Diabetes Roundtable 2010

Leading experts weigh in on important issues in managing diabetes.

Diabetes Roundtable 2010 This Physician’s Weekly monograph provides important information to help practitioners improve their care of patients with diabetes.

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Table of Contents 14

Interpreting Data on Intensive Glucose Control — David M Kendall, MD

18

Battling CKD in Patients With Diabetes — M. SuE Kirkman, MD

16

Effective Approaches to Managing Newly Diagnosed Diabetes Patients — Richard M Bergenstal, MD

12

Overcoming the Hurdles of Insulin Initiation — Mary T Korykowski, MD

20

Setting the Stage for Good Nutrition in Diabetes — Wahida Karmally, DrPH, RD, CDE, CLS, FNLA

24

Helpful Guidelines for Heart Health in Diabetes — Craig D. Williams, PharmD

A Message From the Editor We at Physician’s Weekly are excited to present you with an eBook dedicated to feature stories we’ve covered that are pertinent to physicians and healthcare providers who care for patients with diabetes and those who may be at risk for the disease. In recent months, our publication has published a variety of news items in diabetes, with a focus on information that is based on clinical research. The content in these articles relies on the expertise of our contributing physician authors. We anticipate that Physician’s Weekly will continue to feature news in diabetes in the coming months, and hope that you find this information useful in your practice. Please let us know your thoughts by contacting us at keithd@physweekly.com.

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Interpreting Data on Intensive Glucose Cont New data shed light on whether or not patients with type 2 diabetes should intensive glucose control to reduce their risk of developing heart disease.

This Physician’s Weekly feature on interpreting new data on glucose control was completed in cooperation with the experts at the American Diabetes Association.

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ntrol

David M. Kendall, MD Chief Scientific & Medical Officer American Diabetes Association Associate Professor of Medicine University of Minnesota Adjunct Medical Director International Diabetes Center

G

lycemic control is fundamental to the management of type 2 diabetes, and studies have demonstrated that intensive therapy can result in significant reductions in microvascular and neuropathic complications associated with the disease. “Over the years, epidemiological studies have suggested that higher glucose levels result in higher rates of cardiovascular disease (CVD) events, and lower glucose values result in lower rates of CVD,” says David M. Kendall, MD. “Only recently have researchers explored the impact of getting patients with type 2 diabetes to

go from high or moderate levels of glucose control to even lower A1C values with intensive or very intensive interventions and its role in CVD.”

Three Important Investigations Several large long-term trials have been launched to compare the effects of intensive versus standard glycemic control on CVD outcomes in relatively high-risk patients with established type 2 diabetes.

In particular, three trials from 2008—the Action to Control Cardiovascular Risk in Diabetes (ACCORD) study, the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) study, and the Veterans Affairs Diabetes Trial (VADT)—have shed some light on the subject, but have also further fueled the debate regarding the role of intensive glucose therapy. “A common link between ACCORD, ADVANCE, and VADT is that they explored the potential impact of intensive glucose control strategies visit www.physiciansweekly.com

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on the rates of CVD in patients with type 2 diabetes,” Dr. Kendall says (Table). “However, interpreting this data may be challenging for some physicians because each study had key differences to consider.”

ACCORD Data from the ACCORD study demonstrated that using a strategy of intensively treating patients to achieve an A1C value of less than 6% had no impact on the rates of major CVD events when compared with patients randomized to achieve A1C levels between 7.0% and 7.9%.

“ACCORD was unique in that it was interrupted because of an unanticipated finding of higher mortality in patients who were treated with an intensive strategy,” says Dr. Kendall. “To date, however, this is the only study in which this observation has been made. At this point, we have limited understanding as to the origins of this observed increase in mortality.”

Dr. Kendall adds that “physicians should recognize that although normalizing A1C in all patients with type 2 diabetes is probably not advisable, achieving reasonable glucose control is still quite effective and has been shown to improve outcomes in these individuals.”

ADVANCE The ADVANCE study, according to Dr. Kendall, implemented an intensive glycemic control strategy in patients with lesser degrees of antecedent hyperglycemia. “These patients presented at baseline with lower A1C levels (7.2%) than participants in the ACCORD study (8.1%), suggesting less glucose exposure over the years prior,” he says. “They also had slightly shorter durations of diabetes and were using less medication at baseline to treat their diabetes.”

In ADVANCE, the goal was to reduce A1C to 6.5% in one cohort of patients and use local A1C guidelines for the other cohort. Findings demonstrated a significant reduction in the cumulative primary endpoint of microvascular

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and macrovascular outcomes. “However,” Dr. Kendall says, “there was no specific reduction in the rate of CVD events in the intensive glucose control group. Most of the advantages derived in ADVANCE resulted from decreased rates of microvascular complications, a finding that is consistent with other published literature.”

VADT The study population in VADT had longerstanding diabetes and entered the trial with much higher A1C values (median A1C, 9.4%). Patients were older and had failed to achieve glycemic control with usual non-insulin therapies. “The ADVANCE patient population was earlier in the disease course and, theoretically, a relatively simpler group to treat,” explains Dr. Kendall.

“Conversely, the VADT patient group was likely to require more complex treatment regimens and medications. In VADT, the intensive glucose lowering intervention was effective, achieving an average A1C of 6.9%. Again, however, it failed to show an effect on reducing the rate of future CVD events.”

Translating the Data Findings from ACCORD, ADVANCE, and VADT suggest that intensive glucose control interventions appear to have a limited impact on future CVD events when other risk factors (eg, blood pressure and cholesterol) are well controlled in patients with longer duration type 2 diabetes. “It should be noted, however, that these studies do provide helpful information for practitioners,” Dr. Kendall says. “For example, an important finding consistent within all three studies was a reduction in the risk of early evidence of renal disease for patients receiving the more intensive glycemic strategy. ACCORD, ADVANCE, and, to a lesser degree, VADT also confirmed that glucose control—albeit not more intensive glucose control—may still play a small role in CVD risk reduction. They all support the concept that glucose control remains essential for reducing the risk of the microvascular complications of diabetes.”

Table

Comparing 3 Trials of Intensive Glucose Control & CVD Outcomes

Participant Characteristics

ACCORD

ADVANCE

VADT

Number of patients

10,251

11,140

1,791

Mean age

62 years

66 years

60 years

Duration of diabetes

10 years

8 years

11.5 years

History of CVD

35%

32%

40%

Median baseline A1C

8.1%

7.2%

9.4%

On insulin at baseline

35%

1.5%

52%

<6.0% vs 7.0%-7.9%

≤6.5% vs “based on local guidelines”

<6.0% (action if >6.5%) vs planned separation of 1.5%

Multiple drugs in both arms

Multiple drugs added to gliclizide vs multiple drugs with no gliclizide

Multiple drugs in both arms

Embedded blood pressure and lipid trials

Embedded blood pressure trial

Protocol for intensive treatment in both arms

Achieved median A1C (I vs S)

6.4% vs 7.5%

6.3% vs 7.0%

6.9% vs 8.5%

On insulin at study end (I vs S) *

77% vs 55%

40% vs 24%

89% vs 74%

Intensive glycemic control arm

+3.5 kg

-0.1 kg

+7.8 kg

Standard glycemic control arm

+0.4 kg

-1.0 kg

+3.4 kg

Intensive glycemic control arm

16.2%

2.7%

21.2%

Standard glycemic control arm

5.1%

1.5%

9.9%

Nonfatal MI, nonfatal stroke, CVD death

Microvascular plus macrovascular (nonfatal MI, nonfatal stroke, CVD death) outcomes

Nonfatal MI, nonfatal stroke, CVD death, hospitalization for heart failure, revascularization

Hazard ratio for primary outcome

0.90

0.90

0.88

Hazard ratio for mortality findings

1.22

0.93

1.07

Protocol characteristics A1C goals (I vs S)*

Protocol for glycemic control (I vs S)*

Management of other risk factors On-study characteristics

Weight change

Severe hypoglycemia (participants with 1 or more episodes during study)

Outcomes

Definition of primary outcome

*Insulin rates for ACCORD are for any use during the study Abbreviations: ACCORD, Action to Control Cardiovascular Risk in Diabetes; ADVANCE, Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation; VADT, Veterans Affairs Diabetes Trial; CVD, cardiovascular disease; MI, myocardial infarction; I, intensive glycemic control; S, standard glycemic control.

Source: Adapted from: American Diabetes Association. Diabetes Care. 2010;33(Suppl 1):S11-S61.

David M. Kendall, MD, has indicated to Physician’s Weekly that he works full time for the American Diabetes Association (ADA). He currently serves on either Scientific or Advisory Oversight Committees for studies being conducted by the ADA, the National Kidney Foundation, and HealthPartners.

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This Physicianâ&#x20AC;&#x2122;s Weekly feature on chronic kidney disease and diabetes was completed in cooperation with the experts at the American Diabetes Association.

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Battling CKD

in Patients With Diabetes

The total number of new cases of chronic kidney disease (CKD) from diabetes in America is rising, but strides are being made toward better prevention and treatment of CKD, with the hope of reducing its burden in the future.

M. Sue Kirkman, MD Vice President of Clinical Affairs American Diabetes Association

E

ach year in the United States, more than 100,000 people are diagnosed with kidney failure, and diabetes is the most common cause of it, accounting for nearly 44% of new cases.

Even when diabetes is controlled, it can lead to chronic kidney disease (CKD) and kidney failure.

“According to current estimates, about 20% to

30% of people with diabetes have at least some CKD, although not necessarily end-stage renal disease,” explains M. Sue Kirkman, MD. “More patients with diabetes also have very early signs of kidney damage, such as microalbuminuria.

Fortunately, we now have interventions to help prevent early CKD from progressing or worsening in people with diabetes.”

Diabetic kidney disease takes many years to develop. In some patients, the filtering function of the kidneys is higher than normal in the first few years of the development of diabetes. Over several years, patients may develop low levels of albuminuria—termed microalbuminuria—but the visit www.physiciansweekly.com

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If kidney disease is detected, it should be addressed as part of a comprehensive approach to the treatment of diabetes.

—M. Sue Kirkman, MD

kidneys’ filtration function usually remains normal during this period. Greater amounts of albuminuria (macroalbuminuria) occur in parallel with the kidneys’ filtering function declining, forcing the body to retain various wastes along the way. As kidney disease progresses, physical changes in the kidneys can increase blood pressure. As such, early detection and treatment of even mild hypertension are essential for people with diabetes.

Early Screening is Imperative The American Diabetes Association recommends that every patient diagnosed with diabetes be screened for CKD (Table 1). “It’s better to

Screening for CKD & Defining Albumin Excretion Abnormalities

Table 1

The American Diabetes Association recommends the following screening tests for chronic kidney disease (CKD): • Perform an annual test to assess urine albumin excretion in type 1 diabetic patients with diabetes duration of 5 years, and in all type 2 diabetic patients, starting at diagnosis.

• Measure serum creatinine at least annually in all adults with diabetes regardless of the degree of urine albumin excretion. The serum creatinine should be used to estimate glomerular filtration rate, or GFR, and stage the level of CKD, if present.

Below are the definitions of abnormalities in albumin excretion: Category Normal

Spot collection <30 µg/mg creatinine

Microalbuminuria

30–299 µg/mg creatinine

Macroalbuminuria (clinical)

≥300 µg/mg creatinine Source: Adapted from: American Diabetes Association.

Diabetes Care. 2010;33(Suppl 1):S11-S61.

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diagnose it early and address problems at that time rather than waiting until more advanced CKD develops,” says Dr. Kirkman. The American Diabetes Association recommends administering an annual urine albumin assessment and a serum creatinine test with a calculation of the estimated glomerular filtration rate (eGFR). The annual urine albumin assessment is typically a spot urine albumin-to-creatinine ratio. The serum creatinine and eGFR are tested to measure kidney function.

“This second test is important because there is a fair amount of CKD that is not accompanied by albuminuria in patients with type 2 diabetes,” Dr. Kirkman says. “Simply looking for albumin excretion alone is probably not sufficient to catch kidney disease.”

A key part of screening for CKD in patients with diabetes is to become aware of the risk factors for it. Patients with longer duration of diabetes, poorly controlled diabetes for long periods of time, and uncontrolled hypertension are at greater risk for CKD than others. Smoking and obesity have also recently been identified as risk factors for CKD. In addition, African Americans, Native-American, and Hispanics/Latinos tend to have a higher risk for CKD than other racial and ethnic groups.

“When physicians see patients with these risk factors, it’s important for them to be screened as early as possible for CKD,” says Dr. Kirkman. “If kidney disease is detected, it should be addressed as part of a comprehensive approach to the treatment of diabetes.”

Interventions Can Prevent or Slow Kidney Disease

Great strides have been made in the development of interventions that slow the onset and progression

of kidney disease in people with diabetes, and anti­ hypertensive medications have been particularly useful. “Two types of medications—ACE inhibitors and angiotensin receptor blockers (ARBs)— have proven effective in slowing the progression of CKD,” Dr. Kirkman says (Table 2). It should be noted that many people require two or more drugs to control their blood pressure. In addition to an ACE inhibitor or an ARB, a diuretic can also be helpful. Other classes of drugs, including b-blockers, calcium channel blockers, and other antihypertensives, may also be needed. ACE inhibitors and ARBs not only lower blood pressure, but they also help protect the kidneys’ glomeruli.

These medications lower proteinuria and slow kidney deterioration even in people with diabetes who do not have high blood pressure. Both classes may also lower the risk of cardiovascular events.

Excessive consumption of protein may be harmful to the kidneys, so experts recommend that people with CKD resulting from diabetes consume no more than the recommended dietary allowance for protein and avoid high-protein diets. For people with greatly reduced kidney function, a diet containing reduced amounts of protein may help delay the onset of kidney failure.

Aim for Good Glycemic Control Research has also demonstrated that intensive glycemic control benefits patients with diabetes, especially for preventing onset or progression of the early stages of CKD. “Once kidney disease is more advanced, intensive glycemic control may not have an impact, but good blood pressure control is critical to slowing decline in kidney function,” says Dr. Kirkman. “In the future, it’s hoped that we’ll discover ways to more effectively predict which patients will develop CKD so that prevention and treatment strategies can be enhanced.”

M. Sue Kirkman, MD, has indicated to Physician’s Weekly that she has or has had no financial interests to report.

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Critical Treatment Recommendations

Table 2

General recommendations • To reduce the risk or slow the progression of nephropathy, optimize glucose control.

• To reduce the risk or slow the progression of nephropathy, optimize blood pressure control.

Treatment • In the treatment of the nonpregnant patient with micro- or macroalbuminuria, either ACE inhibitors or angiotensin receptor blockers (ARBs) should be used.

• While there are no adequate head-to-head comparisons of ACE inhibitors and ARBs, there is clinical trial support for each of the following statements: - In patients with type 1 diabetes, hypertension, and any degree of albuminuria, ACE inhibitors have been shown to delay the progression of nephropathy.

- In patients with type 2 diabetes, hypertension, and micro­albuminuria, both ACE inhibitors and ARBs have been shown to delay the progression to macroalbuminuria.

- In patients with type 2 diabetes, hypertension, macro­albuminuria, and renal insufficiency (serum creatinine >1.5 mg/dL), ARBs have been shown to delay the progression of nephropathy.

- If one class is not tolerated, the other should be substituted.

• Reduction of protein intake to 0.8-1.0 g · kg body wt–1 · day–1 in individuals with diabetes and the earlier stages of chronic kidney disease (CKD) and to 0.8 g · kg body wt–1 · day–1 in the later stages of CKD may improve measures of renal function (urine albumin excretion rate and glomerular filtration rate, or GFR) and is recommended.

•W hen ACE inhibitors, ARBs, or diuretics are used, monitor serum creatinine and potassium levels for the development of acute kidney disease and hyperkalemia.

• C ontinued monitoring of urine albumin excretion to assess both response to therapy and progression of disease is recommended.

• C onsider referral to a physician experienced in the care of kidney disease when there is uncertainty about the etiology of kidney disease (active urine sediment, absence of retinopathy, or rapid decline in GFR), difficult management issues, or advanced kidney disease.

Source: Adapted from: American Diabetes Association.

Diabetes Care. 2010;33(Suppl 1):S11-S61.

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This Physicianâ&#x20AC;&#x2122;s Weekly feature covering insulin initiation and strategies to overcome hurdles was completed in cooperation with the experts at the American Diabetes Association.

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Overcoming the Hurdles

of Insulin Initiation Insulin is generally viewed as an effective treatment for type 2 diabetes, but both physicians and patients often consider the drug as a last resort. Identifying barriers and solutions to insulin initiation may help enhance outcomes.

Mary T. Korytkowski, MD Professor of Medicine University of Pittsburgh School of Medicine, Division of Endocrinology

A

ccording to current recommendations for the management of type 2 diabetes, timely initiation of both oral medications alone or

in combination with insulin therapy is paramount to ensuring a desired level of glycemic control and improved patient outcomes. Although most providers agree that insulin is an effective approach to treating diabetes, many still consider it a last resort. “Patients are hesitant to take insulin for a variety of reasons,” says Mary T. Korytkowski, MD. “It is important that providers understand some of the barriers that exist among patients for insulin initiation as a way of reducing some of the negative attitudes many express to this form of therapy as a way of ensuring good outcomes.” visit www.physiciansweekly.com

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Questions to Ask Patients When Initiating Insulin Table 1

To determine a patient’s concerns when initiating insulin, consider the following:

1)

hat do you need to know to consider insulin W therapy?

2)

What problems do you think you will encounter?

3)

hat do you see as the biggest negative of insulin?

W The greatest benefit?

4)

What would help you overcome your concerns?

5)

A re you willing to try insulin? If not, what would cause you to consider insulin?

Source: Funnell MM. Clin Diabetes. 2007;25:36-38.

Before initiating insulin, it can be helpful to obtain an understanding of a patient’s view of insulin therapy. “When patients express apprehension, efforts to identify the reasons underlying this apprehension or refusal to take insulin can provide clinicians with the information they need to improve acceptance,” Dr. Korytkowski says.

“Insulin therapy means different things to different people. When barriers exist, it is important to determine the level of concern among patients and ask open-ended questions [Table 1]. Responses to such questions allow for the ability to follow up with additional inquiries that can help guide physicians to better understand and support their patients’ concerns.”

Assessing Patient Barriers

Several common patient related barriers to insulin initiation have been identified. These include: • Beliefs that insulin is a personal failure.

• Beliefs that insulin causes complications or death.

• Beliefs that insulin injections are painful.

• Fears of hypoglycemia, loss of independence, weight gain, and cost.

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Fortunately, there are strategies providers can use to address each of these barriers. “Providers previously used insulin as a threat to promote meal planning and exercise behaviors, but we’ve learned that this approach ultimately backfires when insulin is needed,” says Dr. Korytkowski. “To diminish beliefs that insulin results from personal failure, inform patients that non-insulin treatment options are no longer effective and describe insulin therapy as the next step in the continuum of treatment.

Informing patients that they may eventually require insulin early in the disease can prepare patients well in advance of a need for insulin initiation.”

Regarding efficacy, it is important to inform patients that insulin is a hormone normally made by their own pancreas. “Tell patients that they can continue to have flexibility in their lives—sometimes with more energy—for activities they enjoy with the initiation of insulin,” says Dr. Korytkowski. Some patients with diabetes have had experiences with the disease through relatives or friends. The belief that insulin causes complications or death may stem from these experiences. “Facts alone may do little to allay patients’ fears,” adds Dr. Korytkowski.

“Instead, acknowledge fears and then provide information about your own experiences as a clinician managing patients with diabetes. To address fears about painful injections, tell patients that insulin needles are smaller and thinner than ever before, and that most patients find it less painful than testing their blood glucose levels.”

Clinicians can acknowledge fears of hypoglycemia by discussing strategies for minimizing this risk and by providing education regarding early warning symptoms and treatment. Patients should be reassured that they will be taught strategies to prevent, recognize, and treat hypoglycemia while avoiding severe events. If weight gain is a concern, offer to arrange a meeting with a dietitian before initiating insulin to identify strategies to prevent weight gain. When costs are a concern, it may behoove physicians to inform patients that insulin can sometimes be less expensive than using multiple

Informing patients that they may eventually require insulin early in the disease can prepare patients well in advance of a need for insulin initiation.

—Mary T. Korytkowski, MD

Strategies for Providers to Overcome Barriers to Insulin Therapy

oral medications while also improving glycemic outcomes; this may ultimately reduce costs.

efer patients for diabetes self-management 1) Reducation and medical nutrition therapy:

While patient-identified barriers are the most common reasons cited for delays in initiating insulin therapy, many providers are also hesitant to initiate the drug. Some of these barriers are identified in Table 2. “Strategies exist to help physicians overcome barriers to insulin initiation,” says Dr. Korytkowski. “For example, patients can be referred to certified diabetes educators for diabetes self-management education and medical nutrition therapy. Diabetes educators can have a significant impact on helping patients both initiate and titrate insulin therapy. Patients require initial education about insulin as well as continued followup and support to sustain gains in diabetes self-care behaviors. Office staff can help in supporting and reinforcing self-management efforts related to insulin therapy, particularly in early phases.”

Table 2

• D iabetes educators can be powerful allies and assist with insulin initiation and dose titration.

•M any insurers cover the cost of education for these services. ongoing self-management support: 2) Provide

• P rovide patients with initial education about insulin and continued follow-up and support.

• U tilize office staff to further support and reinforce patients’ self-management efforts, particularly in the early phases. successful strategies: 3) Adopt

• I mplement strategies used by other successful practices.

• F oster collaborative relationships with patients.

• C reate proactive methods to evaluate outcomes and monitor results.

• E stablish frequent plans for follow-up by telephone or in person. emotional issues: 4) Address

• D iscuss concerns about diabetes in general.

• A sk patients about their thoughts or feelings about insulin.

• E nsure that messages about insulin are supportive, individually tailored, and effective.

Source: Funnell MM. Clin Diabetes. 2007;25:36-38.

Consider Provider Barriers Too

The key to overcoming insulin initiation issues, Dr. Korytkowksi says, is to create proactive, collaborative relationships with patients. “It’s essential to ask patients about their thoughts or feelings on insulin. Clinicians cannot forget the emotional toll that diabetes may take on patients, especially when insulin is necessary. By taking time to educate patients and address potential concerns early and throughout the course of treatment, physicians can help ensure that their messages about insulin are supportive, tailored for each individual, and effective.”

Mary T. Korytkowski, MD, has indicated to Physician’s Weekly that she has received consultant fees from Eli Lilly, and has served as an ad hoc grant reviewer for Pfizer.

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This Physicianâ&#x20AC;&#x2122;s Weekly feature covering effective approaches to managing newly diagnosed diabetes patients was completed in cooperation with the experts at the American Diabetes Association.

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Effective Approaches to Managing

Newly Diagnosed Diabetes Patients

Patients who learn that they have type 2 diabetes may find the news difficult to take. However, encouraging patients to learn about their disease and giving them the tools they need to manage it are important steps toward enabling them to feel better and live longer, healthier lives.

Richard M. Bergenstal, MD President, Medicine & Science American Diabetes Association Executive Director International Diabetes Center at Park Nicollet Adjunct Professor Department of Family Health Practice & Community Health & Medicine University of Minnesota

A

ccording to the American Diabetes Association, 23.6 million children and adults in the United States have diabetes,

25% of whom are undiagnosed. Approximately 1.6 million new cases of diabetes are diagnosed in people aged 20 and older each year. In addition, another 57 million people have pre-diabetes, a condition in which blood glucose levels are higher than normal but not yet high enough to be diagnosed as diabetes. People with prediabetes are at an increased risk of developing diabetes and cardiovascular disease. â&#x20AC;&#x153;Identifying diabetes and pre-diabetes early is critical because the earlier clinicians take measures to help patients with lifestyle changes and appropriate visit www.physiciansweekly.com

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medication choices the most initial success they will have and the more successful they will likely be in the long run in controlling their disease and preventing diabetes complications,” says Richard M. Bergenstal, MD.

Making the Diagnosis Historically, clinicians have used tests that are based on the measurement of plasma glucose to detect diabetes in people without symptoms.

These tests include a fasting plasma glucose (FPG) test or an oral glucose tolerance test (OGTT). Recently, the American Diabetes

Criteria for a Diagnosis of Diabetes Table 1

1)

A1C ≥6.5%

The test should be performed in a laboratory using a method that is National Glycohemoglobin Standardization Program certified and standardized to the Diabetes Control and Complications Trial assay.* For a diagnosis of pre-diabetes, A1C can range between 5.7% and 6.4%.

OR

2)

Fasting plasma glucose test (FPG) ≥126 mg/dL

Fasting is defined as no caloric intake for at least 8 hours.* OR

3)

2-hour plasma glucose ≥200 mg/dL during oral glucose tolerance test (OGTT). an

The test should be performed as described by the World Health Organization, using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water.* OR

4)

A random plasma glucose ≥200 mg/dL.

Only in a patient with classic symptoms of hyperglycemia or hyperglycemic crisis. *In the absence of unequivocal hyperglycemia, criteria 1-3 should be confirmed by repeat testing.

Source: American Diabetes Association. Diabetes Care. 2010;33(Suppl 1):S11-S61.

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Association suggested adding the A1C test as another diagnostic tool for identifying diabetes and pre-diabetes (Table 1). The A1C test reflects the average amount of glucose in the blood over the last 2 to 3 months, and is not affected by short-term physical and emotional stresses that can temporarily affect a blood glucose test. “A1C tests are accurate and precise, and offer several advantages over FPG and OGTT in diagnosing diabetes, including better technical attributes and greater clinical convenience,” Dr. Bergenstal says.

“A key advantage of the A1C test is that patients don’t have to fast for 8 hours, which is necessary for the FPG test. They also don’t have to endure several blood samples being taken over 2 hours, which is required for an OGTT.” Another advantage of the A1C test is that the sample is stable and can be stored at room temperature for longer times than samples for glucose testing. It should be noted, however, that using the A1C test to diagnose diabetes may not be appropriate in some situations, such as patients with heavy bleeding, those who are pregnant, and those with certain anemias. “Great strides have been made in standardizing the A1C test,” says Dr. Bergenstal, “and these assays are now accepted as diagnostic and screening tools if run in labs with appropriate standardization.” He adds that it is equally important for clinicians to understand who should be screened, as patients with several characteristics are considered at higher risk (Table 2).

Delivering the News It can be challenging for clinicians to inform patients that they have a type 2 diabetes diagnosis because they are often forced to balance being supportive with instilling a sense of urgency.

“As clinicians, it’s important to recognize that a diabetes diagnosis may leave patients in shock or feeling disappointed in themselves,” Dr. Bergenstal says. “Patients may also be in disbelief, or they may feel stressed, angry, or guilty upon hearing their diagnosis. It’s important for physicians to take extra time to tell patients

that they’re there to support them through their journey and that effective treatments are available to enable them to live long, healthy lives. At the same time, patients must understand that their disease is serious. Actions must be taken because their diabetes must not be ignored.”

Criteria for Testing for Diabetes in Asymptomatic Adults Table 2

1)

Testing should be considered in all adults who are overweight (BMI ≥25 kg/m2*) and have additional risk factors:

• Physical inactivity.

Dr. Bergenstal also says that clinicians should take time to find out what patients know about diabetes. He stresses that patients understand the ramifications of letting their diabetes go uncontrolled. “In addition to managing blood glucose, patients must also be advised to get their blood pressure and cholesterol levels under control and to exercise and eat right. The sooner actions are taken to fight diabetes, the better the long-term outcomes. Intervening early can pay off in the long run. Patients should become involved with a multidisciplinary team, which will treat them throughout their disease course. They should also talk with family, friends, and others with diabetes, and seek out ways to reduce stress, become more informed, and engage in a healthy lifestyle.”

Support is Available The American Diabetes Association (www. diabetes.org) is one of several well-respected advocacy groups that provide resources for newly diagnosed patients to improve their knowledge and understanding of diabetes. In November 2010, the ADA will make a new booklet available called Where Do I Begin Living With Type 2 Diabetes. Designed to help answer many of the questions new patients have on day one of diagnosis while not overwhelming them with too much information, this new patient resource launches the Living With Type 2 Diabetes program. It engages newly diagnosed patients by providing them with educational materials at various intervals in order to share information and support throughout their first year of life

• First-degree relative with diabetes.

• Members of a high-risk ethnic population (eg, African American, Latino, Native American, Asian American, Pacific Islander).

• Women who delivered a baby weighing >9 lb or were diagnosed with gestational diabetes.

• Hypertension (≥140/90 mmHg or on therapy for hypertension) • HDL cholesterol level <35 mg/dl (0.90 mmol/l) and/ or a triglyceride level >250 mg/dl (2.82 mmol/l).

• Women with polycystic ovary syndrome.

• A1C ≥5.7%, impaired glucose tolerance, or impaired fasting glucose on previous testing.

• O ther clinical conditions associated with insulin resistance (eg, severe obesity, acanthosis nigricans).

• History of cardiovascular disease.

2) 3)

In the absence of the above criteria, testing diabetes should begin at age 45.

If results are normal, testing should be repeated at least at 3-year intervals, with consideration of more frequent testing depending on initial results and risk status.

*At-risk BMI may be lower in some ethnic groups.

Source: American Diabetes Association. Diabetes Care. 2010;33(Suppl 1):S11-S61.

with type 2 diabetes. Dr. Bergenstal says “the hope is that clinicians will provide their patients with this booklet and encourage them to enroll in the Living With Type 2 Diabetes program so that they can live long, healthy lives even though they have this chronic disease.”

Richard M. Bergenstal, MD, has indicated to Physician’s Weekly that he is a volunteer officer of the American Diabetes Association, a member of Endocrine Society, and a member of the American Association of Clinical Endocrinologists, all of whom are interested in diagnosis of diabetes. No consulting has been relevant to the diagnosis of diabetes. He is also a shareholder of Merck and has received grants/ research aid from Bayer, Roche, Johnson & Johnson, Abbott Laboratories, Eli Lilly and Company, Novo Nordisk, and sanofi-aventis.

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This Physicianâ&#x20AC;&#x2122;s Weekly feature covering nutritional recommendations and interventions for diabetes was completed in cooperation with the experts at the American Diabetes Association.

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Setting the Stage for Good Nutrition in Diabetes

Patients with pre-diabetes or diabetes should receive individualized medical nutrition therapy, and counseling should be sensitive to their personal needs, willingness to change, and ability to make changes.

Wahida Karmally, DrPH, RD, CDE, CLS, FNLA Associate Research Scientist Lecturer in Dentistry Director of Nutrition Irving Institute for Clinical and Translational Research Columbia University

M

edical nutrition therapy (MNT) is an important part of preventing prediabetes and diabetes, managing existing diabetes, and preventing or slowing the rate of the development of diabetes complications. MNT is also an integral component of diabetes self-

management education and training. The goals of MNT are to achieve and maintain healthy A1C, blood pressure, and cholesterol levels by modifying the intake of nutrients and improving lifestyle behaviors. “The United States has about 57 million people with pre-diabetes, and most of these people have problems with being overweight and obese,” says Wahida Karmally, DrPH, RD, CDE, CLS, FNLA. “In addition, people with diagnosed diabetes are often already overweight or obese.

Using MNT and increasing physical activity are paramount to managing these individuals.”

Clinical practice recommendations on MNT, which are based on scientific evidence, have visit www.physiciansweekly.com

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recently been updated by the American Diabetes Association. Available at http://care. diabetesjournals.org, the recommendations can assist clinicians as they provide MNT to patients and offer strategies for specific patient groups (Table 1). “With MNT, it’s important to address individual nutrition needs,” says Dr. Karmally.

“That requires taking into account personal and cultural preferences as well as willingness to change. Another goal is to help people maintain the pleasure of eating by only limiting food choices when indicated by scientific evidence.”

Assessing the Evidence Clinical trials and outcome studies of MNT have reported decreases in A1C of about 1% in type 1 diabetes and 1% to 2% in type 2 diabetes, depending on the duration of the disease. The American Diabetes Association notes that the first nutrition priority in MNT is to encourage patients to implement lifestyle strategies that

Nutritional Interventions for Type 2 Diabetes & Older Adults Table 1

The American Diabetes Association recommends to following: Nutrition interventions for type 2 diabetes: • Implement lifestyle modifications that reduce intakes of energy, saturated and trans fatty acids, cholesterol, and sodium and to increase physical activity in an effort to improve glycemia, dyslipidemia, and blood pressure.

• Plasma glucose monitoring can be used to determine whether adjustments in foods and meals will be sufficient to achieve blood glucose goals or if medication(s) needs to be combined with MNT. Nutrition interventions for older adults with diabetes: • Obese older adults with diabetes may benefit from modest energy restriction and an increase in physical activity; energy requirement may be less than for a younger individual of a similar weight.

• A daily multivitamin supplement may be appropriate, especially for those older adults with reduced energy intake.

Abbreviation: MNT, medical nutrition therapy.

Source: American Diabetes Association. Diabetes Care. 2010;33(Suppl 1):S11-S61.

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will improve glycemia, dyslipidemia, and blood pressure (Table 2). Structured, intensive lifestyle programs involving participant education, individualized counseling, reduced dietary energy and fat intake, regular physical activity, and frequent participant contact are necessary to produce long-term weight loss.

Being Supportive “Many patients fail to understand the connection between losing weight and managing diabetes or preventing pre-diabetes,” Dr. Karmally points out. “Weight loss is necessary more for their overall health than for cosmetic value. Physicians need to articulate this to patients and counsel them as to how they can accomplish weight loss.

Simply telling patients to lose weight sets them up for failure because they often don’t know how to start or what they should be doing to lose weight. We should encourage even small health changes and provide concrete recommendations to get there. For example, instead of saying that patients need to cut back on their fat intake, explain to them that their dinner plate should be half vegetables, a quarter lean meat, fish, or chicken, and a quarter whole grains. This can help them visualize the advice.”

Individualizing Approaches People who have pre-diabetes or diabetes should receive individualized MNT. While utilizing MNT, it is important to consider the individual being treated. “If a young person has type 1 diabetes, MNT will need to be adjusted to account for body development and growth that comes with age,” explains Dr. Karmally. “If a woman is pregnant and has diabetes, we must think of the woman and her fetus. For people with type 2 diabetes who are overweight or obese, caloric reductions and nutrient supplementation are likely to be different than for other patients with diabetes. Furthermore, cultural differences should be considered. When creating MNT plans, it’s important to ask about what types of foods and snacks patients like to eat and what their families like to eat. After getting this information, healthcare providers can then help

Physicians are powerful motivators and can set the stage for successful MNT by encouraging their patients to collaborate with their diabetes care team.

—Wahida Karmally, DrPH, RD, CDE, CLS, FNLA

patients find ways to eat healthier without giving up their favorite foods.”

Physicians can play an integral role by advising their patients to visit registered dietitians or diabetes educators who are familiar with the components of MNT, Dr. Karmally says.

“Research suggests that patients are more likely to follow through with MNT when they are recommended to do so by their physician.

Physicians are powerful motivators and can set the stage for successful MNT by encouraging their patients to collaborate with their diabetes care team.”

Lifestyle changes typically do not happen overnight, says Dr. Karmally, and ongoing support is crucial. “Habits form over many years, so clinicians must understand that it may take time before patients make sustained changes in their nutrition and lifestyle and then maintain these changes. Physicians should take a patientcentered approach and provide individuals with the education and information they need to prepare them to take action. Diabetes is a chronic disease that requires ongoing, tailored counseling to ensure that nutritional and lifestyle changes are upheld by patients for the long haul.”

Energy Balance, Overweight, and Obesity Table 2

The American Diabetes Association recommends to following: • In overweight and obese insulin-resistant individuals, modest weight loss has been shown to improve insulin resistance.

-W eight loss is recommended for all such individuals who have or are at risk for diabetes.

• For weight loss, either low-carbohydrate or low-fat calorie-restricted diets may be effective in the short term (up to 1 year).

• For patients on low-carbohydrate diets, monitor lipid profiles, renal function, and protein intake (in those with nephropathy).

- A djust hypoglycemic therapy as needed.

• Physical activity and behavior modification are important components of weight loss programs and are most helpful in maintenance of weight loss.

•W eight loss medications may be considered in the treatment of overweight and obese individuals with type 2 diabetes and can help achieve a 5%-10% weight loss when combined with lifestyle modification.

• B ariatric surgery may be considered for some individuals with type 2 diabetes and BMI ≥35 kg/m2 and can result in marked improvements in glycemia.

- T he long-term benefits and risks of bariatric surgery in individuals with pre-diabetes or diabetes continue to be studied.

Source: American Diabetes Association. Diabetes Care. 2010;33(Suppl 1):S11-S61.

Wahida Karmally, DrPH, RD, CDE, CLS, FNLA, has indicated to Physician’s Weekly that she has worked as a consultant for Shionogi, Porter Novelli, JSH Management, and the Almond Board of California.

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visit www.physiciansweekly.com

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This Physicianâ&#x20AC;&#x2122;s Weekly feature covering guidelines for heart health in diabetes was completed in cooperation with the experts at the American Diabetes Association.

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Helpful Guidelines for

Heart Health in Diabetes A new position statement released by the American College of Cardiology Foundation, the American Diabetes Association, and the American Heart Association recommends that fewer patients with diabetes at risk for cardiovascular disease take low-dose aspirin than was previously recommended.

Craig D. Williams, PharmD Clinical Associate Professor Department of Pharmacy Practice Oregon State University College of Pharmacy Oregon Health & Science University

R

esearch has shown that patients with diabetes are at two to four times greater risk of suffering cardiovascular disease (CVD) events

when compared with patients who do not have diabetes. Several mechanisms have been linked to the increased CVD risk in people with diabetes, including increased intracoronary thrombus formation, elevated platelet reactivity, and worsened endothelial dysfunction. “Aspirin has been shown to be effective in reducing cardiovascular morbidity and mortality in high-risk patients with heart attack or stroke,” explains Craig D. Williams, PharmD. “However, there has been some confusion surrounding the use of aspirin in patients who do not yet have CVD. That confusion is even greater among patients with diabetes.” visit www.physiciansweekly.com

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In 2007, the American Diabetes Association and the American Heart Association (AHA) jointly recommended that aspirin be used as a primary prevention strategy in patients with diabetes who are at increased cardiovascular risk.

This patient group includes those who are older than 40 or who have additional risk factors, such as a family history of CVD, hypertension, smoking, dyslipidemia, or albuminuria. “These recommendations were derived from older trials that included fewer patients with diabetes,” says Dr. Williams. “We now have results from two recent randomized controlled trials—the Japanese Primary Prevention of Atherosclerosis with Aspirin for Diabetes and the Prevention of Progression of Arterial Disease and Diabetes trials—in which aspirin use was examined specifically in patients with diabetes. These studies provide important insights on the efficacy of aspirin for primary prevention in diabetes, but they have also stirred some controversy because findings were somewhat conflicting with previous recommendations.”

Updating Recommendations In light of new data, the American Diabetes Association, AHA, and the American College of Cardiology Foundation convened a group of experts to review and synthesize available evidence to update recommendations about the efficacy of aspirin for primary prevention in people with diabetes. Published jointly in the Journal of the American College of Cardiology, Diabetes Care, and Circulation in 2010, the new recommendations continue to strongly recommend low-dose aspirin for all patients who have previously had a heart attack or stroke. The update also indicates that low-dose aspirin therapy is a reasonable measure to prevent a first heart attack or stroke among people with diabetes who also have a high risk for CVD (Table 1).

Dr. Williams, who was a co-author of the guideline, notes that a key change from previous recommendations is the age at which patients with diabetes should receive low-dose aspirin as primary prevention. “People with diabetes who

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Highlighting Key Recommendations Table 1

• Low-dose (75-162 mg/day) aspirin use for prevention is reasonable for: - Adults with diabetes and no previous history of vascular disease who are at increased CVD risk (10 year risk of CVD events over 10%).

- Adults with diabetes and no previous history of vascular disease who are not at increased risk for bleeding based on a history of previous gastrointestinal bleeding or peptic ulcer disease or concurrent use of other medications that increase bleeding risk, such as NSAIDs or warfarin.

• Adults with diabetes at increased CVD risk include most men older than 50 and women older than 60 who have one or more of the following additional major risk factors: - Smoking.

- Hypertension.

- Dyslipidemia.

- Family history of premature CVD. - Albuminuria.

• Aspirin should not be recommended for CVD prevention for adults with diabetes at low CVD risk, including men younger than 40 and women younger than 60 with no major additional CVD risk factors; or those with 10-year CVD risk under 5%.

- The potential adverse effects from bleeding offset the potential benefits.

• Low-dose (75-162 mg/day) aspirin use for prevention might be considered for those with diabetes at intermediate CVD risk (younger patients with one or more risk factors, or older patients with no risk factors, or patients with 10-year CVD risk of 5–10%) until further research is available.

Abbreviation: CVD, cardiovascular disease.

Source: Adapted from: Pignone M, et al. Diabetes Care, 2010;33:1395-1402.

are eligible for low-dose aspirin therapy generally include most men over the age of 50 and most women over the age of 60 who have at least one additional risk factor,” he says. “Trials to determine whether aspirin can prevent a first heart attack or stroke in adults with diabetes have had mixed results. Overall, however, they suggest that aspirin modestly reduces the risk of CVD events.”

Low-dose aspirin therapy is a reasonable measure to prevent a first heart attack or stroke among people with diabetes who also have a high risk for CVD. Another key update to the guideline is that some patients with diabetes are now not recommended to receive aspirin. “Low-risk patients—those who have a 10-year risk of a heart attack or stroke of less than 5%—should not receive low-dose aspirin therapy because their risks for bleeding likely outweigh any benefit,” Dr. Williams says. “The major adverse effects of aspirin therapy include intracranial and gastrointestinal bleeding. For lowrisk patients, the potential benefits of aspirin are less likely than the potential harm brought on by increased bleeding rates.” The guideline also notes that scientific evidence to support aspirin therapy depends on underlying CVD risk. Patients with higher risk are expected to have greater benefits by taking aspirin, but the decision to use this therapy depends on the use of other treatments, including cholesterol-lowering agents, blood pressure control, and smoking cessation (Table 2).

Looking Ahead The guideline notes that more research is needed to better define the specific effects of aspirin in patients with diabetes, including gender-specific differences. “We’re eagerly anticipating the result of other larger ongoing clinical trials on the use of aspirin specifically in patients with diabetes,” says Dr. Williams. “In addition, the development of an effective surrogate test for analyzing antiplatelet function—similar to what is currently available to assess A1C, blood pressure, and cholesterol— is paramount to gaining a more meaningful understanding of the efficacy of antiplatelet therapy in patients with diabetes. The hope is that more data on aspirin use in patients with

diabetes and progress toward the development of antiplatelet function testing will provide clinicians with more clarity and direction on how to manage patients optimally based on their unique characteristics.”

Aspirin Use & Concurrent Therapies Table 2

The decision as to whether or not patients have sufficient CVD risk to warrant aspirin use will depend on several factors, including the use other effective techniques for CVD risk reduction, including statins, blood pressure control, and smoking cessation. Consider the following: • Each of these therapies also lowers the risk of CVD events and should be considered when deciding about aspirin use.

• If other effective treatments are adopted first, then fewer patients with diabetes will remain at sufficient risk to warrant aspirin use, in light of its potential adverse effects.

- For example, a patient at 20% 10-year risk based on elevated blood pressure and suboptimal lipid levels would have their risk reduced from 20% to 13% by taking a statin and from 13% to 10% based on effective blood pressure control.

- This makes the decision about whether to take aspirin more complex.

• Although the risk reduction with these additional therapies does not occur immediately, their effects can be assumed to occur with rapidity sufficient to incorporate them in the initial decision-making process.

Abbreviation: CVD, cardiovascular disease.

Source: Adapted from: Pignone M, et al. Diabetes Care, 2010;33:1395-1402.

Craig D. Williams, PharmD, has indicated to Physician’s Weekly that he has worked as a paid speaker and has received grants/research aid from Merck and Co.

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