%), 2 (1.6%); vaginal mycosis – 1 (0.8%), 3 (2.4%), 8 (6.4%), 4 (3.2%); breast tenderness – 3 (2.5%), 7 (5.7%), 11 (8.8%), 2 (1.6%); metrorrhagia – 5 (4.1%), 7 (5.7%), 12 (9.6%), 2 (1.6%). Application site reactions were seen in <1% of subjects. The following additional adverse reactions have been reported with estrogen and/or progestin therapy. 1. Genitourinary system: Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding; spotting; dysmenorrhea; increase in size of uterine leiomyomata; vaginitis, including vaginal candidiasis; change in amount of cervical secretion; changes in cervical ectropion; ovarian cancer; endometrial hyperplasia; endometrial cancer; vaginal discharge. 2. Breasts: Tenderness; enlargement, pain, nipple discharge, galactorrhea, fibrocystic breast changes; breast cancer; nipple pain. 3. Cardiovascular: Deep and superficial venous thrombosis, pulmonary embolism; thrombophlebitis; myocardial infarction; stroke; increase in blood pressure. 4. Gastrointestinal: Nausea; vomiting; abdominal cramps; bloating; cholestatic jaundice; increased incidence of gallbladder disease; pancreatitis; enlargement of hepatic hemangiomas; abdominal pain. 5. Skin: Chloasma or melasma, which may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism; pruritus; rash. 6. Eyes: Retinal vascular thrombosis, intolerance to contact lenses. 7. Central Nervous System: Headache; migraine; dizziness; mental depression; chorea; nervousness; mood disturbances; irritability; exacerbation of epilepsy; dementia. 8. Miscellaneous: Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria; edema; arthralgias; leg cramps; changes in libido; urticaria; angioedema; anaphylactoid/anaphylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides; muscle cramps. OVERDOSAGE: Serious ill effects have not been reported following acute ingestion of large doses of estrogen-containing drug products by young children. Overdosage of estrogen may cause nausea and vomiting, and withdrawal bleeding may occur in females. Distributed by UPSHER-SMITH LABORATORIES, INC. Minneapolis, MN 55447 1-800-654-2299 DVBS00 Revised 0607

For more information, including a copy of the full prescribing information, call 1-800-654-2299 or visit www.divigel.com.

References: 1. Divigel® [package insert]. Minneapolis, MN: Upsher-Smith Laboratories, Inc; 2007. 2. EstroGel® [package insert]. Herndon, VA: ASCEND Therapeutics, Inc; 2007. 3. Elestrin™ [package insert]. Philadelphia, PA: Azur Pharma Inc; 2007. 4. Estrasorb® [package insert]. Bristol, TN: Graceway Pharmaceuticals, LLC; 2008. 5. Evamist™ [package insert]. St. Louis, MO: Ther-Rx Corporation; 2008.

Contents Features 16 36

Hormone therapy? That is the question When the uncomfortable symptoms of perimenopause become just too much perhaps hormone therapy is the answer.

In Transition 06 Expert advice and guidance on the journey leading to menopause.

Apples and Pears 40 Follow our tailored exercise program to help you make the most of your classic body shape.

President/Publisher President/Publisher

Charles Porter Amanda Gerrard

Editor Tina White Art Director

Naturally does it Considering complimentary or even alternative therapies? Here’s some tried and tested low risk options.

Marlon Ruddock

Finance Hayley Crossman Oliver Hall Advertising Sales Account Managers Suzanne Gardiner Stuart McKenzie James Pashley For all advertising enquiries call (866) 368 0001 CHANGES™ magazine is owned and published by Affinity Magazines. www.changesmagazine.org ©2010 Affinity Magazines 305 Madison Ave, Suite 449, New York, NY 10165 Phone: (866) 368-0001 Fax: (866) 566-0002 www.affinitymagazines.com ©Affinity Magazines 2010. All rights reserved. No part of this publication may be reproduced without prior written permission from Affinity Magazines. Affinity Magazines does not endorse or make any representation or warranty, express or implied, with respect to any of the products or services advertised herein, including but not limited to any warranty of merchantability or fitness for any particular purpose. We recommend that you independently evaluate all products and services before purchasing. The appearance of advertising in this publication does not constitute a guarantee or endorsement of the advertised product or service by Affinity Magazines. Not all advertised products are required to meet rigorous scientific standards set by the U.S. Food and Drug Administration for over-the-counter and prescription medication. If you have any questions about a product advertised in this magazine, ask your clinician for more information.

menopause & health 05

Research Round-up

Dear Changes

The latest menopause related news and tips for a healthier, happier you.

Your most frequently asked menopause questions answered.

menopause Symptoms 24

Feeling Flushed

Hot flashes and night sweats getting you down? Here’s some good advice.

In The Pink

Heart Beat

Healthy Bodies Healthy Minds

Breast health is more important now than ever before. Changes experts guide you through.

Often ignored until it is too late your heart health must be a priority now.

Soothing advice on how to get a good nights sleep.

Rest Assured

Seeing is believing

How to manage those worrying changes to your eyesight.

Now is the time to indulge in some extra TLC to your skin. Great results that really show.

postmenopausal Health

Shine On

Act now to prevent bone deterioration and avoid osteoporosis.

In Control

diet & Exercise

Take control of bladder weakness - it is possible.

Light Your Fire

Losing it

How to win the battle with an ever increasing waistline.

Loss of libido is common around menopause - but this needn’t be the case.

menopause & health

Research Round-up Here’s the latest news for a healthier, happier you.

Walkies!

For middle aged women the key to happiness could be as simple as a walk in the park. According to a recent US study brisk walking can help not just physical health but mental health too. “You don’t need to run 20 miles a week to reap the benefits of exercise”. Says Dr Nelson who headed the study, “If you stick to a moderate-paced walking schedule it can keep your weight down and lower the risk of stress anxiety and depression.” The study followed 380 women over 40 years old and found over an eight year period that the more active the women were the greater the benefits. High levels of activity were particularly beneficial to postmenopausal women. Walking five times a week for up to 60 minutes improved emotional well-being and helped women to handle the stresses of every day life. However there was little benefit for the lower activity group who only walked for 15 minutes a day five times a week. The official recommendation for maximum bebefits is 30 minutes a day five times a week, so perhaps less is more. Either way our advice is get those walking shoes on and just do as much as you possibly can.

The happiness hit Want an instant happiness hit? Force yourself to laugh. Even if it feels insincere at first, it’ll trigger a cascade of feel-good hormones in your body, and it blitzes calories. If you can’t pluck up the courage to sit alone laughing then make a date to meet with friends or family with the intention of having a really good chortle. A 15 minute daily giggle burns enough fat to lose 4lb over the course of a year. And that's not all, surrounding yourself with a group of good friends or family could also help you live longer. According to studies of centenariens in Japan and here in the US. Having strong support networks, managing stress and keeping active are the key to a long life.

A chocolate a day keeps the blues away

Italian Urologists at San Rafaelle hospital in Milan can confirm that small amounts of chocolate can help boost our spirits and as those cheeky Italians should know boost our sex lives as well. Researchers found that women who had a daily intake of chocolate showed higher levels of desire than those who did not. Its thought that chocolate helps to release the feel-good hormones associated with being in love. Remember though girls its quality not quantity that counts so choose brands with a 70% cocoa content and enjoy a guilt free treat.

In Transition

Life is full of changes, some good, some bad and menopause is no exception. But what most women agree on is that the menopause transition marks a beginning

not an ending.

ntering the menopause transition may seem like a daunting prospect for most women–particularly in a society that places far too much value on youth and fertility. Traditionally menopause is also associated with a raft of unpleasant symptoms, but hay these symptoms can be managed and what most women say about living in their fifties is that life is great, they feel a sense of empowerment and freedom from the shackles of family responsibilities. In fact, 51 percent of women said they felt the most empowered and fulfilled just after they reached menopause. So why are the years beyond menopause such an invigorating time? In some ways, it’s the quiet after the storm. Crying babies who became turbulent teens have left the nest. Cracks in longtime marriages have healed or women have broken their spousal shackles to enjoy freedom again. After years of hard work, some have reached the pinnacle of their professions. Trying perimenopausal times of raging hormones and sleepless, bed-drenched nights–are dwindling. “We’ve earned the right to be wise women; we’ve been there, done that,” says Ann Louise Gittleman, Ph.D, and

author of the book, ‘Hot Times’. Reveling in her “second adolescence,” Gittleman is reinventing herself with a distinct advantage. “I know myself, have selfconfidence, and am much more in tune with the courage of my convictions,” she says. “I’m not afraid to say, speak, or write what I perceive as the truth. I wouldn’t go back to 25. I’m happier at 55. It’s enthralling and invigorating.”

Taking Care of Yourself Leil Lowndes, 64, a New York City professional speaker, also found a new persona after 50. “Before, I identified with my children. Once they were gone, I discovered a new person–myself. I think you learn to love yourself because with each daily decision you’ve created yourself.” She also makes sure to pamper her new self. “My machine isn’t as well oiled as it once was, so now I’m taking more care of myself,” she says. “I exercise more and I see the benefits so much more than when I was younger.” Indeed, a survey conducted by the North American Menopause Society found that many recently postmenopausal women start taking care of their health for the first time: exercising, eating healthy foods, quitting smoking, and more closely

monitoring medical conditions. “Preventative care is important for all our lives but, unfortunately, many of us don’t think seriously about it until midlife, when the end is in sight,”says Leon Speroff, M.D., an obstetrics/gynecology professor at Portland’s Oregon Health and Science University. “The most important thing is making the decision: ‘I’m going to take charge of my life and do all the things that will make it better, and I’m going to enjoy my remaining years.’” This was certainly true for 52-year-old Jennifer Shepherd, a receptionist from St. Cloud, Minn. Shepherd always felt that because she was active, she was not at risk from osteoporosis, but although she was fit, she neglected her diet. “I was always on the run so I grabbed food where I could. When I learned that I had osteoporosis, it was a real shock–I was worried I wouldn’t be able to exercise anymore, but it just meant I had to reassess what my body could and could not do. I took up yoga, and it was a whole new discipline. I was still working my muscles and building strength, but I was also learning to slow down and focus on my breathing. I’m a lot more centred now, and I genuinely feel like the woman I would have wanted to be when I was 20!”

menopause & health

Symptoms of the menopause transition The most common symptoms of the menopause transition are:

»»Irregular periods (unless surgical menopause)

»»Hot flashes »»Vaginal dryness »»Mood swings »»Insomnia

(from hot flashes)

»»Irritability

(from insomnia)

menopause & health

The Stages

of Menopause Perimenopause

Am I or Aren’t I? So how do we know when we’re transitioning into menopause? For many women, there are no clear signs that they are experiencing menopause, or perimenopause–the stage before a woman’s periods stop–which can last from a few months to several years. While some women go straight from experiencing regular periods to having no periods at all, for others, menstrual irregularity of all varieties can occur. So, knowing whether you’re entering perimenopause or not isn’t always straightforward. Jessie Morgan, a photographer from Augusta, Maine, usually put her irregular periods down to stress. “Whether I was traveling, working to tight deadlines, or suffering from a viral infection, the first thing to go would be my menstrual cycle,” she says. “I don’t think it’s ever been regular.” So when Morgan’s periods stopped in her late 40s, she didn’t think much about it. “It wasn’t until I started getting hot flashes that I realized I was entering menopause.”

invalid if you’re using hormone therapy, including oral contraceptives. Self tests work by measuring urine FSH levels, usually at least twice over a period of time. A urine sample is checked against a test panel, and menopause is supposedly indicated when all results indicate high FSH. But the tests, which cost about $20, can be inconclusive. Unlike a pregnancy test, which provides a simple“yes”or“no”answer, the question of perimenopause isn’t quite so simple. Felicia Cosman, M.D., director of Helen Hayes Hospital in West Haverstraw, N.Y., says. “During perimenopause, any FSH test can only give you a snapshot of your hormone level on that particular day, information that may not be very useful.” This is because hormone levels can fluctuate wildly during perimenopause. Self tests try to compensate for this by requiring two or three tests at various intervals. You also may ask your healthcare provider about getting an FSH blood test, but it, too, may be unreliable.

Tracking Your Periods Home Tests If you’d like to know your menopause status, home testing kits aim to give you some indication. These tests measure urine levels of follicle-stimulating hormone (FSH), a hormone made by the pituitary gland in the brain, which increases as estrogen levels drop. They won’t work for everyone, though: they’re

Traditionally, you are considered to have reached menopause after 12 months without any periods. However, for some women, this method is not sufficient. Oral contraceptives often extend periods beyond menopause. And, if you had your uterus removed, you’ll no longer have periods, even when your ovaries continue their monthly hormonal ups and downs.

Physical signs of menopause begin many years before the final menstrual period. This menopause transition phase is called perimenopause and is mainly identified by menstrual irregularity. It can last for several years, usually beginning when a woman is in her mid forties. The median age is actually 47.5 and for most women lasts for four years.

Menopause Menopause is the permanent end of menstruation and fertility. It is a normal, natural event, usually confirmed when a woman has not had a menstrual period for 12 consecutive months. The average age of menopause is 51.

Postmenopause Postmenopause refers to all the years beyond menopause, whether induced or natural menopause.

Your Best Bet? Pay attention to your body and your symptoms. Use a home test kit if you want, but if you’re in your 40s and having night sweats and hot flashes, skipping periods or having them more often, or find that your flow is lighter or heavier, you’re probably in perimenopause. The important thing is not to try to guess. Discuss your symptoms with a knowledgeable healthcare provider to assess your personal situation.

Naturally

does it

Many women look to alternative or complimentary approaches to fight the uncomfortable symptoms of menopause and find great relief. Here are some low risk lifestyle and herbal therapies to consider.

or Mary Levering, now 65, the hot flashes and sleep deprivation of perimenopause sent her spiraling into a depression. She tried hormone therapy but quit pretty quickly because of side effects. Instead of more drugs, the Chevy Chase, Md., attorney turned to Ayurveda, a 5,000-year-old Eastern healing tradition that relies on herbs, nutrition, exercise, and other alternative approaches to maintain health. “The depression lifted, and it’s never come back,” says Levering, who began taking various herbal mixtures, following a special vegetarian diet, and doing yoga about five years ago, when her menopausal symptoms were at their worst. “I’m sleeping fine. I lost the weight. I don’t even remember having a hot flash at all after I started my Ayurvedic lifestyle.” Not all women who try complementary and alternative medicine (CAM) approaches to treat their menopausal symptoms have such success. But more women are giving alternative approaches a try than ever before. And what was once called “CAM” in some cases is being evaluated and then embraced by mainstream medicine. The Study of Women’s Health Across

the Nation, or SWAN, surveyed menopausal women in 2003 and found that about half had tried at least one CAM therapy in the past year. However, included in their definition of CAM therapy were therapies such as vitamin/mineral supplements; a therapy that is probably considered mainstream by many. “The first thing I say to women is they need to look at why they’re avoiding hormones and whether they understand what the real risks and benefits are,’’ says Alan Altman, M.D., an assistant clinical professor of obstetrics, gynecology, and reproductive biology at Harvard Medical School. “Too many women avoid hormone therapy because they’re worried about long-term risks that may not apply to them,” he says. “Estrogen therapy (with or without progestogen) remains the most effective treatment for hot flashes and other menopausal symptoms. Alternative approaches just don’t seem to work for those with the most severe symptoms,” he warns. Still, for those who want or need to avoid hormones, alternative approaches may help, says Machelle Seibel, M.D., a professor of obstetrics and gynecology

at the University of Massachusetts in Worcester. “Just be realistic about your expectations,” she says. “For instance, alternative therapies may not completely eliminate symptoms, and they may take several weeks to begin working.” “Sometimes alternative remedies that help don’t make things perfect, but they improve things enough so the symptoms can be tolerated,’’ Seibel says. “You can’t promise the moon, but you can promise to work with women to see what’s out there, then they can make an informed choice.”

Looking at Other Options After four months, Jane Ibbs, 53, from Silver Spring, Md., decided that the side effects of her combined estrogen-progestogen therapy, particularly the headaches and nausea, were enough to motivate her to seek alternative treatments. “Even after dosage regulation and switching to a skin patch, I still felt nauseous, and the daily headaches didn’t stop.” Her first priority was “to look for something to help with the hot flashes.” CAM includes a diverse group of practices and products not currently used in conventional medicine. Complementary medicine is used with traditional medicine, while alternative

menopause & health

medicine is used in place of it. “A good place to start is with treatments that don’t require you to take anything internally,” says Tieraona Low Dog, M.D., director of the Fellowship for the Program in Integrative Medicine at the University of Arizona School of Medicine in Tucson, “because they are far less likely to cause side effects.” Mary Levering believes that herbal products should only be used as a single component in a holistic approach to treating menopause, not on their own. Through Ayurveda, she notes, she’s overhauled her entire lifestyle, adopting a vegetarian diet, regular massage, and yoga sessions—all of which work together. “My body works about a hundred times better than it ever did,’’ she says. “I sleep better and my energy’s back. I’m going to have a healthier old age because of Ayurveda and yoga.” And Jane Ibbs is still searching for the “wonder cure.” Although she is very positive about the improvements she has experienced through her use of soy products and a black cohosh supplement, she does still experience the odd hot flash. “I try to avoid hot flash situations. I have tried to reduce stress in my life by working fewer hours, and I do follow a sensible diet—avoiding alcohol and spicy foods as well as aiming toward a heart-healthy diet. I believe that if I incorporate many positive lifestyle changes that will reduce my symptoms, and if things continue to improve, I’ll never need to go back to prescription hormone therapy.”

Dear Vicki, Life is good here. I'm sleeping through the night, my hot flashes h ave cooled, a nd my moods have stopped swinging. Thanks for t he tip on Es troven. What a diff erence. Well, gotta g o to yoga cla you soon. ss. See

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Love, Margie

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In the vitamin section

menopause & health

Low-risk Options Some common forms of CAM therapy include the following low-risk options. Acupuncture. Some small studies have found that acupuncture decreased the severity and frequency of hot flashes by as much as half. Further studies, funded by the National Center for Complementary and Alternative Medicine, are currently underway. Massage. Although studies are inconclusive many women reoprt the thereputic benefits of massge during the menopause transition. Deep tissue relaxation and the trained use of pressure points can relieve symptoms such as anxiety, insomnia and depression. Therapists who perform massage often choose to specialise in a certain area of women’s health such as massage for menopause. These therapists will pay attention to the lower back areas of menopausal women as well as their abdomen. They may add in aromatherapy treatments with oils that are known to provide benefits to women’s health during menopause.

Meditation. Although research is sketchy meditation is believed to be helpful in calming both the physiological and psychological impacts of the menopause and can help one to come to a better acceptance of such a big life change, both on its own and in conjunction with other treatments and lifestyle changes. Yoga. The benefits of yoga are well documented and reported by perimenopausal and postmenopausal women. Reputable and well established yoga classes can be found fairly easily and women seem to reap positive benefits. Studies tend to conclusively suggest that regular and well planned yoga sessions do have a positive impact on the direct and indirect symptoms associated with menopause from hot flashes to mood swings. One study of 164 sedentary women by Pennsylvania State University found that after just 4 months of participating in a regular program of yoga and walking experience physical, emotional and sexual benefits during menopausal years. All women had previously reported

menopausal symptoms such as hot flashes and night sweats. Women doing yoga and walking described “higher levels of general happiness” than those who remained sedentary, including feelings of better emotional and sexual health.“ Pilates. The type of physical training that pilates demands can be especially beneficial for women approaching menopause, since it not only helps to maintain strength for everyday activities, it improves core strength and helps women maintain a healthy weight when combined with a healthy diet. With a strong emphasis on core, pelvic and back strength pilates can offer help with many symptoms such as back pain, urinary incontinence and stave off bone loss. In postmenopausal women pilates has been reported to help maintain enough strength and mobility to be able to perform daily activities easily and more safely. Building inner core strength through pilates can also help protect the back, hips, knees and other joints, as well as correct the upper back.

Herbal and Nutritional Remedies While most non-supplement approaches are relatively safe, Low Dog notes that there is a somewhat greater risk when it comes to herbal products, particularly those sold over-the-counter as supplements versus herbal teas and other mixtures individually prepared from plants by a trained herbalist. If they are strong enough to potentially help your symptoms, she says, supplements are also strong enough to cause side effects. But we may not know what the risks are because, in this country, herbal supplements are not required to undergo testing for effectiveness, safety, proper dose, or purity like prescription drugs. Thus, says Altman, there’s no guarantee you’re getting what the label promises. For instance, supplements may be contaminated with harmful ingredients that aren’t listed on the label. “Buying an over-the-counter herbal supplement is a shot in the dark,” he says. He prefers to refer his patients to a reputable herbalist. The practitioner should take a medical history to make an informed recommendation on what herbs to try and in what doses, Altman says. “That’s better than relying on the advice of a health food store clerk.” Many of today’s herbal supplements are highly concentrated and much stronger than the original herbal teas,

The

PlaceboEffect When researchers study products for the treatment of menopausal symptoms, most studies find over 30 percent of women improve even when they’re given a pill with no active ingredients in it. This is the placebo effect. Just thinking that you’re receiving the treatment, whether or not you actually do, seems to improve symptoms in many people. In well-designed clinical trials, researchers compare the real treatment to a placebo so they can tell whether the treatment really worked, or whether the benefit it produced was due to the placebo effect. Not that the placebo effect is necessarily a bad thing. “So they get better with a placebo, so what?” says Machelle Seibel, M.D., a professor of obstetrics and gynecology at the University of Massachusetts in Worcester. “What does it matter if 30 percent (of women) are seeing improvement in hot flashes?”’ For instance, Seibel says, many women who add soy foods to their diets and claim their hot flashes improved may be experiencing a placebo effect rather than a real benefit from the soy. But if they feel better and that improves their quality of life, why worry so long as the treatment is safe?

says Low Dog. Don’t assume that an over-the-counter product is safe just because it’s based on thousands of years of tradition—it could have many times the recommended dosage, she warns.

What Do We Know About Herbal Supplements? When it comes to herbal supplements for relieving menopause symptoms,

the quality of evidence is fairly weak, says Low Dog. However, the National Institutes of Health has funded studies of black cohosh, red clover, and soy for the treatment of menopause symptoms. Here’s what we know about common remedies. As all of the therapies listed can cause side effects and most interact with medications, make sure your clinician agrees that it’s safe for you to try them.

menopause & health

Black cohosh. This herb appears to be the most promising for relieving hot flashes, although the results are not conclusive, says Low Dog. A 2002 review of existing evidence found that three of the four reviewed trials showed a potential benefit with mild hot flashes. Only mild side effects have been noted. However, more research is needed before this herb can be strongly recommended, particularly for long-term use. There are more studies showing the effects of black cohosh in progress. Soy. Consuming isoflavones, weak estrogen-like compounds most commonly found in soy foods, has been found in some studies to reduce mild hot flashes by 15 percent, but many other studies show no effect at all. Eating one or two servings of soy foods daily may bring greater benefit than soy supplement pills. Diets high in soy are considered safe, Low Dog notes, but supplements that provide highly concentrated doses of isoflavones are more questionable. Red clover, evening primrose oil, vitamin E, wild yam, dong quai. Studies are unconclusive on the benefits of these supplements in relieving menopause symptoms, notes Low Dog. St. Johnâ&#x20AC;&#x2122;s wort. This supplement may be helpful for women who are experiencing some mood problems along with menopause symptoms, says Low Dog, with several studies documenting efficacy for relieving mild depression. Side effects include gastrointestinal upset, fatigue, and increased sensitivity to sunlight. Users should avoid sun exposure. The herb should not be taken with psychotropic medications and may decrease the activity of blood-thinners and other prescription medication.

The

Facts The following resources offer information on quality herbal products: U.S. Pharmacopeia This nonprofit company sets quality standards and verifies compliance for supplement makers. www.usp.org/ USPVerified/ The National Sanitation Foundation An independent nonprofit that tests supplements to make sure they contain what they promise www.nsf.org Consumer Lab Unbiased testing information for better quality health and nutritional products. www.consumerlab.com

Hormone Therapy?

That is the Question! Why suffer the sometimes unbearable symptoms associated with perimenopause when a Rx of carefully monitored therapy can make

all the difference?

arilyn Joseph, a 59-yearold graphic designer from Portland, Ore., has strong memories of the turbulent years surrounding menopause. “Although the hot flashes were unpleasant, they were, at least, predictable, unlike my emotions, which were all over the place,” she says. When her doctor prescribed oral estrogen therapy, Joseph thought she had a solution. “It was fantastic. I was back to the premenopause me–levelheaded, reliable, and capable of watching a movie without bursting into tears every five minutes.” However, within a few months, Joseph started to experience irregular uterine bleeding. In retrospect, she says, “Hormone therapy suits some women, but I had to accept that I wasn’t one of them.” Joseph eventually managed to reduce her symptoms with herbal medicine, but it took a lot of trial and error, and maybe it was just the passage of time. Like Joseph, not all women are convinced that the benefits of hormone therapy outweigh the risks. Indeed, many women are decidedly cautious–partly due to the well-publicized results of the Women’s Health Initiative (WHI), a

federally funded study of the effects of the most common form of oral hormone therapy used by postmenopausal women in the United States. The WHI’s goal was to see if most postmenopausal women should use hormone therapy (HT) to prevent heart disease. The findings were surprising. One part of the study, which included 16,608 healthy postmenopausal women aged 50 to 79 who still had their uterus, found a small increased risk of heart attack, blood clots, stroke, and breast cancer in those taking oral Prempro®, an estrogen/progestogen form of hormone therapy (EPT). A second arm, studying 10,739 older women who had had hysterectomies, found an increased risk of stroke in those taking oral Premarin®, estrogen-only therapy (ET). In the aftermath of the findings, millions of women quit using hormone therapy. The FDA directed that estrogen products approved for hormone therapy needed to state in their prescribing information that hormones should be used for the shortest possible time and the lowest possible dose. The North American Menopause Society (NAMS) has published a series of position papers on hormone use. They conclude, “current evidence supports the

use of ET and EPT for menopause related symptoms and disease prevention in appropriate populations … of women.” Basically, hormone therapy continues to be prescribed because nothing seems to work as well for moderate to severe hot flashes, night sweats, sleep disturbances, and vaginal changes associated with menopause. “Hormone therapy is the drug of choice for these symptoms,” says Wulf H. Utian, M.D, Ph.D., NAMS executive director and a menopause researcher. “With the information that we have, it’s a remarkably safe approach.” The WHI also confirmed that hormone therapy helps prevent osteoporosis and bone fractures and may have a positive effect on other conditions, such as colon cancer risk. “Because the WHI findings were based on older (average age 63), postmenopausal women with

menopause & health

What Does The Women’s Health Initiative (WHI) Study Mean for Hormones? The WHI was the largest

scientific research trial ever conducted using the most widely prescribed hormone therapy. Initially, it was an inquiry into whether estrogen, with or without added progestogen, had a cardiovascular benefit in postmenopausal women. The participants were healthy postmenopausal women with an average age of 63. It studied women who used estrogenprogestogen therapy (EPT) consisting of Prempro®, a pill combination of an estrogen (conjugated estrogens) and a progestin (MPA), as well as women who had had a hysterectomy and who used estrogen therapy (ET) alone, consisting of just an estrogen pill (Premarin®). In 2002, the EPT part of the study was halted early when analysis found a small increased risk of developing breast cancer, blood clots, and stroke. In 2004, the ET part of the study ended because of increased risk of stroke. Neither part showed any reduction in coronary heart disease risk, as the study hoped to prove. Both EPT and ET were found to reduce risk of fractures from osteoporosis, while EPT reduced colon cancer risk. The data gathered during WHI continues to be studied and reported upon.

minimal symptoms, it’s unclear what the results mean for younger women whose symptoms are more severe,” says Utian. A re-analysis of the WHI study data found reduced mortality rates where women were younger than 60, but no change for women over 60. Further research is needed to determine the difference in the way women of differing ages respond to hormone therapy. The suggestions are clear: use of hormone therapy should be examined on an individual basis, taking into account age, symptoms, and risk factors. “The risks are very small,” says Susan Hendrix, D.O., a professor of obstetrics and gynecology at Wayne State University School of Medicine in Detroit and a principal investigator in the WHI. “But they’re real risks. They’re life-altering events (stroke, heart attack, breast cancer), and they can be serious.” The hormones studied in the WHI were

oral therapies providing “systemic” levels of hormones throughout all the body’s systems. These medications are proven to be effective for treating most menopause symptoms, including hot flashes and vaginal dryness. However, if vaginal dryness is the only reason for considering hormone therapy, local estrogen therapy applied inside the vagina is the best choice. Nothing else works as well–and risks are thought to be minimal.

A Personal Decision The decision to use hormone therapy, to try an alternative, or to simply adopt a healthy lifestyle and wait out menopause symptoms with no treatment, is highly personal. Each woman needs–and deserves–individualized care, not a blanket one-size-fits-all prescription. Although healthcare providers continue to learn more about the effects of hormone therapy on groups of women,

EVOLUTION OF ESTROGEN THERAPY 1960s 1970s

1990s

Today

A Modern Solution to Managing Menopause: Gel Today there’s EstroGel for managing your hot flashes; night sweats; and vaginal dryness, itching, and burning with a low dose of estrogen.1 • Plant based and bio-identical to the estrogen your body makes naturally1-3 • FDA approved; manufactured under stringent FDA specifications to meet consistent quality standards • Unlike oral therapies, it is delivered directly to your bloodstream without first going through the liver4 – Can be administered at a lower dose than estrogen pills4

• Unlike a patch, it has no adhesive • Easy to use, easy to apply, and fits comfortably into active women’s lives Talk with your doctor today about a prescription for EstroGel, the #1 estrogen-only product in Europe.2 Visit our web site for money-saving coupons.

www.estrogel.com

Please see Patient Information and boxed warning on the following page. WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT EstroGel (AN ESTROGEN HORMONE)? Estrogens increase the chance of getting cancer of the uterus (womb). Do not start using EstroGel if you have unusual vaginal bleeding, currently Report any unusual vaginal bleeding right away while you are using EstroGel. have or have had certain cancers, had a stroke or heart attack in the past Vaginal bleeding after menopause may be a warning sign of cancer of the year, currently have or have had blood clots, currently have or have had liver uterus (womb). Your healthcare provider should check any unusual vaginal problems, are allergic to EstroGel or any of its ingredients, or think you may be pregnant. bleeding to find the cause. Do not use estrogens with or without progestins to prevent heart disease, heart attacks, strokes, or dementia. Using estrogens with or without progestins may increase your chance of getting heart attacks, strokes, breast cancer, and blood clots. Using estrogens, with or without progestins, may increase your risk of dementia, based on a study of women age 65 or older.

Common side effects of estrogens include headache, breast pain, irregular vaginal bleeding or spotting, stomach/abdominal cramps, bloating, nausea, vomiting, hair loss, fluid retention, and vaginal yeast infection. You and your healthcare provider should talk regularly about whether you still need treatment with EstroGel. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

REFERENCES: 1. EstroGel 0.06% [package insert]. Herndon, VA: ASCEND Therapeutics, Inc; 2008. 2. Data on file, ASCEND Therapeutics, Inc. 3. Boothby LA, Doering PL, Kipersztok S. Bioidentical hormone therapy: a review. Menopause. 2004;11:356-367. 4. Powers MS, Schenkel L, Darley PE, Good WR, Balestra JC, Place VA. Pharmacokinetics and pharmacodynamics of transdermal dosage forms of 17ß-estradiol: comparison with conventional oral estrogens used for hormone replacement. Am J Obstet Gynecol. 1985;152:1099-1106.

PATIENT INFORMATION (updated 2008)

only

Read this PATIENT INFORMATION before you start using EstroGel, and read the patient information each time you refill your EstroGel prescription. There may be new information. This information does not take the place of talking to your healthcare provider about your menopausal symptoms and their treatment. WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT EstroGel (AN ESTROGEN HORMONE)? • Estrogens increase the chance of getting cancer of the uterus. Report any unusual vaginal bleeding right away while you are using EstroGel. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find the cause. • Do not use estrogens with or without progestins to prevent heart disease, heart attacks, strokes or dementia. Using estrogens, with or without progestins, may increase your chance of getting heart attacks, strokes, breast cancer, and blood clots. Using estrogens, with or without progestins, may increase your risk of dementia, based on a study of women age 65 or older. You and your healthcare provider should talk regularly about whether you still need treatment with EstroGel. What is EstroGel? EstroGel is a clear, colorless gel medicine that contains estradiol (an estrogen hormone) which is absorbed through the skin into the bloodstream. How is EstroGel used? EstroGel is used after menopause to: • Reduce moderate to severe hot flashes Estrogens are hormones made by a woman’s ovaries. The ovaries normally stop making estrogens when a woman is between 45 and 55 years old. This drop in body estrogen levels causes the “change of life” or menopause (the end of monthly menstrual periods). Sometimes, both ovaries are removed during an operation before natural menopause takes place. The sudden drop in estrogen levels causes “surgical menopause.” When the estrogen levels begin dropping, some women have very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest, or sudden intense episodes of heat and sweating (“hot flashes” or “hot flushes”). In some women, the symptoms are mild, and they will not need estrogen treatment. In other women, symptoms can be more severe. You and your healthcare provider should talk regularly about whether you still need treatment with EstroGel. • Treat moderate to severe dryness, itching, and burning in or around your vagina You and your healthcare provider should talk regularly about whether you still need treatment with EstroGel to control these problems. If you use EstroGel only to treat your dryness, itching, and burning in and around your vagina, talk with your healthcare provider about whether a topical vaginal product would be better for you. Who should not use EstroGel? Do not start using EstroGel if you: • Have unusual vaginal bleeding • Currently have or have had certain cancers Estrogens may increase the chance of getting certain types of cancer, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should use EstroGel. • Had a stroke or heart attack in the past year • Currently have or have had blood clots • Currently have or have had liver problems • Are allergic to EstroGel or any of its ingredients See the list of ingredients in EstroGel at the end of this leaflet. • Think you may be pregnant Tell your healthcare provider: • If you are breastfeeding The hormone in EstroGel can pass into your breast milk. • About all of your medical problems Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), migraine, endometriosis, lupus, or problems with your heart, liver, thyroid, kidneys, or high calcium levels in your blood. • About all the medicines you take This includes prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how EstroGel works. EstroGel may also affect how your other medicines work. • If you are going to have surgery or will be on bedrest You may need to stop taking estrogens. How should I use EstroGel? EstroGel is available in a metered-dose pump that delivers a measured amount of estradiol to the skin each time the pump is depressed. It is important that you read and follow these directions on how to use the EstroGel pump properly. 1. Before using the pump for the first time, it must be primed. Remove the large pump cover, and fully depress the pump twice for the 93-gram pump or 3 times for the 50-gram pump and the 25-gram pump. Discard the unused gel by thoroughly rinsing down the sink or placing it in the household trash. After priming, the pump is ready to use, and 1 complete pump depression will dispense the same amount of EstroGel each time. 2. Apply EstroGel at the same time each day. You should apply your daily dose of gel to clean, dry, unbroken skin. If you take a bath or shower or use a sauna, apply your EstroGel dose after your bath, shower, or sauna. If you go swimming, try to leave as much time as possible between applying your EstroGel dose and going swimming. 3. Be sure your skin is completely dry before applying EstroGel. 4. To apply the dose, collect the gel into the palm of your hand by pressing the pump firmly and fully once, as illustrated. 5. Apply the gel to the skin of one arm using your hand. Spread the gel as thinly as possible over the entire area on the inside and outside of your arm from wrist to shoulder, as illustrated. 6. Always place the small protective cap back on the tip of the pump and the large pump cover over the top of the pump after each use.

7. Wash your hands with soap and water after applying the gel to reduce the chance that the medicine will spread from your hands to other people. 8. It is not necessary to massage or rub in EstroGel. Simply allow the gel to dry for up to 5 minutes before dressing. 9. Alcohol-based gels are flammable. Avoid fire, flame or smoking until the gel has dried. 10. Once dry, EstroGel is odorless. 11. Never apply EstroGel directly to the breast. Do not allow others to apply the gel for you. 12. The EstroGel 93-gram pump contains enough medicine to allow for initial priming of the pump twice and delivery of 64 daily doses. After you have initially primed the pump twice and dispensed 64 doses, you will need to discard the pump. 13. The EstroGel 50-gram pump contains enough medicine to allow for initial priming of the pump 3 times and delivery of 32 daily doses. After you have initially primed the pump 3 times and dispensed 32 doses, you will need to discard the pump. 14. The EstroGel 25-gram pump contains enough medicine to allow for initial priming of the pump 3 times and delivery of 14 daily doses. After you have initially primed the pump 3 times and dispensed 14 doses, you will need to discard the pump. What should I do if someone else is exposed to EstroGel? If someone else is exposed to EstroGel by direct contact with the gel, that person should wash the area of contact with soap and water as soon as possible. The longer the gel is in contact with the skin before washing, the greater the chance that the other person will absorb some of the estrogen hormone. This is especially important for men and children. What should I do if I get EstroGel in my eyes? If you get EstroGel in your eyes, rinse your eyes right away with warm, clean water to flush out any gel. Seek medical attention if needed. What should I do if I miss a dose? If you miss a dose, do not double the dose on the next day to catch up. If your next dose is less than 12 hours away, it is best just to wait and apply your normal dose the next day. If it is more than 12 hours until the next dose, apply the dose you missed, and resume your normal dosing the next day. What should I avoid while using EstroGel? It is important that you do not spread the medicine to others, especially men and children. Be sure to wash your hands after applying EstroGel. Do not allow others to make contact with the area of skin where you applied the gel for at least 1 hour after application. Alcohol-based gels are flammable. Avoid fire, flame or smoking until the gel has dried. What are the possible side effects of estrogens? Side effects are grouped by how serious they are and how often they happen when you are treated. Serious but less common side effects include: • Breast cancer • Gallbladder disease • Cancer of the uterus • Ovarian cancer • Stroke • High blood pressure • Heart attack • Liver problems • Blood clots • High blood sugar • Dementia • Enlargement of benign tumors of the uterus (“fibroids”) Some of the warning signs of these serious side effects include: • Breast lumps • Shortness of breath • Unusual vaginal bleeding • Pains in your legs • Dizziness and faintness • Changes in vision • Changes in speech • Vomiting • Severe headaches • Yellowing of the skin, eyes or nail beds • Chest pain Call your healthcare provider right away if you have any of these warning signs or any other unusual symptoms that concern you. Less serious but common side effects include: • Headache • Nausea and vomiting • Breast pain • Hair loss • Irregular vaginal bleeding or spotting • Fluid retention • Stomach/abdominal cramps, bloating • Vaginal yeast infection These are not all of the possible adverse events of EstroGel. For more information, ask your healthcare provider or pharmacist. What can I do to lower my chances of having an adverse event with EstroGel? • Talk with your healthcare provider regularly about whether you should continue using EstroGel. • If you have a uterus, talk with your healthcare provider about whether the addition of a progestin (a different prescribed hormone) is right for you. The addition of a progestin is generally recommended for women with a uterus to reduce the chance of getting cancer of the uterus. • See your healthcare provider right away if you get vaginal bleeding while using EstroGel. • Have a pelvic exam, breast exam and mammogram (breast x-ray) every year unless your healthcare provider tells you otherwise. If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram, you may need to have breast exams more often. • If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances of getting heart disease. Ask your healthcare provider for ways to lower your chances of getting heart disease. General information about the safe and effective use of EstroGel Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use EstroGel for conditions for which it was not prescribed. Do not give EstroGel to other people, even if they have the same symptoms you have. It may harm them. Keep EstroGel out of the reach of children. This leaflet provides a summary of the most important information about EstroGel. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about EstroGel that is written for health professionals. You can get more information by calling the toll-free number, 1-877-204-1013. What are the ingredients in EstroGel? EstroGel contains estradiol (an estrogen hormone), purified water, alcohol, triethanolamine, and carbomer 934P. EstroGel should be stored with the cap on securely. Do not freeze. The gel should not be used after the date printed on the end of the metered-dose pump after the term “Exp.” (expiration date). Manufactured for: ASCEND Therapeutics, Inc. Herndon, VA 20170 By Laboratoires Besins International Montrouge, France 5000718 E01306 Utilizes EHGTM Technology ©2008 ASCEND Therapeutics, Inc.

menopause & health

When you shouldn’t take HT »»If you are experiencing undiagnosed, abnormal genital bleeding »»If you have or suspect you have breast cancer »»If you have or suspect you have any estrogendependent neoplasia (benign or cancerous growths)

»»If you have a history of blood clots in your legs (deep vein thrombosis) or lungs (pulmonary embolism)

»»If you have had a stroke or heart attack in the past year »»If you suffer from liver dysfunction »»If you may be pregnant »»If you have a known hypersensitivity to HT

they will never know the complete impact for each individual. What’s important is that you make your decision fully aware of what is known about any potential consequences and what is uncertain. “What you choose should be based upon your health, symptoms, lifestyle concerns, and discussions with your healthcare provider about the pros and cons, as they apply to you,” says Marcie K. Richardson, M.D., director of the Harvard Vanguard Menopause Consultation Service in Boston. “I say to women, ‘These are what the benefits might be. These are what the harms might be. How scary are these harms to you? How important are these benefits?’ If the potential benefits outweigh the potential harms, then a trial of hormone therapy–starting with a low dose–has very little downside for most women.” It’s worth remembering the effect of hormones on your bones. After menopause, without using systemic estrogen, bone strength falls off rapidly. Long-term estrogen therapy helps keep bones strong, but its associated risks limit its use for this purpose alone.

Time to End the Hormones? As you progress into menopause and your symptoms subside, reduce or stop hor-

mones as appropriate and in consultation with your healthcare provider. If symptoms persist, hormone therapy can be resumed. In Richardson’s practice, women had a wide range of experiences when they ended hormone therapy after WHI. “Some went off and didn’t notice much of a difference. Some went off and had horrendous symptoms.” Some even had worse symptoms after stopping the medication than when they first started taking it, she adds. Richardson advises her patients to taper off, although she admits there is few data on whether this limits symptoms. “If a woman doesn’t want to go back on estrogen, I try to help her find alternatives,” she says. “If someone’s symptoms are making her miserable, and she understands the potential risks, I help her go back on hormones, identifying the lowest dose that provides enough relief of symptoms to make her comfortable.” Hot flashes generally end eventually, usually a few years after menopause is reached, although sometimes they go on longer. Vaginal dryness can continue to worsen as women age. As you progress beyond menopause and your symptoms subside, it may be time to rethink your options–again.

Dear Changes…

Your Menopause Questions Answered Need advice on resources available to you for controlling menopausal symptoms? Here are some frequently asked questions about what options are available to you. What is the best way to relieve my typical symptoms of hot flashes and vaginal dryness, and if it’s estrogen, what dosage form is the best? Prescription estrogen therapy (ET)—as an oral tablet, skin patch, gel, mousse, spray, or lotion—remains the most effective treatment for hot flashes. When this type of “systemic” (circulated through the body) ET is chosen, women with a uterus must also use another prescription hormone, progestogen, to protect the uterus. This combined estrogen-progestogen therapy is called EPT. If hot flash relief from hormone therapy is the goal, systemic ET or EPT is best. ET in all dosage forms (oral tablets, skin products, and vaginal products) is also the most effective treatment for moderate to severe vaginal dryness. Vaginal forms of ET provide estrogen “locally” (not circulated through the body); in this case, progestogen may not be required. If vaginal symptoms are the only reason to consider hormone therapy, local vaginal ET is the most appropriate choice. Choices include vaginal creams (Estrace Vaginal Cream, Premarin Vaginal Cream), a vaginal ring (Estring), and a vaginal tablet (Vagifem). The newer vaginal ring (Femring) has both local and systemic effects.

menopause & health

Is hormone therapy for life? In the past, most women who started hormone therapy for relief of symptoms such as hot flashes and vaginal dryness stayed on hormone therapy for life. Although the time of symptoms may have passed, women liked the fact that using estrogen reduced their risk of fractures from osteoporosis. Newer research has resulted in a different practice for most women. Hormone therapy, even at the lowest dose, should always be used for the shortest duration possible consistent with treatment goals. A woman should eventually attempt to reduce or stop hormone therapy when appropriate for her, and always in consultation with her healthcare provider. If bothersome symptoms persist, hormone therapy can be resumed or other strategies can be tried. For the majority of women, a point will be reached when symptoms are gone for good, and hormone therapy can be stopped. Importantly, however, hormone therapy is an effective option for some women to use long-term to keep bones strong. Some women may decide to continue long-term hormone therapy for other potential or perceived benefits. The decision should be revisited regularly to reassess the risk/benefit ratio for each individual in light of her health and research advances.

I have a very similar body type to my sister, so why do we receive very different dosages of hormone therapy? Each woman experiences their menopausal transition in a unique way, and therapy needs can vary. Several factors to consider include the kind of therapy as well as the dose. These decisions will be based on finding a treatment that works while minimizing any associated risks. One way to lower potential risk with any type of drug treatment, including hormone therapy, is to use the lowest effective dose. Some clinicians start with a standard dose and adjust up or down as needed for symptom relief. Other clinicians start very low and go up when required. Today’s hormone therapies are available in very low doses to help with this approach. Research has shown that “lower than standard” doses of estrogen are almost as effective for symptom relief as standard doses. It is important to remember that one milligram of one type of estrogen doesn’t always equal one milligram of another in

its effects on the body. More oral estrogen is required, because much of it is lost as it passes through the gastrointestinal system and is broken down in the liver before it reaches the blood stream. Transdermal estrogen goes through the skin and right into the bloodstream. The best thing is to listen to your body and have your clinician monitor you and continuously reassess your options.

Remember: Every woman experiences menopause differently. Always discuss your options with a clinician.

Bioidentical Hormones What are bioidentical hormones, and what are their benefits? When scientists and healthcare providers talk about “bioidentical” hormones, they’re usually referring to products that are chemically identical to those produced by premenopausal women, such as 17 beta–estradiol or progesterone. Some bioidentical hormones made by drug companies are available in FDA-approved products. Bioidentical hormones are also available as customcompounded formulations, sometimes referred to as BHT (bioidentical hormone therapy), and are usually prepared at special compounding pharmacies. These individualized doses and combinations of hormones are based on a healthcare provider’s prescription. But compounded formulations have not been tested for effectiveness and safety, and custom-made prescriptions are not approved by the FDA. In fact, the FDA recently issued warning letters to many of these pharmacies forbidding them from making false and unsupported claims of effectiveness and safety of their BHT products. Further research is needed to establish the benefits and harms of BHT, as they have not been proven to be safer than FDA-approved hormones. And both the North American Menopause Society and the Endocrine Society have issued statements that there isn’t yet enough scientific evidence to support claims that there is an increased efficacy or safety of custom-compounded formulations, including BHT. It is recommended that before you decide to start BHT that you speak with a qualified healthcare provider to discuss your options.

flushed Feeling

menopause symptons

You know the feeling - that gradual feeling of warmth that turns to full on heat in almost an instant. You may think that there’s nothing to be done about these seemingly uncontrollable symptoms - but help is at hand.

or the 75 percent of perimenopausal women who experience them, hot flashes are sometimes the worst symptom associated with menopause. Most women feel a sudden wave of heat spread over the body, especially the upper body. Sweating follows, and heart rate increases by seven to 15 beats a minute. As the flash passes, skin temperature gradually returns to normal, but this can take several minutes. If you’ve ever had a hot flash, you’ll know they’re no fun, but these flashes are the body’s way of reacting (or overreacting!) to internal temperature changes.

What is a Hot Flash? Some researchers believe hot flashes are related to unstable levels of estrogen that confuse the hypothalamus, the area in the brain that regulates body temperature. The dropping estrogen levels change the way the hypothalamus responds to heat, and tells the body to get rid of it, so the heart pumps faster, blood vessels in the skin dilate, and sweat glands activate to cool you off. Flash! This sounds like a good theory, but studies find no differences in estrogen levels between women who have hot flashes and those who don’t. So why do some women suffer while others stay cool and collected? “(Post)menopausal women who suffer from hot flashes have a lower-than-normal sweating threshold, thus it’s easier to trigger sweating,” says Robert Freedman, Ph.D., professor of psychiatry at Wayne State University School of Medicine in Detroit, who

has studied thermoregulation and menopause. Fluctuating levels of estrogen trigger hot flashes by decreasing the sweating threshold, he says, although we don’t know just how it does this.

Managing Hot Flashes Lifestyle Changes Experts advise to first try cooling off with lifestyle changes. For many years, women have passed on the following advice to one another, confident that these strategies helped them reduce the severity of their hot flashes. There is some evidence that small changes such as choosing fabrics that breathe, such as cotton and washable linens, and avoiding turtlenecks can make hot flashes more bearable. The following suggestions will do no harm, often cost nothing, and are just common sense– and can provide relief, particularly for mild hot flashes. Stay cool. Dress in layers so you can peel clothing off before and during flashes. Keep ice water in an insulated bottle handy for sipping, and use a fan and open windows to keep air flowing. Identify your triggers. Alcohol, caffeine, sugar, and spicy food trigger hot flashes in certain women. Keep a daily hot flash diary and limit foods and beverages or activities you notice act as triggers. Stop smoking. This habit is linked to increased hot flashes as well as serious health conditions, such as heart disease, stroke, and cancer. Even passive exposure to smoke has been shown to

reduce estrogen levels; cigarette smoke is toxic to the ovaries. Remain physically active. Exercise is important during the perimenopausal years and beyond, not just for the health benefits, but because studies find it may help reduce hot flashes and improve sleep (provided the exercise is not too close to bedtime). Keep your cool. A study conducted by doctors at the University of Pennsylvania found that controlling stress in our lives may help reduce the number and severity of hot flashes. The researchers studied over 400 women between 37 and 47 who still had regular menstrual cycles at the beginning of the study over a six-year period and found that those women with the highest anxiety reported almost five times as many hot flashes as those lessanxious women. Studies were needed, however, to determine whether specific anxiety treatments could effectively reduce menopausal hot flashes. But effective ways to stay calm include low-intensity forms of exercise like tai chi, deep breathing techniques, and meditation. Breathe deeply. Slow, deep, rhythmic breathing calms the nervous system, making this one of the simplest, most effective ways to avert hot flashes as they come on or to stop them mid-flash, says Freedman. Inhale deeply, then exhale, trying to make your exhalation as long as your inhalation. Repeat several

menopause symptons

MEMO

Some women

report that various herbal remedies helped relieve their hot flashes, although scientific studies supporting their use have found mixed results. The most-tested black cohosh supplement, Remifemin®, may provide some relief from mild hot flashes and has few side effects, but evidence is lacking. And vitamin E (400 to 800 IU a day) is another option, although evidence as to its efficacy is inconclusive. Clinicians may also recommend soy foods or soy supplements; food sources may be preferable to prevent the possibility of overdosing on isoflavones. Consult your healthcare provider before increasing your soy intake.

Heat Wave Hot flashes are the second most common perimenopausal symptom (after irregular periods). An individual flash lasts from one to five minutes, and skin temperature in the fingers and toes may rise by as much as 10ºF. Hot flash frequency peaks in the first two to five years of postmenopause and then declines. Most women experience hot flashes for between six months and three to seven years.

times as needed. This paced respiration technique has been studied and definitely works for some.

Prescription Hormone Therapy If you’re having flashes severe enough to interfere with your quality of life, you may want some help. Multiple studies have proven that prescription hormone therapy that includes systemic estrogen (levels that circulate in the bloodstream through the body, provided by pills, skin patches, gels, and even one type of a vaginal ring) remains the most effective treatment for hot flashes and often with lower doses than those used in the past. Hormone therapy is the most effective therapy for treating hot flashes but is approved for moderate to severe hot flashes. Today, estrogen-containing therapy is recommended for the shortest time necessary–and at the lowest effective dose consistent with treatment goals,

says Nanette Santoro, M.D., professor and director of the division of reproductive endocrinology at the Montefiore Medical Center in Hartsdale, N.Y. During perimenopause, a woman who needs contraception plus hot flash relief can choose a combination estrogenprogestin birth control pill, provided she is healthy and doesn’t smoke. Progestinonly contraceptives are available for women who can’t use estrogen.

Other Prescription Drugs When hormones are not an option, some other prescription drugs are available to ease hot flashes, although they haven’t been approved by the FDA for this use. However, clinical evidence shows that antidepressants such as paroxetine (Paxil®/Paxil CR®), fluoxetine (Prozac®), venlafaxine (Effexor®), and desvenlafaxine (Pristiq®); the antiseizure medication gabapentin (Neurontin®); and the blood pressure medication clonidine (Catapres®) can relieve hot flashes in some women.

“I feel a whole lot better. My hot flashes lessened. I was more sexually motivated. My moods were positive in social events, and just everyday life. Thank you.” – Teresa M, Gilroy, CA

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Callll 1.800.963.2844 Ca 1.8 or visit Avlimil.com for a 30 day cycle! Avlimil Complete is a trademark of Berkeley Premium Nutraceuticals, Inc. and its subsidiaries. ©2008 Berkeley Premium Nutraceuticals. All rights reserved. Made in the U.S.A. These statements have not been reviewed by the Food and Drug Administration, and individual results may vary. Avlimil should be taken as part of a healthy lifestyle and is not intended to diagnose, treat, cure, or prevent any disease. *Source: Talk2Rep, Inc. Avlimil Complete Survey, 2006

menopause symptons

est

Assured

A good nights sleep is important no matter what life stage you are at, but menopausal symptoms and everyday pressures at this time of life can make night time a nightmare. But it needn’t be that way, simple changes can make big differences.

aking up after a restful sleep can make getting through the day a lot easier, and also comes with many health benefits. But sleep disturbances and insomnia are common among perimenopausal and postmenopausal women. There are ways to get back on track and get the sleep you require to stop the inevitable cycle of sleeplessness, worrying, and irritability of insomnia.

Night Sweats Hot flashes can occur at night or during the day. At night, if sweating accompanies the flashes, they are known as night sweats. As with hot flashes, the cause is uncertain, but it’s thought to be the result of changes in the hypothalamus—the part of the brain that regulates body temperature. The hypothalamus mistakenly senses that the woman is too warm and begins a chain of physiological events to cool her down.

Blood vessels close to the skin dilate to increase blood flow to the surface and give off heat. This produces a red flushed face and neck, as well as an increased pulse rate and a sensation of rapid heart beating. A chill often follows. The first time this happens can be very upsetting—no matter how prepared you might be. Jan Makovick, a hairdresser from Baltimore, Md., couldn’t believe the intensity of her night sweats. “The first time it happened I was shaken by the experience. The sheets were drenched, and I had to strip the bedclothes and replace them, and then an hour or so later it happened again. I sat on the floor and cried. My husband couldn’t believe it. He just said, ‘OK, well, here we are with this. Let’s work it out.’” The next day, Makovick made an appointment to see her clinician, who understood just how disturbing and inconvenient it was but explained that it was really quite normal. The clinician

Or Is It Depression?

suggested she consider hormone therapy. Makovick gave it a try, and very quickly the night sweats reduced, dwindling to no flashes over time. She hasn’t looked back.

Night Sweat Treatment The treatment options for night sweats are the same as for hot flashes. Prescription estrogen therapy remains the most effective treatment, particularly for moderate to severe symptoms. A systemic level of estrogen, delivered by a tablet, through the skin or by one type of vaginal ring, is required. Most local vaginal estrogen therapy is not enough for relief of hot flashes or night sweats. Lower doses than were used in the past have been shown to be effective in helping with hot flashes, and experts and the FDA recommend using the lowest possible dose for the shortest possible time.

Is It Anxiety? Although night sweats account for a dramatic form of sleep disruption, it’s not uncommon to experience insomnia caused by anxiety. If a perimenopausal woman is not experiencing hot flashes or night sweats, then hormone therapy may not be of any use, and lifestyle changes should be tried instead. Ally Parker, 52, a fashion buyer from Michigan City, Ind., remembers her sleeplessness taking its toll on her family. “I was uncharacteristically irritable, particularly

in the mornings and evenings, and so short-tempered and stressed.” Although Parker had not discussed the possibility of her being perimenopausal with her family, the tag was soon attached. “I became aware of my lack of patience when I was 48, and my daughters identified me as ‘menopausal.’” Parker thought it was normal to be miserable around menopause. “After all, we all know your hormones dictate your mood, right?” The red light came on when her eldest daughter threatened to move out. Parker sought help from her doctor, who asked a whole range of questions, many about her sleep patterns. Through the completion of a sleep diary, Parker realized she was getting enough hours of sleep for her age, but that she was restless and constantly waking. Her physician recommended a sleep specialist who found that the probable cause of her sleeplessness was anxiety. “It was anxiety about getting older, but mainly anxiety about my two teenage daughters growing up and leaving home,” she admitted. Midlife can bring with it associated anxieties such as older children leaving the nest (or, as is more and more the case for older mothers, bringing up young children), caring for aging parents, floundering relationships, divorce or widowhood, career issues, and anxiety about aging in a society that values youth.

Lying awake or waking very early in the morning and not being able to go back to sleep may be a sign of depression. Depressed women feel blue or discouraged most of the time. Sometimes they sleep all the time or lose or gain weight. A lack of motivation and sadness, coupled with fatigue caused by prolonged sleep deprivation, is not pleasant and sometimes can be paralyzing: It can disrupt relationships and interfere with work or home life.

Treatment for Anxiety and Depression While stressful times happen, and we may cope with them adequately most of the time, there may be times when professional assistance is needed. Talk therapy (psychotherapy) with a trained psychotherapist can often be helpful. Cognitive behavioral therapy (CBT) is a way of changing your thought patterns and behavior in small ways, which can then help you see and deal with problems differently. Drugs such as oral contraceptives may help with mild perimenopausal mood swings, particularly if you’ve suffered from difficulty with hormone fluctuations (such as PMS or postpartum depression) in the past. However, no hormone drug is FDA approved for the relief of anxiety or depression. For mild to moderate depression, herbal remedies such as St. John’s wort may be helpful, but always consult with a clinician before taking any herbal remedies. If other options don’t provide the needed relief, prescription antidepressants may be the best choice. Prescription anti-anxiety drugs are also available. Studies show drug therapies work best when accompanied by talk therapy.

menopause symptons

Everyday Stressors

Getting a Restful Night

And if you’re not suffering from anxiety or depression? Well, the regular everyday stresses of life can take their toll without you even realizing it. Make sure you’re allowing yourself to get into the “zone” before going to bed. Breathing exercises or practices such as Hatha yoga, which focus on concentrating on and slowing the breath, are great for relaxing the mind in preparation for sleep. Simply setting aside 15 minutes to read a book or magazine before you turn the lights out also can help you empty your head of the day’s worries. Certainly you should make sure you’re tired both physically and mentally before you hit the sack. Ensure you’ve had some exercise during the day, but don’t exercise within two hours before bedtime, as it can overstimulate your body and brain. Hunger can also keep you awake or cause you to wake in the early hours when your blood sugar levels drop, so eating a snack before getting some shut-eye can aid a restful night’s sleep. And before you get any ideas, we’re not talking milk and cookies!

Treatment of sleep disturbances should first focus on improving sleep routines and maintaining an environment conducive to sleep. Try the following: Maintain a regular schedule of going to bed at the same time each night and getting up at the same time each morning, even on the weekend. The bedroom should be quiet, cool, and dark. Research has found that without full darkness, the body cannot produce the hormone melatonin effectively. Melatonin is vital in inducing sleepiness within the body, and during the menopausal transition it is in short supply as the decline in estrogen reduces melatonin levels. Make sure to keep light out sufficiently until morning, when light levels should gradually increase, helping you to wake naturally. Your bedroom should be cool and have good air circulation—this is especially important for women with night sweats. Make sure you only use your bedroom for sleeping and sexual activity, otherwise it could become associated with things like work or study. If you don’t fall to sleep within about 15 minutes, get up, leave the bedroom, and do something relaxing, such as reading,

Medical causes for insomnia There are several medical conditions that lead to sleep disruption, and some of these are made worse by menopause.

»»Sleep-disordered breathing—or sleep apnea—can emerge at midlife »»Restless legs syndrome interferes with sleep »»Some medications interfere with sleep patterns Be sure to talk with your healthcare provider and consider attending a sleep clinic if you have ongoing sleep difficulties.

Sweet Dreams If you need additional help to get to sleep, discuss these options with your healthcare provider. Tryptophan is an amino acid that stimulates the production of serotonin. It, in turn, produces the hormone melatonin, which is needed for sleep. Tryptophan is found naturally in turkey, bananas, figs, dates, yogurt, tuna, and whole-grain crackers, all great for snacking on before bedtime. Don’t overeat, though. Maybe try a smaller dinner with a small snack later to avoid gaining weight. The botanical sedative valerian has been recognized by the World Health Organization for treating insomnia and nervousness, and chamomile tea is another old favorite remedy for easing into sleep.

until you become drowsy. If this doesn’t help, you may have to keep trying. The following can all trigger poor sleep, so try to avoid: ➤➤ ➤➤ ➤➤ ➤➤ ➤➤ ➤➤

Heavy meals in the evening Exercising close to bedtime Alcohol Nicotine Caffeine OTC medicines with stimulants

Prescription therapies are also available, but these should be used only for a short time. If you and your primary care clinician cannot solve the problem of sleep disturbances, think about consulting a sleep specialist. Adequate sleep is an important component of good heath and a healthy life.

menopause symptons

Seeing Changes to the eye and sight at mid life can be annoying and irritating at best and at worst incapacitating and worrying. However there is help available which should bring back the sparkle.

y the time she reached menopause, Lynn Adams was fully prepared for hot flashes and night sweats. What she didn’t expect were the changes that affected her eyes. “I felt like I had sand in my eyes every hour of the day,” says the 53-yearold from Atlanta, Ga. “One minute they were burning and irritated; the next they were feeling terribly tired.” For Adams, eye discomfort was the most unpleasant of her menopause symptoms. Known as dry eye syndrome, it’s a common, yet annoying, condition that often surfaces in perimenopausal and postmenopausal women. But, while it can cause a lot of discomfort, it rarely threatens sight. So what exactly happens in dry eye syndrome? Tear production decreases naturally with age, but around menopause this can be exacerbated by hormonal changes (particularly falling androgen levels), which subtly increase inflammation in the eye. Because the lacrimal gland, known as the tear gland, isn’t producing sufficient tears to keep the conjunctiva and cornea covered, the eyes dry out and become

irritated. Then they suddenly produce a large amount of tears to compensate, explains Stephen Pflugfelder, M.D., professor of ophthalmology at Baylor College of Medicine in Houston, Texas. You may experience dry eye as an overly watery eye, or you may feel stinging, burning, scratchiness, and the feeling that there’s something in your eye. Occasionally, environmental factors such as low humidity or winds can worsen symptoms. Hormone receptors have been identified in many parts of the eye, and it is known that the quantity of tears produced is lower in postmenopausal women. In America, 3.2 million women are affected with dry eye syndrome. Luckily, some simple changes can help. Craig Skolnick, M.D., an ophthalmologist at Bascom Palmer Eye Institute in Palm Beach, Fla., recommends: ➤➤ Avoid sitting close to air blowing from fans and air conditioning vents ➤➤ Use a humidifier, particularly during the winter months when indoor air is drier

➤➤ When using a computer, make sure you blink often and take frequent breaks. Keep your computer screen at or below eye level so your eyes don’t have to open quite so wide to see the screen; that way they’ll be less likely to dry out

Protect Your Sight Not all eye conditions are as benign as dry eye syndrome. Some, such as macular degeneration and glaucoma, can lead to vision loss or even blindness. And this issue is particularly relevant for women, who are nearly three times as likely as men to lose their sight. Worldwide, studies show that women make up twothirds of those who are blind. But you can protect your vision with good eye care and some healthy lifestyle changes. “Women reaching menopause should have a complete eye exam,” says Janine Smith, M.D., deputy clinical director of the National Eye Institute in Bethesda, Md. “You can’t take your eye health for granted, just like you can’t take any other part of your body for granted.”

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menopause symptons

Managing Dry Eye Eyedrops. Over-the-counter artificial tears may be helpful, but they’re only likely to ease symptoms. Make sure you choose a product specifically designed for dry eyes, not just to get the redness out. Anti-inflammatories. If over-the-counter drops don’t work, the prescription eye drop drug cyclosporine (Restasis®) could be the next step. Restasis dampens the eye inflammation that leads to irritation and tearing. Punctal plugs. These tiny silicone plugs block the drain that normally allows tears to flow down the nose. If the plugs fall out, your healthcare provider may decide to cauterize the drains to permanently close them. Corticosteroids. Studies show corticosteroids eye drops provide some symptomatic relief. They may have adverse effects, though, so they’re not suitable for long-term use.

The Aging Eye While dry eye may have a hormonal basis, other eye conditions related to aging are simply the result of, well, age. Many of us reach midlife already using glasses or contacts to see objects far away. But as we age, the lens of the eye, which helps focus images, loses its flexibility. This results in presbyopia, difficulty in seeing objects close up. The solution may be reading glasses or bifocals, or possibly one of the newer laser surgeries that may give you back your pre-forties vision, at least for a while. Floaters—those shadowy squiggles and dots that drift into your field of vision—also increase as we age. They’re the result of changes in vitreous gel, liquid inside the eye that helps give it its shape. You usually don’t need to worry about floaters, says Skolnick. They’re just the outlines of debris drifting along in the liquid. However, if they suddenly increase, see an eye specialist immediately. They could be a sign of a detached or detaching retina. Then there are the big guns of aging eyes: cataracts, macular degeneration, and glaucoma—leading causes of blindness and vision loss in older Americans. Cataracts, or a clouding of the lens in the eye, used to be the primary thief of eyesight in the elderly. Today, however, a simple, outpatient procedure to remove

the cloudy lens and replace it with an artificial lens is one of the most commonly performed surgical procedures in the country. Your risk of cataracts increases with age, sun exposure, smoking, diabetes, steroid use, or a family history of cataracts. A few studies show that estrogen users have fewer cataracts. Age-related macular degeneration, or AMD, destroys the cells in the macula, the part of the eye responsible for central vision. It can begin in middle age, with the risk increasing as you get older. As a woman, your risk of AMD is higher than a man’s. It’s also higher if you’re white, smoke, or have a family history of the disease. Glaucoma is usually caused by increased pressure from the buildup of fluid in the eye, which can slowly damage the optic nerve. You are at risk if you are over 60, African American, Mexican American, have a family history of the disease, have ever had an eye injury, have diabetes, or have taken steroids. If caught early, drugs can keep glaucoma under control, preventing vision loss. Regular eye exams are so important, says Skolnick. Early detection, along with lifestyle changes (See “Boost Your Eye Health” on page 71) to boost eye health, will help ensure your eyes remain in optimum condition as long as possible.

Boost Your Eye Health About three-quarters of all vision loss is preventable or correctible, says the National Eye Institute’s Janine Smith, M.D. Healthy lifestyle changes, along with regular eye screenings and early treatment, can make a difference in quality of life.

Stop smoking. The chemicals in cigarette smoke travel in the blood to every cell in the body and can cause eye damage in addition to other problems. For example, studies find that about one-third of macular degeneration cases may be caused by smoking. Lose weight. A healthy diet and regular exercise appear to reduce the risk of serious eye disease. Manage your weight to reduce the risk of diabetes, which is a major risk factor for cataracts, glaucoma, and a nerve-destroying condition called diabetic neuropathy. Eat an apple a day. Several studies suggest diets rich in fruits and vegetables may reduce the risk of cataracts and macular degeneration by providing valuable antioxidants to prevent age-related damage. Vitamin supplements may be necessary if you find it hard to increase your level of antioxidants. Shade out the sun. Too much sun exposure can lead to cataracts and macular degeneration, says Smith. Look for sunglasses that block 90 percent to 100 percent of both UVA and UVB light.

Losing it An ever increasing midriff is a fact of mid life for most women- but you can beat the bulge. Here we look at some of our readers letters and answer your most common questions. We follow on with the best ever tried and tested exercises that you can do at home.

diet & exercise

I’m 50, and I’ve started putting weight on around my midriff, but nowhere else. Could this be due to menopause? Yes and no. Many women gain an average of 10 pounds during the menopause transition, but there’s little scientific evidence to link the weight gain to either menopause or hormone therapy. Instead, research suggests weight gain is largely a result of lifestyle and aging factors. As you get older, reduced activity levels play an important part. Lack of sleep, which, in turn, can make you less active during the day, may contribute. In the Nurses’ Health Study, researchers found that women who slept for five hours or less gained 2.5 pounds more than those who slept for seven hours a night. There is some suggestion, however, that menopausal changes to body composition or fat distribution could be part of the picture. Research shows that menopause is associated with increased fat around the abdominal region. It’s important to control weight gain in this area because not only does it make it harder to zip your pants, an increase in central abdominal body fat increases your risk for type 2 diabetes, high cholesterol, hypertension and heart disease.

Since I started using estrogen therapy I seem to be putting on a lot of extra weight. Could it be due to the hormones? No, don’t blame your hormone therapy for those 10 pounds you’ve packed on since perimenopause. Despite previous beliefs that hormone therapy led to weight gain, well-designed clinical

trials show that isn’t so, says JoAnn Pinkerton, M.D., director of Midlife Health Center at the University of Virginia in Charlottesville and professor of obstetrics and gynecology. In the Postmenopausal Estrogen/ Progestin Intervention (PEPI) trial, a three-year study of 875 women aged 45 to 64, researchers found no differences in weight change between women using any of four types of hormone therapy and women taking a placebo. This doesn’t mean you should look to hormone therapy as a means of weight loss or maintenance. Most health experts, such as the North American Menopause Society, recommend using hormone therapy only to help with specific menopauserelated symptoms, such as hot flashes and vaginal dryness, and for preventing menopause-related diseases such as osteoporosis.

I want to lose the weight I’ve recently gained. Are there diets tailored to menopausal women? There are no tricks or magic when it comes to losing weight. So forget low-carb, low-fat, low-sugar, body-type, or any of the other dozens of diets out there that promise to let you eat whatever you want, watch TV all day, and still lose weight. To maintain a healthy weight you must balance the calories coming in with the calories going out. And the drop in estrogen and the eventual slowing of your metabolism means you will have to work harder. It is a simple math problem. The number of calories you burn a day— called your basal resting metabolic rate—drops steadily with each passing decade. “So a 5-foot-8-inch woman who needed 1,411 calories a day at age

35 will only need 1,313 at age 55,” says Ivy Alexander, Ph.D., Changes medical advisor and a woman’s health expert at Yale University School of Nursing. If you don’t adjust the amount of food you eat to match this decrease in your metabolism—or balance it with increased energy expenditure—the weight will slowly but surely pile on.

I’m concerned my weight could increase my risk of illness. How can I get back to a healthy size? By doing simple exercises and eating a healthy diet you should be able to watch the scales drop. But it’s a good idea to get some support to help you through the process. In the Women’s Healthy Lifestyle Project, a clinical trial of 535 healthy perimenopausal women, participants were assigned to lose 10 to 15 pounds. The first group received a structured lifestyle intervention program, consisting of a low-fat, 1,300-calorie per day diet and a physical activity program of two to three miles of brisk walking most days. The second group was told to lose weight on their own. Researchers found that women in the intervention group remained at their baseline weight, or lost weight, whereas women left on their own gained, on average, 5 pounds. Some structure is helpful and sometimes necessary. “If women are committed to changing their diet and exercise patterns in ways that work for them, then they are much more likely to be successful over the longterm,” says Pinkerton. Ease yourself into a healthy diet, then combine this with a healthy dose of exercise every day, and you should start to see the weight gain slow down or stop.

diet & exercise

Take

Control

Find out how many calories you need to maintain your weight (see sidebar, below). If you eat more than the recommended intake, compensate with extra exercise or lowering your intake for a day or two.

Eat plenty of fruit and vegetables They’re high in vitamins, minerals, and fiber and low in calories.

Switch to whole grains

Enjoy yourself! If you like your exercise routine, you’re less likely to quit. Find a class you enjoy at your local recreation center or train with a friend for added motivation.

Unrefined whole-grain foods contain fiber that will help you lower blood cholesterol and fill you up for longer.

Don’t always clean your plate! Portion control at home is key, but, more importantly, remember not to overeat when you eat out. Remember, you can always take home something for tomorrow!

Cut out high-fat protein Choose lean cuts of skinless meat and poultry, and cook them without saturated or trans fats. Add spices for extra flavor.

Reduce your saturated fat intake Switch to healthy fats such as olive oil, canola oil, and flaxseed oil. Avoid frying foods. Instead, grill or bake whenever possible.

Select low-fat dairy products

How Many Calories?

What to eat to maintain your weight.

Get moving Aim to do at least 30 minutes of moderate exercise most days of the week. If you can’t manage 30 minutes at a time, try three 10-minute sessions. Not only will this help keep off the weight, it will improve your cardiovascular fitness, too.

Try weight-bearing exercise This strengthens bone structure and burns calories. Aim to fit in a brisk walk three times a week or a quick game of tennis twice a week. Thirty minutes of brisk walking a day can lead to a 15-pound weight drop in a year.

Age

Sedentary

Moderately Active

Active

31-50

1,800

2,000

2,200

51+

1,600

1,800

2,0002,200

Sedentary: You regularly partake in typical day-to-day activities. Moderately active: You partake in day-to-day activities, plus

you exercise equivalent to walking about 1.5 to 3 miles per day at a 3 to 4 mile per hour pace.

Active: You partake in day-to-day activities, plus you do activity equivalent to walking more than 3 miles per day at a 3 to 4 mile per hour pace.

Source: American Heart Association

When you reduce your fat intake with low-fat foods, watch out for hidden sugars, because these products often beef up the sugar content to add extra taste.

Can you imagine developing a complex which actually addresses the core reason why we gain weight? Leading scientists have made what we believe may be one of the greatest discoveries of our time. They discovered a unique complex of natural fibers that can have a positive impact on something that affects most people – blood sugar levels. These researchers learned that many

overweight individuals suffer from blood sugar levels that rapidly rise and fall throughout the day. When blood sugar drops rapidly, your brain sends out powerful messages to eat resulting in food cravings that are almost impossible to ignore. Why? The brain regulates two primary functions every minute; oxygen and blood sugar. When levels of either drop too quickly, your brain senses danger and reacts. With blood sugar – the brain tells your body that you need to eat.

Why PGX Works Unlike many “diet” products that try to suppress appetite – PGX corrects appetite by addressing one of the core reasons behind unhealthy food cravings; blood sugar levels. PGX is taken with each meal and slows the digestion of food which helps control and balance blood sugar levels. This slowed digestion further helps reduce food cravings by keeping you full for a longer period of time. For more information visit www.pgx.com. Aside from slowing digestion, PGX expands quickly and gently in your stomach when taken with water. This expansion creates more volume in your stomach, which allows you to eat smaller meal portions. The key to effective weight loss is calorie reduction – 500 calories less a day will help you lose 1 pound every week. PGX can help you accomplish your goals by allowing you to eat smaller portions, keeping you full for longer and by reducing unhealthy food cravings.

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Unlike many “diet” products that try to suppress appetite – PGX corrects appetite

Apples &Pears When we gain midlife weight we do so differently depending on our body shape. There are two classic problem body shapes: The Apple - where excess weight is carried around the middle, and The Pear - where weight tends to gather more around the hips. Sound familiar? Well we can’t change what we were born with but with a little tailored exercise we can make the most of what we’ve got.

Which Body Shape are you? ✔✔ You have a large bust, a

Before starting your moves you need to achieve a 30 minute cardio fat burn. We suggest power walk interval training to start and increasing the intensity of your power walk as you improve. This can be done outdoors with a good pair of training shoes and a watch or on a treadmill at the gym.

✔✔ You are likely to have a

Power Walk Interval Training

Apple heavy waistline, and a problem tummy—your waist, hip, and bust measurements are pretty much the same. relatively small backside and perhaps find jeans hard to fit because of this.

✔✔ You tend to lose weight

from your arms and legs first, but find it difficult to shift it from your midriff.

Pear ✔✔ You tend to gain most

weight on the lower half of your body.

✔✔ You tend to lose weight

from your bust and waist first, but find it difficult to shift it from your hips and backside.

Walk The Walk

Power walking is walking briskly as though you were almost about to break out into a jog. Keep your arms tight to your side and controlled and walk right through your foot from heel to toe.

THE MOVES THE APPLE MOVES Problem areas: Waist - Stomach - Bust 1. Waist Nipper = The Plank 2. Tummy Tuck = Ball Hip Lift 3. Bust Booster = Curl & Press

Breathing should be controlled and even, you should never feel completely out of breath. Begin by walking fairly slowly for 3 minutes to warm up and then pick up the pace to a moderate intensity for 2 minutes and then if you can pick up the pace for a further 2 minute blast. That is your first cycle. Then repeat with 2 minutes low intensity, followed by 2 minutes moderate intensity and then a 2 minute high intensity blast. Increase the length of the moderate and high intensity blasts as you improve. For maximum results repeat the 30 minute session at least 5 times per week.

THE PEAR MOVES Problem areas: Stomach - Thighs - Bottom 1. Tummy Tuck = Ball Hip Lift 2. Thigh Firmer = Stability Ball Leg Curls 3. Bottom Blaster = Step & Squeeze

Begin with 3 sets of 10 reps for each move, increasing the reps as you improve.

diet & exercise

The Plank

Waist Nipper

Lie facedown with your forearms resting on the floor. Your elbows should be under your shoulders and bent 90 degrees. Push off your elbows, lifting your body off the floor, so your torso is supported on your elbows and forearms and your body forms a straight line from your head to your heels. Keep your navel pulled toward your spine and your head in line with your spine. Hold for 10 to 15 seconds. Then lower to starting position.

Ball Hip Lift

Tummy Tuck

Lie on your back with your arms at your sides and hook the ball with your knees so itâ&#x20AC;&#x2122;s nestled between your heels and your hamstrings. Contract your abs and lift the ball off the floor, rolling your hips up and drawing your knees toward your chest. Keep your navel pulled toward your spine throughout the move. Pause; then slowly lower back to the starting position.

Curl & Press

Bust Booster

Sit on a chair (preferably one without arms), feet flat on the floor. Hold a dumbbell in each hand, arms extended down to your sides and palms facing out. Keeping your upper body stable, bend your elbows and curl the weights up toward your shoulders. Immediately rotate your wrists so your palms are facing out in front of you and press the weights above your head. Pause. Then reverse the move, lowering the weights to your shoulders, rotating your palms in toward your body and lowering the weights back down to your sides.

Stability Ball Leg Curls

Thigh Firmer

Lie on your back on the floor. Extend your legs and place your heels on the top of the ball. Rest your arms on the floor by your sides, palms down. Press your heels into the ball and lift your rear off the floor a few inches. Bend your knees, using your heels to pull the ball toward your rear, so your feet end up flat on the ball. Pause, then extend your legs back to the starting position.

Step & Squeeze

Bottom Blaster

Stand about a foot away from a step with your feet about hip-width apart. Place hands on your hips. Step forward with your left foot, placing it on the center of the step. All in one move, straighten your left leg, lift your right foot off the floor, squeeze your buttocks, and extend your right leg behind you. Hold, then reverse the motion. Repeat with the opposite leg. Alternate legs until you complete a full set with each leg.

beauty

Shine With the onset of menopause and natural ageing, your skin may need a little extra boost to help renew itself. But drastic steps are not in order it just takes a little extra pampering to get your natural glow back. Practicing Preventive Maintenance As you can imagine, skin takes quite a beating as the outer layer of the body. Yet no matter whether you’ve worn sunscreen religiously or spent your younger years smoking, drinking, and basking in the sun, one fact remains: your skin ages more quickly after menopause. That said, you can take effective, affordable steps to slow this aging process, says Wilma Bergfeld, M.D., head of clinical research in the department of dermatology at the Cleveland Clinic in Ohio. “You don’t have to accept aging skin,” she says. “Adding a few inexpensive products to your daily routine can make a dramatic difference.”

Love Those Layers Much like an onion, your skin is composed of layers. The top layer, the epidermis, is the toughest but thinnest. It is constantly creating new cells that rise to the surface, causing older cells to flake off. Next comes the multilayered dermis, which

houses the blood supply, sebaceous (oil) glands, collagen, and nerve receptors. Under the dermis lies a layer of fat. When levels of estrogen and other hormones drop at menopause, these layers begin to thin. Estrogen is vital for keeping the skin plumped up and responsive, says Bergfeld. Specialized cells in your skin called fibroblasts house estrogen receptors on their cell membranes. When estrogen levels drop, these fibroblasts don’t produce as much protein, especially collagen, which provides bulk to the dermis. So the epidermis begins to “float” over the dermis, explains Val Lambros, M.D., a plastic surgeon in Newport Beach, Calif. It then bunches and crinkles like the skin on an overripe peach. Falling estrogen levels also affect the blood vessels in your skin, making them stiffer and narrower, reducing blood flow. That, in turn, reduces the amount of oxygen and nutrients your skin gets, starving it. Prevention is the best remedy, but it’s never too late to start giving your skin the TLC it needs.

Skin Changes to Expect The drop in hormones at menopause results in: ➤➤ Dry skin. As collagen shrinks and fades and blood vessels deliver fewer nutrients, the oil glands in your skin don’t work as well. Even if you had oily skin in your 30s and 40s, you’ll get dry skin after menopause. “Enzymes in the skin do not renew as quickly, so less oil and vitamin E are produced, causing the skin to dry out,” says Jeannette Graf, M.D., a dermatologist and skin-care ingredient consultant in Great Neck, N.Y. ➤➤ Acne. Just as when you were going through adolescence, the shifting hormone levels of menopause can trigger breakouts, usually in the jaw area, says Elizabeth A. Liotta, M.D., a dermatologist in private practice

beauty

in Rockville, Md. But don’t reach for your teenager’s alcohol-based, over-the-counter remedy; it will only dry and irritate your skin. You need something specifically formulated for menopausal women, such as water-based, over-the-counter acne gels and lotions designed for

adults; prescription low-dose topical antibiotics; or even birth control pills. ➤➤ Rosacea. If you have rosacea, a skin condition that generally causes flushing and redness on the face, you may suffer more flares during perimenopause, when hot flashes increase skin temperature.

➤➤ Reduced immunity. Compromised blood flow to the skin also affects its ability to heal. The consequence: you bruise more easily, cuts take longer to heal, and ultraviolet light penetrates the skin more deeply, increasing your risk of skin cancer, says Bergfeld.

Five Steps to Perfect Skin

Experts recommend these five essentials to take care of your face every day.

Use a moisturizing cleanser. Detergent

soaps are too drying for your face and body. “For your face, switch to a moisturizing, foaming cleanser, and use no more than twice a day, once in the morning before applying makeup and once at night”, says Graf. “For the shower, use a moisturizing body wash. Because hot water can dehydrate your skin, keep your time in the shower to a minimum.”

Exfoliate gently. “Cell division slows with 2 age”, explains Bergfield, “so daily exfoliation is important to ensure that active ingredients are properly absorbed. “Before you go to bed, use a cream or lotion that contains lactic acid, glycolic acid, alpha hydroxy acid (AHA), or poly hydroxy acid (PHA). (Note: do not use if you have rosacea; these ingredients will make your skin even redder.) In addition to removing dead skin cells and other facial debris, these products may help restore skin thickness and reduce acne breakouts.” In one study of 65 women, a 15 percent glycolic acid solution increased skin thickness by 27 percent.

moisturizing a priority. To 3 Make hydrate your skin, use a moisturizer on your face and body twice a day. “For your face, choose a fragrance-free moisturizer designed specifically for the face; using a body cream on your face can trigger acne breakouts,” explains Graf. “During the day, wear a lighter cream or lotion-based moisturizer that contains an SPF (sun protection factor) of at least 15, preferably 30.” Look for facial moisturizers that contain soy and/ or retinol. Soy contains phytoestrogens, plant-based

estrogens that may mimic the action of your body’s natural estrogen, says Graf. “On your skin, soy works like an antioxidant and offers deep moisturizing properties,” she says. It also can lighten and even skin tone, inhibit facial hair growth (common after menopause) and shrink pores, she says. Retinol, a precursor to vitamin A, helps restore collagen and skin thickness, forestalling the sagging and wrinkling that tend to occur after menopause. Use a body moisturizer that contains urea and follow up with a body oil, such as almond oil, to help replace the natural oils in your skin.

sunscreen religiously. Wear 4 Wear sunscreen or sun block every day, even in the winter, says Graf. “Everyone thinks about UVB rays when they think of sun exposure. These rays, more prevalent in the summer, tend to cause sunburns. UVA rays, however, are just as intense all year round, and these rays penetrate more deeply. They are the ones that cause collagen degradation, freckling, and wrinkling.” Your moisturizer and makeup foundation should both contain an SPF of 15 or higher. This protects you as you walk to and from your car and sit in front of windows.

Use a night cream. Applying a night 5 cream that works on skin while you sleep will add a deep moisturizing benefit that will soon show results. Again a deep-penetrating retinol or soy-based night cream is advised, but any moisturizing treatment that works through the night will provide results. Vitamin-based moisturizers are also recommended.

post menopausal health

In the

Pink

Breast health is more important than ever as you approach menopause. Yet the same old myths abound - donâ&#x20AC;&#x2122;t be fooled hereâ&#x20AC;&#x2122;s the low down.

post menopausal health

Feeling tense during a mammogram makes it more uncomfortable.

Estrogen fuels breast cell growth, so breast cancer risk declines after menopause. Breast cancer rates rise with age, despite the drop in estrogen levels. The good news is that postmenopausal breast cancers tend to grow more slowly than those in younger women, making them less dangerous. No FALSE matter what your age, early detection is the key. It is important to continue screening through regular clinical breast exams and mammograms or other tests. You and your healthcare provider also should discuss the option of breast self-exams. While research has not established its value in early detection of cancer, they may help you become more familiar with your breasts and therefore better able to notice any problems and seek further screening.

Lumpy, sensitive breasts are normal in perimenopause. Breast pain is very common during perimenopause. In fact, uncomfortable breast true pain is sometimes an early sign that menopause is approaching. Don’t fret, though, it won’t go on forever. The tenderness and lumpiness should subside after menopause. Fluctuating hormones are likely to blame, though sagging breasts may contribute. They are thought to create discomfort as fat pulls the breasts downward. To alleviate that discomfort, sleep in a light cotton or sports bra.

Anxiety can lead to greater discomfort, so try using some relaxation techniques before your true appointment. Deep breathing exercises and meditation can go a long way in reducing pre-appointment jitters. The more relaxed you feel going into the mammogram, the less uncomfortable the procedure will be. Remember, any discomfort is over very quickly.

Mammograms work better on postmenopausal women.

There’s a new drug available that can help reduce the risk of breast cancer. In 2007, the U.S. Food and Drug Administration approved Raloxifene, marketed true as Evista®, to reduce the risk of certain breast cancers in postmenopausal women. It’s not suitable for everyone, though, and it doesn’t treat existing breast cancer or lower the risk of recurrence. If you have a history of clotting disorders or are at risk of having a stroke, you’ll need to assess the risk-benefit ratio with your healthcare provider.

Not necessarily. In fact, breast density is more a factor than age. It is difficult to detect FALSE cancer in women with dense breasts at any age, because glands, ligaments, and other non-fat tissues appear white on a mammogram, as do cancer cells. Fat, on the other hand, looks black, making tumors easier to spot. About half of postmenopausal women experience a reduction in the density of their breasts significant enough to improve a mammogram reading. Using hormone therapy can increase breast density, adding to the challenge of detecting tumors.

Self-Exam Tips Even though breast self-exam has not been proven to improve breast cancer outcomes, women can and do find their own cancerous lumps. The more often you examine your breasts, the more you’ll learn about them, which may make it easier to detect when something unusual has occurred. However, don’t use regular self-exams as an excuse to skip your mammogram or clinical breast exam. Mammograms and other diagnostic tools, such as ultrasound and MRI, often catch cancer earlier than breast self-exams. Breastcancer. org has the following advice:

A mammogram is the only way to detect cancer.

If you don’t wear a bra your breasts will eventually sag. This is a common misconception. But in fact, even if you had diligently worn a bra 24/7, FALSE your breasts would inevitably sag after menopause. The mammary glands in your breasts usually shrink after menopause. For some women, fat replaces the glands that once filled out the breast. Because fat tissue has no structure, it sags. Other than a surgical breast lift or strength-training exercises, such as push-ups, which strengthen the pectoral muscles in the chest, nothing’s going to reduce that sagging.

If you are a breast cancer survivor, have dense breasts, have a strong family history of FALSE cancer, or have the BRCA1 and BRCA2 cancer genes, consider having a breast ultrasound or breast MRI in addition to your mammogram. If you’re at high risk for developing breast cancer, some experts recommend a breast MRI every three years. Using a facility dedicated to breast health is another good option. Studies find that radiologists who specialize in reading mammograms catch twice as many cancers as those who don’t. If you find a breast lump, it needs follow-up with a surgeon, even if the mammogram is negative.

If you’re still menstruating, do a breast self-exam (BSE) a few days after your period ends; your breasts will be less lumpy and less tender at this time. If you’re postmenopausal, check your breasts on the first or last day of the month. Different areas of the breasts often feel quite distinct. For example, the upper, outer quarter (close to your armpit) tends to be lumpy and bumpy, while the lower half may feel like a sandy or pebbly beach. Another area might feel like a lumpy bowl of oatmeal. The important thing is to get to know what is normal for you. If you do feel an unusual lump, don’t panic. Book an appointment with your healthcare provider to get it checked out. And finally, remember that eight out of 10 lumps that are removed will turn out to be noncancerous.

Importance of Early Detection Finding breast cancer early means that you have more treatment options, and your chances of survival are better. Survival is less likely if the cancer has already spread outside the breast when it is diagnosed. As an example, about nine out of 10 women whose cancer is diagnosed before it has spread outside the breast will be alive five years later. However, if the cancer has spread to other parts of the body outside the breast and lymph nodes at diagnosis, only about two out of 10 women will be alive five years later. This means that you should be getting regular clinical breast exams and mammograms or other breast imaging at the interval recommended by your healthcare provider.

MEMO

The best way to be breast healthy is to maintain a healthy weight with diet and exercise, as obesity increases cancer risk. After turning 40, schedule regular mammograms. If you have a family history of breast cancer or are at high risk for other reasons, your healthcare provider may recommend starting mammograms at a younger age, getting additional screening tests, or having more frequent breast exams.

ÂŠ2009 Novartis (10/09) C-FEM-100088

Women who’ve faced breast cancer surgery are beautiful. Women with a plan to help keep breast cancer from coming back are smart.

START WITH A DIFFERENCE

After 24 months of treatment, clinical trial results show that Femara ® is more effective than tamoxifen at reducing the risk of breast cancer returning after surgery for hormone receptor-positive early stage breast cancer. Femara was 21% more effective than tamoxifen in reducing the risk of breast cancer returning.

potential to become pregnant, if you are not sure of your postmenopausal status, or if you recently became postmenopausal. Femara is WITH FEMARA only indicated in postmenopausal women. Talk 296 Patients out of 4,003 to your doctor if you’re allergic to Femara or any In this clinical trial, after 24 months of treatment, (7.4%) recurred of its ingredients. You should not take Femara Femara was 21% more effective than tamoxifen if you are pregnant as it may cause harm to WITH TAMOXIFEN in reducing the risk of breast cancer returning. an unborn child. Some women reported fatigue 369 Patients out of 4,007 During the clinical trial, a return of breast cancer and dizziness with Femara. Until you know (9.2%) recurred was observed in 296 of 4,003 (7.4%) patients how it affects you, use caution before driving taking Femara, and 369 of 4,007 (9.2%) patients 1.8% absolute difference at 24 months or operating machinery. Some patients taking taking tamoxifen. After 24 months of treatment, Femara had an increase in cholesterol. Additional there is a 1.8% absolute difference in favor of Femara in the number of follow-up is needed to determine the risk of bone fracture associated overall recurrence events. Femara was not shown to improve survival with long-term use of Femara. versus tamoxifen in the same clinical trial. The primary end point of the trial was disease-free survival. Approval in the adjuvant setting was In the adjuvant setting, commonly reported side effects are generally based on a median follow-up of 26 months. mild to moderate. The most common side effects seen with Femara include hot flashes, joint pain, night sweats, weight gain, nausea, Indication tiredness, other heart-related events and bone fractures. Other less Femara® (letrozole tablets) is approved for the adjuvant (following surgery) commonly reported side effects include vaginal bleeding, blood clots, treatment of postmenopausal women with hormone receptor-positive other cancers, osteoporosis, stroke, heart attack and endometrial cancer. early stage breast cancer. The benefits of Femara in clinical trials are based on 24 months of treatment. Further follow-up will be needed to Femara is a once-daily, convenient prescription tablet. determine long-term results, safety and efficacy. For additional information, please see brief summary on adjacent page. Important Safety Information You should not take Femara if you are premenopausal. Your doctor You are encouraged to report negative side effects of prescription should discuss the need for adequate birth control if you have the drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. An international clinical study involving more than 8,000 postmenopausal women shows that Femara reduces the chance of breast cancer returning after surgery versus tamoxifen.

Ask your doctor if Femara is right for you. Call 1-866-972-5242 or visit www.femaracares.com

Femara®

(letrozole tablets) 2.5 mg Tablets

Rx only BRIEF SUMMARY: Please ® see package insert for full prescribing information. INDICATIONS AND USAGE ® (letrozoletablets) (letrozole tablets) is indicated for the adjuvant treatment of postmenopausal women with horFemara mone2.5 receptor mg positive Tabletsearly breast cancer (see CLINICAL STUDIES in the full prescribing information). The effectiveness of Femara in early breast cancer is based on an analysis of disease-free survival in Rx only patients treated for a median of 24 months and followed for a median of 26 months (see CLINICAL BRIEF Please see package insert for fullanalyses prescribing information. STUDIES in SUMMARY: the full prescribing information). Follow-up will determine long-term outcomes for both safety and efficacy. INDICATIONS AND USAGE ® Femara (letrozole tablets) is indicated for the adjuvant treatment of postmenopausal women with horCONTRAINDICATIONS ® (letrozole mone receptor tablets) positive is early breast cancerin(see CLINICAL in the full prescribing information). contraindicated patients withSTUDIES known hypersensitivity to Femara or any of Femara The effectiveness of Femara in early breast cancer is based on an analysis of disease-free survival in its excipients. patients treated for a median of 24 months and followed for a median of 26 months (see CLINICAL Femara is contraindicated in women of premenopausal endocrine status (see WARNINGS, Pregnancy). STUDIES in the full prescribing information). Follow-up analyses will determine long-term outcomes for WARNINGS both safety and efficacy. Pregnancy: Femara® (letrozole tablets) may cause fetal harm when administered to pregnant women. CONTRAINDICATIONS Studies in rats at doses equal to or greater than 0.003 mg/kg (about 1/100 the daily maximum recomFemara® (letrozole tablets) is2 contraindicated in patients with known hypersensitivity to Femara or any of mended human dose on a mg/m basis) administered during the period of organogenesis, have shown its excipients. that letrozole is embryotoxic and fetotoxic, as indicated by intrauterine mortality, increased resorption, Femara is contraindicated in women of premenopausal endocrine (seeanomalies WARNINGS, Pregnancy). increased post-implantation loss, decreased numbers of live fetusesstatus and fetal including WARNINGS absence and shortening ®of renal papilla, dilation of ureter, edema and incomplete ossification of frontal Pregnancy: Femara (letrozole tablets) may cause fetal harm when administered to pregnant women. skull and metatarsals. Letrozole was teratogenic in rats. A 0.03 mg/kg dose (about 1/10 the daily maxiin rats at doses equal to or greater2 than 0.003 mg/kg (about 1/100 the daily maximum recommum Studies recommended human on2abasis) mg/madministered basis) caused fetalthedomed and cervical/centrum vermended human dose ondose a mg/m during periodhead of organogenesis, have shown tebralthat fusion. letrozole is embryotoxic and fetotoxic, as indicated by intrauterine mortality, increased resorption, Letrozole is embryotoxic at doses equal to or greater than 0.002 mg/kg and fetotoxic when administered to increased post-implantation loss, decreased numbers of live fetuses and fetal anomalies including rabbits at 0.02and mg/kg (about of 1/100,000 and dilation 1/10,000 dailyedema maximum recommended humanofdose on absence shortening renal papilla, of the ureter, and incomplete ossification frontal 2 basis, respectively). Fetal anomalies included incomplete ossification of the skull, sternebrae, a mg/m skull and metatarsals. Letrozole was teratogenic in rats. A 0.03 mg/kg dose (about 1/10 the daily maxiand forehindlegs. human dose on a mg/m2 basis) caused fetal domed head and cervical/centrum vermumand recommended Theretebral are nofusion. studies in pregnant women. Femara is indicated for postmenopausal women. If there is Letrozole is embryotoxic at doses equal or greater thanbe 0.002 mg/kgof and when administered exposure to letrozole during pregnancy, thetopatient should apprised thefetotoxic potential hazard to the to at 0.02 risk mg/kg and 1/10,000 the daily maximum recommended human dose on fetus rabbits and potential for(about loss of1/100,000 the pregnancy. Fetal anomalies included incomplete ossification of thewho skull,have sternebrae, a mg/m2 basis, The physician needs respectively). to discuss the necessity of adequate contraception with women the potenfore- and hindlegs. tial toand become pregnant including women who are perimenopausal or who recently became postThere areuntil no studies in pregnant women. Femara is established. indicated for postmenopausal women. If there is menopausal, their postmenopausal status is fully exposure to letrozole during pregnancy, the patient should be apprised of the potential hazard to the PRECAUTIONS and potential risk for loss of the pregnancy. Sincefetus fatigue and dizziness have been observed with the use of Femara® (letrozole tablets) and somnoneedsreported, to discusscaution the necessity of adequate contraception women who have the potenlence The wasphysician uncommonly is advised when driving or usingwith machinery. tial to become pregnant including women who are perimenopausal or who recently became postLaboratory Tests: until No dose-related effect of Femara any hematologic or clinical chemistry parameter menopausal, their postmenopausal status ison fully established. was evident. Moderate decreases in lymphocyte counts, of uncertain clinical significance, were observed PRECAUTIONS in some patients Femara 2.5been mg.observed This depression transient about halftablets) of those Since fatiguereceiving and dizziness have with the was use of Femara®in(letrozole andaffected. somnoTwo patients on Femara developed thrombocytopenia; relationship to the study drug was lence was uncommonly reported, caution is advised when driving or using machinery. unclear. Patient withdrawal due toTests: laboratory abnormalities, related study treatment or not, was infrequent. Laboratory No dose-related effectwhether of Femara on anytohematologic or clinical chemistry parameter Increases in SGOT,Moderate SGPT, and gammainGT ≥5 timescounts, the upper limit of normal and ofwere bilirubin was evident. decreases lymphocyte of uncertain clinical (ULN) significance, observed ≥1.5 times thepatients ULN were mostFemara often associated with metastatic in in theabout liver.half About 3% ofaffected. study in some receiving 2.5 mg. This depression wasdisease transient of those participants receiving Femaradeveloped had abnormalities in liver chemistries associated withwas documented Two patients on Femara thrombocytopenia; relationshipnot to the study drug unclear. Patient metastases; these abnormalities have beenwhether related related to study Inorthenot, megestrol acetate withdrawal due to laboratory may abnormalities, to drug studytherapy. treatment was infrequent. comparative study about SGPT, 8% of and patients treated withtimes megestrol acetate abnormalities in liver chemistries Increases in SGOT, gamma GT ≥5 the upper limithad of normal (ULN) and of bilirubin that were associated with most documented liver metastases; in the disease aminoglutethimide study 3% about 10% ≥1.5 not times the ULN were often associated with metastatic in the liver. About of study of aminoglutethimide-treated patients had abnormalities inchemistries liver chemistries not associated with hepatic participants receiving Femara had abnormalities in liver not associated with documented metastases. metastases; these abnormalities may have been related to study drug therapy. In the megestrol acetate study about 8% of patients with megestrol had abnormalities liver had chemistries In thecomparative adjuvant setting, an increase in total treated cholesterol (generallyacetate non-fasting) in patientsinwho basethat were not associated with documented metastases; in thethen aminoglutethimide study 10%in line values of total serum cholesterol within theliver normal range, and subsequently had an about increase of aminoglutethimide-treated patients had abnormalities in liver chemistries not associated with hepatic total serum cholesterol of 1.5 ULN was 173/3203 (5.4%) on letrozole vs 40/3224 (1.2%) on tamoxifen. Lipid metastases. lowering medications were used by 18% of patients on letrozole and 12% on tamoxifen. the adjuvant an adjuvant increase in total cholesterol non-fasting) in patients who had baseBone In Effects: In the setting, extended setting, preliminary(generally results (median duration of follow-up was 20 line from valuestheofbone total serum cholesterol within range,Dand subsequently had anbisphosincrease in months) sub-study (Calcium 500 the mg normal and Vitamin 400then IU per day mandatory; total serum cholesterol of 1.5 ULN was 173/3203 (5.4%) on letrozole vs 40/3224 (1.2%) on tamoxifen. phonates not allowed) demonstrated that at 2 years the mean decrease compared to baseline in hip BMD Lipid lowering medications were used by 18% of patients on letrozole and 12% on tamoxifen. in Femara patients was 3% vs 0.4% for placebo (P=0.048). The mean decrease from baseline BMD Bone Effects: In the extended adjuvant resultsand (median duration of follow-up was 20 results for the lumbar spine at 2 years wassetting, Femarapreliminary 4.6% decrease placebo 2.2% (P=0.069). months) from the bone sub-study (Calcium 500 mg and Vitamin D 400 IU per day mandatory; bisphosConsideration be given to monitoring BMD. phonates should not allowed) demonstrated that at 2 years the mean decrease compared to baseline in hip BMD Drug in Interactions: Clinical studies with cimetidine indicated the coadminisFemara patients wasinteraction 3% vs 0.4% for placebo (P=0.048). and The warfarin mean decrease fromthat baseline BMD trationresults of Femara these drugs result in clinically-significant drug interactions. (See CLINIfor thewith lumbar spine at 2does yearsnot was Femara 4.6% decrease and placebo 2.2% (P=0.069). CAL PHARMACOLOGY in the full prescribing information.) Consideration should be given to monitoring BMD. Coadministration of Femara andinteraction tamoxifenstudies 20 mgwith dailycimetidine resulted and in a warfarin reductionindicated of letrozole plasma levels Drug Interactions: Clinical that the coadminisby 38% on average. no clinical experience to in date on the use of Femara in combination tration of FemaraThere with is these drugs does not result clinically-significant drug interactions. (Seewith CLINIother CAL anticancer agents. in the full prescribing information.) PHARMACOLOGY Coadministration Femara with and tamoxifen daily hepatic resulteddysfunction in a reduction of letrozole plasma levels Hepatic Insufficiency:ofSubjects cirrhosis 20 andmg severe (see CLINICAL PHARMAby 38% on average. Thereinis the no clinical experience to date on the usewere of Femara combination COLOGY, Special Populations full prescribing information) who dosed in with 2.5 mg ofwith Femara other anticancer agents.twice the exposure to Femara as healthy volunteers with normal liver function. experienced approximately Hepatic Insufficiency: with cirrhosis andpatient severe population. hepatic dysfunction (seeofCLINICAL PHARMATherefore, a dose reductionSubjects is recommended for this The effect hepatic impairment COLOGY, SpecialinPopulations in thewith full prescribing information) dosed with 2.5 mg(See of Femara on Femara exposure cancer patients elevated bilirubin levelswho has were not been determined. experienced approximately twice the exposure to Femara as healthy volunteers with normal liver function. DOSAGE AND ADMINISTRATION.) Therefore, a dose reduction is recommended for this patient population. The effect of hepatic impairment Drug/Laboratory Test Interactions: None observed. on Femara exposure in cancer patients with elevated bilirubin levels has not been determined. (See Carcinogenesis, Impairment of Fertility: A conventional carcinogenesis study in mice at DOSAGE ANDMutagenesis, ADMINISTRATION.) dosesDrug/Laboratory of 0.6 to 60 mg/kg/day (about 1 to 100 times the daily maximum recommended human dose on a Test Interactions: None observed. mg/m2 basis) administered by oral gavage for up to 2 years revealed a dose-related increase in the inciCarcinogenesis, Mutagenesis, Impairment of Fertility: A conventional carcinogenesis studyand in mice dence of benign ovarian stromal tumors. The incidence of combined hepatocellular adenoma carci-at of 0.6 to 60 mg/kg/day 1 towhen 100 times the daily on a nomadoses showed a significant trend in(about females the high dose maximum group wasrecommended excluded duehuman to lowdose survival. mg/m2 basis) administered by oral gavage for up to 2 years revealed a dose-related increase in the inciIn a separate levels in mice at 60 mg/kg/day 55 times higher thanand thecarci0-12hrtumors. dence ofstudy, benignplasma ovarianAUC stromal The incidence of combinedwere hepatocellular adenoma AUC0-24hr in breast cancer trend patients at the recommended The carcinogenicity study in rats at nomalevel showed a significant in females when the high dose. dose group was excluded due to low survival. oral doses of 0.1 tostudy, 10 mg/kg/day (about levels 0.4 toin40mice times themg/kg/day daily maximum recommended human In a separate plasma AUC at 60 were 55 times higher than the dose 2 basis) for up to 2 years 0-12hr also produced an increase in the The incidence of benignstudy ovarian stromal on a mg/m level in breast cancer patients at the recommended dose. carcinogenicity in rats at AUC0-24hr tumors 10 mg/kg/day. Ovarian hyperplasia wastoobserved at dosesrecommended equal to or greater oralatdoses of 0.1 to 10 mg/kg/day (about 0.4 40 times in thefemales daily maximum humanthan dose 2 basis) 0.1 mg/kg/day. 10 mg/kg/day, AUCproduced in rats were times higher than ovarian the levelstromal in 0-24hr levels on a mg/mAt for up to 2plasma years also an increase in the80incidence of benign breasttumors canceratpatients at the recommended dose.was observed in females at doses equal to or greater than 10 mg/kg/day. Ovarian hyperplasia 0.1was mg/kg/day. At 10 mg/kg/day, plasma AUC0-24hr rats were 80 times higher than the level Femara not mutagenic in in vitro tests (Ames and E.levels coli in bacterial tests) but was observed to be a in breast cancer patients at assays the recommended dose. potential clastogen in in vitro (CHO K1 and CCL 61 Chinese hamster ovary cells). Letrozole was not Femarainwas mutagenic in test in vitro tests (Ames and E. coli bacterial tests) but was observed to be a clastogenic vivonot (micronucleus in rats). potential clastogenthe in in vitroofassays (CHOonK1fertility and CCL 61 Chinese ovaryhowever, cells). Letrozole wasdosnot Studies to investigate effect letrozole have not beenhamster conducted; repeated clastogenic in inactivity vivo (micronucleus in atrophy rats). of the reproductive tract in males and females at ing caused sexual in femalestest and effectinofmice, letrozole not been(about conducted; however, repeated dosdosesStudies of 0.6, to0.1investigate and 0.03 the mg/kg rats on andfertility dogs, have respectively one, 0.4 and 0.4 the daily ing caused sexual inactivity females atrophy of the reproductive tract in males and females at 2 basis, maximum recommended humanindose on aand mg/m respectively). doses of 0.6, 0.1 and 0.03 mg/kg in mice, rats and dogs, respectively (about one, 0.4 and 0.4 the daily Pregnancy: Pregnancy Category D (See WARNINGS.) maximum recommended human dose on a mg/m2 basis, respectively). Nursing Mothers: It is not known if letrozole is excreted in human milk. Because many drugs are Pregnancy: Pregnancy Category D (See WARNINGS.) excreted in human milk, caution should be exercised when letrozole is administered to a nursing woman Nursing Mothers: It is not known if letrozole is excreted in human milk. Because many drugs are (see WARNINGS and PRECAUTIONS). excreted in human milk, caution should be exercised when letrozole is administered to a nursing woman Pediatric The safety effectiveness in pediatric patients have not been established. (see Use: WARNINGS and and PRECAUTIONS). Geriatric Use: Use: The median ageand of patients in allinstudies of patients first-linehave and not second-line treatment of metastaPediatric The safety effectiveness pediatric been established. tic breast cancer was 64-65 years. 1/3 ofinthe ≥70 years old. In thetreatment first-line of study, Geriatric Use: The median ageAbout of patients all patients studies ofwere first-line and second-line metastapatients ≥70 years ofwas age64-65 experienced longer1/3time to patients tumor progression andold. higher response than tic breast cancer years. About of the were ≥70 years In the first-linerates study, patients <70. patients ≥70 years of age experienced longer time to tumor progression and higher response rates than For the extended patients <70.adjuvant setting, more than 5,100 postmenopausal women were enrolled in the clinical study.For In the total, 41% ofadjuvant patientssetting, were aged years or older at enrollment, while 12% were 75 or older. extended more65 than 5,100 postmenopausal women were enrolled in the clinical In thestudy. extended adjuvant setting, nowere overall differences inolder safetyator efficacy were these In total, 41% of patients aged 65 years or enrollment, whileobserved 12% werebetween 75 or older. older In patients and younger patients, other reported clinical experience haswere not observed identifiedbetween differences the extended adjuvant setting, and no overall differences in safety or efficacy these older patients andthe younger and other reported identified differences in responses between elderlypatients, and younger patients, butclinical greaterexperience sensitivityhas of not some older individuals in be responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot ruled out. be ruled out.more than 8,000 postmenopausal women were enrolled in the clinical study. In In thecannot adjuvant setting, the of adjuvant setting, more 65 thanyears 8,000 women were enrolled study. In total, In 36% patients were aged orpostmenopausal older at enrollment, while 12% were in75the or clinical older. More total, 36% of patients were aged 65 years or older at enrollment, while 12% were 75 or older. More

Femara

adverse events were generally reported in elderly patients irrespective of study treatment allocation. However, in comparison to tamoxifen, no overall differences with regards to the safety and efficacy profiles were observed between elderly patients and younger patients. ADVERSE REACTIONS Femara® (letrozole tablets) was generally well tolerated across all studies in first-line and second-line metastatic breast cancer, adjuvant treatment, as well as extended adjuvant treatment in women who have receivedevents prior adjuvant tamoxifen treatment. Generally, the observed reactions are mild or modadverse were generally reported in elderly patients irrespective of adverse study treatment allocation. erate in nature. However, in comparison to tamoxifen, no overall differences with regards to the safety and efficacy proAdjuvant Treatment of Early Breast Cancer inyounger Postmenopausal files were observed between elderly patients and patients. Women: The median duration of adjuvant treatment was 24 months and the median duration of follow-up for safety was 26 months for ADVERSE REACTIONS patients® receiving and generally tamoxifen. Femara (letrozole Femara tablets) was well tolerated across all studies in first-line and second-line Certain adverse prospectively analysis, based treatment on the known pharmacologic metastatic breastevents cancer,were adjuvant treatment,specified as well asfor extended adjuvant in women who have received prior tamoxifen Generally, properties andadjuvant side effect profilestreatment. of the two drugs. the observed adverse reactions are mild or moderate in nature. Adverse events were analyzed irrespective of whether a symptom was present or absent at baseline. Most Adjuvant Treatment of Early Breast Postmenopausal Women: The median duration of adjuadverse events reported (82%) wereCancer Grade 1inand Grade 2 applying the Common Toxicity Criteria Version 2.0. vant was 24 months and the median1-4) duration of follow-up for safety to was 26 months for in the adjuTabletreatment 13 describes adverse events (Grades irrespective of relationship study treatment patients receiving Femara and tamoxifen. vant BIG 1-98 trial (safety population, during treatment or within 30 days of stopping treatment). Certain adverse events were prospectively specifiedTable for analysis, based on the known pharmacologic 13 properties and side profiles of the(CTC two Grades drugs. 1-4, Irrespective of Relationship to Study Drug) Patients witheffect Adverse Events Adverse events were analyzed irrespective of whether a symptom was present or absent at baseline. Most in the Adjuvant Study BIG 1-98 adverse events reported (82%) were Grade 1 and Grade 2 applying the Common Toxicity Criteria Version 2.0. Grades Grades 3-4adjuTable 13 describes adverse events (Grades 1-4) irrespective of 1-4 relationship to study treatment in the ® Femara®or withintamoxifen Femara tamoxifen vant BIG 1-98 trial (safety population, during treatment 30 days of stopping treatment). N=3975 N=3988 N=3975 N=3988 Table 13 Adverse Eventwith Adverse Events (CTC Grades n (%) n of (%)Relationshipnto(%) Patients 1-4, Irrespective Study Drug) n (%) in the Adjuvant Study BIG1515 1-98 (38.0) Hot Flashes/Flushes 1338 (33.7) 0 – 0 – Arthralgia/Arthritis 840 (21.1) 88Grades (2.2) 3-4 49 (1.2) Grades 1-4 535 (13.4) ® Night Sweats 561 (14.1) 654 (16.4) Femara 0 ® – tamoxifen 0 – tamoxifen Femara Weight Increase 425 (10.7) 515 (12.9) N=3975 21 (0.5) N=3988 44 (1.1) N=3975 N=3988 Nausea Event 378 6 (0.2) n (%) 10 (0.3) Adverse n (%)(9.5) n416 (%) (10.4) n (%) Fatigue (Lethargy, Malaise, Asthenia) 1338 333(33.7) (8.4) 1515345 (8.7) Hot Flashes/Flushes (38.0) 0 9– (0.2) 0 –9 (0.2) Edema 286(21.1) (7.2) (7.2) 88 (2.2) 5 (0.1) 49 (1.2) 2 (<0.1) Arthralgia/Arthritis 840 535287 (13.4) Myalgia 255(14.1) (6.4) (6.1) Night Sweats 561 654243 (16.4) 0 26– (0.7) 0 17 – (0.4) Bone Fractures 223(10.7) (5.6) (4.0) 21 76 45 (1.1) Weight Increase 425 515158 (12.9) (0.5)(1.9) 44 (1.1) Vaginal Bleeding 177(9.5) (4.5) (10.3) 6 (0.2) 2 (<0.1) 10 (0.3) 7 (0.2) Nausea 378 416411 (10.4) Headache 141(8.4) (3.5) 6 (0.2) Fatigue (Lethargy, Malaise, Asthenia) 333 345126 (8.7)(3.2) 9 12 (0.2)(0.3) 9 (0.2) Vaginal Irritation 139(7.2) (3.5) 6 (0.2) 2 (<0.1) 3 (<0.1) Edema 286 287122 (7.2)(3.1) 5 (0.1) Myalgia 255 243106 (6.1)(2.7) 26 (0.7) Vomiting 109(6.4) (2.7) 6 (0.2) 17 (0.4) 8 (0.2) Bone Fractures 22396(5.6) 158110 (4.0)(2.8) 76 (1.9) Dizziness/Light-Headedness (2.4) 1 (<0.1) 45 (1.1) 8 (0.2) Vaginal Bleeding 17779(4.5) 411 44 (10.3) 2 (<0.1) Osteoporosis (2.0) (1.1) 6 (0.2) 7 (0.2) 7 (0.2) Headache 14159(3.5) 126 95 (3.2)(2.4) 12 (0.3) Constipation (1.5) 4 (0.1) 6 (0.2) 1 (<0.1) Vaginal Irritation 13910(3.5) 122 71 (3.1)(1.8) 6 (0.2) Endometrial Proliferation Disorders (0.3) 1 (<0.1) 3 (<0.1) 12 (0.3) Vomiting 109 (2.7) 106 (2.7) 6 (0.2) 8 (0.2) 1 7/3089 (0.2) 12/3157 (0.4) – – – – Endometrial Cancer Dizziness/Light-Headedness 96 3(2.4) 1 (<0.1) 8 (0.2) Other Endometrial Disorders (<0.1) 110 (2.8) 4 (0.1) 0 – 1 (<0.1) Osteoporosis 7917(2.0) 44 14 (1.1)(0.4) 6 15 (0.2)(0.4) 7 (0.2) Myocardial Infarction (0.4) 11 (0.3) Constipation 59 (1.5) 95 (2.4) 4 (0.1) 1 (<0.1) Cerebrovascular/TIA 44 (1.1) 41 (1.0) 43 (1.1) 40 (1.0) Endometrial Proliferation Disorders 1027(0.3) 71 24 (1.8)(0.6) 1 17 (<0.1) Angina (0.7) (0.4) 12– (0.3) 7– (0.2) Endometrial Cancer1 7/3089 (0.2) 12/3157 (0.4) – – Thromboembolic Event 44 (1.1) 109 (2.7) 29 (0.7) 79 Other Endometrial Disorders 3 (<0.1) 4 (0.1) 0 – 1 (<0.1)(2.0) Other Cardiovascular 261(0.4) (6.6) 71 (1.8) Myocardial Infarction 2 17 14248 (0.4)(6.2) 15 97 (0.4)(2.4) 11 (0.3) Second Malignancies 76/4003 (1.9) 96/4007 – – 40 (1.0) – – Cerebrovascular/TIA 44 (1.1) 41 (1.0)(2.4) 43 (1.1) 1Based on safety population excluding patients Angina 27 (0.7) 24 (0.6) hysterectomy; 17 (0.4) time frame 7 (0.2) who had undergone is any time Thromboembolic Event 44 (1.1) 109 (2.7) 29 (0.7) 79 (2.0) after randomization; no CTC grades collected (yes/no response) 2Based Other Cardiovascular 97 (2.4) no CTC 71 grades (1.8) colon the intent-to-treat population; 261 time (6.6) frame is any248 time(6.2) after randomization; 2 76/4003 (1.9) 96/4007 (2.4) – – – – Second Malignancies lected (yes/no response) 1When Basedconsidering on safety population excluding whoofhad undergone hysterectomy; time frame isfractures any time all grades, a higherpatients incidence events were seen for Femara regarding after randomization; no CTCinfarctions grades collected response) (5.7% vs 4%), myocardial (0.6%(yes/no vs 0.4%), and arthralgia (21.2% vs 13.5%) (Femara vs 2Based on the intent-to-treat population; time frame is any time after randomization; no CTC grades coltamoxifen respectively). A higher incidence was seen for tamoxifen regarding thromboembolic events lected vs (yes/no response) (1.2% 2.8%), endometrial cancer (0.2% vs 0.4%), and endometrial proliferative disorders (0.3% vs When grades, arespectively). higher incidence of events were seen for Femara regarding fractures 1.8%)considering (Femara vsall tamoxifen (5.7% vs 4%), myocardial infarctions vs 0.4%), (21.2% vs enzymes, 13.5%) (Femara vs Post-Marketing Experiences: Cases(0.6% of blurred visionand andarthralgia increased hepatic angioedema, anatamoxifen respectively). A higher incidence was seen for tamoxifen regarding thromboembolic events phylactic reactions, toxic epidermal necrolysis, erythema multiforme and hepatitis have been reported. (1.2% vs 2.8%), endometrial cancer (0.2% vs 0.4%), and endometrial proliferative disorders (0.3% vs OVERDOSAGE 1.8%) (Femara vs tamoxifen respectively). Isolated cases of Femara® (letrozole overdose been hepatic reported. In these instances, anathe highPost-Marketing Experiences: Cases oftablets) blurred vision and have increased enzymes, angioedema, est singlereactions, dose ingested was 62.5 necrolysis, mg or 25 tablets. While no serious adverse have events were reported in phylactic toxic epidermal erythema multiforme and hepatitis been reported. these cases, because of the limited data available, no firm recommendations for treatment can be made. OVERDOSAGE However, emesis could ®be(letrozole inducedtablets) if the patient is alert. general, supportive and frequent Isolated cases of Femara overdose have In been reported. In these care instances, the high-monitoring of vital are was also62.5 appropriate. single-dose studies, highest dosewere usedreported was 30 in mg, which est single dosesigns ingested mg or 25Intablets. While no seriousthe adverse events was well tolerated; trials, the largest of 10 mg was for welltreatment tolerated.can be made. these cases, becauseinofmultiple-dose the limited data available, no firmdose recommendations Lethality was observed in induced mice and ratspatient following single oral doses that were equal or greater However, emesis could be if the is alert. In general, supportive care and to frequent moni-than 2,000 of mg/kg (aboutare4,000 8,000 times the daily maximum recommended dose mg/m2 toring vital signs also to appropriate. In single-dose studies, the highest dosehuman used was 30 on mg,a which basis); was associated with trials, reduced Lethality was observed in was welldeath tolerated; in multiple-dose themotor largestactivity, dose of ataxia 10 mgand wasdyspnea. well tolerated. cats following single IVindoses thatrats were equal tosingle or greater than that 10 mg/kg (about times the Lethality was observed mice and following oral doses were equal to 50 or greater thandaily max2 basis); 2 imum mg/kg recommended human dose times on a mg/m deathrecommended was precededhuman by depressed pressure 2,000 (about 4,000 to 8,000 the daily maximum dose on blood a mg/m and arrhythmias. basis); death was associated with reduced motor activity, ataxia and dyspnea. Lethality was observed in cats following IV doses that were equal to or greater than 10 mg/kg (about 50 times the daily maxDOSAGE ANDsingle ADMINISTRATION imum human dose a mg/m2 basis); death was preceded by depressed blood ® (letrozole tablets) is one pressure 2.5 mg tablet Adult recommended and Elderly Patients: The on recommended dose of Femara and arrhythmias. administered once a day, without regard to meals. In patients with advanced disease, treatment with DOSAGE AND ADMINISTRATION Femara should continue until tumor progression is evident. ® (letrozole tablets) is one 2.5 mg tablet Adult Elderlyadjuvant Patients:setting, The recommended of Femara In theand extended the optimal dose treatment duration with Femara is not known. The planned administered once a day, regard meals.However, In patientsatwith disease, treatment with treatduration of treatment in without the study was to 5 years. the advanced time of the analysis, the median Femara should continue until tumor progression evident. ment duration was 24 months, 25% of patientsiswere treated for at least 3 years and less than 1% of In the extended adjuvant setting, the optimal treatment duration with Femara is not known. The planned patients were treated for the planned duration of 5 years. The median duration of follow-up was 28 duration treatmentshould in the study was 5 years.atHowever, at the time the analysis, the median months. of Treatment be discontinued tumor relapse (see of CLINICAL STUDIES in thetreatfull prement duration was 24 months, 25% of patients were treated for at least 3 years and less than 1% of scribing information). patients were treated for the planned duration of 5 years. The median duration of follow-up was 28 In the adjuvant setting, thebeoptimal duration of treatment letrozole isSTUDIES unknown. Thefull planned months. Treatment should discontinued at tumor relapse with (see CLINICAL in the pre- duration of treatment in the study is 5 years. However, at the time of analysis, the median duration of treatment scribing information). was months, median of follow-up was 26 months, and 16% of the patients haveduration been treated In the24adjuvant setting, theduration optimal duration of treatment with letrozole is unknown. The planned fortreatment 5 years. Treatment be discontinued at relapse (see CLINICAL STUDIES in the full prescribing of in the studyshould is 5 years. However, at the time of analysis, the median duration of treatment information). was 24 months, median duration of follow-up was 26 months, and 16% of the patients have been treated No 5dose adjustment required for elderly patients. Patients treated with Femara do full notprescribing require glucofor years. Treatmentisshould be discontinued at relapse (see CLINICAL STUDIES in the information). corticoid or mineralocorticoid replacement therapy. No dose adjustment is required for elderly patients. Patients treated with Femara do not require glucoRenal Impairment: (See CLINICAL PHARMACOLOGY in the full prescribing information.) No dosage corticoid or mineralocorticoid replacement therapy. adjustment is required for patients with renal impairment if creatinine clearance is ≥10 mL/min. Renal Impairment: (See PHARMACOLOGY in the full prescribing information.) dosage hepatic Hepatic Impairment: NoCLINICAL dosage adjustment is recommended for patients with mild toNomoderate adjustment required for patients withconcentrations renal impairment if creatinine mL/min. impairment,isalthough Femara blood were modestlyclearance increasedisin≥10 subjects with moderate Hepatic Impairment:due No dosage adjustment is recommended patients mild toand moderate hepatic impairment to cirrhosis. The dose of Femara in for patients withwith cirrhosis severehepatic hepatic dysimpairment, although Femaraby blood modestly increased subjects with moderate function should be reduced 50%concentrations (see CLINICALwere PHARMACOLOGY in thein full prescribing information). hepatic impairment due Thesuch dosepatients of Femara with cirrhosis andother severeday. hepatic The recommended dosetoofcirrhosis. Femara for is in 2.5patients mg administered every The dyseffect of function should be reduced by 50% (see CLINICAL PHARMACOLOGY in thewith full prescribing information). hepatic impairment on Femara exposure in noncirrhotic cancer patients elevated bilirubin levels has not The dose CLINICAL of Femara PHARMACOLOGY for such patients is in 2.5the mgfull administered every other day. The effect of beenrecommended determined. (See prescribing information.) hepatic impairment on Femara exposure in noncirrhotic cancer patients with elevated bilirubin levels has not HOWdetermined. SUPPLIED (See CLINICAL PHARMACOLOGY in the full prescribing information.) been 2.5 mg tablets - dark yellow, film-coated, round, slightly biconvex, with beveled edges (imprinted with HOW SUPPLIED the letters FV on oneyellow, side and CG on theround, other slightly side). biconvex, with beveled edges (imprinted with 2.5 mg tablets - dark film-coated, Packaged in HDPE with safety screwside). cap. the letters FV on onebottles side and CGaon the other Bottles of 30 tablets ..................................................................................................NDC 0078-0249-15 Packaged in HDPE bottles with a safety screw cap. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Bottles of 30 tablets ..................................................................................................NDC 0078-0249-15 Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. REV: FEBRUARY 2009

REV: FEBRUARY 2009

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post menopausal health

Heart

Beat

Often ignored until its too late heart disease is Americas number one killer of women. The chances of a fatal heart attack are greatly increased with age, so now is a good time to make those lifestyle changes to help prevent the worst from happening.

nitially, Beth Harrington, a 56-yearold interior designer from Lansing, Mich., couldn’t believe the diagnosis. “I’d always thought of heart disease as a problem for middle-aged men who smoked too much. I was astonished when my doctor told me if I didn’t lose weight and start to exercise I would have a heart attack within a year.” Cornfield’s condition is not that unusual. What surprises most people is that more women die from these cardiovascular diseases than men. And, statistics from the American Hear Association show that two-thirds of women who die suddenly from heart disease have no warning signs. Their first symptom is also their last: a heart attack. However, just because you don’t have any warning signs doesn’t mean you don’t have any risk factors. “Women have just as many cardiovascular risks and problems as men”, says Nanette K. Wenger, MD, professor of cardiology at Emory School of Medicine in Atlanta. “Coronary

disease is the leading cause of death and disability for women.” In fact, after age 50, more than half of all deaths in women are due to heart-related conditions.

Hormones and Your Heart So how does your menopause status affect the health of your heart? Many experts believe premenopausal women have a lower incidence of cardiac problems because they have higher levels of estrogen, which raise levels of “good” HDL cholesterol. This form of cholesterol is like the garbage truck of coronary arteries, carting “bad” LDL cholesterol off to the liver for processing and excretion, helping keep arteries clear. Also, observational studies find that women who take estrogen after menopause have a lower incidence of heart disease than those who don’t, says Howard Hodis, MD, professor of medicine and preventive medicine at the University of Southern California in Los Angeles. But another story emerged when re-

searchers conducted a large, controlled clinical trial comparing older postmenopausal women who took hormone therapy to those who didn’t. This study, called the Women’s Health Initiative, found a slightly increased risk of heart disease among women taking one type of oral hormone therapy (Prempro®). The findings resulted in the U.S. Food and Drug Administration (FDA) and most scientific organizations, including The North American Menopause Society, recommending that hormone therapy not be used solely to prevent heart disease in postmenopausal women.

The Influence of Age Estrogen’s possible role in cardiovascular protection is just part of the picture. For most women, Wenger says, heart disease develops gradually, from childhood to midlife and beyond. “There isn’t an abrupt change at menopause. But one of the things we tend to see—and we don’t

post menopausal health

know if it’s menopause-related—is that as women age, they are more likely to have risk factors.” After age 45, for instance, women are more likely to develop diabetes, high cholesterol levels, and high blood pressure, all of which increase the risk of heart disease. While there is a genetic component to these risk factors, there are also many lifestyle components—such as eating a high-fat, high-sugar diet, being physically inactive, smoking, and being overweight. “Women during the menopause transition have to be aware that if they guard against weight gain and maintain their physical activity, they will likely do better,” says Wenger. By the time a woman reaches age 55, however, her age is her most significant cardiac risk, regardless of any other factors.

in her health. “At first I was shocked into action, but once I started to notice how good I felt after exercise, it was easy to continue. I’ve got much more energy now, and my sleep has improved also.” Along with more exercise, Harrington follows a heart-healthy diet rich in fruit, vegetables, white meat, fish, and good fats, and has been happy with the results—especially the loss of a few inches around her middle. For more information, visit the following web sites: www.americanheart. org and www.womenheart.org.

exercise into your day by walking to the store or work or taking the stairs every time rather than the escalator or elevator. Heart healthy diet. The American Heart Association (AHA) suggests a diet high in fresh fruit and vegetables, whole grains and high-fiber foods. Aim to eat two portions of oily fish a week, and limit your salt intake to 1 teaspoon a day (2.3 grams sodium). Reducing saturated and trans fat intake will also improve the health of your arteries.

Nonprescription Therapies Treatment Options When treatment is needed, always focus first on the treatment that has no risks: lifestyle changes. Nonprescription and prescription therapies are also available when lifestyle changes alone are not enough.

Taking Control

Lifestyle Changes

Small, consistent steps make a difference toward taking control of risk factors, no matter how great the risks or the warning signs. After adapting her diet and taking swimming lessons at the local gym, Harrington was surprised at the difference

Plenty of exercise. The best way to a healthy heart is through exercise. Thirty minutes a day is all you need to make a difference. Take part in an enjoyable physical activity at least every other day, such as swimming, walking, or weightbearing exercise. Or build thoughtful

Nonprescription therapies are also used by many women to lower their heart disease risk. Soy. The FDA has approved health claims that soy products benefit cardiovascular health due to their high levels of polyunsaturated fats, fiber, vitamins, and minerals and their low levels of saturated fat. Aspirin. AHA guidelines recommend that women with a high risk of heart disease take a daily low-dose aspirin (75 to 325 mg). Talk to your healthcare provider for advice. The evidence is unclear regarding vitamin supplements. Vitamins E, B

post menopausal health

and C were thought to have a beneficial effect in preventing heart disease, but studies are inconclusive. However, a daily multivitamin-mineral supplement provides good insurance for women who may not get all the proper nutrients in their diets.

Drug Therapies There are many effective FDA-approved therapies to treat specific conditions and help prevent heart disease. For example, diuretics are highly effective in controlling high blood pressure; statins are the preferred therapy for normalizing cholesterol. Estrogen. This should not be used solely for preventing heart disease, as studies have shown that some types of hormone therapy may increase the risk of heart disease, blood clots, and stroke in postmenopausal women.

Risk Factors for Heart Disease Studies have identified a number of consistent risk factors that increase a woman’s threat of heart disease or stroke. High levels of blood fats. High levels of “bad” LDL cholesterol, low levels of “good” HDL cholesterol or high levels of another blood fat (triglycerides) are important

markers when it comes to heart disease. Triglycerides and LDL cholesterol tend to stick to blood vessels, narrowing the space through which blood can flow and increasing the risk that a piece of plaque (the gunk accumulating on blood vessel walls) could break off and clog a vessel downstream. Clogged vessels in the heart result in a heart attack; in the brain, a stroke. Being overweight. The pounds are harder to shift at midlife, but maintaining your ideal weight can reduce your risk of heart disease by 35 percent to 55 percent. If you have a waist circumference of 35 inches or more, you have an increased risk of high blood pressure, diabetes, high cholesterol, and elevated triglycerides as well. Having an unhealthy diet. Aim to reduce saturated fat and cholesterol from your diet. One study from Stanford University found that a low-fat diet containing lots of vegetables, fruits, beans, and whole grains lowered total and “bad” LDL cholesterol levels more than one that didn’t. The AHA recommends regularly eating a diet high in fiber. Soluble fiber has been shown to help lower blood cholesterol, and includes foods such as oatmeal, beans, bran, and citrus fruits. Having diabetes. People with diabetes are more likely to die of a heart attack or

stroke than of the disease itself. Plus, women with diabetes tend to have higher rates of heart disease and death from heart disease than men with diabetes. High blood pressure. Ideally, your blood pressure should be 120/80 mm Hg or less. Your doctor should check it at every visit, at least once a year. Smoking. Women who quit smoking— no matter how much they smoked or how long ago—drastically lower their risk of coronary heart disease. Studies find that women who smoke are two to six times more likely to have a heart attack than nonsmokers. Stress. A stressful lifestyle increases the risk of heart disease. Try to incorporate exercise, meditation, and relaxation techniques into your life. They can significantly reduce stress. Family history of cardiac disease. Your risk of heart disease is higher than the average person’s if anyone in your immediate family had early onset cardiovascular disease (before age 55 for men, before age 65 for women). You also have a higher risk if you’re African American, Mexican American, Native American, Native Hawaiian or belong to some Asian American groups, all of whom tend to have high blood pressure rates.

When it comes to soy supplements,

you have a choice.

Make sure you choose supplements containing Soyselect® soy isoflavones from Indena If you want assurance that the soy supplements you’re taking are effective, it’s important to know if the ingredients are proven.

For supplement brands containing Soyselect , visit www.soyselect.info ®

soyselect

product

One soy ingredient supported by clinical trials is Soyselect® from Indena, a leading supplier of botanical extracts with more than 80 years of experience in manufacturing pharmaceutical grade ingredients. Soyselect® is supported by published human clinical trials in postmenopausal women that reduced symptoms and improved cognitive function.1, 2 And Soyselect® is standardized for both isoflavones and saponins, the two active constituents responsible for its efficacy. Soyselect® may just be the most complete and effective soy isoflavone product available so look for it in leading soy supplements. For more information about the benefits of Soyselect® and where to buy products containing it, visit www.soyselect.info. Indena USA, Inc. 811 First Avenue, Suite 218 Seattle, WA 98104

1 2

Menopause. The Journal of The North American Menopause Society. (2000); Vol. 7, No. 4, pp. 236-242. Menopause. The Journal of The North American Menopause Society. (2003); Vol. 10, No. 3, pp. 196-202.

Tel.: 206-340-6140 Fax: 206-340-0863

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Healthy Bodies

Healthy Bones

Post menopause marks a period of potential bone deterioration, but looking ahead and acting now can easily prevent osteoporosis and its debilitating effects. Follow our tried and tested advice to maintain healthy bones through midlife.

he National Osteoporosis Foundation estimates that 8 million women are affected by osteoporosis, and those women who have experienced menopause are more likely to be affected as women lose up to 20 percent of their bone mass in the five to seven years following menopause. But osteoporosis is an avoidable disease, so act now to prevent the effects of weakening bones. We tend to think the bones we have in our 20s are the same as the ones we have in our 50s. They’re not. Bones are constantly being remodeled throughout our lifetime to maintain their strength. So how does it work? Special cells called osteoclasts break down old bone tissue and remove it. Then bone-building cells, known as osteoblasts, replace that tissue with healthy new bone.

When you’re young, the bone-building cells work faster than the bone-destroying cells, and your bones grow larger and denser. This continues until about age 30, when women reach their peak bone mass. From then on, bones gradually lose their strength. Your risk of osteoporosis will depend on your peak bone density and your rate of bone loss.

Helpful Hormones But it’s not just age that determines bone health. Bone remodeling is regulated by several hormones, particularly estrogen. During perimenopause, women lose 2 percent of bone density each year due to decreasing estrogen levels. This loss continues until a few years after menopause, at which point, bone loss will slow to 1 percent a year. While the rapid loss of bone around

menopause puts women at greater risk of osteoporosis and makes menopause a good time to get serious about preserving bone, it doesn’t mean you have to rush into treatment, says Bruce Ettinger, MD, an osteoporosis specialist at the University of California, San Francisco. Osteoporosis, or the fractures it causes, isn’t an immediate risk for women during the menopause transition, he says. “Relax about osteoporosis—that’s the message I would give to healthy women at the time of menopause,” says Ettinger. “Women at the age of 50 or 55 who are generally healthy have a very low risk of having a fracture in the next five to 10 years.” Instead, now is a time of prevention. That means finding out if you’re at high risk for osteoporosis and discussing a bone-healthy lifestyle with your healthcare provider.

post menopausal health

Maintaining Strong Bones The most important strategy for preventing osteoporosis is making sure you get enough calcium, says Michael McClung, MD, director of the Oregon Osteoporosis Center in Portland. Calcium deficiency speeds the rate of bone loss, he notes, and studies find calcium supplementation can slow the rate of bone loss in women with low dietary intake of the mineral. Ideally, premenopausal women should aim for 1,000 milligrams a day of elemental calcium, while perimenopausal and postmenopausal women should try to get 1,200 milligrams a day. Try to get your daily calcium from your diet rather than supplements, says McClung, because your body can better absorb the mineral from food sources. It’s easy enough: three servings a day of dairy products like milk and cheese, or calcium-fortified foods like some orange juices, will do it. If you can’t get enough calcium from food (maybe you’re lactose intolerant), consider a supplement. You may need only about 600 milligrams extra a day, says Felicia Cosman, MD, an osteoporosis specialist and the medical director of the Clinical Research Center at Helen Hayes Hospital in West Haverstraw, N.Y. And don’t forget vitamin D, the socalled sunshine vitamin. Without it, your body can’t absorb calcium. If you drink milk fortified with vitamin D or spend at least 15 minutes a day in the sun with your arms, hands, and face exposed and not covered in sunscreen, you may be getting what you need. Vitamin D deficiency is especially prevalent in older women in the North where the winter is dark. If you’re over 50, aim for at

Understanding

Your Risk Healthy women with no risk factors for osteoporosis don’t need bone screenings until age 65, according to most guidelines, including those of The National Osteoporosis Foundation. If you have an increased risk of osteoporosis, you may need to start screening sooner. Numerous factors can increase your osteoporosis fracture risk, including:

»» Low bone-mineral density »» Previous fracture (other than skull, facial bone, ankle, finger, or toe) as an adult

»» History of previous hip fracture in a parent

»» Being small and thin (less than 127 pounds)

»» Smoking and drinking too much alcohol

»» Calcium or vitamin deficiency

»» Use of certain bone-robbing prescription medications (such as steroids for more than three months)

»» Increased risk of falls (e.g.,

from poor balance, dizziness from medications, etc.)

post menopausal health

least 400 IU a day of vitamin D; if you’re 70 or older, increase that to at least 600 IU. A cup of milk contains about 100 IU. Because your body has a harder time manufacturing vitamin D, even as your need for it increases, you may need to supplement, says McClung. Most calcium supplements and multivitamins contain enough vitamin D to meet your needs.

Work It, Baby! In addition to proper nutrition, exercise is critical when it comes to strong bones, says Cosman. Bone is like muscle, she explains, responding to the stress of exercise by growing stronger. Studies find that inactivity increases the rate of bone loss, and that exercising can slow that loss. Not just any exercise will do, however. Building bone requires exercise that forces your skeleton to carry your body’s weight. Brisk walking, jogging, and aerobics will do the trick; swimming and biking won’t. Strength training is also important, Cos-

man says, because it builds bone and lowers your fracture risk by helping you keep your balance and reduce your chance of falling. But if you stop exercising, she warns, you’ll lose both the muscle you built up and the bone. Before you begin any exercise program, check with your healthcare provider to discuss the type that’s best for you. Other measures to prevent osteoporosis include: quitting smoking, as studies find smoking doubles the risk of osteoporosis; keeping alcohol consumption to a moderate level; and limiting your consumption of salt, caffeine, and protein, all of which may deplete calcium.

Stay Safe Prevent accidental falls in the home with these suggestions from the National Institute on Aging:

»»Make sure you can see and

hear well. Use your glasses or a hearing aid if needed.

»»Ask your doctor if any of the drugs you are taking can make you dizzy or unsteady on your feet.

»»Use a cane or walker if your walking is unsteady.

»» Wear rubber-soled and lowheeled shoes.

Breaking the Silence: Getting Screened

»»Make sure all the rugs and

There’s a reason osteoporosis is called the “silent disease,” says Charles Kahn, MD, a rheumatologist at Memorial Regional Hospital in Hollywood, Fla. “Most patients don’t get any pain. They never know they have it.” Until, that is, they fracture a wrist

»»Keep your rooms well lit and

carpeting in your house are firmly attached to the floor, or don’t use them. the floor free of clutter.

»»Use nightlights.

I wanted to stop my bone loss. But I did more. I reversed it with BONIVA.*

Did you know osteoporosis runs in families? My mother and I both have it. I tried to keep my bones strong, but it wasn’t enough. Now, once-monthly BONIVA is helping me do more. Studies show, after a year on BONIVA, 9 out of 10 women stopped † and reversed their bone loss. BONIVA is a prescription medication to treat and prevent postmenopausal osteoporosis. Ask your doctor if BONIVA is right for you. Important Safety Information: You should not take BONIVA if you have low blood calcium, cannot sit or stand for at least 60 minutes, have severe kidney disease, or are allergic to BONIVA. Stop taking BONIVA and tell your doctor right away if you experience difficult or painful swallowing, chest pain, or severe or continuing heartburn, as these may be signs of serious upper digestive problems. Follow the dosing instructions for once-monthly BONIVA carefully to lower the chance of these events occurring. Side effects may include diarrhea, pain in the arms or legs, or upset stomach. Tell your doctor and dentist about all the medicines you take. Tell them if you develop jaw problems (especially following a dental procedure) or severe bone, joint, and/or muscle pain. Your doctor may also recommend a calcium and vitamin D supplement. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

*Bone density measured at the lumbar spine after 1 year of treatment. Individual results may vary. †

Bone density measured at the lumbar spine, total hip, or trochanter; 3 out of 4 at the femoral neck. Please read Patient Information on the next page.

Enroll today. Call 1-866-571-6893 or visit BONIVAfreetrial.com and try BONIVA free. Help Stop and Reverse Bone Loss

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Patient Information BONIVA® [bon-EE-va] (ibandronate sodium) TABLETS Rx only Read this patient information carefully before you start taking BONIVA. Read this patient information each time you get a refill for BONIVA. There may be new information. This information is not everything you need to know about BONIVA. It does not take the place of talking with your health care provider about your condition or your treatment. Talk about BONIVA with your health care provider before you start taking it, and at your regular check-ups. What is the most important information I should know about BONIVA? BONIVA may cause serious problems in the stomach and the esophagus (the tube that connects your mouth and stomach) such as trouble swallowing, heartburn, and ulcers (see “What are the possible side effects of BONIVA?”). You must take BONIVA exactly as prescribed for BONIVA to work for you and to lower the chance of serious side effects (see “How should I take BONIVA?”).

BONIVA MAY CAUSE: • pain or trouble swallowing (dysphagia) • heartburn (esophagitis) • ulcers in your stomach or esophagus (the tube that connects your mouth and stomach) Common side effects with BONIVA are: • diarrhea • pain in extremities (arms or legs) • dyspepsia (upset stomach)

harder type of tissue. Bone is always changing. Your body keeps your bones strong and healthy by replacing old bone with new bone. Osteoporosis causes the body to remove more bone than it replaces. This means that bones get weaker. Weak bones are more likely to break. Osteoporosis is a bone disease that is quite common in women after menopause. At first, osteoporosis has no symptoms, but people with osteoporosis may develop loss of height and are more likely to break (fracture) their bones, especially the back (spine), wrist, and hip bones. Osteoporosis can be prevented, and with proper therapy it can be treated. Who is at risk for osteoporosis? Talk to your health care provider about your chances for getting osteoporosis. Many things put people at risk for osteoporosis. The following people have a higher chance of getting osteoporosis: Women who: • are going through or who are past menopause (“the change”) • are white (Caucasian) or Asian People who: • are thin • have a family member with osteoporosis • do not get enough calcium or vitamin D • do not exercise • smoke • drink alcohol often • take bone thinning medicines (like prednisone) for a long time General information about BONIVA Do not use BONIVA for a condition for which it was not prescribed. Do not give BONIVA to other people, even if they have the same symptoms you have. It may harm them. Store BONIVA at 77°F (25°C) or at room temperature between 59°F and 86°F (15°C and 30°C). Keep BONIVA and all medicines out of the reach of children. This summarizes the most important information about BONIVA. If you would like more information, talk with your health care provider. You can ask your health care provider or pharmacist for information about BONIVA that is written for health professionals. For more information about BONIVA, call 1-888-MY-BONIVA or visit www.myboniva.com. What are the ingredients of BONIVA? BONIVA (active ingredient): ibandronate sodium BONIVA (inactive ingredients): lactose monohydrate, povidone, microcrystalline cellulose, crospovidone, purified stearic acid, colloidal silicon dioxide, and purified water. The tablet film coating contains hypromellose, titanium dioxide, talc, polyethylene glycol 6000 and purified water. BONIVA is a registered trademark of Roche Therapeutics Inc.

Less common side effects with BONIVA are shortlasting, mild flu-like symptoms (which usually improve after the first dose). These are not all the possible side effects of BONIVA. For more information ask your health care provider or pharmacist. Rarely, patients have reported allergic and skin reactions. Contact your health care provider if you develop any symptoms of an allergic reaction including skin rash (with or without blisters), hives, wheezing, or swelling of the face, lips, tongue or throat. Get medical help right away if you have trouble breathing, swallowing or feel light-headed. Rarely, patients have reported severe bone, joint, and/or muscle pain starting within one day to several months after beginning to take, by mouth, bisphosphonate drugs to treat osteoporosis (thin bones). This group of drugs includes BONIVA. Most patients experienced relief after stopping the drug. Contact your health care provider if you develop these symptoms after starting BONIVA. Rarely, patients taking bisphosphonates have reported serious jaw problems associated with delayed healing and infection, often following dental procedures such as tooth extraction. If you experience jaw problems, contact your health care provider and dentist. What is osteoporosis? Osteoporosis is a disease that causes bones to become thinner. Thin bones can break easily. Most people think of their bones as being solid like a rock. Actually, bone is living tissue, just like other parts of the body, such as your heart, brain, or skin. Bone just happens to be a

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What is BONIVA? BONIVA is a prescription medicine used to treat or prevent osteoporosis in women after menopause (see the end of this leaflet for “What is osteoporosis?”). BONIVA may reverse bone loss by stopping more loss of bone and increasing bone mass in most women who take it, even though they won’t be able to see or feel a difference. BONIVA may help lower the chances of breaking bones (fractures). For BONIVA to treat or prevent osteoporosis, you have to take it as prescribed. BONIVA will not work if you stop taking it. Who should not take BONIVA? Do not take BONIVA if you: • have low blood calcium (hypocalcemia) • cannot sit or stand up for at least 60 minutes • have kidneys that work very poorly • are allergic to ibandronate sodium or any of the other ingredients of BONIVA (see the end of this leaflet for a list of all the ingredients in BONIVA) Tell your health care provider before using BONIVA: • if you are pregnant or planning to become pregnant. It is not known if BONIVA can harm your unborn baby • if you are breast-feeding. It is not known if BONIVA passes into your milk and if it can harm your baby • have swallowing problems or other problems with your esophagus (the tube that connects your mouth and stomach) • if you have kidney problems • if you are planning a dental procedure such as tooth extraction Tell your health care provider (including your dentist) about all the medicines you take including prescription and non-prescription medicines, vitamins and supplements. Some medicines, especially certain vitamins, supplements, and antacids can stop BONIVA from getting to your bones. This can happen if you take other medicines too close to the time that you take BONIVA (see “How should I take BONIVA?”). How should I take BONIVA? • Take BONIVA exactly as instructed by your health care provider. • Take BONIVA first thing in the morning at least 60 minutes before you eat, drink anything other than plain water, or take any other oral medicine. • Take BONIVA with 6 to 8 ounces (about 1 full cup) of plain water. Do not take it with any drink other than plain water. Do not take it with other drinks, such as mineral water, sparkling water, coffee, tea, dairy drinks (such as milk), or juice. • Swallow BONIVA whole. Do not chew or suck the tablet or keep it in your mouth to melt or dissolve. • After taking BONIVA you must wait at least 60 minutes before: - Lying down. You may sit, stand, or do normal activities like read the newspaper or take a walk. - Eating or drinking anything except for plain water. - Taking other oral medicines including vitamins, calcium, or antacids. Take your vitamins, calcium, and antacids at a different time of the day from the time when you take BONIVA. • If you take too much BONIVA, drink a full glass of milk and call your local poison control center or emergency room right away. Do not make yourself vomit. Do not lie down. • Keep taking BONIVA for as long as your health care provider tells you. BONIVA will not work if you stop taking it. • Your health care provider may tell you to exercise and take calcium and vitamin supplements to help your osteoporosis.

• Your health care provider may do a test to measure the thickness (density) of your bones or do other tests to check your progress. What is my BONIVA schedule? Schedule for taking BONIVA 2.5 mg once-daily: • Take one BONIVA 2.5 mg tablet once a day first thing in the morning at least 60 minutes before you eat, drink anything other than plain water, or take any other oral medicine (see “How should I take BONIVA?”). What to do if I miss a daily dose: • If you forget to take your BONIVA 2.5 mg tablet in the morning, do not take it later in the day. Just return to your normal schedule and take 1 tablet the next morning. Do not take two tablets on the same day. • If you are not sure what to do if you miss a dose, contact your health care provider who will be able to advise you. Schedule for taking BONIVA 150 mg once-monthly: • Take one BONIVA 150 mg tablet once a month. • Choose one date of the month (your BONIVA day) that you will remember and that best fits your schedule to take your BONIVA 150 mg tablet. • Take one BONIVA 150 mg tablet in the morning of your chosen day (see “How should I take BONIVA?”). What to do if I miss a monthly dose: • If your next scheduled BONIVA day is more than 7 days away, take one BONIVA 150 mg tablet in the morning following the day that you remember (see “How should I take BONIVA?”). Then return to taking one BONIVA 150 mg tablet every month in the morning of your chosen day, according to your original schedule. • Do not take two 150 mg tablets within the same week. If your next scheduled BONIVA day is only 1 to 7 days away, wait until your next scheduled BONIVA day to take your tablet. Then return to taking one BONIVA 150 mg tablet every month in the morning of your chosen day, according to your original schedule. • If you are not sure what to do if you miss a dose, contact your health care provider who will be able to advise you. What should I avoid while taking BONIVA? • Do not take other medicines, or eat or drink anything but plain water before you take BONIVA and for at least 60 minutes after you take it. • Do not lie down for at least 60 minutes after you take BONIVA. What are the possible side effects of BONIVA? Stop taking BONIVA and call your health care provider right away if you have: • pain or trouble with swallowing • chest pain • very bad heartburn or heartburn that does not get better

post menopausal health

or hip. Other osteoporosis signals include chronic back pain or a loss of more than 1.5 inches in height—both signs of vertebral fractures. Thus, regular screenings are vital beginning at age 65 or earlier if you are at high risk of the disease (See “Understanding Your Risk” on page 59). The most common and most accurate form of bone mineral density testing is dual energy X-ray absorptiometry (DXA). DXA produces a T-score, a measure of how your bone density differs from that of a healthy young person of the same gender. The normal range is above -1. If your T-score is below -2.5, you’re diagnosed with osteoporosis. The problem with T-scores is they don’t tell the whole story, says McClung. They can vary from individual to individual, and age also plays a part. “The bone density value itself tells us almost nothing about the fracture risk,” says McClung. “You may want to ask your provider to put your T-score into context by providing a sense of your overall risk of fracture, before starting any drug therapy,” suggests Cosman. The World Health Organization has recently announced a new system to replace T-scores that will analyze risk in the context of a woman’s general health, explains Ettinger. “This is going to make it easier to make decisions about when it’s right to treat,” he says. The National Osteoporosis Foundation will provide an analysis of when treatments should and should not be used.

Treating Osteoporosis If you have osteoporosis, there are lots of medical options. All of which require long-term use to prevent bone loss returning. “Regardless of what medication you’re taking, you need to make sure you’re getting adequate calcium and vitamin D to maximize their effectiveness,” Kahn warns.

Prescription Drugs There is a range of medications you may be offered to treat your osteoporosis. Discuss your needs with your healthcare provider to ensure your treatment meets your needs

Bisphosphonates. This class of drugs, which includes alendronate (Fosamax), risedronate (Actonel), etidronate (Didronel), ibandronate (Boniva) and zolendronic acid (Reclast), works by slowing the rate of bone loss, giving bone-producing cells a chance to catch up and strengthen bone. Bisphosphonates are proven to be very effective in preserving bone strength and preventing fractures. Raloxifene (Evista). This type of hormone is an estrogenreceptor modulator (SERM). It aims to provide the bone benefits of estrogen without an adverse effect on the uterus or breast; however, raloxifene is not as effective as estrogen (it hasn’t been shown to prevent hip fractures) and may make hot flashes worse. Teriparatide (Forteo). This daily injectable drug is the first medication to stimulate accumulation of new bone growth to improve bone density. It’s reserved for women at high risk for fracture. Estrogen therapy. Hormone therapy with oral or transdermal estrogen has also proven very effective in preserving bone strength and preventing fractures. Long-term estrogen therapy is not recommended, however, because of its risks. Other options should be considered in most cases.

post menopausal health

ol r t t n n o e c n i In

The phrase “I nearly wet myself laughing” loses its sense of fun when it becomes a daily reality for many postmenopausal women.

ncontinence, defined as the persistent involuntary leaking of urine, is more common around and, particularly after, menopause, but it’s a condition that can pop up, unannounced, regardless of your menopause status. Urinary incontinence has many causes, including pregnancy and childbirth. But menopause and the natural effects of aging also play a role. So what’s the menopause link? Estrogen? Maybe or maybe not. Prior to menopause, estrogen helps increase blood flow to your urogenital tract (the vagina and the urethra—the tube extending from the bladder to the outside), which helps keep muscles and tissue toned and flexible. Estrogen levels become consistently low in postmenopausal women and the linings of the urethra, the bladder, and the vagina become thinner and weaker. But then, as you age, the bladder muscle also weakens; the bladder simply can’t hold as much as it once did. It is estimated that among midlife women about 5 percent suffer severe incontinence, while 60 percent suffer mild incontinence.

So aging is certainly a factor, but not all postmenopausal women experience incontinence, says G. Willy Davila, M.D., who heads the urogynecology and reconstructive pelvic surgery section at Cleveland Clinic Florida in Weston, Fla. Three main types of urinary incontinence affect women: ➤➤ Stress incontinence. When you leak urine during a cough, sneeze, laugh, or physical activity ➤➤ Urge incontinence. When you feel the sudden and intense “urge” to urinate, even shortly after emptying your bladder ➤➤ Mixed incontinence. This is a combination of stress and urge incontinence Even with so many women between ages 45 and 64 being affected by urinary incontinence, very few seek evaluation and treatment. Often it’s due to embarrassment, or because many women believe that it’s a normal aspect of aging and can’t be treated. Treatment can be very successful—from simple interven-

post menopausal health

Get Checked Out Don’t be afraid to make an appointment with your healthcare provider to discuss incontinence symptoms, specifically addressing:

»»When and how often your tions such as treating a persistent cough, or taking antibiotics for a urinary tract infection, to doing regular Kegel exercises and biofeedback, to taking daily medicine or even having surgery. The most effective approach teams the woman with a healthcare provider and a continence educator (typically a nurse) for coaching and personal support.

Talk about Your Symptoms Rebecca Kightlinger, D.O., an assistant professor of obstetrics and gynecology at the University of Virginia in Charlottesville, says that up to half of her postmenopausal patients leak urine. She notes, “If I didn’t ask, many of them wouldn’t bring it up because they think it’s normal.” Incontinence isn’t normal. And it can have a major impact on your quality of life, from curtailing leisure activities and wardrobe

choices to snuffing out your sex life. Yet, studies find less than half of women aged 45 to 64 with urinary incontinence seek evaluation and treatment.

Getting Treatment When determining how to treat your condition, your healthcare provider will first consider the type of incontinence you have. Not all treatments are appropriate for every type. Most experts recommend trying the least invasive, non-medical options before opting for medication or surgery:

Best for … … all types of incontinence Behavioral therapies. These include Kegel exercises to strengthen and condition pelvic floor muscles and bladder training to lengthen the time between voiding and to control urination urges.

symptoms occur and how they affect your life

»»Your typical bathroom patterns (Some clinicians will request a detailed diary, including when and how much you drink, as well as when and how much you urinate—and when you leak)

»»How much you urinate »»Medications you take »»Health conditions you may have

»» What, if anything, makes your symptoms worse or better. For example, bladder irritants such as coffee, colas, and citrus fruits may make symptoms worse

Case Study

When Brenda Strong, 61, from Tampa, Fla., was forced to decline an invitation to her local golf invitational, she realized that it was time to do something about her bladder control problems. “It happened gradually with leakage, but it had gotten to the point of embarrassment for me, and the thought of spending 18 holes without being close to a bathroom caused me anxiety. I couldn’t handle the thought of embarrassing myself in front of all my friends and the members of the club,” Strong remembers. But it wasn’t until an appointment with her physician that she realized there were lifestyle changes that she

could make to lessen the frequency of her urges to use the bathroom and resulting urine leakage. Strong started a program of Kegel exercises to strengthen her pelvic floor, and, although an avid golfer, started swimming at her local pool three times a week to trim down her tummy. “After about six weeks of adjusting my exercise routine, by adding three days of swimming along with starting up my weekly golfing schedule again, I started to lose weight. With the added strength of my pelvic muscles, I felt more confident about spending time away from the bathroom without embarrassing myself.”

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©2005 Astellas PharmaUS,Inc. & GlaxoSmithKlineVPI-005 VES112008-3 November2008 ©2009 Astellas Pharma US, Inc. and The GlaxoSmithKline Group of Companies VES01402-03/09 All rights reserved. Printed in USA. VS2097R0 March 2009

… stress incontinence Injectable implants. Collagen is injected into the tissue surrounding the opening of the urethra, adding bulk and helping to close it. Surgery. Surgical techniques, some using “slings” or tape-like material, can prevent further sagging of pelvic structures. Support and plug devices. These are inserted into the vagina or the urethra to stop urine leakage. These also have good results for mixed incontinence.

… urge incontinence Medication. Options include oxybutynin (Ditropan®, Oxytrol®), tolterodine (Detrol®), darifenacin (Enablex®), solifenacin (Vesicare®), and trospium (Sanc-

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Patient Information VESIcare® – (VES-ih-care) (solifenacin succinate) Read the Patient Information that comes with VESIcare before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor or other healthcare professional about your condition or treatment. Only your doctor or healthcare professional can determine if treatment with VESIcare is right for you. What is VESIcare? VESIcare is a prescription medicine used in adults to treat the following symptoms due to a condition called overactive bladder: • Having to go to the bathroom too often, also called “urinary frequency,” • Having a strong need to go to the bathroom right away, also called “urgency,” • Leaking or wetting accidents, also called “urinary incontinence.” VESIcare has not been studied in children. What is overactive bladder? Overactive bladder occurs when you cannot control your bladder contractions. When these muscle contractions happen too often or cannot be controlled, you can get symptoms of overactive bladder, which are urinary frequency, urinary urgency, and urinary incontinence (leakage). Who should NOT take VESIcare? Do not take VESIcare if you: • are not able to empty your bladder (also called “urinary retention”), • have delayed or slow emptying of your stomach (also called “gastric retention”), • have an eye problem called “uncontrolled narrow-angle glaucoma,” • are allergic to VESIcare or any of its ingredients. See the end of this leaflet for a complete list of ingredients. What should I tell my doctor before starting VESIcare? Before starting VESIcare tell your doctor or healthcare professional about all of your medical conditions including if you: • have any stomach or intestinal problems or problems with constipation, • have trouble emptying your bladder or you have a weak urine stream, • have an eye problem called narrow-angle glaucoma, • have liver problems, • have kidney problems, • are pregnant or trying to become pregnant (It is not known if VESIcare can harm your unborn baby.), • are breastfeeding (It is not known if VESIcare passes into breast milk and if it can harm your baby. You should decide whether to breastfeed or take VESIcare, but not both.). Before starting on VESIcare, tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. While taking VESIcare, tell your doctor or healthcare professional about all changes in the medicines you are taking including prescription and nonprescription medicines, vitamins and herbal supplements. VESIcare and other medicines may affect each other. How should I take VESIcare? Take VESIcare exactly as prescribed. Your doctor will prescribe the dose that is right for you. Your doctor may prescribe the lowest dose if you have certain medical conditions such as liver or kidney problems. • You should take one VESIcare tablet once a day. • You should take VESIcare with liquid and swallow the tablet whole. • You can take VESIcare with or without food. • If you miss a dose of VESIcare, begin taking VESIcare again the next day. Do not take 2 doses of VESIcare in the same day. • If you take too much VESIcare or overdose, call your local Poison Control Center or emergency room right away. What are the possible side effects with VESIcare? The most common side effects with VESIcare are: • blurred vision. Use caution while driving or doing dangerous activities until you know how VESIcare affects you. • dry mouth. • constipation. Call your doctor if you get severe stomach area (abdominal) pain or become constipated for 3 or more days. • heat prostration. Heat prostration (due to decreased sweating) can occur when drugs such as VESIcare are used in a hot environment. Tell your doctor if you have any side effects that bother you or that do not go away. These are not all the side effects with VESIcare. For more information, ask your doctor, healthcare professional or pharmacist. How should I store VESIcare? • Keep VESIcare and all other medications out of the reach of children. • Store VESIcare at room temperature, 50° to 86°F (15° to 30°C). Keep the bottle closed. • Safely dispose of VESIcare that is out of date or that you no longer need. General information about VESIcare Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use VESIcare for a condition for which it was not prescribed. Do not give VESIcare to other people, even if they have the same symptoms you have. It may harm them. This leaflet summarizes the most important information about VESIcare. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about VESIcare that is written for health professionals. You can also call (800) 727-7003 toll free, or visit www.VESICARE.com. What are the ingredients in VESIcare? Active ingredient: solifenacin succinate Inactive ingredients: lactose monohydrate, corn starch, hypromellose 2910, magnesium stearate, talc, polyethylene glycol 8000 and titanium dioxide with yellow ferric oxide (5 mg VESIcare tablet) or red ferric oxide (10 mg VESIcare tablet) Manufactured by: Astellas Pharma Technologies Inc. Norman, Oklahoma 73072 Marketed by: Astellas Pharma US, Inc. Deerfield, Illinois 60015-2548 Marketed and Distributed by: GlaxoSmithKline Research Triangle Park North Carolina 27709

tura®) to calm an overactive bladder and topical estrogen therapy to help restore blood flow to the urethra and vagina, and to strengthen the tissue lining. Electrical stimulation devices. These direct a painless, mild electrical current to the urogenital area to strengthen the muscles around the urethra. These devices can also be used for stress incontinence. “Women need to understand that incontinence symptoms are common and can be treated,” says Lindsey A. Kerr, M.D., codirector of the Pelvic Care and Continence Center at the University of Utah in Salt Lake City. “They don’t have to accept them, and there are solutions other than wearing pads to stay dry.”

Kegel Exercises: Get Them Right Studies find that Kegel exercises, which aim to strengthen pelvic floor muscles, can be more effective than medication in treating urge incontinence, because they address the cause of the problem, not the symptoms. But, there’s a catch. You need to learn to do them properly, do them regularly, and keep doing them, says Ivy Alexander, Ph.D, a woman’s health expert at Yale University School of Nursing and Changes medical advisor. Here’s how:

»»Identify the correct muscle

groups to strengthen. Try to stop the urine stream while you’re urinating. Those are the correct muscle groups, the ones you want to work on. (But don’t try Kegels while you’re urinating. It could cause irregular voiding patterns)

»»Try the strongest contraction

you can manage and count to

10, then relax. And go slow, says Alexander. “Quickies” won’t make muscles stronger. Each time you contract, hold for increasing lengths of time until you can hold for 10 seconds

»»Try five sets of contractions and releases twice a day. Increase to 10 sets twice a day, then 10 sets three times daily

»»Schedule Kegels every day. You

can practice the contractions throughout your day—waiting in line at the store, on the bus, at your desk—no one needs to know. Challenge yourself by coughing or clearing your throat while performing the exercise. You’ll be laughing without fear of leaks in no time!

Still finding it difficult? You can find Kegel instructions and diagrams on the American Physical Therapy Association Web site at www.apta.org (type “Kegel” into the search engine).

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So, what is one to do about these personal “embarrassing” problems? “Our products change peoples’ lives,” says Mr. Conant. “When they [new customers] first come to us, many feel trapped by their condition, unable to find an effective solution. We show them safe, drug-free solutions that allow them to improve the quality of life - without the fear, stress or anxiety!” People like Jeri Cates of California whose mother at 67 years of age was afraid to travel because of her health

conditions that caused embarrassment. Jeri wrote to Flat-D Innovations and states “We are so thrilled with your product, Flat-D, and it really proved effective with my mom’s health problems. I can’t even begin to tell you how Flat-D’s are already changing her life! Now, she’ll be able to travel without embarrassment of odors she has no control over.” Through research, prototypes and live testing (with real customers) Flat-D introduces a new line of women’s only products: The “FEM-D”, “Thong-D” and “Overpad Plus.” These products will give women confidence and eliminate the embarrassment caused by the types of odors women only experience. Flat-D Innovations, Inc., an FDA registered company, is a significant part of the very large worlds of flatulence, incontinence and feminine hygiene and feminine odor problems. They manufacture effective activated charcoal products to over 50 countries worldwide. Their products are commonly recommended by doctors. View 1 year of survey results at http://flat-d.com/survey-results.html

For more information contact: Frank Morosky, VP, Flat-D innovations, Inc., 319-447-4840, www.flat-d.com 69

How Do You Intelligently Navigate Through Menopause? Read HORMONES AND YOUR HEALTH:

The Smart Woman’s Guide to Hormonal and Alternative Therapies for Menopause. In her eighth book, author and reproductive biologist, Winnifred Cutler, Ph.D. offers intelligent women and their physicians the current research information needed to map a personal-best health plan after age 35. Hormones and Your Health culminates six years of her research of published studies – and is important, essential reading for any woman. Dr. Cutler earned her Ph.D. in biology from the University of Pennsylvania followed by a postdoctoral fellowship at Stanford, where she co-founded The Stanford Menopause Study. Dr. Cutler founded Athena Institute for Women’s Wellness in 1986 with the mission of improving the quality of healthcare for women. Dr. Cutler’s other books include; Menopause, Love Cycles: The Scence of Intimacy, Searching for Courtship and Hysterectomy: Before and After. Hormones and Your Health, 336 pages, has 880 references. Also from Dr. Cutler: Athena Pheromone 10:13 for Women Based on her 1986 co-discovery of pheromones in humans, which made front page news in the Washington Post, add this cosmetic to your favorite scent and enjoy more romantic attention from others. Online ordering at:

www.Athenainstitute.com

Call: 610-827-2200, Or send coupon to: Athena Institute, Dept CHG, 1211 Braefield Rd. Chester Springs, PA 19425.

“Winnifred Cutler's message is clear, precise and correct that women have choices as far as hormone therapy is concerned and they are in charge. She provides ample information, peppered with wisdom, in order to help in these important health decisions... The reader will have to try hard to find an area that isn't covered in a succinct yet comprehensive manner.” Alan De Cherney, MD. Editor in Chief, Fertility and Sterility, branch chief National Institutes of Health, research

Dr. Cutler ‘demystifies’ complex health issues and ‘translates’ the best current research information on: • Hormone Replacement Therapy: the RIGHT regimens for you • Mammography: the current controversy • Hysterectomy: there are better options for fibroids, bleeding and prolapse • Bone, Cardiovascular, Memory and Vision: the best hormone, diet and exercise regimens to stay vibrant. • Maintaining Your Sexual Health after 35: with appropriate HRT regimens • Pelvic Problems and Fibroids: the top treatments and why they may or may not work for you • Protecting Your Breasts: which hormone therapies reduce and which increase the risk of breast cancer

Please send me: FOR US SHIPMENTS (Foreign please order online); ____copies HORMONES and your HEALTH hardback @$25.95 $_______ ____vials of Athena Pheromone 10:13 for women @ $98.50 $_______ Shipping Costs Books: $5 each (max $12) $_______ Free shipping for 10:13 vials- PA addressees: add 6% tax. $_______ TOTAL $_______ My Payment Method Enclosed: � U.S. MONEY ORDER ; � U.S. CHECK to"Athena Institute" � VISA/MC/DSC #_______ - ________-________-_______ Exp:___/___ Code:_____Sign:______________________

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YourFire

post menopausal health

Light

There may be a number of reasons why your sexual desire has reduced recently and menopause is just one of them but this needn’t be the case.

aving been single for seven years, 56-year-old Sara Thomas* wasn’t too concerned about having sex anymore. But the reality of falling estrogen levels hit when she met her second husband. “It was the beginning of a relationship so, of course, we wanted to be together all the time,” she says. “But that wasn’t possible. It wasn’t that I wasn’t interested, it was just too painful to consider.” This experience isn’t unusual, says Susan Kellogg-Spadt, Ph.D., CRNP, director of sexual medicine at The Pelvic and Sexual Health Institute of Philadelphia. “The three most common complaints I hear from middle-aged women about sex are lack of desire, difficulty in arousal and response, and painful intercourse.” But, she says, women don’t have to let these issues hold them back.

Sex and the Sixties Sex drive slowly declines with age in both sexes, but everyone has a unique experience. Some notice a decline in desire and others have no change at all. Research shows, however, that women are two to three times more likely than men to be affected by a low sex drive, especially when they are in long-standing relationships. So what’s menopause got to do with it? The relationship between menopause and sexual desire is complex and still under study. Reduced estrogen levels can contribute to hot flashes and night sweats, robbing a woman of restful sleep and reducing her interest in sex. “With less estrogen, the walls of the vagina become thinner and lose their elasticity, and vaginal secretions diminish,” explains Mary Jane Minkin, M.D., an obstetrician/ gynecologist and clinical professor of medicine at Yale Medical School. Translation: dryness, irritation, and pain. Also, loss of estrogen results in an increase in vaginal pH, changing the healthy acidic environment to an alkaline one that is more susceptible to vaginal infection. This condition, known as atrophic vaginitis, affects an estimated four in 10 postmenopausal women. This not only can make sex painful, but it can increase your risk of sexually transmitted diseases. Fragile vaginal tissues are prone to injury, tearing, and bleeding during sexual intercourse or even during a pelvic examination. At the same time, the ovaries’ production of another hormone—testosterone—lessens

with aging, possibly decreasing desire. Women experiencing induced menopause caused by removal of both ovaries or by chemotherapy have an accelerated decrease in both estrogen and testosterone levels, thereby resulting in more severe problems than women having natural menopause.

The Good News Although hormonal changes may play a significant role in any loss of libido, the Massachusetts Women’s Health Study, which surveyed 2,569 middle-aged women, found a woman’s menopausal status has a lesser impact on her sexual functioning than other aspects of middle age. So consider the following before chalking up your loss of libido to hormones: Your sexual history. If you used to want sex every night, you’ll still be more interested in lovemaking than a woman who has never had much interest in sex. Occasionally, however, women may have an increased interest in sex at perimenopause possibly due to changes in the ratio of estrogen and androgens. Your relationship. “If there’s tension in your relationship, for whatever reason, it’s going to affect what goes on in the bedroom,” says Minkin. Health issues. If you’ve had breast surgery or hysterectomy, you may feel less secure in your identity as a woman and be reluctant to initiate sex, or your partner may be concerned and protective. Stress. “Maybe you’ve got kids or grandkids in the house, and you think you can’t have sex, or you’re worried about putting your parents in a nursing

post menopausal health

Enhance the Mood Implementing a few lifestyle changes can often make a difference for your love life. However, there are some prescription and non-prescription options available. Speak with your healthcare provider for further options.

Lifestyle Changes Lifestyle changes can help you feel better and can make a positive difference to your body image and self-perception. Midlife brings about many different physical changes; however, these tips can improve your health and help you achieve a positive self-image.

home—all of these things impede your sex life,” says Minkin. Insomnia. Whether it was a hot flash at 2 a.m. or your husband’s lumberjack-like snoring, irritability from lack of sleep can be a block to sex, says Minkin. Prescription drugs. “There’s a lot of press about how certain medications affect erectile dysfunction in men, but there’s little understanding about how they affect sexual function in women,” says Ivy Alexander, Ph.D., an associate professor of nursing at Yale. One theory is that anything that dries out mucous membranes—such as allergy medications or antidepressants— will also dry out the vagina. Self-esteem. If you feel unattractive and undesirable, you can create a self-fulfilling prophecy when its time to undress in front of your partner. Your partner’s attitude toward sex. Whether your partner is disinterested in sex, has a sexual dysfunction, or is reaping the rewards of Viagra®—his attitude can affect your sexual function and satisfaction as well. Often, a partner’s sexual issues need addressing also.

Stop smoking. Giving up smoking is one of the best actions you can do to improve your health, appearance, and self-esteem. If you need it, seek support from your healthcare provider. Reduce alcohol consumption. Cutting down to one alcoholic beverage per day will help to relieve sleeping difficulties, depression, and, with some women, hot flashes. Drink plenty of water. Increasing water consumption counters the drying effects of aging, helping all organs, especially relieving dryness of the skin. Healthy diet. Eating an appropriately sized diet rich in fruit, vegetables, protein, and good oils will not only provide you with more energy throughout the day, but it will also help to stabilize your weight. Exercise. Regular exercise releases feel-good hormones called endorphins, so find a pleasurable activity, such as dancing or yoga. This way you can spend more time feeling good while enjoying your body.

Reduce stress. Learn how to reduce anxiety. Relaxation techniques and meditation significantly reduce stress.

Drug Therapies Research into drug therapy for women’s sexual function is still in its infancy, although changing some medications for other conditions or lowering doses may be helpful. Here’s what’s available: Nonprescription therapy. For mild vaginal dryness, using a vaginal lubricant or moisturizer may be sufficient to reduce friction during sexual activity, but make sure to opt for watersoluble lubricants and avoid oil-based products. Natural products such as Erosyn claim to enhance libido with the use of polyamines. Polyamines have shown to be important in cell growth and regeneration and are found in foods such as some vegetables and oats. As with any product, check with your clinician to see if it is right for you. Prescription therapy. Studies show that estrogen improves blood flow to the vagina, increases the thickness and elasticity of vaginal tissues, and lowers vaginal pH to help fight infection. It’s the only treatment FDA approved for atrophic vaginitis. If this is the only reason to consider estrogen therapy, choosing a low-dose vaginal estrogen product that delivers local, not systemic doses, is preferred to minimize risk.

More of what you want in life, less of what you don’t. That’s the promise of VirMAX DS, the remarkable daily supplement for women. It’s patented, clinically tested formula contains soy isoflavones which studies have found reduce menopausal symptoms such as hot flashes and loss of bone density.

Ever wished you could feel 20 years younger? Wish granted. Just as important, when taken daily, VirMAX DS’ other ingredients help increase blood flow, and estrogen levels and promote a more spontaneous, reliable, intense and healthy sex life. Now that’s a change of life you can really look forward to.

Available at Rite Aid, Walgreens.com, CVS.com, Target.com, Publix, Drugstore.com, and other ﬁne retailers www.virmaxds.com Distributed by Natural Product Solutions, LLC 11221 Dolﬁeld Blvd. Suite 103 Owings Mills, MD 21117

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