March 2016 • Volume 14 Number 3
Epidemic Gun Violence Gary Slutkin, MD
Antidepressants By Lee Beecher, MD
Atrial Fibrillation By Lin Yee Chen, MD, MS
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CONTENTS
4 7 8
MARCH 2016 • VOLUME 14 NUMBER 3
16
NEWS
PEOPLE
PERSPECTIVE A new ecosystem for health Creating a shared vision
Center for Innovation at Mayo Clinic
10 QUESTIONS Expanding access to care
PUBLIC HEALTH America’s gun violence epidemic Applying a medical model of control By Gary Slutkin, MD
14
18 20
FORTY-FIFTH SESSION
CARDIOLOGY Atrial fibrillation Irregular heartbeats take a toll
CALENDAR
SENIOR CARE Adult day programs Looking at a well-kept secret
Medical Innovation vs. Medical Economics Ecconomics W h e n p a y m e nt p o l i c i es limit q u a lit y o f li f e
By Barb Zeis
22
Jane Anderson, APRN, CNP, DNP Director, M Health Nurse Practitioners Clinic
12
PEDIATRICS Childhood obesity Assessing risks and prevention By Jessica Larson, MD, and Claudia Fox, MD, MPH
Douglas L. Wood, MD, FACP, FACC
10
MINNESOTA HEALTH CARE ROUNDTABLE
26
DENTAL HEALTH Implants A permanent solution to missing teeth By Matthew Karban, DMD, MD, and Paul Thai, DDS
ONCOLOGY Colon cancer Preventable, treatable, and survivable By Avina Singh, MD
28
BEHAVIORAL HEALTH Antidepressants Treating the whole patient By Lee Beecher, MD, DLFAPA, FASAM
By Lin Yee Chen, MD, MS
PUBLISHER Mike Starnes | mstarnes@mppub.com EDITOR Lisa McGowan | lmcgowan@mppub.com ASSOCIATE EDITOR Richard Ericson | rericson@mppub.com ART DIRECTOR Joe Pfahl | joe@mppub.com
Thursday, April 21, 2016 • 1:00-4:00 PM The Gallery (lobby level), Downtown town Minneapolis Hilton Hi and Towers Background and Focus: Th The pace off iinnovation ti in i medical di l science i iis rapidly idl escalating. From more accurate diagnostic equipment, to the use of genomic data, to better surgical techniques and medical devices, to new and more efficacious pharmaceuticals, breakthroughs occur nearly every day. These advances face many challenges when incorporated into medical practice. Several significant factors limit this adoption, including the economic models around how patient use of new science will be utilized. Twentieth century health insurance, medical risk management, and reimbursement models are controlling 21st century medical care and patients are the losers. Objectives: We will review examples of recent scientific advances and the difficulties they face when becoming part of best medical practice, despite their clear superiority over existing norms. We will look at prevailing thinking behind economic models that govern how health care is paid for today. Our panel of industry experts will explore potential solutions to these problems. We will look at ways to create balance between payment models, new technology, and increased quality of life. Panelists include: • Hamid R. Abbasi, MD, PhD, FACS, FAANS Board Certified Neurosurgeon, Tristate Brain and Spine Institute • Susan McClernon, PhD Faculty Director, U of M Health Services Management Program Sponsors include: Tristate Brain and Spine Institute Please send me tickets at $95.00 per ticket. Tickets may be ordered by phone at (612) 728-8600, by fax at (612) 728-8601, on our website (mppub. com), or by mail. Make checks payable to Minnesota Physician Publishing. Mail orders to MPP, 2812 East 26th Street, Mpls, MN 55406. Please note: tickets are non-refundable. Name Companyy Address
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Minnesota Heath Care News is published once a month by Minnesota Physician Publishing, Inc. Our address is 2812 East 26th Street, Minneapolis, MN 55406; phone 612.728.8600; fax 612.728.8601; email mpp@mppub.com. We welcome the submission of manuscripts and letters for possible publication. All views and opinions expressed by authors of published articles are solely those of the authors and do not necessarily represent or express the views of Minnesota Physician Publishing, Inc., or this publication. The contents herein are believed accurate but are not intended to replace medical, legal, tax, business, or other professional advice and counsel. No part of this publication may be reprinted or reproduced without written permission of the publisher. Annual subscriptions (12 copies) are $36.00/ Individual copies are $4.00.
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MARCH 2016 MINNESOTA HEALTH CARE NEWS
3
News
Essentia Health Using Technology to Remotely Monitor Heart Health Essentia Health — Fargo has started using implanted miniature, wireless monitoring sensors to help manage heart failure in patients. It is the first in the region to use the CardioMEMS HF System. The system measures pressure in the artery using a sensor that is implanted in the pulmonary artery in a non-surgical procedure. Increased pulmonary artery pressures occur before weight and blood pressure changes, and are often considered as indirect measures of worsening heart failure. Patients transmit daily sensor readings to their health care providers from their homes, allowing providers to easily track the data and adjust treatment if needed to reduce the likelihood of hospitalization. “This is something that is going to be very beneficial in patients who have heart failure,” said Samantha
4
Kapphahn, interventional cardiologist at Essentia Health. “For patients who have been hospitalized in the last year, this can decrease their risk of being readmitted, help with medication changes, and overall improve their quality of life.”
Minnesota Makes Progress on Some Adverse Health Events There were a total of 316 adverse health events reported to the Minnesota Department of Health (MDH) from October 2014 to October 2015, according to the department’s 12th annual Adverse Health Events report. That number is up slightly from last year’s report, which showed 308 reported adverse health events. Of the 316 reported events, 30 percent (93 cases) resulted in serious injury and about 5 percent (13 cases) led to death. Both statistics were similar to last year’s report, which included 98 serious injuries and 13 deaths. The number of deaths associated with adverse health events has
Minnesota Health care news March 2016
stayed steady over the last four years. The most frequently reported adverse health events were pressure ulcers (104), falls associated with serious injury or death (67), and surgeries/invasive procedures performed on the wrong site/body part (29). There was an increase in procedures done at the wrong spine level in this year’s report. The type of event most likely to lead to serious patient harm or death was falls, with four of the 67 cases leading to death. Medication errors accounted for 14 cases (four of which led to death) and neonatal events accounted for seven cases (five of which led to death). Overall, in the 12 years the report has been published, the most common causes of serious harm or death have been falls, medication errors, and suicide/ attempted suicide. Improvements were made in the categories of falls and surgical errors related to a failure to remove all materials involved in the operation. The number of falls associated with serious injury or death declined to
67, the lowest ever reported, and the number of fall-related deaths is the lowest it has been since 2011. Those related to retained foreign objects from surgery declined to 22, also the lowest ever reported and a significant decrease from the previous year’s 33 cases. “Although even one avoidable death or injury is too many, this year’s report shows the progress we are making, especially in preventing falls,” said Ed Ehlinger, MD, Minnesota commissioner of health. “Our approach of openness and public reporting is helping to encourage overall improvements and new opportunities to protect patients.” MDH and its partners will work to improve these statistics in 2016 by focusing on addressing prenatal safety; working with surgery and procedural teams to address full and accurate completion of the Minnesota Time Out process for every patient every time; and implementing standardized processes for specimen collection and transport to prevent biological specimen loss or damage.
Study Finds Rural Obstetric Units Closing A study from the University of Minnesota School of Public Health shows that obstetric units in rural hospitals are closing because of staffing difficulties, low birth volume, and financial burdens. Researchers analyzed hospital discharge data from between 2010 and 2014 and conducted interviews to identify factors that contributed to the closing of obstetric units at rural hospitals. They found that 7.2 percent of the hospitals had closed their obstetric units. The units that closed were within hospitals that were typically small and located in communities with reduced resources such as lower family incomes and fewer obstetricians and family physicians. “The decline of obstetric units interferes with the goals set by the Patient Protection and Affordable Care Act concerning timely access to quality care for women,” says Peiyin Hung, doctoral student and lead author of the study. “Rural women in these communities need to travel an average of 29 miles— and up to 65 miles—for intrapartum care.” Researchers found that women living in low-income communities and places where there were fewer obstetric providers were more likely to terminate their obstetric services. “The continued decreases in the number of family physicians being trained and choosing to provide obstetric care may put obstetric services in rural communities in danger,” said Hung. “Appropriate regionalization of maternity care needs to be implemented, particularly in rural communities with greater risk of obstetric service discontinuation.” According to Hung, future policy changes could help rural hospitals keep their obstetric units open. “Currently, the Improving Access to Maternity Care Act is under revision. This Act aims to identify maternity care workforce shortage areas and it may help in monitoring and preparing for potential obstetric unit closures based on local perinatal needs,” said Hung.
In addition, the study showed that more than half of pregnant women in rural areas are covered by Medicaid, which means the program plays a substantial role in the future of rural hospitals’ obstetric units.
Life.
And all the living that goes with it.
“Future studies should examine the effects of obstetric unit closures on local women’s maternity care accessibility, childbirth costs, and maternal/neonatal outcomes, especially among women in rural areas where obstetric resources are very limited,” said Hung.
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EMTs Using New Technology to Determine Children’s Medication Dosage North Memorial has begun using new software to help its first responders determine appropriate medication dosages for children. The system, made by Handtevy, helps get medication to children faster by quickly calculating precise dosages based on size and weight. Emergency medical technicians and paramedics use the system on electronic tablets, which allow them to make dosage adjustments quickly while in the field.
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Previously, emergency responders used paper materials to calculate proper dosages. North Memorial is the first ambulance service in Minnesota to use the new technology. “Fortunately we don’t get kids who are extremely sick very often, but when we do they need help very fast,” said John Lyng, MD, medical director for North Memorial Ambulance and Air Care. “Any type of condition for a child that you can think of we are able to treat more effectively now.” North Memorial is using about 300 tablets with the new technology—one for each ambulance and a helicopter. The health care system hopes to implement it into North Memorial Medical Center’s emergency room in the future.
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News to page 6
March 2016 Minnesota Health care news
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News from page 5
HCMC Richfield Clinic to Move, Double in Size HCMC has announced its Richfield Clinic at the Hub Shopping Center will move to a location two blocks away at Market Plaza in Richfield. The new clinic location will be twice the size it is now. “The current location has served our patients well for 20 years, but we’ve simply outgrown the physical space,” said Scott Wordelman, vice president of ambulatory care at HCMC. The new clinic will have a full-service pharmacy, offer extended hours and Saturday appointments, and offer free parking. “As we add new community and neighborhood locations, like Golden Valley and St. Anthony Village where we opened clinics in recent years, we also want to improve our existing clinics where we have a loyal patient base and we are doing that in Richfield,” said Wordelman.
“The Market Plaza location gives us flexibility to respond to the health care needs of the community while providing room to do even more, like expand our Health Care Home program.”
Fairview Health Opens Sleep Center in Burnsville Fairview Health Services has opened a new sleep center on the Fairview Ridges Hospital Campus in Burnsville. The center offers treatment for disorders such as sleep apnea, insomnia, narcolepsy, snoring, and sleep walking, which can affect overall health and contribute to problems such as weight gain, diabetes, mood disturbances, and higher mortality rates. The center offers home sleep studies and virtual care for certain sleep conditions to make it more convenient for patients. “In simple terms, our brain will not work well without sleep and
our body needs the restoration sleep provides,” said Conrad Iber, MD, medical director of the Fairview Sleep Program. “Our happiness, safety, critical thinking, and physical health all depend on regular, uninterrupted, and adequate daily dose of sleep.” With the new location, sleep specialists now offer consultations and studies at five Fairview Health locations in the metro area. More than 3,500 patients visited the sleep centers last year.
HCMC Tests Bikes as Winter Emergency Disaster Response Tools Hennepin County Medical Center (HCMC) partnered with the 2016 Winter Cycling Congress’ three-day conference to test whether bicycles could assist during winter disasters. On the morning of Feb. 3, 20 to 30 participating bicyclists rode across an area encompassing 30
miles of checkpoints along the Minneapolis bikeway system and neighborhood streets. The situation simulated a power outage over a widespread area with gridlocked traffic that prevented emergency vehicles from reaching disaster scenes. Bicyclists completed assignments meant to test the effectiveness of using bikes to respond to emergency situations under winter conditions, such as moving supplies, where they were asked to haul a 40 pound sandbag, or just clock their speed in reaching a destination. “They may be asked to deliver supplies to a specific location or complete other tasks as assigned,” said John Hick, MD, medical director for emergency preparedness at HCMC. “Should there be a disaster that affects traffic or infrastructure downtown, having bicycles navigate alternative routes could prove to be an essential resource to perform emergency response activities.” Similar simulations have taken place at previous cycling congress events, but this is the first time one has taken place in winter.
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UCare for Seniors is an HMO-POS plan with a Medicare contract. Enrollment in UCare for Seniors depends on contract renewal. ©2015, UCare H2459_101512 CMS Accepted (10202012) Minnesota Health care news March 2016 6 UC693 2015 Boomer MPP MN Health Care News_Hippie.indd 1
9/14/15 9:03 AM
PEOPLE
Nancy Rost, MD
Ryan Lussenden, MD
Nancy Rost, MD, board-certified specialist in pediatrics, has joined Affiliated Community Medical Centers (ACMC)–Willmar. She earned her medical degree from the University of New Mexico School of Medicine and completed her residency in general pediatrics at Mayo Clinic. Most recently, Rost worked at Children’s Hospital of Aurora in Denver, Colorado. Ryan Lussenden, MD, general and bariatric surgeon, has also joined ACMC–Willmar. Lussenden earned his medical degree from Albany Medical College in New York. He completed his general surgery residencies at Mayo Clinic and Santa Barbara Cottage Hospital in California and a bariatrics fellowship at Lahey Clinic in Burlington, MA. Most recently, Lussenden worked at Florida Medical Center in Sunrise, FL. In his position at ACMC, Lussenden will also provide outreach to the clinic in Benson.
Sounally Lehnhoff, CRNA, certified registered nurse anesthetist at Northwest Anesthesia, has received the quarterly Minnesota Hospital Association’s Good Catch for Patient Safety award. She was recognized for taking action during a preoperative timeout when she noted that the patient’s blood bank band had the wrong patient name and did not Sounally match the patient’s identification band. Surgery was Lehnhoff, CRNA delayed an hour so a new blood type test and crossmatch could be conducted. Lehnhoff earned her master of nurse anesthesia degree at Mayo School of Health Sciences. Elizabeth Moorhead, MD, hospitalist physician, has joined Hennepin County Medical Center. Moorhead cares exclusively for hospitalized patients and works with primary care providers to ensure a smooth transition for the patient as they move from the hospital to their home. She earned her medical degree at the University of Minnesota and completed a residency in internal medicine at the University of Illinois in Chicago.
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Sister Mary Madonna Ashton, of the Sisters of St. Joseph, has been named a 2016 National Women’s History Month honoree by the National Women’s History Project. She served as president and CEO of St. Mary’s Hospital in Minneapolis (now owned by Fairview) for 20 years before becoming the first woman, nun, and non-physician to serve as Sister Mary Minnesota Commissioner of Health from 1983 to Madonna Ashton 1991. In her role as commissioner, she made progress addressing smoking cessation and AIDS prevention in Minnesota. After her term, she founded St. Mary’s Health Clinics for people without access to heath care, run by volunteer physicians and nurses. She opened the first clinic in 1992 and that grew to 11 clinics by the time she retired in 2000. Sister Mary Madonna earned her master of social work from St. Louis University and a master of hospital administration from the University of Minnesota. At age 92, she is the oldest living recipient and the second sister to be honored since the project launched in 1980. MARCH 2016 MINNESOTA HEALTH CARE NEWS
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PERSPECTIVE
A new ecosystem for health Creating a shared vision
H
ealth does not mean the absence of disease. It means enabling people to live their lives fully so that they can meet the needs of all those who rely upon them. Health care innovations can promote these aims, by discovering and implementing solutions to improve both health and care processes.
The problem with such innovation is not a lack of advances in genetics, drugs, and devices, but rather a lack of innovation in the delivery system itself. Successful innovation is significantly impeded by payment systems that focus on the number of visits, tests, and procedures, rather than on the need to improve health.
Douglas L. Wood, MD, FACP, FACC Center for Innovation at Mayo Clinic Dr. Wood is the medical director of the Center for Innovation and a practicing cardiologist at Mayo Clinic. He previously served as vicechair of the Department of Medicine, and chair of the Division of Health Care Policy and Research at Mayo. He served on the Governor’s Health Care Reform Task Force and has been a leader in health reform in Minnesota. Dr. Wood has held important posts in the American College of Cardiology and the American Medical Association and has been an adviser to the Secretary of Health and Human Services in both Republican and Democratic administrations.
A new vision of what health should be
This new ecosystem starts with a vision of what health should be, including all the determinants of health, in which innovation is needed to make our new vision function. It should start with a deep understanding of what people need, followed by a way to bring about accessible and affordable services within a system that is capable of rapid, adaptive change. In my view, this new ecosystem for health will be initiated and implemented by individuals and organizations outside of established medical institutions, in response to real and personal challenges. The resulting products and services could create a new network of resources, or could alter existing networks. Of course, success will depend on access, affordability, outcomes, and trust. Established medical institutions—such as Mayo Clinic—will need to remain relevant and identify their place and role within the new ecosystem. With these forces at play, the new ecosystem for health will thrive because it will be based on people’s actual needs. Every year, I see more individuals, entrepreneurs, and health care providers challenge assumptions, take risks, and make significant changes for the future of health. These brave souls recognize that the existing structure is too entrenched, and we find our country, for the most part, still burdened with skyrocketing pharmaceutical prices, shackled to reimbursement systems based on sickness care,
MINNESOTA HEALTH CARE NEWS MARCH 2016
There is no question that we need a new model to achieve changes in health. Some of the most promising momentum I’ve seen comes from a relatively small annual gathering of innovators and disruptors called the Transform conference, hosted by the Mayo Clinic Center for Innovation. Transform engages people to boldly create a sustainable future for health. In 2015, more than 700 attendees from 34 states and 15 countries participated in the three-day event, where they learned of innovations such as: • A remote blood glucose monitoring system that allows parents to view blood sugar levels of children when they are away from home. Software developer John Costik created the device for his son, who was born with type 1 diabetes.
Consumers need to insist on having health.
Health care is just a small part of the larger ecosystem of health. We have to think about health at home, at work, or at school, and then integrate in aspects of public health, mental health, access to care, integration of care, affordability, insurance, technology, and infrastructure.
Signs of change
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and wrestling with rising insurance costs, despite the Affordable Care Act (ACA).
• “Oscar,” an alternative insurance company developed by entrepreneur Mario Schlosser. Paying its first benefits in 2014, Oscar now claims 40,000 members, more than doubling the number of members in the last open enrollment period in New York, one of the most competitive insurance markets in the country. • Latino Health Access in Santa Ana, California, created by America Bracho, MD, to improve the health of those living at or near the poverty line. Latino Health Access trains local community health workers or “promotores,” who go door-to-door to promote healthful eating, exercise, and preventive medical tests.
Taking the first steps Physicians need to think about health first, and then what it means to truly understand people’s health needs. Physicians then have to create care plans that focus on their patient’s health goals rather than on narrowly defined treatments or guidelines based solely on clinical measures or processes. Consumers need to insist on having health, meaning the ability to live a meaningful, productive life without the burden of illness. This includes burdens imposed by physicians with prescriptions and proscriptions that are not relevant to a person’s goals for health. This new ecosystem is already starting to form, as people and organizations gravitate toward resources and connections that work for them and as entrepreneurs create innovations in response to what truly benefits people. I hope that we continue to see more changes like these within our health care system.
rehabilitate a body, we start T owith the mind and soul. If you y or someone someeone you y u kn kknow ow nee needs eeds d reh ds rehabilitation ehab abil ilitat atio ioon af afte after terr an n aaccident, c iden cc iden id e t, t, ssurgery, u gge ur gery ery r y, il illness lln nes ess or sstroke, trok trok tr oke,, w wee ha h have ve a ve If you or someon ne you kn know w nee e ds reh eh habillit i at atio ion n affte t r an acc c id i en nt, t, surrge gerryy, gery y il illn ln nesss oorr str troke okkee,, we ha have ve a ve recover physically, need support mentally simple imple premise pre p emise miise ffor or you to consider consid cconsider: co nsider: nsider nsid der: r: To T rrec recov ec e oovver p ecov h ssi hysi hy sica ica call all lly, lly, y, yyou ou un eeed ee ed d su supp upp ppor p poort orrt me ment m men ent ntal nt aally lly lly ly and and nd emotionally. eemo moti mo oti tion oonal nally alllly al ly. How How Ho simple premise forr you o to consid der: Too reccov o er phyysi sica call ca llyy, you u nee e d su supp pp port ort me or ment nttally alllyy and d em mootion tiion nal ally ally ly. y. Ho H w make most effective positive p po sitive t ve and and d how how determined det dete deter e ermined ined ed d someone soome meon eone iiss ccan aan nm ake aak ke aal all ll tthe th he difference. diff di d ifff ffer eerrren een nce ce. We We believe beelliieevee the the he m ost eef os ost fffeect ctiiv ive ve therapy ther tth heer erap rap apy positiive and how deterrmineed some meone iss can mak akee al alll th he diifffer eren en ence nce c . We bellieevee the mos ost effe effe ef fect ctive ct ivve th her e ap apy approach. treats yyour our body, body, mind and soul. bod sou soul oul ul. l Tha T That’s Th h tt’ss ou ourr ap appr proa proa p oach h. treats your body d , mi m nd d and n sou ul. Thaat’’s ou ourr ap ppr proa oaach h. Post-acute services Samaritan Society Po Post t-acute rehabilitation rehabil i itation se erviccess from m th the Go Good o S am mar a ittan S o ieetyy aare oc re ooffered re ffferred e at at multiple mu m ult l ip iple ple inpatient inp pat atieent and atie and d Post-acu ute reh habil i itation servvices es froom the Goood d Sam amar arit i an it n Soccieety ty are re off ffer erred d at mult mult mu l iple ip ple le inpat npat np a ie ient ent and locations throughout Minnesota the Minneapolis/St. Paul outpatient p lloc ocat atio at iions ns throu thr uggh ghou hout hout o t Minn Mi inn n es esot sota o a an and d th he Mi M inn nnea nea eapo pooliis//S p Stt.. P Pa aul ul are aarea. rea. rre ea o tpat ou atient loccations n throu o gh g ou ut Mi Minn n es e ot otaa an nd th he Miinn nnea e po ea p li lis/ is/ s St St.. Paul Paull are Pa rea. ea. a. To make mak a referr referral rrall or or for fo or more more information, iinforma informati nfor nf orma mati tiion tion n, call caalll us us at at To make a reeferr r al or fo rr f r mo more inf n or orma mati tion on caall l us at (888) (888 88) 8) GSS-CARE GSS CARE or visit visi i it www.good-sam.com/minnesota. www ww ww. w good w.go good od-s d-ssam am am.com m.c .com com/m om m//min m/ /m min inne neso eso ota ta. (888) GSS-CA ARE E or vi visi s t ww www. w go good o -s od -sam aam m.ccom m/m min i neeso sota ta..
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MARCH 2016 MINNESOTA HEALTH CARE NEWS
9
10 QUESTIONS
Expanding access to care Jane Anderson, APRN, CNP, DNP Dr. Anderson, a nurse practitioner, is director of the M Health Nurse Practitioners Clinic and clinical assistant professor at the University of Minnesota’s School of Nursing.
Please tell us about the kinds of care you provide at the Nurse Practitioners Clinic? The Nurse Practitioners Clinic offers broad primary care for the majority of everyday health needs, including wellness and preventive care, acute and shortterm illness care, minor injury care, and ongoing chronic care. That means men, women, and children can be seen for everything from routine health maintenance exams to throat/chest infections, bone/ joint injuries, and diabetes care. Our providers are able to prescribe medication when appropriate. If a patient needs more complex or emergency care, we quickly arrange for them to see a University of Minnesota Health physician or specialist. Services also include routine lab tests and a pharmacy consultant to meet with patients about multiple medications. How are you different from a regular primary care physician clinic? There are more similarities than differences. The first major difference is that this clinic is led by experienced nurse practitioners who focus on the quality of care and a pleasant care experience. Our certified nurse practitioners are especially known for their gentle, holistic care and for considering a person’s overall health situation when treating a specific need. Second, the clinic was designed for convenience for the majority of health needs. We offer easy access for those who live or work downtown as well as same-day and walk-in care.
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MINNESOTA HEALTH CARE NEWS MARCH 2016
What are the biggest reasons a patient would come to your clinic? Patients tell us that they like both the convenience and quality of care for most of their health needs. Sameday and walk-in appointments are other important reasons. It’s a good solution for anyone looking for compassionate, thorough care providers who are backed by the expertise of University of Minnesota Health world-class research and innovative care and treatments. It fills the gap between a retail/convenience clinic and a clinic for medically complex specialty care patients. What are the biggest misperceptions about the services you offer? There are two. The first is misunderstanding the role of nurse practitioners. Nurse practitioners are educated to treat a broad range of patient needs. They earn a master’s or doctoral degree plus advanced graduate education, and they have clinical experience in a specialty beyond their four-year degree in nursing. They undergo national certification, state licensing, periodic peer review, and evaluations—similar to physicians. The second misconception is that a nurse practitioner-led clinic is similar to a retail walk-in clinic. In fact, this clinic is more similar to a family practice primary care clinic that serves as both a health care home and an acute care destination. Where are you in terms of patient census projections? Since opening in April 2015, we are seeing increased awareness of the clinic as we get more established. We’re meeting expected projections and plan to continue growth to meet the needs of the growing East Downtown Minneapolis area.
What can you tell us about your relationship with the University of Minnesota? We are part of University of Minnesota Health (or M Health, for short). M Health is a partnership between University of Minnesota Physicians and Fairview Health Services. The clinic was opened as a result of the University’s School of Nursing partnering with University of Minnesota Physicians to fill a downtown Minneapolis clinic gap. The clinic also serves as a clinical rotation site for nursing, pharmacy, and other health professional students from the University of Minnesota. When needed, we are able to collaborate seamlessly with and to refer patients to specialty partners and expertise at M Health.
continue to ask patients for feedback. We are considering bringing additional services to this clinic as well. As demand grows, we will consider options such as evening and weekend hours and on-site care at large employers. How do patients pay for your services? We accept most insurance plans, including the Hennepin Health Plan, to best serve the population and community around us. Patients can also pay out of pocket. What are the most important things you want the public to know about the services you offer? We’re proud of a 97 percent patient satisfaction rate, demonstrating that patients value this care model. We’re dedicated to convenient, quality care for busy people in downtown Minneapolis. Patients appreciate the great variety of services from minor to complex and acute to ongoing care—all delivered in a calm, pleasant environment. Our patients often visit us the first time for convenience, and then they come back based on their satisfying experience.
Nurse practitioners are educated to treat a broad range of patient needs.
How did you choose your location for the first clinic? RS Eden, owner of the adjacent Emanuel House for low income, transitional adults, asked us to partner and provide a community clinic for their tenants and clients and for the greater East Downtown as their community initiative. With all of the housing growth, new stadium, and other retail construction and light rail transit blue and green lines just one block from the clinic, we knew it would be convenient for people in the surrounding area. What criteria will be used for expansion? We are able to take care of patient same-day needs in the current clinic and
The University of Minnesota Health Nurse Practitioners Clinic is located at 814 S. Third St., Minneapolis, MN 55415. Hours are 8 a.m. to 5 p.m., Mondays through Fridays.
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PUBLIC HEALTH
Applying a medical model el of control By Gary Slutkin, MD
P
eople have known for a long time that violence begets violence, but I don’t think people truly understood that violence is scientiďŹ cally a contagious problem. When we apply epidemic control methods to prevent violence, we are able to drastically reduce shootings, killings, and other violent acts. A disease control model After my medical training in infectious diseases, I landed in the middle of a refugee crisis in Somalia—one million refugees spread over 40 camps with six doctors to provide health services. I focused on
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MINNESOTA HEALTH CARE NEWS MARCH 2016
containing and treating tuberculosis t and cholera; three years later, I was hired by the World Health Organization (WHO) and assigned to containing the AIDS epidemic in Uganda. When I returned to Chicago 10 years later, friends began telling me about kids shooting other kids with guns. I asked many people: â&#x20AC;&#x153;What are you doing about it?â&#x20AC;? No one seemed to have any new or promising solutions. The way I saw it, politicians and public policy experts were calling for the same â&#x20AC;&#x153;solutionsâ&#x20AC;? to what was clearly a growing problem of violence, particularly in urban areas. The problem was â&#x20AC;&#x153;stuck.â&#x20AC;? Trained in science as a physician, I turned to data for answers. When I mapped areas of high violence in Chicago and other cities, I saw that violence clearly â&#x20AC;&#x153;clusteredâ&#x20AC;? in communities, reminding me of the clustering I had seen overseas with infectious epidemics, including cholera. After years of research, it became abundantly clear that violence behaves like contagious disease, sharing the same characteristics of clustering, spread, and transmission. And thatâ&#x20AC;&#x2122;s good news overall, as epidemics are most effectively reversed not by antibiotics or vaccines, but by behavioral changes centering on a three-step, common-sense health approach: UĂ&#x160; Interrupt transmission: detect and ďŹ nd ďŹ rst cases. UĂ&#x160; Prevent further spread: ďŹ nd others who have been exposed but may not be contagious now. UĂ&#x160; Shift the community norms: build group immunity through community activities, public education, and remodeling of behavior. This health approach successfully reversed Ugandaâ&#x20AC;&#x2122;s AIDS epidemic and contained the Ebola virus in Sierra Leone and Liberia. Itâ&#x20AC;&#x2122;s also the basis for the Cure Violence model, which strives to make violence as rare as plague or cholera are today. Strategies Cure Violence applies disease control strategies to: 1) Detect and interrupt potentially violent conďŹ&#x201A;icts. Whenever a shooting happensâ&#x20AC;&#x201D;whether it involves a crime, a personal dispute, a domestic assault, or a mass shootingâ&#x20AC;&#x201D;trained outreach workers deploy in the community and at the hospital to cool down emotions and to prevent retaliations. Workers also talk to key people in the
community about ongoing disputes, recent arrests, recent prison releases, and other situations, using mediation techniques to resolve disputes peacefully. They follow up with conflicts for as long as needed to ensure that they do not become violent.
reduce violence and reinvent high-risk, violent communities, transforming them into growing, economically viable, vibrant neighborhoods.
2) Identify and treat people at the highest risk of violence. Trained outreach workers establish contact, develop relationships, and work with those most likely to be involved in violence. After establishing trust, they attempt to convince these high-risk individuals to reject the use of violence, discussing the cost and consequences and teaching alternative responses to situations. Workers then provide ongoing treatment, seeing clients several times a week and assisting with needs such as drug treatment, employment, and leaving gangs.
Health as the solution to violence Cure Violence, along with other health leaders who have implemented or researched successful violence reduction efforts, believes that we need a national movement focused on explaining violence as a barrier to health and, ultimately, a national priority to bring evidence-based practices to scale. In light of this philosophy, our work is now focused around:
ÊUÊÊÊ1Ã }ÊÌ iÊ i> Ì ÊV>ÀiÊÃÞÃÌi Ê>ÃÊ>Ê« ÌÊ vÊ ÌiÀvention to interrupt the spread of violence; and
In the U.S., homicide is the leading cause of death for African Americans ages 10 to 24.
Outcomes In 2000, Cure Violence received its first grant to create a demonstration site focusing on this new health approach to violence prevention in the most violent Chicago neighborhood. The first experiment resulted in a 67 percent drop in shootings and killings in West Garfield Park. Our next four high-risk neighborhoods resulted in a 45 percent drop. The approach has since been replicated over 60 times in 25 U.S. cities and in eight countries on four continents. Cure Violence is currently ranked 17th on the list of Top 500 global NGOs (non-governmental organizations) by the Swiss non-profit Global_Geneva, which also lists it as the top NGO focused on reducing violence. Multiple independent evaluations supported by the Justice Department, the Centers for Disease Control (CDC), Johns Hopkins University, Northwestern University, and the University of Chicago have documented 30 to 50 percent and 40 to 70 percent reductions in shootings and killings under the Cure Violence approach to violence prevention. Personal transformations The model transforms not just communities, but individual lives as well. Meet Stacy L., a participant in the CeaseFire Illinois program (the Chicago arm of Cure Violence) from Englewood, Chicago’s most violent neighborhood: “First I got shot at 18. Then I got shot again at 21. I was just in a rage of revenge, revenge, revenge. The Cure Violence staff came to me and taught me how to let go. I feel like if he (a Cure Violence staff member) wouldn’t have never taught me how to let go, I’d still be blood thirsty….” Stacy L., a program participant in Englewood, Chicago. Stories such Stacy’s demonstrate how this global program can save lives. Deploying this common-sense, proven, evidence-based health approach, rooted in science, as a complement to traditional law enforcement, has been proven—over and over—to drastically
UÊÊÊÊ À } }Ê«ÕL VÊ i> Ì Ê> `Êi« `i gy tools to community-based violence prevention programs
ÞÊÕ `iÀÃÌ> ` }ÊÛ i ViÊ>ÃÊ>Ê i> Ì Ê problem, we recognize that the people committing violence, as well as those who have been affected through injury and exposure, essentially have a health problem—a problem of exposure, contagion, and trauma. Violence poses a serious public health threat
America’s gun violence epidemic to page 34
Telephone Equipment Distribution (TED) Program
3) Mobilize the community to change norms. Workers engage leaders in the community, residents, business owners, faith leaders, service providers, and those at high risk, to stress that violence should not be viewed as normal, but as a behavior that can be changed.
UÊÊÊ >VÌ }ÊÃ V > Ê> `ÊLi >Û À> ÊV> «> } ÃÊÌ Ê reduce violence
Do you have patients with trouble using their telephone due to hearing loss, speech or physical disability? If so…the TED Program provides assistive telephone equipment at NO COST to those who qualify. Please contact us, or have your patients call directly, for more information.
1-800-657-3663 www.tedprogram.org Duluth • Mankato • Metro Moorhead • St. Cloud The Telephone Equipment Distribution Program is funded through the Department of Commerce Telecommunications Access Minnesota (TAM) and administered by the Minnesota Department of Human Services MARCH 2016 MINNESOTA HEALTH CARE NEWS
13
CARDIOLOGY
Atrial fibrillation Irregular heartbeats take a toll By Lin Yee Chen, MD, MS
A
trial ďŹ brillation (AF) is the most common heart rhythm abnormality in the adult population. The lifetime risk of AF is one in four and there are at least 2.7 million people living with AF in the U.S., according to the Centers for Disease Control and Prevention. In the most basic terms, AF occurs because electrical signals cause the chambers of the heart to beat out of sync, too fast, or too slow. These irregular beats donâ&#x20AC;&#x2122;t effectively circulate blood through the heart, creating an environment that is conducive to clotting.
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MINNESOTA HEALTH CARE NEWS MARCH 2016
This condition is an important public health problem for two reasons. First, AF is becoming increasingly common. Researchers attribute this increase to the aging population and growing prevalence of risk factors such as obesity. Second, AF contributes to 130,000 deaths per year and is associated with an increased risk of stroke, heart failure, cognitive decline, and dementia. How is AF diagnosed? In most cases, patients will feel palpitations or the sensation of an irregular heartbeat. It is common for AF patients to experience other symptoms such as shortness of breath, chest discomfort, fatigue, or poor stamina. Though rare, some patients may not experience any symptoms whatsoever. However, these patients are still at risk for the potentially deadly health events that other AF patients face. Because the condition can go undetected, itâ&#x20AC;&#x2122;s important to routinely visit a primary care physician who can determine a patientâ&#x20AC;&#x2122;s risk factor. The condition can be easily diagnosed using a standard electrocardiogram (ECG), performed in a clinic or physicianâ&#x20AC;&#x2122;s ofďŹ ce, or by an ambulatory heart rhythm monitor, which may be worn by patients at home or in the course of daily activities. Both devices are painless ways to record the electrical activity that takes place in your heart. The ECG test captures data from short durations. But, the ambulatory heart rhythm monitorâ&#x20AC;&#x201D;a portable set-upâ&#x20AC;&#x201D;records longer periods of electrical activity. Because the ambulatory heart rhythm monitor reďŹ&#x201A;ects intermittent episodes of heart activity, this arrangement is particularly useful in diagnosing early stage AF. What causes AF? The common risk factors for AF include advancing age, hypertension or high blood pressure, diabetes, heart disease, coronary artery disease, heart failure, obesity, and obstructive sleep apnea. Men are also more likely to experience this condition. Similar to other heart conditions, AF can sometimes cluster in families. Other health conditions such as lung disease, pneumonia, and even surgery can cause a person to develop AF. In particular, an overactive thyroid gland, called hyperthyroidism, is linked to AF. Itâ&#x20AC;&#x2122;s important to test for hyperthyroidism upon receiving an AF
diagnosis. That’s because overactive thyroids can be treated, mitigating the risk of AF. As with other heart conditions, behaviors like binge drinking and smoking can cause or exacerbate AF. The stages of AF As researchers have learned with heart failure, there are various stages of AF progression. In its earliest stage, AF is intermittent or “paroxysmal.” During this stage, there may be mild enlargement of the atria, which are the upper chambers of the heart. As early stage AF progresses, it becomes “persistent,” lasting more than 7 days. During this stage, more structural changes can occur, such as tissue scarring called fibrosis and further enlargement of the heart’s upper chambers.
1) preventing strokes or blood clots using anticoagulants, commonly referred to as “blood thinners” 2) preventing AF recurrences by striving to maintain normal heart rhythm 3) controlling the rate of AF without aiming to maintain normal rhythm To prevent strokes, physicians can use warfarin (common brand names include Coumadin and Jantoven) or other new blood-thinning agents. Warfarin blocks the liver’s ability to produce proteins that are necessary to coagulate blood. This means clots are less likely to form, which reduces the risk of stroke.
Some patients may not experience any symptoms whatsoever.
When it is at its most advanced stage—also called the “permanent” stage—AF is entrenched and the heart’s normal rhythm can no longer be maintained. During this stage, the upper chambers of the heart can be severely enlarged. This stage is sometimes accompanied by other cardiovascular complications. Treating AF There are three pillars of treatment for AF:
Often, heart experts will use these anticoagulants as they work to achieve and maintain normal rhythm in patients. To achieve normal rhythm, doctors can use rhythm medications or anti-arrhythmic medications designed to reset the electrical impulses that are causing AF. This approach works well for some patients, but not all patients. Another commonly prescribed medication is beta-blockers, which help control a patient’s heart rate. One effective alternative for maintaining normal rhythm is catheter ablation, a minimally invasive medical procedure that Atrial fibrillation to page 32
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3.19.16
St. Paul RiverCentre
engage.connect.learn. KEYNOTE SPEAKERS Mary Mittelman, D.P. H. Research Professor of Psychiatry and Rehabilitative Medicine, NYU School of Medicine
Donald Warne, M.D., MPH Director of the Master of Public Health Program, North Dakota State University; Senior Policy Advisor, Great Plains Tribal Chairmen’s Health Board
Learn more and register at
alz.org/mnnd #ALZminds MARCH 2016 MINNESOTA HEALTH CARE NEWS
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PEDIATRICS
Assessing risks and prevention By Jessica Larson, MD, and Claudia Fox, MD, MPH
C
hildhood obesity has reached epidemic proportions. In the U.S., nearly one out of every three children and adolescents is overweight or obese. Minnesota is no exception: 27 percent of our youth are overweight or obese, triple the rate from just one generation ago. Although the rates of childhood obesity seem to be leveling off, the numbers of kids with severe forms of obesity are increasing. Common questions As rates of childhood obesity increase, many parents seek information regarding terms and definitions. Among their questions:
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MINNESOTA HEALTH CARE NEWS MARCH 2016
How do I know if my child has a problem with extra weight? Doctors use the body mass index, or BMI, to determine if a person has overweight or obesity. The BMI is a calculation that uses height and weight to estimate how much body fat someone has. If the BMI is between the 85th and 95th percentile for age and sex, then the child has “overweight.” If the BMI is above the 95th percentile for age and sex, then the child has “obesity.” (To calculate your child’s BMI, visit the Centers for Disease Control’s calculator at nccd.cdc. gov/dnpabmi/calculator.aspx). These words, “overweight” and “obesity,” are clinical terms used to characterize the risk someone has for developing weight-related health problems. People with overweight have a modestly increased risk of developing weight-related health problems, and people with obesity have a high risk of developing health problems. So what’s wrong with having overweight or obesity? Multiple studies show that carrying extra weight stresses our bodies and our minds. Children and adolescents with overweight or obesity are at risk of developing multiple health problems. These include, for example, high blood pressure, diabetes, liver disease, irregular menstrual periods, sleep apnea, and joint pain. Further, some children and adolescents with extra weight have difficulties with socialization due to bullying or mental health issues, such as low self-esteem or even depression. Finally, studies also show that youth with severe forms of obesity, especially teenagers, do not grow out of their extra weight; very often they become adults with obesity. That’s why prevention and early intervention are so important. How did obesity become such a problem? There are multiple contributors to carrying extra weight. The primary determinant of a person’s shape or size is their genetics. Simply put, carrying extra weight tends to run in families. But there are many other factors at play. These include dietary factors, such as easy access to high calorie, ultra-palatable foods (think cheesy crackers) and large portion sizes. (Ask your grandparents how many french fries came with restaurant meals in their day. It was likely a tiny fraction of what is served today.) Other factors include limited physical activity and poor sleep. The use of technology, such as cell phones and video games, has crept into many of our lives and displaced our outdoor free play and even our sleep time. Increasingly, stress has also been linked to obesity. Some people eat in response to stress, i.e., for coping. Additionally, increases in stress hormones can lead to weight gain.
Addressing the problem Addressing a widespread problem such as pediatric obesity can seem overwhelming. It will likely take the coordinated efforts of families and health care providers, as well as schools and communities, to solve this problem. We know that prevention is the most effective strategy. Teaching families healthy habits and creating an environment that encourages those habits is the best approach. Preventing pediatric overweight and obesity A number of common-sense practices can help prevent obesity and promote overall health:
Finally, it is important for children and families to have a regular eating schedule. Children should have breakfast every day, and families should try to sit down to have a meal together as many nights a week as they can. When families eat together, they tend to consume less and eat healthier. Regular physical activity. Too many of our children do not get enough physical activity. The American Academy of Pediatrics recommends children get at least one hour of physical activity every day. This may be accumulated through the day, and includes time spent in recess, gym class, team sports, and outside play. A good strategy is to make it part of family time. Families that are active and play together tend to be healthier.
Tw Twenty-seven perc percent cen nt of our youth are overweig ight or obese.
Healthy eating. Since children have lower daily calorie needs, it is very easy for extra calories to start adding up quickly. A diet high in fruits, vegetables, and whole grains will fill children up without giving them extra calories. On the same note, avoiding or limiting processed and “fast” foods will minimize foods that are high in calories and low in nutritional content. Many experts recommend that families limit “eating out” to no more than once per week. Additionally, many children also get a significant number of extra calories in the beverages they drink. This is especially true for so called sugar-sweetened beverages, such as soda, sports drinks, flavored milks, and fruit drinks. Doctors recommend that children avoid these beverages. Too many children drink sugar-sweetened beverages regularly, when they really should be treated like a dessert.
Limiting screen time. As our children spend more time in front of screens, they spend less time in active play. Simply by limiting screen time, children will spend more time being active. It has also been found that children tend to eat while they’re in front of a screen, and the foods are not usually as healthy. Most importantly, there is a direct correlation between having a television or other screen in a child’s bedroom and the time they spend with that screen. Keeping screens out of children’s bedrooms allows parents to monitor both the quantity and the quality of screen time. The American Academy of Pediatrics recommends limiting screen time to less than two hours per day and keeping screens out of children’s bedrooms. Childhood obesity to page 19
MARCH 2016 MINNESOTA HEALTH CARE NEWS
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Calendar Mar.-April 2016 Mar.19
Hearing Loss Support Group
Allina Health and the Hearing Loss Chapter of America host this free support group for anyone who is hard of hearing. Come meet others in similar situations and gain insights from their experiences. For more information or to sign up, call Bob at (763) 537-7558. Saturday, March 19, 9:30 a.m.–12:00 p.m., Courage Kenny Rehabilitation Institute, 2nd Flr. Boardroom, 3915 Golden Valley Rd., Minneapolis
21
Infertility Support Group
RESOLVE: The National Infertility Association offers peer-led support groups for couples experiencing infertility to connect with one another, share their stories, and receive support from others going through similar experiences. Contact the group hosts, Katie and Kendra, at NorthMetroMNresolve@gmail.com before attending your first meeting. Monday, March 21, 6:30–8 p.m., Ramsey County Upperwood Library, 3025 Southlawn Dr., Maplewood
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Varicose Vein Screening
Park Nicollet offers free screenings for anyone bothered by visible, bulging veins in their legs that cause pain, swelling, or cramping. Surgeons will perform the screening and recommend a course of action. Those covered by Medicare or Medicaid are not eligible due to federal regulations. Other dates are also available. Call (952) 993-2651 to schedule your screening. Monday, March 21, 3:00–4:30 p.m., Park Nicollet Heart and Vascular Center, Women’s Center, 5th Floor, 6500 Excelsior Blvd., St. Louis Park
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Diabetes on a Budget
Fairview Health Services hosts this new class for anyone with diabetes. Come learn how to eat healthy and manage your diabetes without breaking the bank. Learn strategies for cost-effective diabetes testing supplies and determine if and how your medication costs can be lowered. For more information or to sign up, call (612) 672-6700. $5 fee. Thursday, March 24, 2–3:30 p.m., Fairview Clinics–Edina, 6545 France Ave. S., Ste. 150, Edina
Apr.4
C l Colorectal t lC Cancer Awareness Month
HealthEast hosts this weekly group meeting for anyone who is grieving the loss of a loved one. While grieving can be painful and lonely, sharing experiences and support with others going through similar losses can help. Contact Ted at (651) 232-7397 or thein@healtheast.org for more information.
Colorectal cancer is the third most common type of non-skin cancer and the second-leading case of cancer death among both men and women in the U.S. Each year about 136,000 people are diagnosed with colorectal cancer and more than 50,000 die of the disease. Men and women have similar incidence rates through age 39, but at age 40 and older, rates are higher in men.
Monday, April 4, 4–5:30 p.m., Maplewood Professional Building—St. John’s Hospital, Watson Education Center, 2nd Flr., 1575 Beam Ave., Maplewood
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Dads of Children with Special Needs Group Arc Greater Twin Cities and
Colorectal cancer often starts as polyps (growths on the walls of the intestine), which can become cancer over time. Undergoing a screening can help prevent colorectal cancer by allowing doctors to detect and remove polyps before they become cancerous. Rates of colorectal cancer incidence and mortality due to the disease have been declining over the past two decades, largely to increased use of screening tests.
Minneapolis Early Childhood Family Education host this free networking group for fathers of children with all types of intellectual and developmental disabilities. Come meet others in similar situations and gain insights from their experiences. Childcare available. For more information or to sign up, call (952) 920-0855. Monday, April 11, 5:30–7:30 p.m., Wilder School, ECFE Parent Rm., 3328 Elliot Ave. S, Minneapolis
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Screenings are recommended for everyone 50 and older, but if you have a family history of the disease, you should talk to your doctor about starting screening earlier.
Mar.17
Growth Through Grieving
Aging in Place Options and Resources
Hennepin County Library and the Metropolitan Area Agency on Aging offer this free class for anyone who prefers to stay in their homes and “age in place” but needs assistance with issues such as home maintenance, personal care, food support, or transportation. Presented by representatives of Senior LinkAge Line. Call (612) 543-5669 for more information.
Colon, Anal, Rectal Cancer Support Group
Minnesota Oncology and Colon & Rectal Surgery Associates offer this free monthly support group for individuals going through diagnosis, treatment, and life after colon, anal, or rectal cancer in a safe and welcoming environment. The group focuses on education, sharing, and connecting. Call Kim at (952) 928-2907 for more information.
Tuesday, April 12, 6–7:30 p.m., St. Anthony Library, 2941 Pentagon Dr. NE, St. Anthony
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Thursday, March 17, 5:30–7:00 p.m., Minnesota Oncology, 6545 France Ave. S., Ste. 210, Edina
Send us your news: We welcome your input. If you have an event you would like to submit for our calendar, please send your submission to MPP/ Calendar, 2812 E. 26th St., Minneapolis, MN 55406. Email submissions to amarlow@mppub.com or fax them to (612) 7288601. Please note: We cannot guarantee that all submissions will be used. CME, CE, and symposium listings will not be published.
Cancer Survivorship Conference
The University of Minnesota hosts this free annual educational conference that focuses on questions and issues survivors and their families often face after cancer treatment or following stem-cell transplantation. Registration required. To sign up, visit cancer.umn. edu/community-events-and-outreach. For more information, call Ashley at (612) 625-9340. Saturday, April 23, 8 a.m.–1:30 p.m., University of Minnesota, McNamara Alumni Center, 200 SE Oak St., Minneapolis
America’s leading source of health information online 18
MINNESOTA HEALTH CARE NEWS MARCH 2016
Childbood obesity from page 17
The 5210 Rule. The American Academy of Pediatrics endorses the “5210” message as a guide for families trying to lead a healthy, active life: 5: Five helpings of a fruit or vegetable daily 2: Less than two hours of screen time per day 1: One hour of active play per day 0: No sugar-sweetened beverages Getting enough sleep. Sleep is now recognized as an increasingly important part of healthy living and preventing overweight and obesity. Due to busy schedules and excessive screen time, many children do not get the sleep that they need at night. These limited or disrupted sleep schedules alter the hormones in the brain, which have a direct effect on metabolism and weight. The National Sleep Foundation recommends that children ages 3 to 5 get 11–13 hours of sleep per night, and children ages 6 to 13 get 9–11 hours. Teenagers generally need at least 8 hours per night.
their child’s weight with their health care provider. This may be a difficult subject to bring up with your child’s doctor because sometimes families feel embarrassed or fear that they will be blamed for their child’s weight status. However, the medical community is there to help you and many doctors will be pleased to know that this is a concern you have. Just remember that if the health care provider uses words such as “overweight” or “obese,” they are not intended to be negative. Instead these words describe the amount of risk your child has for developing weight-related health problems and how serious the problem can be. Depending on your child’s BMI, some doctors may start with simple goal setting, or they may refer you to a dietician or a doctor who specializes in weight management. Treatment is most effective when the whole family is involved.
Simplly put, Simply putt, carrying ng extra ra weig eig igght tend ttends endss to run in families.
Treating pediatric overweight and obesity For children who are overweight or obese, it can be challenging to know where to start. Families should discuss their concerns about
Don’t Suffer Alone
For more information, check out these websites: UÊÜÜÜ° i> Ì iÀ}i iÀ>Ì ° À}É UÊÊÜ ÜÜ° i> Ì ÞV `Ài ° À}É } Ã É i> Ì ÃÃÕiÃÉV ` Ì ÃÉ Lià ÌÞÉ Pages/default.aspx Jessica Larson, MD, is a board-certified general pediatrician with an interest in pediatric obesity, practicing at the Fairview Clinic in Elk River. Claudia Fox, MD, MPH, is an assistant professor in the Department of Pediatrics at the University of Minnesota and medical director of the University of Minnesota Masonic Children’s Hospital Pediatric Weight Management Program.
Gambling Addiction Is Lonely
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For most, gambling is a fun-filled adventure enjoyed in the company of others. But for a gambling addict it is often a lonely pursuit as they become more and more withdrawn and desperate.
Don’t suffer alone. Treatment is free and confidential. And it works.
Gambling addicts don’t need to suffer alone. A full life can be restored with treatment and support.
Call 1-800-333-HOPE s Or visit www.NorthstarProblemGambling.org MARCH 2016 MINNESOTA HEALTH CARE NEWS
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SENIOR CARE
Looking at a well-kept secret By Barb Zeis
M
arshall starts his day chatting with friends over a cup of coffee before he makes his way to exercise and then choir practice. After lunch he heads to the art room for pottery class, followed by a creative writing group. He makes plans with friends for the next day before heading home.
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Visit us online at www.minneapolisclinic.com 20
MINNESOTA HEALTH CARE NEWS MARCH 2016
Marshall is an 82-year-old veteran with early-stage memory loss. He attends an adult day program a few miles away from the home he’s lived in for more than 50 years. Adult day programs such as Marshall’s remain a well-kept secret in the world of senior services. As defined by the National Adult Day Services Association (NADSA), adult day programs are “professional care settings in which older adults, adults living with dementia, or adults living with disabilities receive individualized therapeutic, social, and health services for some part of the day.” Adult day participants maintain their independence and dignity, while caregivers enjoy the peace of mind that comes from knowing their family member is receiving care and staying active. The adult day model Adult day services began to appear in the U.S. in the 1960s as a form of geriatric outpatient hospital care. In subsequent decades the adult day model has expanded to support the physical, mental, and social well-being of older adults and adults with disabilities and/or memory loss. According to NADSA, there are now more than 5,000 adult day centers in the U.S. serving more than 260,000 participants and caregivers. What sets adult day services apart from other services available to seniors is the flexibility they offer families. Seniors and adults can have their health and wellness monitored by trained professionals at day programs while they continue to live independently or with caregivers. This arrangement is often preferable to relocating to a senior living community, especially for older adults who do not require 24-hour assistance or monitoring. Caregivers—often family members—benefit from adult day programs, too. Because adult day services are typically offered during regular business hours, caregivers have opportunities to work, run errands, or just take a break from their caregiving duties while their loved one spends time enjoying the program.
Enrichment opportunities Many adult day programs offer a variety of enrichment activities and outings that improve the overall quality of life for participants. Exercise classes, creative arts programming, guest speakers, and educational field trips are becoming more common offerings at adult day centers. At the Amherst H. Wilder Foundation’s Adult Day program in Saint Paul, participants enjoy numerous creative arts activities thanks to partnerships with local professional artists and arts organizations. From painting to pottery, music, and storytelling, these arts enrichment programs are more than fun and games; they may help improve cognition and daily functioning, sparking interests and talents that go back decades.
UÊ Variety of social, educational, and health activities UÊ Professional staff who specialize in caring for older adults and adults with disabilities and/or memory loss UÊ Community connections: many centers are located in neighborhood settings
Adult day participants maintain their independence and dignity.
Take Marshall, for example. His early-stage memory loss makes it hard for him to make it to doctor’s appointments or remember the names of his grandchildren. But get Marshall singing and he’s able to recall the lyrics to songs he sang more than a half-century ago without skipping a beat. A growing body of research documents experiences similar to Marshall’s, suggesting that Alzheimer’s disease and other forms of memory loss need not impair a person’s creativity or imagination. The Memory and Aging Center’s Hellman Visiting Artist Program at the San Francisco campus of the University of California invites visual artists, musicians, and writers to interact with patients, families, and academic researchers in the fields of dementia and Alzheimer’s. The Alzheimer’s Association, the American Association of Retired Persons, and the National Endowment for the Arts all cite studies supporting the value of arts-based programs for older people. Adult day service providers build on this emerging research by incorporating creative arts activities into their programs.
Determining if adult day is right for someone you care for Adult day services have a wide range of benefits for older adults and caregivers, but, like any form of care, it’s not right for everyone. Adult day services are best suited for older adults and adults with disabilities and/or memory loss who: UÊÊÊ7 à ÊÌ ÊÀi > Ê Û }Ê `ipendently, but need occasional assistance with daily activities UÊÊÊ >ÛiÊ« Þà V> ]Ê i Ì> Ê i> Ì ]Ê ÀÊ cognitive challenges that require professional care
UÊ Seek companionship and enjoy a full, active schedule UÊ Are being cared for by a family member, neighbor, or friend who would benefit from respite Adult day programs to page 25
Beyond the cognitive benefits of creative programs, creative arts encourage a sense of belonging. This becomes increasingly important for seniors who feel isolated from friends, family, and peers. Caregivers with loved ones participating in the Wilder Foundation’s program tell us that creative arts activities help family members be more active, positive, and social overall. Some seniors find new interests and passions. Others rekindle talents and joys they haven’t thought about in years. No matter what a person’s interests or abilities, creative arts programs help our center be a place to belong and succeed. Other benefits of adult day services Each adult day program is different, but many offer similar benefits, such as: UÊ Flexible schedules UÊ Affordability of programming compared to senior living facilities or other, more intensive services UÊ Transportation to, from, and during programming MARCH 2016 MINNESOTA HEALTH CARE NEWS
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DENTAL HEALTH
Implants A permanent solution to missing teeth By Matthew Karban, DMD, MD, and Paul Thai, DDS
T
here have been many advances in modern dentistry, but dental implants may have sparked the most interest and enthusiasm among consumers. The technology to replace missing teeth is hardly new; dental implants have a long and interesting history. There is archeological evidence of dental implants in ancient China dating back 4,000 years, with bamboo pegs placed into the jaws. Throughout the early and mid 1900s, doctors developed varying types of implantable metal devices to help replace missing teeth. Today’s titanium dental implant was originally developed by an orthopedic surgeon in Sweden and brought to North America
In the next issue... Your Guide to Consumer Information
in the early 1980s. Since then, research has transformed the dental implant, as well as the surgery, into one of the fastest growing and most innovative procedures in dentistry. From bridges to implants Prior to titanium dental implants, the dental bridge was the conventional way to replace a missing tooth. After preparing adjacent teeth to fit crowns over them and provide support for the missing tooth in the middle, the dental bridge was then cemented in place and remained fixed. How do implants differ? A dental implant is essentially a titanium screw that is implanted into the upper and/or lower jawbone, where it acts as an anchor. A ceramic or metal tooth is then screwed on top of the implant to replace the missing tooth. Like a conventional dental bridge, multiple implants can be placed in strategic positions, and a multi-tooth bridge can be attached to replace a varying number of teeth. For patients who are missing all of their teeth, multiple implants can be placed and an entire set of teeth can be screwed permanently into place, sometimes within the same day of the surgery. In most cases, dental implants function as a permanent replacement option, but we can also utilize implants to provide support to existing dentures or partial dentures. In these cases, a number of implants, typically two or more, can be placed into the jaw bone and allow the denture to snap into the implants, improving stability, retention, and comfort over the traditional denture.
UÊZika UÊElder nutrition UÊBrain health
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MINNESOTA HEALTH CARE NEWS MARCH 2016
Advantages and disadvantages There are many advantages of dental implants over conventional techniques. Implants have been shown to last longer than a traditional dental bridge or a removable partial denture. Once a dental implant has integrated with the bone, it is then a permanent fixture in the jawbone. Since an implant is comprised of titanium, it will not form cavities like a natural tooth. An implant can last a lifetime, assuming the patient is healthy, has adequate bone volume surrounding the implant, and takes proper care of the implant. Dental implants help stimulate and preserve surrounding bone, preserve surrounding gingival (gum) tissue, and allow the patient to resume a normal diet. Without an implant or tooth root, the jawbone will usually shrink due to lack of stimulation of the bone. Dental implants help preserve the adjacent teeth by avoiding the need to alter additional healthy teeth to accommodate a conventional bridge.
COURTESY OF NOBEL BIOCARE
Conventional bridge
Implants with bridge
Denture over implants
Single implant
Dental implants help preserve the adjacent teeth.
There are some drawbacks and hurdles to dental implant therapy. There can be increased costs for implant procedures compared to other replacement options, and healing times can be longer. As with all surgical procedures, dental implants do have associated risks, such as potential infection, swelling, discomfort, and lack of integration into the bone. Dental implants can also suffer from bone loss and gingival (gum) disease. They are dependent on hygiene habits and medical factors. Some medical conditions and habits—such as uncontrolled diabetes and smoking—can increase the complication rate, but these risks are very rare, and do not necessarily rule out dental implant treatment. In fact, dental implants celebrate a very high success rate when compared to most other medical procedures or implanted devices. Research studies show a success rate of 96 percent and greater for dental implants, depending on certain factors and specifics.
What to expect The procedure is tailored to each individual’s situation, but typically involves removal of the broken or diseased tooth. If possible, depending on bone quantity and quality, the implant is placed immediately after the removal of the tooth or teeth. The implant is then allowed to heal (osseointegrate) for 3 to 6 months. At times it is not possible to place an implant upon removal of a tooth due to a concurrent infection or poor bone quantity/quality. In this situation, a bone graft is usually placed into the extraction site and an implant is placed at a later time, following complete healing of the extraction site. There are certain situations in which a temporary tooth or teeth can be placed immediately on the implant at the time of surgery, but many factors affect this decision. If a tooth cannot be placed on the Implants to page 24
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tŚĞŶ ƚŚĞƌĞ ĂƌĞ ŶŽ ƐŝŐŶƐ Žƌ ƐLJŵƉƚŽŵƐ͕ LJŽƵ ŵĂLJ ŶŽƚ ŬŶŽǁ ƵŶƟů ŝƚ͛Ɛ ƚŽŽ ůĂƚĞ͘ Đƚ ŶŽǁ͘ ^ĐƌĞĞŶ LJŽƵƌ ƉĂƟĞŶƚƐ ĨŽƌ ƚLJƉĞ Ϯ ĚŝĂďĞƚĞƐ͘ /ƚ͛Ɛ ĞĂƐLJ͘ /ƚ͛Ɛ ĐŽǀĞƌĞĚ͘ /ƚ ǁŝůů ƌĞĚƵĐĞ ƚŚĞŝƌ ƌŝƐŬ͘ ͻ ZĞĨĞƌ LJŽƵƌ ĂƚͲƌŝƐŬ ƉĂƟĞŶƚƐ ƚŽ Ă ƉƌŽǀĞŶ ůŝĨĞƐƚLJůĞ ĐŚĂŶŐĞ ƉƌŽŐƌĂŵ ĂŶĚ ŚĞůƉ ĐƵƚ ƚŚĞŝƌ ƌŝƐŬ ŽĨ ĚĞǀĞůŽƉŝŶŐ ƚLJƉĞ Ϯ ĚŝĂďĞƚĞƐ ŝŶ ŚĂůĨ͘
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MARCH 2016 MINNESOTA HEALTH CARE NEWS
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Implants from page 23
even design a surgical guide for use at the time of surgery to aid in precise placement of the implant fixture. Computer-guided surgery continues to advance and provide patients with a great result.
implant, a dentist can provide other temporary replacement options, allowing the patient to proceed about daily life without cosmetic concern.
The procedure is typically performed under local anesthesia and can usually be performed in the same time it takes to complete a dental filling. After the procedure, discomfort tends to be minimal and does not usually alter a patient’s daily schedule. Pain medication and antibiotics may be prescribed, depending on your doctor’s preferences and protocols.. Following placement, a patient is usuallyy asked to avoid chewing on the area for a specific ifi time i period i d and d to maintain good oral hygiene. Your doctor may require a follow-up visit a week or two following the surgery.
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After the 3 to 6 month healing period, a final crown or multi-tooth prosthesis is placed, offering a cosmetic result often identical to the patient’s original tooth or teeth. The cosmetic results are similar to or better than other current tooth replacement options.
Taking the bite As dental implants become increasingly popular and change the standard of care regarding replacement options, patients may be faced with an overwhelming amount of information. Our recommendation, as doctors who place dental implants, is to research your doctor, ask questions related to the surgical process, experience, success rate, and type/ brand of implant used. Any doctor should be more than happy to educate their patient regarding each of these questions. Whether you are missing one or multiple teeth, ask your dentist if a dental implant is the right option for you.
An implant can last a lifetime.
Technology continues to evolve within the field of implant dentistry. Many doctors are utilizing more detailed radiography, such as cone beam CT scans. These scans, together with specialized computer software, allow the doctor to plan the procedure in advance and
Matthew Karban, DMD, MD, practices with The Dental Specialists in the Blaine/Coon Rapids area, performing mainly dental implant and outpatient oral surgery procedures. He is a diplomate of the American Board of Oral & Maxillofacial Surgery and a fellow of the American College of Oral & Maxillofacial Surgery and American Association of Oral & Maxillofacial Surgery. Paul Thai, DDS, is a general dentist at Park Dental Eden Prairie and an adjunct associate professor at the University of Minnesota.
REMARKABLE CARE WHEN IT COUNTS We realize that any surgery is a major event in your life. That’s why we make every effort to make you feel at ease. When you visit Specialists in General Surgery, you’ll receive care that is tailored to you as an individual. From discussing the details of your surgery in familiar terms to helping answer any questions, our coordinated team of surgeons and staff will be with you every step of the way. At Specialists in General Surgery, you can count on us to provide you the surgical expertise you need and the remarkable care you deserve.
SURGICAL EXPERTISE
Robot
Weight Loss Surgery (bariatrics)
Advanced Laparoscopy
Gallbladder Hernia Endocrine (parathyroid, thyroid and adrenal) +EWXVMG 6I¾Y\ Bowel (colon resections) Oncology/Cancer
To schedule an appointment at any of our 13 locations, please call 763-780-6699 or visit www.sgsmn.com 24
MINNESOTA HEALTH CARE NEWS MARCH 2016
TECHNOLOGY
Breast Cancer
Endoscopy
that adult day strikes the balance of quality, flexibility, and activity you’re looking for.
Adult day programs from page 21
Getting started If adult day services sound like something that may benefit you or someone you care for, the first step is to research programs in your area and set up tours. If you don’t know where to start, visit the Minnesota Adult Day Services Association (http://www. madsa.org/) to find an adult day provider in your area. It’s a good idea to write down a list of questions you’d like to ask before your visit so you don’t forget any topics you’d like to cover. Many adult day centers offer a trial period to see if the program is a fit; don’t feel pressured to make a decision after one visit. Adult day staff are usually happy to meet with families to understand the needs of the potential participant and caregivers.
For more information To learn about Wilder Foundation’s Adult Day program, visit www. wilder.org/adult-day. Additional Wilder Foundation services for older adults are posted under “programs and services” at www.wilder.org. To search for other adult day providers in your area, visit www.madsa. org.
Creative arts encourage a sense of belonging.
Finding the appropriate care for yourself or a loved one is a major decision. I always encourage families to explore all the options available to understand what will best suit their needs. If you find yourself in need of care, or are looking into options for an older adult in your life, be sure to check out adult day programs in your area. Like many of our participants, you may find
For information about senior care options including assisted living, adult day, memory care, and other services, visit www.minnesotahelp.info.
Barb Zeis is manager of Adult Day Services at the Amherst H. Wilder Foundation in Saint Paul. She has more than 35 years’ experience in senior services and was at the forefront of integrating occupational therapy and creative arts in adult day services, receiving the 2014 “Director of the Year” award from the National Adult Day Services Association.
MARCH 2016 MINNESOTA HEALTH CARE NEWS
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ONCOLOGY
Preventable, treatable, and survivable ble By Avina Singh, MD
T
he American Cancer Society estimates that nearly 135,000 Americans will be diagnosed with colorectal cancer this year, and nearly 50,000 people will die from the disease. During this Colon Cancer Awareness Month, my goal as a physician is to give my patients—and the broader public—hope that colon cancer is preventable, treatable, and survivable.
Colon cancer begins in the colon, which is part of the large intestine near the end of the digestive system. At five to six feet in length, the colon is a tubular organ that removes water and any remaining absorbable nutrients from what we eat before pushing the indigestible, solid waste to the rectum. Colorectal cancer includes cancers that form in the rectum, a much smaller section at the end of the large intestine, which prepares to expel solid waste from the body.
What is colon cancer? Cancer develops when abnormal cells grow out of control and invade other tissues in the body. Cancers of the colon and rectum are sometimes grouped together as “colorectal cancer” because of their many commonalities.
Most colon cancers begin as benign polyps, which are non-cancerous growths on the lining of the large intestine. While some polyps remain benign indefinitely, others become malignant, or cancerous.
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Many people with polyps experience no symptoms—regardless of whether they are benign or malignant—so the only way to know if you have them is to be tested. The most common test is a colonoscopy, during which polyps can not only be found, but also removed. Risk factors Colon cancer is the third leading cause of cancer-related deaths nationally among men and women, and also the third most common cancer to be newly detected—behind prostate and lung cancers for men and behind breast and lung cancers for women. The risk of colon cancer increases at age 50, which makes that the age when a first colonoscopy is recommended. But colon cancer rates among adults younger than 50 have risen in recent years, meaning that age doesn’t matter. Men are at greater risk than women, and the incidence of colon cancer is higher among African Americans than the general population—but these factors also shouldn’t give anyone false security or heightened concern. The truth is: Anyone can get cancer. That being said, your risk is higher if you:
Wherever you are!
26
MINNESOTA HEALTH CARE NEWS MARCH 2016
UÊ Have a family history of colon cancer or colon polyps UÊ Are overweight or obese UÊ Eat too many unhealthy fats, such as fried or processed foods UÊ Are more sedentary than active UÊ Smoke UÊ Regularly consume too much alcohol UÊ Have diabetes UÊ Have Crohn’s disease
Prevention Itâ&#x20AC;&#x2122;s never too early or too late to make prevention a priority. Good lifestyle choices reduce your cancer risk and improve your chances of leading a long and healthy life. Please follow these good prevention habits: UĂ&#x160; Eat a variety of fresh fruits and vegetables daily. UĂ&#x160; Choose foods containing whole grains rather than reďŹ ned grains. UĂ&#x160; Avoid processed foods such as cereals, crackers, chips, and cookies. UĂ&#x160; Limit alcohol consumption to one drink per day if you are a woman, or two drinks if you are a man. Less alcohol, less often would be even better. UĂ&#x160; Exercise at least 30 minutes most days of the week. UĂ&#x160; Limit your time spent sitting and lying down to watch TV, playing electronic devices, etc. UĂ&#x160; Maintain a healthy weight through a healthy diet and regular exercise. UĂ&#x160; Do not use tobacco in any form.
Screening Colorectal screening tests are performed to determine the presence of abnormal or cancerous cells in the colon, which appear as polyps. If you have no family history of colon cancer, no symptoms, and no other factors that put you at a higher risk, screenings are generally recommended to begin at age 50. The exact test or tests performed varies from one patient to the next. Each procedure has pros and cons; talk with your doctor about the options before making your decision. Colonoscopies, the screening that most Americans are familiar with, involve a direct colon and rectum exam while the patient is sedated. If the screening detects polyps, they can be removed during the procedure. Removal prevents cancer from developing in many patients, and helps many more ďŹ nd the cancer early, when it is most treatable.
During [a colonoscopy] polyps can not only be found, but also removed.
Also, once you reach age 50â&#x20AC;&#x201D;or sooner if you experience the symptoms noted below or at are high-riskâ&#x20AC;&#x201D;ask your physician about your colon cancer screening options. A colonoscopy is one of several options available, and it is the only screening method during which polyps can be removed. Therefore, it can help prevent benign polyps from becoming malignant polyps. High-risk patients may also be presented with additional prevention measures. If you are in this category, consult with your doctor to make the right choices for you. Symptoms Some people with colon cancer experience no or minor symptoms, some ignore or misinterpret the symptoms, and still others have warning signs that indicate something is signiďŹ cantly wrong. Contact your doctor if you experience any of the following symptoms, and be prepared to describe the onset, frequency, and severity of: UĂ&#x160; Changes in bowel habits, such as prolonged diarrhea or constipation UĂ&#x160; Blood in your stool or in the toilet UĂ&#x160; Dark (even black) stool UĂ&#x160; Changes in the shape of your stool UĂ&#x160; Bleeding from your rectum UĂ&#x160; Lower stomach cramps or discomfort UĂ&#x160; Constant urge to have a bowel movement, without relief after you have one UĂ&#x160; Unexplained weight loss Keep in mind that any of these symptoms could have other causes, ranging from minor to serious. Regardless of the cause, early detection puts you in the best position to respond and recover.
If your screening does not detect polyps or other problems, you generally can wait another 5â&#x20AC;&#x201C;10 years before your next screening, depending on which test is performed. Colonoscopies, for instance, are typically performed every 10 years, assuming the previous test found no polyps and the patient has no symptoms. New and reďŹ ned screenings for colon cancer are on the horizon. Colon cancer to page 31
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BEHAVIORAL HEALTH
Treating the whole patient By Lee Beecher, MD, DLFAPA, FASAM
I
n January, a task force advising the federal government on health care recommended depression screening for all Americans over the age of 18. Characterizing major depressive disorder as a signiďŹ cant health care problem and the leading cause of disability among adults in high-income countries, the U.S. Preventive Services Task Force (USPSTF) called for screening by all physicians, including primary care providers.
DeďŹ ning the issue Americans already spend billions on medications targeting mental health. For psychotherapeutic agents of all kinds, Americans spent $27 billion in 2013, with 32.1 million people prescribed these drugs.
This new emphasis on depression screening is likely to feed arguments over using prescription medicines to alleviate symptoms associated with mental health. Many patients ďŹ nd such medications to be just one step in a treatment plan that includes mental health professionals.
â&#x20AC;&#x153;Much of the growth of antidepressant use has been driven by a substantial increase in antidepressant prescriptionsâ&#x20AC;Śby medical professionals other than psychiatrists,â&#x20AC;? according to a December 2011 article by Thomas Insel, MD, former director of the National Institute of Mental Health. â&#x20AC;&#x153;Many of these prescriptions are written without a speciďŹ c psychiatric diagnosis or plan of care.â&#x20AC;?
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Antidepressants are among the most common prescriptions for those suffering from anxiety or depression, but some commentators warn that they are not always prescribed wisely.
But not all patients are able to seek help from a psychiatrist, in part because of shortages in the profession. For the estimated 20 percent of Americans struggling with some form of behavioral health concern, a simple visit to the family doctor or primary care clinic is the ďŹ rst step. Sarah Anderson, MSW, LICSW, stressed this point during a November 2015 roundtable on behavioral health integration hosted by Minnesota Physician Publishing. â&#x20AC;&#x153;If we could address [mental health issues] in primary care, there would be less suffering,â&#x20AC;? she said, â&#x20AC;&#x153;because people would have access where they would not necessarily have it otherwise...not everyone wants to run off and talk to a psychiatrist or a therapist.â&#x20AC;? The role of primary care The USPSTF recommendations called for primary care clinics to make immediate determinations concerning depression and anxiety. During routine examinations, physicians would ďŹ rst evaluate â&#x20AC;&#x153;physicalâ&#x20AC;? illnesses, suicide risk, and potential danger to others, and conduct a clinical interview to assess alcohol or drug use. Primary care doctors know better than to make assumptions about the causes of depression or anxiety in the short time available in the exam room. They understand they cannot know the long-term implications or outcomes of prescription-only therapies. Knowing if the behavioral health symptoms are chronic, recent, periodic, or perhaps a departure from the patientâ&#x20AC;&#x2122;s most commonly observed state of mind takes timeâ&#x20AC;&#x201D;and time is something few primary care doctors have available. Many primary care clinics use the PHQ-9 (Patient Health Questionnaire) or a similar test to evaluate a patientâ&#x20AC;&#x2122;s stress, anxiety level,
A case study or level of depression. The PHQ-9 questionnaire asks nine weighted questions, providing the physician with a score, a simple number relied upon to “objectively” measure the severity of anxiety or depression. Physicians often repeat this PHQ-9 at subsequent examinations to track the effectiveness of treatment. Many patients might prefer dialogue to forms, but primary care doctors seldom have time to talk. Here is where the patient must be assertive, asking questions about the expected effects, outcomes, and side effects of prescription medicine. “[O]ptimal treatment for depression does not begin or end with medication,” Insel writes. “A quality treatment plan for depression includes a thorough assessment, a comprehensive treatment plan that includes choices tailored to and guided by the individual— whether that be medication, psychotherapy or both—and careful, frequent follow-up.” [Emphasis added] Providing a prescription for antidepressants based on screening scores alone is generally not a “best practice.” Many patients would greatly benefit from talking with and being assessed by a psychiatrist or other mental health professional. The role of mental health professionals Consider the experience of Dale (see sidebar), who went through several weeks of a prescription regimen before finding help from talking to a psychologist. Dale’s primary care physician had prescribed antidepressants based on a PHQ-9 test. If Dale had first spent time talking with a mental health professional, personal counseling might have preceded his drug prescription. Antidepressants to page 30
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Dale’s chest pain didn’t feel like a heart attack, so he called his primary care clinic instead of 911. That office arranged for an ambulance to the hospital emergency department, where Dale received blood tests, an X-ray, and two EKGs. The attending physician told Dale that he probably had not suffered heart damage, but advised him to take a heart stress test to be sure. Dale was discharged after hearing that the chest pain likely resulted from mental stress…but no one in the emergency department had discussed potential mental health issues facing this man in his late 50s. (This story is true, but all of the names have been changed.) The next day, Dale saw his primary care doctor. Dr. Calmer listened, asked questions, and took notes on his laptop. Then he gave Dale a one-sided form—a PHQ-9 questionnaire. “Fill this out as best you can, and I will be right back,” Dr. Calmer said, leaving to see another patient. Dale’s PHQ-9 score suggested that he suffered from moderate to high levels of anxiety. Based on medical practice guidelines, the doctor prescribed a Selective Serotonin Reuptake Inhibitor (SSRI), one of a common class of antidepressants. He explained how SSRIs work, and warned of a serious potential side effect. “Some people actually feel suicidal when they take an SSRI,” he cautioned. “Make sure your wife is aware and that she keeps an eye on you. Be sure to call immediately if this happens to you.” Neither Dale nor Dr. Calmer talked about the life events that may have brought about Dale’s anxiety and stress attack. Dr. Calmer advised Dale to come back to the clinic in a few weeks, or to call “if any problems arose.” Dale disliked taking prescription medicines, but he felt less stigma taking pills than seeing a psychiatrist or other mental health professional—although that might have been the right call, given his subsequent experiences. After starting the SSRI, Dale’s wife told him his face drooped—that he looked and acted sad all the time. He became listless, and experienced sexual dysfunction. He did, however, report a reduction in his anxiety. Dale returned to the clinic, but due to staffing and appointment conflicts, saw a different physician—Dr. Mild. The new doctor looked at Dale’s electronic health care record (EHR) and then placed another PHQ-9 questionnaire in front of him. Once again, Dale’s score was too high, so Dr. Mild explained that some patients respond better to different SSRIs. Dale agreed to try a new medication, but neither he nor the doctor discussed getting help from a mental health professional. The new SSRI left Dale with the same troublesome symptoms, so Dr. Mild switched him to Wellbutrin—a different class of antidepressant. Within days of starting on Wellbutrin, Dale was unable to concentrate, could not relax, and felt he was losing control of his thoughts. Dale arranged to see a third doctor, this time taking his wife along. The new doctor took a different approach. Dr. Sweet skipped the PHQ-9 form and spent 45 minutes talking with Dale and his wife. She listened to Dale explain the struggles he had with SSRIs and Wellbutrin. Dr. Sweet recommended withdrawing him from Wellbutrin, and urged Dale to talk with a psychologist or psychiatrist about the issues contributing to his anxiety. She assured Dale that the door would remain open for additional medications if necessary. Dale immediately made an appointment, even though he had to pay out-of-pocket. Dale wanted relief, and so did his wife. The psychologist encouraged Dale to talk about events that may have created his stress and anxiety. At the end of their first session, the psychologist recommended simple relaxation techniques. Talking about the stressors in his life with a neutral, non-judgmental person helped Dale to release his tension. He came to understand his need to find time to relax, not be so driven, and find a better way to communicate with his business partner. “I think you are doing well now. We won’t need to meet again,” the psychologist said after four sessions. Dale has never since taken an antidepressant, but knows they are available. Dale learned the importance of expressing himself to his doctors, and to ask for and be open to a wider range of therapies. MARCH 2016 MINNESOTA HEALTH CARE NEWS
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Antidepressants from page 29
Dale’s experience shows how important it is for patients to pay careful attention to the outcomes of the prescriptions—and ask for help if they believe they need it. If your individual plan includes medications, for example, make sure you are aware of potential side effects, and call the doctor if they become a problem. Don’t just stop taking medications; this can be dangerous. Establish an open line of communication with your doctor and mental health professionals. Explain your symptoms, ask for suggestions, or, as in Dale’s case, ask for someone to talk to. Too many individuals end up in emergency departments seeking immediate relief from distress, or after they have injured themselves as a result of their depression or anxiety. Emergency departments may be able deal with these emergency situations, but they are not equipped to deal with long-term mental health issues.
websites could illuminate your unique condition. Face-to-face consultations are more advantageous than Google searches. Summing up What is the single common point in all this? It is the patient. Finding short- and long-term relief takes time and, most often, a team approach, but also requires a patient willing and committed to recovery. Family and friends, mental health professionals, and a primary care doctor, working together with the patient, have the best chance of success. Patients dealing with anxiety and depression need time to intelligently evaluate their needs and available resources, then decide on evaluations and treatments. The patient needs to know that the doctor and the clinical team are ready and able to be steady partners in the treatment odyssey. Perhaps more importantly, the patient needs to know there are many resources beyond antidepressants, and these should form part of a complete therapy.
A prescription for antidepressants based on screening scores alone is generally not a “best practice.”
Take control of your own treatment plan. Antidepressants may reduce immediate anxiety, but the intervention of a mental health professional is also necessary. It’s tempting to turn to the Internet, but the causes of distress can be quite complicated, and few, if any,
Lee Beecher, MD, DLFAPA, FASAM, is president of the Minnesota PhysicianPatient Alliance (MPPA), a nonprofit organization committed to improving health care. Now retired, he maintained a solo practice in adult and addiction psychiatry in St. Louis Park for more than four decades.
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MINNESOTA HEALTH CARE NEWS MARCH 2016
Colon cancer from page 27
These screening methods will improve accuracy, safety, and patient comfort in the years ahead. Staging If colon cancer is found, an oncologist will determine the cancer’s stage. Ranging from zero (earliest stage) to four (advanced stage), the stage is based first on imaging and test results, and later on the results of surgery, which many colorectal cancer patients have. The stage reflects how far the cancer has grown into the intestine wall, if it has reached other contiguous areas, and if it has spread to distant organs or to the patient’s lymph nodes. Staging is one of the most stressful questions cancer patients have when they are diagnosed. While this worry is understandable, staging is the gateway from point A (the unknown) to point B (prognosis and treatment).
Minnesota Oncology also participates in clinical trials, making the newest treatment options available to qualified patients. Clinical trials test many types of treatment such as new drugs, new combinations of treatments, new approaches to surgery or radiation therapy, or new methods such as vaccine or gene therapy. Today, cancer research is no longer conducted exclusively at large university cancer centers or major metropolitan hospitals. Community-based oncology practices such as Minnesota Oncology play a critical role in the development of new treatment options for patients. Every patient and every cancer is unique. As an oncologist, my job is to treat each patient individually and to work with each person and family to arrive at the right decisions for them. I consider factors such as the patient’s age, other medical conditions, and overall health in addition to the cancer.
Colon cancer is the third leading cause of cancer-related deaths.
Treatment The type of treatment each patient has depends primarily on the stage of the cancer. The most common options are surgery, chemotherapy, and radiation. Some patients with localized, early-stage cancers may not even need to go that far, because their cancers are removed during a colonoscopy. Some need only surgery, while others also require chemotherapy and/or radiation.
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While each person is different, my one recommendation for everyone is to get a cancer screening beginning at age 50— sooner if you are at a higher risk and as needed if you have symptoms that might indicate the presence of cancer. Patients whose colon cancer is detected early have a five-year survival rate of 92 percent. Avina Singh, MD, is a board-certified medical oncologist and hematologist practicing at Minnesota Oncology’s Burnsville Clinic.
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Atrial fibrillation from page 15
eliminates the electrical triggers that cause AF. These electrical triggers commonly originate in the pulmonary veins, which carry oxygenated blood from the lungs to the heart. During catheter ablation, a cardiologist weaves a catheter through the chambers of the heart and uses heat or cold energy to eliminate the electrical triggers of AF.
of AF in patients with diabetes, compared with 140 mm Hg. Other investigators have shown that weight loss results in lower risk of AF. These findings have helped form the guiding principles at the Atrial Fibrillation Center at University of Minnesota Health, where cardiologists provide comprehensive, evidence-based care based on these four pillars. Pounds of cure When it comes to AF, an ounce of prevention is worth a pound of cure. People—especially those who are predisposed to AF and other heart conditions—should adopt and maintain a healthy life style. People should consider following a heart-healthy diet that is rich with vegetables, fruits, and whole grains, and low in fats and cholesterol. Pairing a healthy diet with daily exercise, such as walking, jogging, or even gardening, can prevent AF and other heart complications. It’s also an effective strategy to use in conjunction with the above treatments.
Binge drinking and smoking can cause or exacerbate atrial fibrillation.
There is an emerging fourth pillar of AF treatment that involves stringent control of atherosclerotic risk factors. Atherosclerosis is when plaque builds up and hardens in a person’s arteries. Obesity, hypertension, diabetes, and smoking are all atherosclerotic risk factors. The National Institutes of Health is sponsoring a research project at the University of Minnesota that aims to clarify the role of atherosclerosis and its risk factors in determining the risk of AF. University of Minnesota researchers recently published a paper showing that smoking is associated with higher risk of stroke or death from cardiovascular reasons in AF patients. In another recent paper, researchers discovered that reducing blood pressure to less than 120 mm Hg (the “top” number that your health care provider provides during a blood pressure test) is associated with lower risk
Lin Yee Chen, MD, MS, is the co-director of the Atrial Fibrillation Center at University of Minnesota Health and the director of the Cardiac Electrophysiology Laboratory at the University of Minnesota Medical Center. Chen is the principal investigator of the NIH study mentioned in this article.
February 2016 Survey M I N N E S OTA H E A LT H C A R E
CO N S U M E R A S S O C I AT I O N
Each month, members of the Minnesota Health Care Consumer Association are invited to participate in a survey that measures opinions around topics that affect our health-care delivery system. There is no charge to join the association, and everyone is invited. 1. I believe that there is a serious problem with gun violence in America today.
2. I believe gun violence is a public health concern.
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4. I believe the purchase of any firearm should be much more tightly regulated. 50 50
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5. I support increased federal funding for research into mental health issues related to gun violence.
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3. I believe the sale and possession of assault weapons and ammunition should be banned.
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MINNESOTA HEALTH CARE NEWS MARCH 2016
Strongly agree
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For more information, please visit www.mnhcca.org. We are pleased to present results of the most recent survey.
Disagree
Strongly disagree
JOIN US.
Be heard in debates and discussions that shape the future of health care policy. There is no cost to join this informed and informative online community. Members receive a free monthly electronic newsletter and the opportunity to participate in consumer opinion surveys.
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America’s gun violence epidemic from page 13
and is considered a growing epidemic in the U.S., claiming close to 60,000 lives per year and securing a spot as one of the nation’s leading causes of death—in fact, the leading cause of death in some cases. In the U.S., homicide is the leading cause of death for African Americans ages 10 to 24 and is the second leading cause of death for all young people in that age group.
Violence behaves like contagious disease.
We’ve gathered a group of over 70 health experts representing more than 15 of our most violent cities across the nation under the leadership of former U.S. Surgeon General David Satcher, MD, and Al Sommer, MD, of Johns Hopkins University. Community leaders across the country are sharing evidence-based approaches to violence prevention to save lives and create a health framework that can be implemented nationwide. For more information on the Cure Violence model and how you can help to contain this epidemic, visit our website at www. cureviolence.org. Gary Slutkin, MD, is founder and executive director of Cure Violence and professor of epidemiology and international health at the University of Illinois at Chicago School of Public Health.
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Now accepting new patients
A unique perspective on cardiac care Preventive Cardiology Consultants is founded on the fundamental belief that much of heart disease can be avoided in the vast majority of patients, and significantly delayed in the rest, by prudent modification of risk factors and attainable lifestyle measures. Elizabeth Klodas, M.D., F.A.S.C.C is a preventive cardiologist. She is the founding Editor in Chief of CardioSmart for the American College of Cardiology www.cardiosmart.org, a published author and medical editor for webMD. She is a member of several national committees on improving cardiac health and a frequent lecturer on the topic.
We are dedicated to creating a true partnership between doctor and patient working together to maximize heart health. We spend time getting to know each patient individually, learning about their lives and lifestyles before customizing treatment programs to maximize their health. Whether you have experienced any type of cardiac event, are at risk for one, or
are interested in learning how to prevent one, we can design a set of just-for-you solutions. Among the services we provide • One-on-one consultations with cardiologists • In-depth evaluation of nutrition and lifestyle factors • Advanced and routine blood analysis • Cardiac imaging including (as required) stress testing, stress echocardiography, stress nuclear imaging, coronary calcium screening, CT coronary angiography • Vascular screening • Dietary counseling/Exercise prescriptions
To schedule an appointment or to learn more about becoming a patient, please contact: Preventive Cardiology Consultants 6545 France Avenue, Suite 125, Edina, MN 55435 phone. 952.929.5600 fax. 952.929.5610 www.pccmn.com
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MINNESOTA HEALTH CARE NEWS MARCH 2016
Victoza® (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY. Please consult package insert for full prescribing information. WARNING: RISK OF THYROID C-CELL TUMORS: Liraglutide causes dose-dependent and treatmentduration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies. Victoza® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Based on the findings in rodents, monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials, but this may have increased the number of unnecessary thyroid surgeries. It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors. Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions]. INDICATIONS AND USAGE: Victoza® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Important Limitations of Use: Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans, prescribe Victoza® only to patients for whom the potential benefits are considered to outweigh the potential risk. Victoza® is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise. Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victoza®. Victoza® has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victoza®. Other antidiabetic therapies should be considered in patients with a history of pancreatitis. Victoza® is not a substitute for insulin. Victoza® should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. The concurrent use of Victoza® and prandial insulin has not been studied. CONTRAINDICATIONS: Do not use in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not use in patients with a prior serious hypersensitivity reaction to Victoza® or to any of the product components. WARNINGS AND PRECAUTIONS: Risk of Thyroid C-cell Tumors: Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas and/or carcinomas) at clinically relevant exposures in both genders of rats and mice. Malignant thyroid C-cell carcinomas were detected in rats and mice. A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls. It is unknown whether Victoza® will cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies. In the clinical trials, there have been 6 reported cases of thyroid C-cell hyperplasia among Victoza®-treated patients and 2 cases in comparator-treated patients (1.3 vs. 1.0 cases per 1000 patient-years). One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations >1000 ng/L suggesting pre-existing disease. All of these cases were diagnosed after thyroidectomy, which was prompted by abnormal results on routine, protocol-specified measurements of serum calcitonin. Five of the six Victoza®-treated patients had elevated calcitonin concentrations at baseline and throughout the trial. One Victoza® and one non-Victoza®-treated patient developed elevated calcitonin concentrations while on treatment. Calcitonin, a biological marker of MTC, was measured throughout the clinical development program. The serum calcitonin assay used in the Victoza® clinical trials had a lower limit of quantification (LLOQ) of 0.7 ng/L and the upper limit of the reference range was 5.0 ng/L for women and 8.4 ng/L for men. At Weeks 26 and 52 in the clinical trials, adjusted mean serum calcitonin concentrations were higher in Victoza®-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator. At these timepoints, the adjusted mean serum calcitonin values (~1.0 ng/L) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 0.1 ng/L or less. Among patients with pre-treatment serum calcitonin below the upper limit of the reference range, shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victoza® 1.8 mg/day. In trials with on-treatment serum calcitonin measurements out to 5-6 months, 1.9% of patients treated with Victoza® 1.8 mg/day developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 0.8-1.1% of patients treated with control medication or the 0.6 and 1.2 mg doses of Victoza®. In trials with on-treatment serum calcitonin measurements out to 12 months, 1.3% of patients treated with Victoza® 1.8 mg/day had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range, compared to 0.6%, 0% and 1.0% of patients treated with Victoza® 1.2 mg, placebo and active control, respectively. Otherwise, Victoza® did not produce consistent dose-dependent or time-dependent increases in serum calcitonin. Patients with MTC usually have calcitonin values >50 ng/L. In Victoza® clinical trials, among patients with pre-treatment serum calcitonin <50 ng/L, one Victoza®-treated patient and no comparator-treated patients developed serum calcitonin >50 ng/L. The Victoza®-treated patient who developed serum calcitonin >50 ng/L had an elevated pre-treatment serum calcitonin of 10.7 ng/L that increased to 30.7 ng/L at Week 12 and 53.5 ng/L at the end of the 6-month trial. Follow-up serum calcitonin was 22.3 ng/L more than 2.5 years after the last dose of Victoza®. The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 19.3 ng/L at baseline to 44.8 ng/L at Week 65 and 38.1 ng/L at Week 104. Among patients who began with serum calcitonin <20 ng/L, calcitonin elevations to >20 ng/L occurred in 0.7% of Victoza®-treated patients, 0.3% of placebo-treated patients, and 0.5% of active-comparator-treated patients, with an incidence of 1.1% among patients treated with 1.8 mg/ day of Victoza®. The clinical significance of these findings is unknown. Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (e.g. a mass in the neck, dysphagia, dyspnea or persistent hoarseness). It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC, and such monitoring may increase the risk of unnecessary procedures, due to low test specificity for serum calcitonin and a high background incidence of thyroid disease. Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation. Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victoza®, if serum calcitonin is measured and found to be elevated, the patient should be referred to an endocrinologist for further evaluation. Pancreatitis: Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with Victoza®. After initiation of Victoza®, observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting). If pancreatitis is suspected, Victoza® should promptly be discontinued and appropriate management should be initiated. If pancreatitis is confirmed, Victoza® should not be restarted. Consider antidiabetic therapies other than Victoza® in patients with a history of pancreatitis. In clinical trials of Victoza®, there have been 13 cases of pancreatitis among Victoza®-treated patients and 1 case in a comparator (glimepiride) treated patient (2.7 vs. 0.5 cases per 1000 patient-years). Nine of the 13 cases with Victoza® were reported as acute pancreatitis and four were reported as chronic pancreatitis. In one case in a Victoza®-treated patient, pancreatitis, with necrosis, was observed and led to death; however clinical causality could not be established. Some patients had other risk factors for pancreatitis, such as a history of cholelithiasis or alcohol abuse. Use with Medications Known to Cause Hypoglycemia: Patients receiving Victoza® in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia. The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogues) or insulin Renal Impairment: Victoza® has not been found to be directly nephrotoxic in animal studies or clinical trials. There have been postmarketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis in Victoza®-treated patients. Some of these events were reported in patients without known underlying renal disease. A majority of the reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status. Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents, including Victoza®. Use caution when initiating or escalating doses of Victoza® in patients with renal impairment. Hypersensitivity Reactions: There have been postmarketing reports of serious hypersensitivity reactions (e.g., anaphylactic reactions and angioedema) in patients treated with Victoza®. If a hypersensitivity reaction occurs, the patient should discontinue Victoza® and other suspect medications and promptly seek medical advice. Angioedema has also been reported with other GLP-1 receptor agonists. Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to angioedema with Victoza®. Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victoza® or any other antidiabetic drug. ADVERSE REACTIONS: Clinical Trials Experience: 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 safety of Victoza® has been evaluated in 8 clinical trials: A double-blind 52-week monotherapy trial compared Victoza® 1.2 mg daily, Victoza® 1.8 mg daily, and glimepiride 8 mg daily; A double-blind 26 week add-on to metformin trial compared Victoza® 0.6 mg once-daily, Victoza® 1.2 mg once-daily, Victoza® 1.8
mg once-daily, placebo, and glimepiride 4 mg once-daily; A double-blind 26 week add-on to glimepiride trial compared Victoza® 0.6 mg daily, Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily, placebo, and rosiglitazone 4 mg once-daily; A 26 week add-on to metformin + glimepiride trial, compared double-blind Victoza® 1.8 mg once-daily, double-blind placebo, and open-label insulin glargine once-daily; A doubleblind 26-week add-on to metformin + rosiglitazone trial compared Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily and placebo; An open-label 26-week add-on to metformin and/or sulfonylurea trial compared Victoza® 1.8 mg once-daily and exenatide 10 mcg twice-daily; An open-label 26-week add-on to metformin trial compared Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily, and sitagliptin 100 mg once-daily; An open-label 26-week trial compared insulin detemir as add-on to Victoza® 1.8 mg + metformin to continued treatment with Victoza® + metformin alone. Withdrawals: The incidence of withdrawal due to adverse events was 7.8% for Victoza®-treated patients and 3.4% for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer. This difference was driven by withdrawals due to gastrointestinal adverse reactions, which occurred in 5.0% of Victoza®-treated patients and 0.5% of comparator-treated patients. In these five trials, the most common adverse reactions leading to withdrawal for Victoza®-treated patients were nausea (2.8% versus 0% for comparator) and vomiting (1.5% versus 0.1% for comparator). Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials. Common adverse reactions: Tables 1, 2, 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer. Most of these adverse reactions were gastrointestinal in nature. In the five double-blind clinical trials of 26 weeks duration or longer, gastrointestinal adverse reactions were reported in 41% of Victoza®-treated patients and were dose-related. Gastrointestinal adverse reactions occurred in 17% of comparator-treated patients. Common adverse reactions that occurred at a higher incidence among Victoza®-treated patients included nausea, vomiting, diarrhea, dyspepsia and constipation. In the five double-blind and three open-label clinical trials of 26 weeks duration or longer, the percentage of patients who reported nausea declined over time. In the five double-blind trials approximately 13% of Victoza®-treated patients and 2% of comparator-treated patients reported nausea during the first 2 weeks of treatment. In the 26-week open-label trial comparing Victoza® to exenatide, both in combination with metformin and/or sulfonylurea, gastrointestinal adverse reactions were reported at a similar incidence in the Victoza® and exenatide treatment groups (Table 3). In the 26-week open-label trial comparing Victoza® 1.2 mg, Victoza® 1.8 mg and sitagliptin 100 mg, all in combination with metformin, gastrointestinal adverse reactions were reported at a higher incidence with Victoza® than sitagliptin (Table 4). In the remaining 26-week trial, all patients received Victoza® 1.8 mg + metformin during a 12-week run-in period. During the run-in period, 167 patients (17% of enrolled total) withdrew from the trial: 76 (46% of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9% of withdrawals) doing so due to other adverse events. Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued, unchanged treatment with Victoza® 1.8 mg + metformin. During this randomized 26-week period, diarrhea was the only adverse reaction reported in ≥5% of patients treated with Victoza® 1.8 mg + metformin + insulin detemir (11.7%) and greater than in patients treated with Victoza® 1.8 mg and metformin alone (6.9%). Table 1: Adverse reactions reported in ≥5% of Victoza®-treated patients in a 52-week monotherapy trial All Victoza® N = 497 Glimepiride N = 248 (%) (%) Adverse Reaction Nausea 28.4 8.5 Diarrhea 17.1 8.9 Vomiting 10.9 3.6 Constipation 9.9 4.8 Headache 9.1 9.3 Table 2: Adverse reactions reported in ≥5% of Victoza®-treated patients and occurring more frequently with Victoza® compared to placebo: 26-week combination therapy trials Add-on to Metformin Trial All Victoza® + Metformin Placebo + Metformin Glimepiride + Metformin N = 724 N = 121 N = 242 (%) (%) (%) Adverse Reaction Nausea 15.2 4.1 3.3 Diarrhea 10.9 4.1 3.7 Headache 9.0 6.6 9.5 Vomiting 6.5 0.8 0.4 Add-on to Glimepiride Trial All Victoza® + Placebo + Glimepiride Rosiglitazone + Glimepiride N = 695 N = 114 Glimepiride N = 231 (%) (%) (%) Adverse Reaction Nausea 7.5 1.8 2.6 Diarrhea 7.2 1.8 2.2 Constipation 5.3 0.9 1.7 Dyspepsia 5.2 0.9 2.6 Add-on to Metformin + Glimepiride ® Victoza 1.8 + Metformin Placebo + Metformin + Glargine + Metformin + + Glimepiride N = 230 Glimepiride N = 114 Glimepiride N = 232 (%) (%) (%) Adverse Reaction Nausea 13.9 3.5 1.3 Diarrhea 10.0 5.3 1.3 Headache 9.6 7.9 5.6 Dyspepsia 6.5 0.9 1.7 Vomiting 6.5 3.5 0.4 Add-on to Metformin + Rosiglitazone ® All Victoza + Metformin + Placebo + Metformin + Rosiglitazone Rosiglitazone N = 355 N = 175 (%) (%) Adverse Reaction Nausea 34.6 8.6 Diarrhea 14.1 6.3 Vomiting 12.4 2.9 Headache 8.2 4.6 Constipation 5.1 1.1 Table 3: Adverse Reactions reported in ≥5% of Victoza®-treated patients in a 26-Week Open-Label Trial versus Exenatide Exenatide 10 mcg twice daily + Victoza® 1.8 mg once daily + metformin and/or sulfonylurea metformin and/or sulfonylurea N = 232 N = 235 (%) (%) Adverse Reaction Nausea 25.5 28.0 Diarrhea 12.3 12.1 Headache 8.9 10.3 Dyspepsia 8.9 4.7 Vomiting 6.0 9.9 Constipation 5.1 2.6 Table 4: Adverse Reactions in ≥5% of Victoza®-treated patients in a 26-Week Open-Label Trial versus Sitagliptin All Victoza® + metformin Sitagliptin 100 mg/day + N = 439 metformin N = 219 (%) (%) Adverse Reaction Nausea 23.9 4.6 Headache 10.3 10.0 Diarrhea 9.3 4.6 Vomiting 8.7 4.1 Immunogenicity: Consistent with the potentially immunogenic properties of protein and peptide pharmaceuticals, patients treated with Victoza® may develop anti-liraglutide antibodies. Approximately 50-70% of Victoza®-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment. Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 8.6% of these Victoza®-treated patients. Sampling was not performed uniformly across all patients in the clinical trials, and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies. Cross-reacting antiliraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 6.9% of the Victoza®-treated patients in the double-blind 52-week monotherapy trial and in 4.8% of the Victoza®-treated patients in the double-blind 26-week add-on combination therapy trials. These cross-reacting antibodies were not tested
for neutralizing effect against native GLP-1, and thus the potential for clinically significant neutralization of native GLP-1 was not assessed. Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 2.3% of the Victoza®-treated patients in the double-blind 52-week monotherapy trial and in 1.0% of the Victoza®-treated patients in the double-blind 26-week add-on combination therapy trials. Among Victoza®-treated patients who developed anti-liraglutide antibodies, the most common category of adverse events was that of infections, which occurred among 40% of these patients compared to 36%, 34% and 35% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. The specific infections which occurred with greater frequency among Victoza®-treated antibody-positive patients were primarily nonserious upper respiratory tract infections, which occurred among 11% of Victoza®-treated antibody-positive patients; and among 7%, 7% and 5% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. Among Victoza®-treated antibody-negative patients, the most common category of adverse events was that of gastrointestinal events, which occurred in 43%, 18% and 19% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. Antibody formation was not associated with reduced efficacy of Victoza® when comparing mean HbA1c of all antibody-positive and all antibody-negative patients. However, the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victoza® treatment. In the five double-blind clinical trials of Victoza®, events from a composite of adverse events potentially related to immunogenicity (e.g. urticaria, angioedema) occurred among 0.8% of Victoza®-treated patients and among 0.4% of comparator-treated patients. Urticaria accounted for approximately one-half of the events in this composite for Victoza®-treated patients. Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies. Injection site reactions: Injection site reactions (e.g., injection site rash, erythema) were reported in approximately 2% of Victoza®-treated patients in the five double-blind clinical trials of at least 26 weeks duration. Less than 0.2% of Victoza®-treated patients discontinued due to injection site reactions. Papillary thyroid carcinoma: In clinical trials of Victoza®, there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victoza® and 1 case in a comparator-treated patient (1.5 vs. 0.5 cases per 1000 patient-years). Most of these papillary thyroid carcinomas were <1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound. Hypoglycemia :In the eight clinical trials of at least 26 weeks duration, hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victoza®-treated patients (2.3 cases per 1000 patient-years) and in two exenatidetreated patients. Of these 11 Victoza®-treated patients, six patients were concomitantly using metformin and a sulfonylurea, one was concomitantly using a sulfonylurea, two were concomitantly using metformin (blood glucose values were 65 and 94 mg/dL) and two were using Victoza® as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treatment during a hospital stay). For these two patients on Victoza® monotherapy, the insulin treatment was the likely explanation for the hypoglycemia. In the 26-week open-label trial comparing Victoza® to sitagliptin, the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose <56 mg/ dL was comparable among the treatment groups (approximately 5%). Table 5: Incidence (%) and Rate (episodes/patient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials Victoza® Treatment Active Comparator Placebo Comparator None Monotherapy Victoza® (N = 497) Glimepiride (N = 248) Patient not able to self-treat 0 0 — Patient able to self-treat 9.7 (0.24) 25.0 (1.66) — Not classified 1.2 (0.03) 2.4 (0.04) — Add-on to Metformin Victoza® + Metformin Glimepiride + Placebo + Metformin (N = 724) Metformin (N = 242) (N = 121) Patient not able to self-treat 0.1 (0.001) 0 0 Patient able to self-treat 3.6 (0.05) 22.3 (0.87) 2.5 (0.06) ® ® None Insulin detemir + Continued Victoza Add-on to Victoza + Metformin Victoza® + Metformin + Metformin alone (N = 158*) (N = 163) Patient not able to self-treat 0 0 — Patient able to self-treat 9.2 (0.29) 1.3 (0.03) — Rosiglitazone + Placebo + Add-on to Glimepiride Victoza® + Glimepiride (N = 695) Glimepiride (N = 231) Glimepiride (N = 114) Patient not able to self-treat 0.1 (0.003) 0 0 Patient able to self-treat 7.5 (0.38) 4.3 (0.12) 2.6 (0.17) Not classified 0.9 (0.05) 0.9 (0.02) 0 Placebo + Metformin Add-on to Metformin + Victoza® + Metformin None + Rosiglitazone + Rosiglitazone Rosiglitazone (N = 175) (N = 355) Patient not able to self-treat 0 — 0 Patient able to self-treat 7.9 (0.49) — 4.6 (0.15) Not classified 0.6 (0.01) — 1.1 (0.03) Add-on to Metformin + Victoza® + Metformin Insulin glargine Placebo + Metformin + Glimepiride + Metformin + Glimepiride + Glimepiride (N = 114) Glimepiride (N = 232) (N = 230) Patient not able to self-treat 2.2 (0.06) 0 0 Patient able to self-treat 27.4 (1.16) 28.9 (1.29) 16.7 (0.95) Not classified 0 1.7 (0.04) 0 *One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat. This patient had a history of frequent hypoglycemia prior to the study. In a pooled analysis of clinical trials, the incidence rate (per 1,000 patient-years) for malignant neoplasms (based on investigator-reported events, medical history, pathology reports, and surgical reports from both blinded and open-label study periods) was 10.9 for Victoza®, 6.3 for placebo, and 7.2 for active comparator. After excluding papillary thyroid carcinoma events [see Adverse Reactions], no particular cancer cell type predominated. Seven malignant neoplasm events were reported beyond 1 year of exposure to study medication, six events among Victoza®-treated patients (4 colon, 1 prostate and 1 nasopharyngeal), no events with placebo and one event with active comparator (colon). Causality has not been established. Laboratory Tests: In the five clinical trials of at least 26 weeks duration, mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 4.0% of Victoza®-treated patients, 2.1% of placebo-treated patients and 3.5% of active-comparator-treated patients. This finding was not accompanied by abnormalities in other liver tests. The significance of this isolated finding is unknown. Vital signs: Victoza® did not have adverse effects on blood pressure. Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victoza® compared to placebo. The long-term clinical effects of the increase in pulse rate have not been established. Post-Marketing Experience: The following additional adverse reactions have been reported during post-approval use of Victoza®. Because these events are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Dehydration resulting from nausea, vomiting and diarrhea; Increased serum creatinine, acute renal failure or worsening of chronic renal failure, sometimes requiring hemodialysis; Angioedema and anaphylactic reactions; Allergic reactions: rash and pruritus; Acute pancreatitis, hemorrhagic and necrotizing pancreatitis sometimes resulting in death. OVERDOSAGE: Overdoses have been reported in clinical trials and post-marketing use of Victoza®. Effects have included severe nausea and severe vomiting. In the event of overdosage, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms. More detailed information is available upon request. For information about Victoza® contact: Novo Nordisk Inc., 800 Scudders Mill Road, Plainsboro, NJ 08536, 1−877-484-2869 Date of Issue: April 16, 2013 Version: 6 Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark Victoza® is covered by US Patent Nos. 6,268,343, 6,458,924, 7,235,627, 8,114,833 and other patents pending. Victoza® Pen is covered by US Patent Nos. 6,004,297, RE 43,834, RE 41,956 and other patents pending. © 2010-2013 Novo Nordisk 0513-00015682-1 5/2013
®
A change with powerful, long-lasting benefits
Reductions up to -1.1%a
Weight loss up to 5.5 lba,b
Low rate of hypoglycemiac
1.8 mg dose when used alone for 52 weeks. Victoza® is not indicated for the management of obesity. Weight change was a secondary end point in clinical trials. c In the 8 clinical trials of at least 26 weeks’ duration, hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victoza®-treated patients. a
b
A 52-week, double-blind, double-dummy, active-controlled, parallel-group, multicenter study. Patients with type 2 diabetes (N=745) were randomized to receive once-daily Victoza® 1.2 mg (n=251), Victoza® 1.8 mg (n=246), or glimepiride 8 mg (n=248). The primary outcome was change in A1C after 52 weeks.
The change begins at VictozaPro.com. Indications and Usage Victoza (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans, prescribe Victoza® only to patients for whom the potential benefits are considered to outweigh the potential risk. Victoza® is not recommended as firstline therapy for patients who have inadequate glycemic control on diet and exercise. Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victoza®. Victoza® has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victoza®. Other antidiabetic therapies should be considered in patients with a history of pancreatitis. Victoza® is not a substitute for insulin. Victoza® should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. Victoza® has not been studied in combination with prandial insulin. ®
Important Safety Information
Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies. Victoza® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Based on the findings in rodents, monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials, but this may have increased the number of unnecessary thyroid surgeries. It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors. Patients should be counseled regarding the risk and symptoms of thyroid tumors. Do not use in patients with a prior serious hypersensitivity reaction to Victoza® or to any of the product components. Postmarketing reports, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. Discontinue promptly if pancreatitis is suspected. Do not restart if Victoza® is a registered trademark of Novo Nordisk A/S. © 2013 Novo Nordisk All rights reserved.
pancreatitis is confirmed. Consider other antidiabetic therapies in patients with a history of pancreatitis. When Victoza® is used with an insulin secretagogue (e.g. a sulfonylurea) or insulin serious hypoglycemia can occur. Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemia. Renal impairment has been reported postmarketing, usually in association with nausea, vomiting, diarrhea, or dehydration which may sometimes require hemodialysis. Use caution when initiating or escalating doses of Victoza® in patients with renal impairment. Serious hypersensitivity reactions (e.g. anaphylaxis and angioedema) have been reported during postmarketing use of Victoza®. If symptoms of hypersensitivity reactions occur, patients must stop taking Victoza® and seek medical advice promptly. There have been no studies establishing conclusive evidence of macrovascular risk reduction with Victoza® or any other antidiabetic drug. The most common adverse reactions, reported in ≥5% of patients treated with Victoza® and more commonly than in patients treated with placebo, are headache, nausea, diarrhea, dyspepsia, constipation and anti-liraglutide antibody formation. Immunogenicity-related events, including urticaria, were more common among Victoza®-treated patients (0.8%) than among comparator-treated patients (0.4%) in clinical trials. Victoza® has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patients. There is limited data in patients with renal or hepatic impairment. In a 52-week monotherapy study (n=745) with a 52-week extension, the adverse reactions reported in ≥ 5% of patients treated with Victoza® 1.8 mg, Victoza® 1.2 mg, or glimepiride were constipation (11.8%, 8.4%, and 4.8%), diarrhea (19.5%, 17.5%, and 9.3%), flatulence (5.3%, 1.6%, and 2.0%), nausea (30.5%, 28.7%, and 8.5%), vomiting (10.2%, 13.1%, and 4.0%), fatigue (5.3%, 3.2%, and 3.6%), bronchitis (3.7%, 6.0%, and 4.4%), influenza (11.0%, 9.2%, and 8.5%), nasopharyngitis (6.5%, 9.2%, and 7.3%), sinusitis (7.3%, 8.4%, and 7.3%), upper respiratory tract infection (13.4%, 14.3%, and 8.9%), urinary tract infection (6.1%, 10.4%, and 5.2%), arthralgia (2.4%, 4.4%, and 6.0%), back pain (7.3%, 7.2%, and 6.9%), pain in extremity (6.1%, 3.6%, and 3.2%), dizziness (7.7%, 5.2%, and 5.2%), headache (7.3%, 11.2%, and 9.3%), depression (5.7%, 3.2%, and 2.0%), cough (5.7%, 2.0%, and 4.4%), and hypertension (4.5%, 5.6%, and 6.9%). Please see brief summary of Prescribing Information on adjacent page. 1013-00018617-1
December 2013