Minnesota Healthcare News April/May 2015 by Minnesota Physician Publishing

April/May 2015 â&#x20AC;˘ Volume 13 Number 4

Proper Nutrition Jillian G. Lampert, PhD

Alcohol Use Disorder Janet Schmitt, MD

Diverticular Disease Mark Y. Sun, MD

WHERE

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April/May 2015 • Volume 13 Number 4

4 7 8 10 12 14 16

News

People

Perspective Rebecca Covington Minnesota Consortium for Citizens with Disabilities

10 QUESTIONS Janet Schmitt, MD

22 26 28 30

Nutrition

Proper understand By Jillian G. Lampert, PhD, LD, MPH, FAED

MINNESOTA HEALTH CARE ROUNDTABLE

Hematology Bruising By M ohammed K. Nashawaty, MD

cALENDAR

FORTy-FOURTH SESSION

Policy

long-term plan for A long-term care By Rep. Joe Schomacker

Behavioral Health Homes

Digestive Health

A new pathway to care

Diverticular Disease By Mark Y. Sun, MD

Drug Class

Proton pump inhibitors By Andrea Rosenberg, PharmD, and Anita Sharma, PharmD, BCACP

Otolaryngology

Balloon sinus dilation By Theodore O. Truitt, MD

Caregiving

ome care eligibility H requirements By J ulia Endres-Spray, RN, PHN, MA

Thursday, October 29, 2015 • 1:00-4:00 PM Downtown Minneapolis Hilton and Towers Background and Focus: Increasing evidence supports the link between access to mental health care and reducing health care costs. Primary care physicians often lack the expertise to diagnose behavioral health correctly and are not always able to easily refer a patient to a mental health care provider. Many initiatives nationwide are addressing this issue. It is so important that the ACA stipulated the development of the Behavioral Health Home in 2015. Some states, including Minnesota, are also creating Behavioral Health Home programs. Objectives: We will review numerous initiatives that support the development of the Behavioral Health Home. We will define this term and discuss how to incorporate it into our health care delivery system. We will examine the value it can bring and the challenges it will face. Our panel of industry experts will outline the steps that must be taken to increase the overall access to mental health care and the broad improvement in population health that this increased access will bring. Panelists include: • L. Read Sulik, MD, PrairieCare Sponsors include: • PrairieCare

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 Company Address City, State, ZIP Telephone/FAX Card #

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 Check enclosed  Bill me 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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News

Two Twin Cities Orthopedic Practices to Merge Twin Cities Orthopedics and St. Croix Orthopaedics have announced they will integrate their practices this summer to create what they call “one of the largest privately owned orthopedic practices in the United States.”

similar cultures and are focused on improving patient care and finding ways to be efficient in the current health care environment. The geographic coverage of the two groups together creates a tremendous opportunity to serve the entire metro area and western Wisconsin with a broader service offering.”

The groups plan to complete the integration by mid-summer Currently, Golden Valley-based and don’t anticipate immediate Twin Cities Orthopedics has 84 changes in staffing, though physicians and 970 employees administrative changes will at 24 locations, and treats about continue over the course of the 260,000 patients each year. Oak year. The integrated practice Park Heights-based St. Croix will be under the Twin Cities Othopaedics has 25 physicians and Orthopedics name; St. Croix 170 employees at 11 locations, and Orthopaedics will transition its treats about 92,000 patients each brand over time. year. Once the merger is complete, “This structure allows us the practice will staff more than to be the most flexible with our 100 orthopedic surgeons at 35 service and to prioritize the patient locations across the Twin Cities experience while continuing to and western Wisconsin. carefully manage costs,” said “TCO is excited for the two Melanie Sullivan, CEO of St. groups to join together,” said Croix Orthopaedics. “We have Troy Simonson, CEO of Twin a real opportunity to build Cities Orthopedics. “We have very something truly unique in the

Minnesota Health care news April • MAy 2015

Midwest and we are excited about the possibilities this will provide.”

Initiative Helps Nursing Home Residents Move Home Two thousand Minnesotans previously living in nursing homes have been able to return to their homes since 2010 with help from Senior LinkAge Line community living specialists. They helped those who wished to return to their homes do so through the Return to Community Initiative, a partnership between the Minnesota Department of Human Services (DHS), the Minnesota Board on Aging, Area Agencies on Aging, and Minnesota nursing facilities. According to DHS, nursing homes in Minnesota receive more than 60,000 admissions each year. Care costs an average of $180 per day, which is paid for by Medicare or private insurance on a limited basis only.

“Return to Community helps people return home, which is where most of us want to live, and also prevents or stalls people from going on Medical Assistance, which is a significant government cost,” said Lucinda Jesson, human services commissioner. “The longer people stay in the nursing home, the less likely they are to return to the community and the more likely they are to spend down to become eligible for public assistance.” Community living specialists contact people living in nursing homes and paying for their care out of pocket to offer help in planning a move back to their home or a community living setting. They then stay in contact for up to five years to help with additional services and supports that a person may need to avoid another stay in a nursing home. “In addition to helping people with their initial nursing home discharge and plan to live in the community, community living specialists help people thinking

about moving to assisted living to explore a full range of options, including remaining in their home with appropriate supports,” said Jean Wood, executive director of the Minnesota Board on Aging.

Obesity Rates in Minnesota Remain Steady Obesity rates in Minnesota have stayed steady, unlike other states in the region, according to a recent report from the Minnesota Department of Health (MDH).

diet and exercise are key, and I am confident that Minnesota’s success is closely tied to investments by the Statewide Health Improvement Program and its community and private sector partners to increase Minnesotans’ opportunities for healthy eating and physical activity.”

Ed Ehlinger, MD, Minnesota commissioner of health, reports that Minnesota’s progress on obesity rates is related to the Statewide Health Improvement Program, a program enacted in 2008 in response to increasing health care costs due to obesity. “Obesity is a complex condition with many contributing factors,” said Ehlinger. “We know

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Minnesota Health Plan Enrollment Increases

Health plan enrollment increased 6.8 percent in Minnesota between 2013 and 2014, according to the MDH analyzed data from the Minnesota Council of Health Centers for Disease Control and Plans (MCHP). An additional Prevention’s (CDC) Behavioral 390,000 Minnesotans are now Risk Factor Surveillance covered through the state’s seven System, which surveys 400,000 Minnesotans annually. They found nonprofit health plans and more than 4.8 million are enrolled that obesity rates in Minnesota dropped below 26 percent in 2010 throughout the state. According to the report, individual private and have stayed below that rate coverage and public programs had since. It was the only state in the region to bring the rate below this notable enrollment gains. threshold. Meanwhile, other states “It’s great news that in one in the region, which includes Iowa, year of the ACA (Affordable North Dakota, South Dakota, Care Act), more Minnesotans and Wisconsin, saw obesity rates than ever before have health increase to between 29 percent insurance,” said Jim Schowalter, and 31 percent in 2013, the most president and CEO of MCHP. recent CDC data available. “But digging deeper into the data, we see that this is just the The report also shows that beginning of significant shifts in the number of Minnesotans that the marketplace.” were at a healthy weight in 2013 increased by more than 60,000 since 2010. According to MDH, this is more than 11 percent higher than the U.S. overall. The reduction in obesity rates leads to significant cost savings as well. MDH estimates that the state saved $265 million in obesity-related medical expenses as of 2013. In addition, about 18,600 Minnesotans covered by state health care plans moved to a healthy weight in 2013, which MDH estimates saves up to $9 million for taxpayers each year.

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The report shows a large decline of 16 percent in enrollment through small group health plans. However, there was a 29 percent increase in enrollment in public programs and a 53 percent increase in individual plan enrollment. Most Minnesotans who enrolled in individual plans purchased a plan directly through a health insurance provider, while MNsure enrolled less than 14 percent of individual members. Less than one in four selected a Bronze level plan, and about one in five continued grandfathered plans with coverage that began prior to implementation of the ACA. In addition, more members that were previously unable to get coverage because of highrisk status enrolled through the individual market than originally predicted. Health plans lost money

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Participants Diagnosed with Type 2 Diabetes Needed Job Number

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Peter Tressel

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Terry Thomas

Prism Clinical Research is conducting several studies for participants diagnosed with type 2 diabetes. []

Mark Jenson

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Linda Gogolin

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Krista Kraabel

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Tera Gilmore

Financial compensation is provided for study participation time. Plus, volunteers receive: X Study related medications X Study related medical and laboratory evaluations X Screening laboratory results for personal records

Qualifications, scheduling, and compensation amounts vary from study to study. For more details, contact Molly at: 651-274-5046 or visit www.prismresearchinc.com

News to page 6 April • MAy 2015 Minnesota Health care news

News from page 5

in the individual market in part because of this surge from the high-risk pool whose health care costs are three to four times higher than average. “Minnesotans have more choices than ever before—and that’s good—but it will take time to settle into a new normal,” said Schowalter. “Individual market losses of $316 million create volatility that will take a few years to address.”

Minnesota Hospitals Fare Well on New Medicare Rating System Twelve Minnesota hospitals were awarded the top rating of five stars on the new Centers for Medicare & Medicaid Services (CMS) star rating system based on patient reviews. Results from hospitals’ patient satisfaction surveys have previously been listed on the Medicare website, but this is the first time a star rating has been applied to those scores. Ratings were posted on April 16.

Data reported from health plans in 2014 show a collective operating margin of 0.97 percent, or $229.4 million, making it health Nationally, 251 hospitals, insurers’ most profitable year or about 7 percent of the 3,553 overall since 2011. The operating hospitals rated, received a five-star margin was 0.67 percent in 2013. rating. About 34 percent received four stars, 40 percent received three stars, and 16 percent received two stars. More than 1,100 hospitals did not receive a star rating because not enough patient surveys were completed within the designated timeframe. The highest average ratings

were in Maine, Minnesota, Nebraska, South Dakota, and Wisconsin, while the lowest average ratings were in California, Florida, Maryland, Nevada, New Jersey, New York, and the District of Columbia. There were 34 states that had no one-star rated hospitals and 13 states that had no five-star hospitals. Of the hospitals in Minnesota, 86 had enough patient surveys to receive a star rating. Out of those, 53 received four stars (about 62 percent); 19 received three stars (about 22 percent); and two received two stars (just over 2 percent). The Minnesota hospitals that received five stars are Big Fork Valley Hospital; Fairview Northland Regional Hospital in Princeton; HealthEast Woodwinds Hospital in Woodbury; Lakeview Memorial Hospital in Stillwater; Lakewood Health System in Staples; Mayo Clinic Health System–New Prague; Municipal Hospital and Granite Manor in Granite Falls; New Ulm Medical Center; Redwood Area Hospital

in Redwood Falls; Riverwood Healthcare Center in Aitkin; Sanford Luverne Medical Center; and Sleepy Eye Municipal Hospital. Some experts are concerned that the ratings won’t accurately reflect a hospital’s quality or will be misleading because they are only based on patient reviews. “There’s a risk of oversimplifying the complexity of quality care or misinterpreting what is important to a particular patient, especially since patients seek care for many different reasons,” the American Hospital Association said in a statement. Others don’t think it’s likely that the ratings will have much effect on consumers. “It’s nice they’re going to try to be more consumer friendly,” said Evan Marks of Healthgrades. “I don’t see that the new star rating itself is going to drive consumer adoption. Ultimately, you can put the best content up on the web, but consumers aren’t going to just wake up one day and go to it.”

Choose well New choices in health care are here. Introducing UCare ChoicesSM, affordable new health plans from a leader in Minnesota health care, with coverage for young adults, families, empty nesters and everyone in between. Find out more at UCareChoices.org, and look for us on the MNsure health insurance marketplace and choose UCare Choices.

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Minnesota Health care news April • MAy 2015

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People

Jean Wood, MSW, MAPA, executive director of the Minnesota Board on Aging and director of Aging and Adult Services for the Minnesota Department of Human Services (DHS), has received the Dutch Kastenbaum Outstanding Gerontologist Award from the Minnesota Gerontological Society for her contributions to the lives of older adults Jean Wood in Minnesota. Woodâ&#x20AC;&#x2122;s accomplishments include initiating the development of the Senior LinkAge Line, a statewide information and referral service for older adults and their families and helping lead the development of home and community-based services to help older adults stay in their own homes as they age. Wood has worked with DHS since 1993 and has served as executive director since 2006. She earned masters degrees in both public administration and social work from Ohio State University.

Paul Hartleben, MD, MBA

Love

Paul Hartleben, MD, MBA, board-certified in orthopedic surgery, has joined St. Croix Orthopaedics. He earned his medical degree at the University of Minnesota, completed a residency in orthopedic surgery at the University of Minnesota Hospitals and Clinics, and has more than 30 years of experience in orthopedic surgical practice in the Twin Cities. He is now serving patients at St. Croix Orthopaedics clinics in Stillwater and Wyoming.

Thomas Bracken, MD, board-certified in family medicine, has been named the 2015 Family Physician of the Year by the Minnesota Academy of Family Physicians for representing the highest ideals of family medicine, including caring, comprehensive medical services, community involvement, and service as a role model. Bracken currently practices Thomas Bracken, at Mille Lacs Health System. He earned his medical MD degree at the University of Minnesota Medical School, completed his residency at Hennepin County Medical Center, and has worked as a family physician for more than 30 years. He also teaches one day each month at the Hennepin County Medical Center Family Medicine Residency, mentors premed and physician assistant students at the clinic, and travels to Haiti annually as a volunteer physician.

Laura DuChene, MD

Laura DuChene, MD, board-certified in family medicine, has joined Tri-County Health Care at its Wadena Clinic. She also sees patients on a rotating basis at the new Verndale Clinic. DuChene earned her medical degree from Saba University School of Medicine, Saba, Netherlandsâ&#x20AC;&#x201C;Antilles, completed her residency at the University of Minnesota in St. Cloud. Her special practice interests are in obstetrics and pediatrics.

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April â&#x20AC;˘ MAy 2015 Minnesota Health care news

Perspective

Medical Assistance reform campaign Equity for seniors and people with disabilities helps everyone

innesota holds seniors and individuals with disabilities to different standards than other Minnesotans in order to qualify for Medical Assistance (MA), the largest of Minnesota’s publicly funded health care programs. The Minnesota Consortium for Citizens with Disabilities (MNCCD) is asking state legislators to create the same standards for everyone. Here’s why.

Rebecca Covington The Minnesota Consortium for Citizens with Disabilities Rebecca Covington is the former executive director of the Minnesota Consortium for Citizens with Disabilities (MN-CCD), a broad-based coalition working to change public policy to improve the lives of people with disabilities. MN-CCD envisions equity for all people and the opportunity for those with disabilities to lead meaningful, productive, and self-directed lives.

The problem Many seniors and people with disabilities rely on MA to receive the support services they need to live independently, such as assistance from personal care attendants (PCA). A PCA, for example, can provide assistance with activities of daily living that include grooming, dressing, bathing, transferring from a bed to a chair, mobility, positioning, eating, and toileting. Although the maximum monthly income an adult is allowed to have in order to qualify for MA is $1,342 with unlimited assets, that threshold drops to $973 and no more than $3,000 in assets for seniors and people with disabilities.

According to the 2013 Minnesota Department of Human Services November Budget Forecast, the state saves $31,900 each year for each senior that receives supportive services through MA while living independently instead of moving into institutionalized care. In addition, the same report said that MA saves the state $12,700 annually for each disabled person that lives in the community instead of an institution. So you can see how providing seniors and individuals with disabilities access to waiver services saves the state a significant amount of money.

All individuals deserve to remain independent in their communities.

If a senior or an individual with a disability earns just one dollar more than $973 a month, he or she must spend down his/her income to $730 a month to qualify for MA. Approximately 12,000 Minnesotans are subject to this spend-down. What does “spend down” mean? Victoria F., who depends on MA, explains. In describing her experience with the current asset limit, she says, “The requirements of the medical assistance system force me to give away what little savings I could have to achieve independence. This creates a cycle of poverty for me even though I want to increase my financial independence.” Why it matters The current system requires individuals to impoverish themselves in order to receive the MA waivers that allow them to receive services and support in the community of their own choosing. But what you might not realize is that MA waiver services are

cost-effective for all Minnesotans.

Minnesota Health care news April • MAy 2015

Benefiting everyone MN-CCD is asking Minnesota lawmakers to raise the MA income standards and change asset limits in 2015 through proposed bills SF543 and HF559. There is strong bipartisan backing for this, with Sen. John Hoffman (D–Champlin), the bill’s sponsor in the Senate, and Rep. Nick Zerwas (R–Elk River), the bill’s sponsor in the House. State MA policies vary widely across the United States. No state currently has MA eligibility standards that provide fairness and equity in health care access and affordability for seniors and individuals with disabilities. Massachusetts is currently the only state without an asset limit for Medicaid eligibility for the Disabled and Elderly category. No analysis has been conducted to show the economic benefit that states may receive from raising MA income standards and asset limits. However, raising the income standards and asset limits will allow individuals to retain more of their income to spend at their local grocery stores and at businesses in their communities. The potential economic benefit that this could bring to the state is obvious. All individuals deserve to remain independent in their communities. Creating fair MA thresholds for seniors and individuals with disabilities decreases their cycle of dependence and supports cost savings for all Minnesotans.

Alcohol is more harmful to an unborn baby than cocaine, marijuana or heroin. Drinking during pregnancy can cause Fetal Alcohol Spectrum Disorders (FASD) which permanently harm the way your baby learns and behaves.

- ZERO ALCOHOL FOR NINE MONTHS.

April â&#x20AC;˘ May 2015 Minnesota Health care news

10 Questions

Addressing Alcohol Use Disorder Janet Schmitt, MD Dr. Schmitt is a family practice physician who has spent many years specializing in serving patients with substance abuse issues. She was in an independent private practice when this interview was conducted and has recently accepted a position at HealthEast.

Please give us some examples of behavior that constitute Alcohol Use Disorder. People dependent on alcohol may find that they use more of it than intended; spend excessive amounts of money and time finding alcohol or recovering from its effects; experience intense cravings; or neglect home, work, or community responsibilities. People who continue to drink in spite of loss of home, work, or loved ones, and who endanger others as well as themselves, present a mystery to themselves and to those around them. Alcohol use can be obvious to others, and it can be hidden from all but the alcohol-dependent personâ&#x20AC;&#x2122;s closest associates until it has reached an advanced stage. As time passes, the brain and body adapt to consistent levels of alcohol. A person may die if alcohol is stopped abruptly without interventions. How is treating this different from treating other diseases? There is a spiritual aspect to treatment of all disease but nowhere is it more essential than with Alcohol Use Disorder. Recovery from this dependence requires a connection to something outside oneself. In other respects it should be treated just as we treat other chronic diseases. Medication and lifestyle changes help with acute and chronic issues, and education is important. Improved quality of life is the measurement for chronic illness interventions. Periods of improvement and worsening should prompt reevaluation of treatment methods. Emphasizing failure or denying ongoing treatment is not useful.

Minnesota Health care news April â&#x20AC;˘ May 2015

Approaches to treating this condition differ. What can you tell us about this? Much of our approach to treating this in the United States has been determined by social, political, and cultural practices, with scientific evidence playing an increasing role. Research into the neurobiological aspects of alcohol dependence halted temporarily in 1920 with the passage of the 18th Ammendment. Alcohol-dependent persons were criminalized and considered immoral. Alcoholics Anonymous came into being during this time and offered hope when physicians had no solution. Now we have medications that can aid recovery, and we pay more attention to simultaneous treatment of underlying issues. Screening and Brief Intervention is a campaign to educate problem drinkers to reduce consumption before becoming dependent. Harm Reduction rather than complete abstinence is being explored. Some people say there is a genetic component to alcoholism. How do you feel about this? There is no credible argument against it. Research has identified genes which affect an individualâ&#x20AC;&#x2122;s experience of drinking. There are also specific genes that make particular anti-craving drugs more effective for some individuals. As an example, childhood trauma and neglect, chronic stress from poverty, and other life circumstances can activate genes that increase susceptibility to dependency.

Emerging evidence suggests some individuals drink regularly and don’t have Alcohol Use Disorder, while others drinking the same amount do. What accounts for this? Part of alcohol metabolism is controlled by an enzyme called alcohol dehydrogenase. Some individuals and ethnic groups are genetically programmed to metabolize alcohol faster than others because their bodies make more of this enzyme. This allows them to tolerate alcohol with fewer negative effects. Other individual members of groups, for example, those with Native and Hispanic heritage, may develop Alcohol Use Disorder more quickly.

most, treatment programs have a family component to help those around the dependent person learn more about the disease and how it affects their own well-being. Al-Anon is a useful resource for anyone dealing with someone who has a problem with alcohol. If someone is concerned that he/she or a loved one has an Alcohol Use Disorder, what advice would you give? The faster route to change is often to let your loved ones experience the consequences of their drinking. Progression can be slow, and it can seem kind to intervene and spare someone serious consequences. Often that delays a person’s awareness that they have a problem. There are individuals and organizations that specialize in interventions. Some primary care practitioners are trained to help motivate individuals to change problematic drinking. Online sources of information include The American Society of Addiction Medicine (www.ASAM.org), The National Institute on Alcohol Abuse and Alcoholism (www.niaaa.nih.gov) and The Substance Abuse and Mental Health Services Administration (www.samhsa.gov). Alcoholics Anonymous has open meetings that people can attend without being dependent. To find AA meetings in your city, visit www.aa(city).org (example: www.aaminneapolis.org). Al-Anon meeting sites are listed at www.al-anon.org. Minnesota Recovery Connection (www.minnesotarecovery.org, 612-584-4158) is ideal for any questions or concerns.

Recovery is more than abstinence from alcohol

Considering the overwhelming failure rate of conventional treatment for alcoholism, how is it empirically justifiable? Until recently there have been few options, so some success has been viewed as better than none. Very few resources have been allocated to evaluate what works. Perhaps the question should be: How is it justifiable, based on the widespread nature of the problem and its extensive direct and indirect cost to society, that comprehensive new treatments are not being widely studied? Are new treatments for alcoholism on the horizon? I am not aware of completely new comprehensive treatment methods being studied. Most of the research is focused on evaluating and making improvements to existing methods. While the Twelve Step program of Alcoholics Anonymous is still prominent, individual variation is not only accepted but supported structurally in the regulations directing substance abuse care. Health Recovery, Culturally Specific, and Eastern philosophies are offered. There are some significant similarities between 12-step and Buddhist philosophies. Both focus on fully changing one’s way of life, and neither demands nor expects belief in a religiously defined god. Active medication management, yoga, body-centered therapy for trauma, mindfulness, and acupuncture are becoming more common. It is clear, but inadequately addressed, that access to safe communities—safe housing, employment, and care for physical and mental health—significantly increase the success of all types of treatment. What does “in recovery” mean? It means honestly examining and taking responsibility for yourself and your behavior, and making decisions that enhance your life and well-being as well as that of those around you. You are able to live without alcohol and be comfortable with yourself and your life regardless of struggles that occur. It means that if you should return to drinking, perhaps even more than once, you will repeatedly seek whatever forms of help are needed to live a satisfying, engaged, and responsible life without alcohol. Recovery is more than abstinence from alcohol, although some choose to stop at abstinence. How can the family/loved ones of someone in recovery be most supportive? Learning about the disease and realizing that there are aspects over which those with Alcohol Use Disorder have little control helps to ease resentment. Getting clear about what behavior you will and won’t accept is important too. Many, if not

Minnesota Optometric Association

Doctors on the frontline of eye and vision care Did you know? • Diabetic retinopathy can be controlled and diabetic patients need regular eye exams to maintain vision and good eye health. • Diabetes Type ll can also cause vision changes. • Glaucoma must be diagnosed in early stages in order to prevent vision loss. • All children entering school need a comprehensive eye exam, because vision screenings do not detect a number of eye disorders. • To maintain eye health, everybody from babies to boomers to older adults needs a regular eye exam by a family eye doctor. To locate an optometrist near you and find comprehensive information about eye health visit http://Minnesota.aoa.org April • May 2015 Minnesota Health care news

Drug Class

Proton pump inhibitors Reduce acid, relieve heartburn By Andrea Rosenberg, PharmD, and Anita Sharma, PharmD, BCACP

here is a lot of talk about gastroesophageal reflux disease (GERD) in the media these days, and advertisements abound for proton pump inhibitors and other acid-lowering medications that reduce GERDâ&#x20AC;&#x2122;s signature symptom of heartburn. Heartburn is an uncomfortable feeling that usually begins just below the breastbone and can travel into the throat, causing a sour or bitter taste in the mouth. It is commonly thought that frequent heartburn or excessive eating are the only causes of GERD, but there is an actual physiologic explanation for this disease.

A ring of muscle between the esophagus and stomach normally opens when food is moving to the stomach but otherwise remains closed. If the muscle stays open too long after food has passed through or opens when food is not moving through it, acid from the stomach can flow back into the esophagus. Stomach acid is a natural chemical that is important for digestion in the stomach, but when it is produced in excess or travels outside the stomach, it can cause heartburn or ulcers. Who is affected? Almost every American experiences some degree of heartburn, perhaps after a heavy or spicy meal or after drinking alcohol. While there are no definitive studies of how many Americans actually experience heartburn, some researchers estimate that more than 60 million Americans experience heartburn at least once every month and that more than 15 million suffer from it on a daily basis. There are about 30 million people in the United States that take a proton pump inhibitor (PPI) long term to help treat symptoms of heartburn. What are PPIs? PPIs are the group of medications that produce the strongest and longest-lasting reduction in gastric acid production. They block an enzyme needed to make stomach acid, thereby decreasing the production of acid. These medications help prevent and treat conditions such as GERD, stomach ulcers, stomach infections caused by bacteria in the digestive tract and implicated as the cause of ulcers, and conditions that predispose individuals to overproduce acid. Which PPI is best? Most PPIs are manufactured in oral forms such as tablets and capsules. The speed with which a given PPI takes effect depends on

Minnesota Health care news April â&#x20AC;˘ May 2015

Proton pump inhibitors options treatment is commonly extended whether it is formulated to be Available as Available past 14 days because the provider immediate-release or extendGeneric Brand name a prescription without a facilitates increased monitoring ed-release. There are several generic drug? prescription? of the patient. oral options listed in the table esomeprazole Nexium Yes Yes on this page. All are taken After stopping antiacid dexlansoprazole Dexilant No No once daily for heartburn. medication (also called “antacPrevicid, Prevacid Pantoprazole (Protonix) and id”), there is a chance of experilansoprazole 24HR (nonprescripYes Yes esomeprazole (Nexium) are encing a rebound in heartburn tion version) also available in intravenous symptoms. These symptoms can Prilosec, Prilosec Yes Yes omeprazole (IV) formulations in the Unitbe temporary and are related to OTC ed States. These two are most the way the stomach adjusts to Yes omeprazole/ Zegerid, Zegerid commonly administered in the starting and stopping PPIs. Why Yes (Brand name sodium OTC hospital to treat more serionly) bicarbonate does this occur? Remember that ous conditions or to prevent stomach acid is a natural part of pantoprazole Protonix Yes No complications. Although there digestion. When PPIs are introrabeprazole Aciphex No No are differences in the chemical duced to block acid, the body Adapted from Consumer Reports. Updated July 2013. properties of the seven PPIs tries to restore normal functionand the way they are metabing. The stomach adds acid-proolized in the body, studies ducing pumps in its lining cells in an attempt to remedy its acid that have compared PPIs have not found one particular medication shortage. The PPIs can keep these pumps turned off, even when the in this class to be more effective than another. Therefore, the best body adds new pumps. However, if PPIs are discontinued abruptly, choice for most people is the least expensive PPI. the acid pumps are no longer blocked, which can cause excessive Tips for use Over-the-counter instructions recommend taking a PPI for 14 days, and to seek medical attention if symptoms have not improved after two weeks. When prescribed by a health care provider, the length of

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acid production. Therefore, it is always a good idea to discuss slowly tapering PPIs with your provider or pharmacist, instead of stopping the medications suddenly. Proton pump inhibitors to page 34

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Otolaryngology

Balloon sinus

dilation Improved treatment for chronic sinusitis By Theodore O. Truitt, MD

innesota can be a difficult place to live if you have chronic sinusitis. Our wide and rapid temperature changes, cold winters, and high spring and summer pollen counts all spell misery for those who suffer from the pain, pressure, and repeated infections caused by sinuses that donâ&#x20AC;&#x2122;t drain properly. And there are lots of folks who share that misery. Approximately 29 million Americans have sinus problems, and more than 61 million

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Minnesota Health care news April â&#x20AC;˘ MAy 2015

workdays are lost to acute sinusitis every year in the United States, particularly during the flu and allergy seasons. Standard treatment Medications are usually the first line of treatment for a sinus infection that has lasted longer than a week. These typically include antibiotics, decongestants, and sinus rinses to get rid of bacteria and help promote drainage of mucous from sinus passages. If the inflam-

mation and congestion continue, nasal steroids can be prescribed. Unfortunately, a significant percentage of patients cycle through this process three or four times a year and never seem to clear up their sinus infections. When all else fails, surgery may be required. Functional endoscopic sinus surgery (FESS) became the standard treatment in the 1990s. In this procedure, an endoscope—a narrow tube with a small light—is inserted into the nose to allow the surgeon to visually detect the blockage. Then, a surgical tool is inserted alongside the endoscope. The surgeon uses the tool to cut away the tissue blocking the sinus openings. FESS is usually done in the operating room under a general anesthetic, and has the potential to cause bleeding, pain, and scarring. Recovery can take several weeks.

The biggest advantage of balloon dilation compared with the FESS procedure is that it’s less invasive and less traumatic. The device we insert is smaller than a standard endoscope, and, because no tissue is cut away or pulled out in this procedure, the healing process is much faster and no scar tissue develops. This technique has become so refined that it is done as an office procedure under minimal or no sedation. Recovery from a sinus balloon procedure is counted in hours, rather than in days or weeks, as with FESS. That’s a significant advance. When balloon devices first were used, they were inserted the same way endoscopic surgery was performed i.e., in the operating room with a general anesthetic. But inserting these devices in the doctor’s office with wide-awake patients is much faster, safer, and less expensive.

Twenty-nine million Americans have sinus problems.

Newer treatment Over the past seven to eight years, however, we’ve starting using a minimally invasive procedure that uses balloons instead of cutting instruments. It’s called balloon sinus dilation, and the principle behind it is similar to an angioplasty procedure in the heart, in which a balloon is inflated inside a blocked artery to widen the opening and restore circulation. We’re using the same idea to widen a blocked sinus opening as an equally permanent solution to recurrent sinus infections.

Procedure We begin by anesthetizing the nose by inserting topical anesthetic on a cotton ball into the nasal cavity, followed by an injection of local anesthetic. Patients also often receive an oral medication to relax them, although that’s up to the preference of the individual patient and the doctor. When the patient is ready, a slender endoscope with an attached Balloon sinus dilation to page 32

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Caregiving

Home care eligibility

requirements Helping people stay at home By Julie Endres-Spray, RN, PHN, MA

H Telephone Equipment Distribution (TED) Program

ome care services help people remain safely at home and avoid unnecessary hospitalization. There are many reasons to consider this kind of support: Are you planning knee replacement surgery and wonder how you’ll manage to go up and down stairs to do laundry while recuperating? Does Mom live in a different city and need more help?

Do you have trouble using the 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

Minnesota Health care news April • May 2015

These and many other scenarios can benefit from services such as short-term nursing, rehabilitation, therapy and home health care. Who provides home care? A nonmedical home care agency typically provides unskilled care from home health aides (HHAs); certified nursing assistants (CNAs); and noncertified nurse aides, homemakers and companions. Care ranges from housekeeping and companion care to assistance with bathing, toileting and eating. Unskilled care is not reimbursable under Medicare and therefore is paid for privately or by long-term care insurance. A physician’s prescription for this care is not required because it is not considered medically necessary and the recipient isn’t required to be homebound. A professionally authorized and monitored care plan is unnecessary. Nonmedical home care agencies play a big role by filling gaps in home care services not covered under skilled care. Unskilled home care such as personal care assistance or cooking and cleaning help is often what may be needed most in order to remain at home. Private-pay agencies usually are licensed by the state. Most agencies do background checks and manage payroll and taxes. Most also supervise and monitor their staff with regard to patient care. A home health agency is licensed, usually Medicare-certified, and accepts other third-party health insurance payments. Medicare certification means that the agency meets federal guidelines and criteria regarding patient care. Medicare participants are eligible for home health care benefits as long as they meet Medicare requirements for homebound status and the need for services. Your physician will evaluate the need for home care and write a prescription for services if you qualify. If you do qualify, a home health nurse will visit you at home for an initial assessment to confirm your eligibility. If the assessment confirms that you meet the criteria, home health care will be provided. Home health care agency services include skilled nursing, physical and occupational therapy, social work, and HHAs under profes-

sional supervision. Home health care agencies focus more on skilled medical aspects of care, while HHAs supplement that care. Regardless of reimbursement eligibility, Medicare only pays for skilled inhome care to treat an illness or injury for a limited period of time. HHAs can provide a preauthorized amount of personal care while under professional supervision but must discontinue care when skilled care is no longer justified. However, even after skilled services are no longer required, personal care still may be needed. Hiring a nonmedical home care agency or a private caregiver is an option.

There are some conditions and limitations, however. A doctor must determine the need for home health care and prescribe the care plan; the person receiving home care must be homebound and require intermittent skilled nursing care or physical, occupational, or speech therapies; and services must be received from a Medicare-certified home health agency. Long-term care insurance A long-term care (LTC) insurance policy may cover some costs of in-home care. Some LTC policies only pay home care benefits to a licensed home care agency or other licensed provider. Others pay a set daily amount to the insured person who qualifies for the benefits, who can then hire any caregiver he or she selects, including a family member.

Unskilled home care such as personal care assistance or cooking and cleaning help is often what may be needed most in order to remain at home.

Eligibility Who might meet Medicare’s homebound status requirements? Someone who: • Needs additional physical therapy following orthopedic injury or surgery • Requires wound care • Battles illnesses such as COPD, diabetes, heart disease, unstable blood pressure or congestive heart failure • Is recovering from a stroke and needs rehabilitation therapy or has had a recent fall or balance problem

Read through the LTC policy itself to see if it covers in-home care and what the payment terms are: when someone qualifies, for how much and how benefits are paid. Life insurance Certain life insurance policies can be cashed in with the issuing insurance company for up to 75 percent of the policy’s face value, although some policies permit these “accelerated benefits” or “living Home care eligibility requirements to page 27

The main purpose of this type of agency is to provide skilled care for treatment or rehabilitation services to homebound patients. Home care professionals must adhere strictly to a physician-approved plan of care that is deemed medically necessary and is updated every 60 days in order for Medicare benefits to continue.

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If you believe you might be eligible for home health care benefits with Medicare, discuss it with your doctor. You can choose any agency as long as it is Medicare-certified. Paying for home health care Medicare is the principal provider of home health care and covers a substantial part of this type of care. This care also is covered by Medigap policies D, G, I, and J, and by Minnesota’s Extended Basic Plan policies, Medicaid, Managed Care, long-term care insurance and veteran’s benefits. Medicare Medicare covers: • Part-time or intermittent nursing care provided by or under the supervision of a registered nurse (RN) • Physical, occupational, and speech therapy • Medical social services as directed by a doctor, and home health aides providing personal care services • Prescribed medical supplies and durable medical equipment such as wheelchairs, hospital beds and oxygen pumps

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April • May 2015 Minnesota Health care news

rehabilitation services from P ost-acute the Good Samaritan Society. Post-acute care is designed to heal and assist patients with care and support following a hospitalization from serious illness, injury or elective surgical procedure. Multiple in-patient and out-patient post-acute locations are located throughout the Twin Cities metro area and state of Minnesota. To learn more about our post-acute services, call us at 866-GSSCARE or visit www.good-sam.com/minnesota.

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Minnesota Health care news April â&#x20AC;˘ May 2015

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nutrition

Proper nutrition Understand saturated fats By Jillian G. Lampert, PhD, RD, LD, MPH, FAED

ith all the information we hear about healthy eating, one of the most confusing topics is fat. Read on for clarity and dietary guidance.

Why we need fat Let’s start with the basics. Fat has incredibly important functions

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Minnesota Health care news April • May 2015

in the body, which is why it is a necessary part of a healthy diet. Fat in the diet provides energy; maintains body temperature; helps us absorb and transport certain nutrients; and supports the immune, reproductive, and nervous systems. Fat is an essential form of energy that our bodies need for fuel. It is the only energy source we can easily store and use later in our bod-

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Ways to lower saturated fat intake 1. Choose lean meat and poultry. 2. Trim fat and skin from meat before cooking and eating. 3. Bake, broil, or roast instead of frying. 4. Choose low fat or skim dairy products, or those made from nondairy sources.

ies. While you might think of fat storage as a negative when struggling to lose unwanted pounds, without adequate fat in the diet we can’t absorb certain vitamins, our skin and hair dry out, our hormone production becomes inadequate, and our nervous system is unable to effectively send and receive nerve messages throughout the body.

How much fat is enough? Nutritionists recommend that approximately 25 percent to 6. Minimize consumption of 35 percent of our total processed foods and eat daily energy intake more fruits and vegetables in come from fat. Since their place. energy can be expressed 7. Read food labels. in terms of calories, you can think of that guideline as 25 percent to 35 percent of your daily caloric intake. It’s also recommended that no more than 10 percent of daily caloric intake come from saturated fat, which occurs naturally in both animals and plants. Why should we pay attention to the amount of it we consume? 5. Substitute cooking oils low in saturated fat, such as olive and canola, for butter and lard.

saturated fat or less per day. How can you keep track? There are smartphone apps that you can use to monitor your saturated fat intake. However, there are simpler options that may have a healthful impact on far more than just your saturated fat intake. Instead of focusing primarily on what not to eat, focus on what to eat and what you are doing when you are eating. The beauty of this approach is that it can improve your overall eating and health, as well as your fat intake. Try the following five tips for truly healthy eating: 1. E at when you are eating. Many people drive, work, or watch television while they eat. This often results in mindless eating and consumption of excessive calories. Let eating be the thing you are doing, not just something you do while you do something else. 2. Eat from a plate, not a package. Eating straight from the package typically results in eating way more than you intend or need to eat. Take a serving of food out of the package, put it on a plate or in a bowl, and put the package away. 3. Start with breathing. When you eat, make sure both your body and your brain are paying attention to the fact that you are eating. Take a few deep breaths before you start eating and while you are eating. This will help you recognize when you are hungry and when you are full. 4. K now when you feel good. Pay attention to how your body Proper nutrition to page 25

Risks Research has shown that consuming too much saturated fat raises the risk of several serious diseases. It contributes to increased cholesterol levels, which increase the risk of heart disease and stroke. It also increases the risk of developing diabetes, according to a recent study which reported that overconsumption of saturated fat from plant sources led to excess fat being stored in the liver, a known precursor to diabetes (Diabetes 2014). And, certain cancers are more likely to occur in people whose diets contain more than the recommended amount of saturated fat: breast, colon, prostate, and liver. Guidelines Based on the many studies that show saturated fat’s health risks, the USDA Dietary Guidelines for Americans recommend getting 10 percent or less of our total daily caloric intake from it. But how do you know how much saturated fat a food contains? Look at the nutrition facts label on a package, and you’ll see the total amount of fat in each serving of food, expressed in grams. The next line of the label states the number of saturated fat grams per serving. Since information on the nutrition facts label is based on the 2,000 daily calories recommended for most nonpregnant/nonlactating adults, and since 10 percent of 2,000 is 20, aim for 20 grams of April • May 2015 Minnesota Health care news

Hematology

Bruising Common, but manageable By Mohammed K. Nashawaty, MD

ost people experience bruises, but do you know that they can be caused by certain medicines and medical conditions as well as by trauma? Read on to learn how to avoid bruises and minimize their effects, and when to call your doctor about them.

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What is bruising? Bruises result from the rupture of small blood vessels under the surface of the skin, causing the blood to leak out of the vessels.

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Fresh bruises look red because of the red color of the blood. Their color changes over time while the blood is being reabsorbed by the body. Bleeding also may produce small reddish or purplish spots called petechiae (puh TEE kee eye) under the surface of the skin or mucus membranes. Repeated bruising in the same area can turn skin permanently yellow or brown, as the iron naturally found in blood accumulates in the area of repeated trauma. If leaking blood forms a mass it is referred to as a hematoma, which can occur under the skin or within organs.

3. Decrease in one or more clotting factors due to treatment with blood thinners such as Coumadin (warfarin), Heparin, Lovenox, Pradaxa, Xarelto, and Eliquis. Clotting factor deficiency also may be associated with liver disease; vitamin K deficiency; and inherited bleeding disorders, including hemophilia A, hemophilia B, and Von Willebrand disease. When to contact your doctor It is not surprising to develop a bruise after a strong blow to a part of the body, but consider getting it checked by a health care provider if:

Elderly people are at higher risk for bruising.

Causes There are three major components required to stop bleeding, so anything that affects one or more of them increases the risk of bruising. First is the integrity of blood vessels, the skin around them, and the tissue under the skin. Second are small blood cells called “platelets” that promote clotting by sticking to each other to form a plug at broken areas of vessels. Third are protein clotting factors, activated by vascular injury, that help blood clot. Medical conditions that may cause excessive bruising: 1. D efects in blood vessels, such as vasculitis, connective tissue diseases, vitamin C deficiency, and rare inherited disorders. However, what commonly happens with aging is that the skin becomes thinner and has less of the underlying connective tissue and fat that usually protect the small blood vessels under the skin from injuries. In addition, blood vessels become more fragile with age. This is why elderly people are at higher risk for bruising after minimal trauma. Corticosteroids such as cortisone and prednisone also can lead to thinning of the skin and connective tissue, thereby causing easy bruising. 2. Platelets don’t function properly or there aren’t enough of them. a. Not having enough platelets is referred to as having a low platelet count, or thrombocytopenia. This can be caused by certain drugs, including some antibiotics, heparin, epilepsy medications, and chemotherapeutic medications. Other causes include significant alcohol intake, autoimmune disorders such as ITP (immune thrombocytopenia) and lupus, some pregnancy complications, bone marrow disorders, some viral infections such as hepatitis and HIV, and spleen enlargement due to liver disease or other disorders. b. D ecreased platelet function means that platelets are less sticky. This can be caused by medications, most commonly aspirin and other nonsteroidal anti-inflammatory drugs such as ibuprofen (Advil and Motrin) and naproxen (Aleve). Some supplements, including vitamin E, ginseng, garlic, and ginkgo biloba, can also decrease platelet function, as can kidney failure and rare inherited platelet disorders.

• Bruising occurs with little or no injury. • You have a family history of bruising or excessive bleeding. • You have large bruises, a hematoma, or petechiae. • Bruising is accompanied by severe pain or swelling. This may suggest severe tissue injury or a bone fracture. • Bruising is associated with frequent bleeding from the nose or gums; prolonged or heavy menstrual periods; or prolonged or Bruising to page 24

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raising the injured limb may reduce the swelling.

Bruising from page 23

excessive bleeding after minor cuts, dental cleaning, or extraction and surgeries. If bruising and pain occur after trauma, your doctor may obtain X-rays to check for a bone fracture. Your doctor also may request blood tests to screen you for bleeding disorders such as thrombocytopenia, or refer you to a blood specialist (hematologist). Treatment When your doctor treats the cause of bleeding, it will reduce the chance of recurrent bruising episodes. It is important to note that when a bruise occurs, there are no specific treatments that make it disappear. A bruise will run its course until the blood that collected under the skin is completely absorbed by the body, and may look worse before it disappears. For example, it may expand downward due to gravity, depending on its location on the body. Applying cold compresses to the bruised area shortly after trauma occurs may help constrict blood vessels, thereby reducing the amount of blood that leaks out. This may reduce the size of the bruise and help reduce swelling. If you experience moderate pain, you can take Tylenol (acetaminophen) unless you have liver disease or your doctor has told you to avoid it. It is advisable not to take aspirin or other nonsteroidal anti-inflammatory drugs (NSAID) because these medications interfere with platelet function and may further increase the risk of bleeding. If bruising is associated with swelling in the arms or legs,

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Prevention Better than treatment, of course, is prevention. This is especially true if you belong to one of the groups of people who bruise easily, such as the elderly, patients treated with blood thinners, and people who have bleeding disorders. Eating a good, balanced diet rich in fruits and vegetables is common sense, especially if you bruise easily. It is important to make sure that you do not become deficient in vitamins C or K. Foods rich in vitamin C include citrus fruits, tomatoes, and red and green peppers. Foods rich in vitamin K include green leafy vegetables. It is also important to note that if you are taking warfarin (Coumadin), it is recommended that you keep your intake of foods rich in vitamin K constant from day to day. Consuming too much vitamin K through food or supplements may make warfarin ineffective. Reduce the risk of injury by ensuring that your environment is free from obstacles that could cause falling or injury, including uneven carpet, clutter on the floor, and poor lighting. And by wearing long sleeves and pants, you’ll provide yourself with extra cushioning to protect blood vessels under your skin if you do happen to fall or bump yourself. Mohammed K. Nashawaty, MD, is a board-certified oncologist/hematologist and practices with Minnesota Oncology.

Tim Jackson has been a dairyman most of his life. As the years passed, his knees wore out. “Two years ago they were getting so bad that I could hardly navigate anymore,” said Tim. He began to get depressed because it was too painful to continue his work and enjoy an active lifestyle. Tim sought help from providers and had some treatment before finding St. Croix Orthopaedics (SCO). His treatment journey with SCO helped him find the solution he was looking for. “It was a positive experience from the beginning,” said Tim. “He (the surgeon) painted a whole other picture for my life.”

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Minnesota Health care news April • May 2015

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Proper nutrition from page 21

feels when you eat different foods. You’ll likely find that you feel physically better when you eat more whole foods like fruits, vegetables, nuts, and seeds, and fewer processed, fried, or other foods higher in saturated fat. 5. Make peace with food. Pay attention to what you think and feel about food. If food is your main source of comfort or you find yourself frequently feeling guilty or depressed because of how and what you ate, seek support to bring more peace to your relationship with food.

processed baked goods and some fried foods. Other sources of saturated fat include fat in red meat, lard, and other animal products such as yogurt. The keys to truly healthy eating are not only in the number of grams of saturated fat we eat, but also in the how we eat, why we eat, and the attention we give to our eating. Eating too restrictively or avoiding fat obsessively can be signs of an eating disorder and can pose great risk to health.

Without adequate fat in the diet we can’t absorb certain vitamins.

Healthy choices One way to tell if a fat is saturated is that saturated fats are generally solid at room temperature. For example, butter is high in saturated fat; olive oil is not. However, some plant oils, including palm oil and coconut oil, contain mostly saturated fats and are in many

Practice the techniques above for healthy eating. It may take a fair amount of practice; that’s okay! You don’t have to get it right all the time. Take a few deep breaths, give yourself the gift of a more peaceful relationship with food, and decrease your chance of disease by lowering your saturated fat intake. Jillian G. Lampert, PhD, RD, LD, MPH, FAED, is a dietitian and chief strategy officer for The Emily Program, a comprehensive eating disorder treatment program with multidisciplinary outpatient and inpatient treatment facilities throughout Minneapolis/St. Paul and Duluth, and in Ohio and Washington.

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Calendar National Stroke Awareness Month

May 16

Ataxia Social Group

The National Ataxia Foundation offers this free social group for people living with ataxia, their family members, and friends. Join others who understand to make new connections and gain new insights. Call Lenore at (612) 724-3784 for more information. Saturday, May 16, 10–11:30 a.m., Langton Place, 1910 Cty. Rd. D W., Roseville

Ovarian Cancer Survivors Meeting

Minnesota Ovarian Cancer Alliance (MOCA) offers gathering for women who are in treatment for or remission from their initial ovarian cancer treatment to learn more about MOCA and meet other survivors. Join others who understand to gain insight and support. Call (612) 822-0500 for details. Tuesday, May 19, 10–11:30 p.m., Minnesota Ovarian Cancer Alliance, 4604 Chicago Ave. S., Minneapolis

Nutrition and Cancer

Allina Health hosts this free class for cancer patients who are facing treatment, undergoing treatment, or have finished treatment. Come learn how food can help nourish you no matter what stage you are at to practice healing through food. No registration required; call (651) 241-5111 with any questions. Tuesday, May 26, 12–1 p.m., Virginia Piper Cancer Institute, 310 N. Smith Ave., Ste. 300, St. Paul

Scleroderma Support Group

The Scleroderma Foundation Minnesota Chapter presents this free support group for those affected by scleroderma to share concerns, information, peer support, and encouragement. For more information, call Diane or Bob at (877) 794-0347. Wednesday, May 27, 7–8:30 p.m., Battle Creek Recreation Center, 75 Winthrop St. S., St. Paul

Each year almost 800,000 strokes occur in the U.S. This means that on average, a stroke occurs every 40 seconds, according to the Centers for Disease Control and Prevention. More than 137,000 people die from strokes each year, making it the fourth leading cause of death in the nation. However, the sooner a patient receives treatment, the more likely they are to survive and have a lower risk for long-term problems. May was named National Stroke Awareness Month to help people become aware of the warning signs of a stroke and remind them to call 911 immediately when these signs are present. Warning signs of a stroke include numbness or weakness of the face, arm, or leg (especially on the left side of the body); confusion; trouble speaking or understanding speech; difficulty seeing, walking, or keeping balance; and severe headaches with no known cause. When these signs are present, every minute counts. Calling 911 immediately can lower the risk of death or disability.

June 8

North Memorial Health Care offers this free Discovery Circle support group for people who have had a stroke and their loved ones. Come talk with others who share similar feelings and experiences to gain insights and strength. Call (763) 581-3650 for more information. Monday, June 8, 7–8:30 p.m., North Memorial Medical Center, Stroke Center, Plaza Level, 3300 Oakdale Ave. N., Robbinsdale

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. Fax submissions to (612) 728-8601 or email them to amarlow@mppub.com. Please note: We cannot guarantee that all submissions will be used. CME, CE, and symposium listings will not be published.

Stroke Support Group

Minnesota Health care news April • May 2015

June 3

Medical Programs for Children

Hennepin County and Arc Greater Twin Cities offer this class for anyone wanting to learn more about programs that can pay children’s medical bills, provide income or food assistance, and more. Call (612) 596-6631 to register. Wednesday, June 3, 10:30 a.m.– 12:30 p.m., Plymouth Library, 15700 36th Ave. N., Plymouth

Preserving Your Joints

St. Croix Orthopaedics hosts this educational class on health and wellness related to joint pain and its impact on your life. There will be a presentation followed by a discussion to ask any questions you may have. Please call (651) 275-2717 to register or for more information. Wednesday, June 17, 4–5 p.m., St. Croix Orthopaedics, 5803 Neal Ave. N., Oak Park Heights

Binge Eating Disorder Class

Park Nicollet’s Melrose Center offers this free information session for anyone who would like to learn what binge eating disorder is and what treatments are available. No registration required. Call 952-993-1000 for more information. Thursday, June 18, 6–7 p.m., Melrose Center, 1st Floor Community Room, 3525 Monterey Dr., St. Louis Park

Brush Your Brightest

Hennepin County Library hosts this educational session by Children’s Dental Services. Join other families for interactive activities and information on how to brush your teeth, what to eat, and how to take the best care of your teeth. For more information, call (612) 543-8450. Tuesday, June 23, 2:30–4 p.m., North Regional Library, 1315 Lowry Ave. N., Minneapolis

Home care eligibility requirements from page 17

To find out about Medicaid eligibility, contact your local Area Agency on Aging (www.mn4a.org/ aaas/) or Minnesota’s Medicaid agency: www.medicaid.gov/ Medicaid-CHIP-ProgramInformation/By-State/minnesota. html

benefits” only if the policyholder is terminally ill. If accelerated insurance benefits aren’t available, investigate whether a “life settlement” (also called a “senior settlement” or “viatical settlement”) is possible. This involves selling the policy to a life settlement company (different from the insurance company that issued the policy) for a lump sum. Depending on the policy, this type of settlement may provide 50 percent to 75 percent of the policy’s face value.

Veteran’s benefits Veterans and surviving spouses of veterans may qualify for in-home care assistance from the Department of Veterans Affairs (VA), either through health benefits or through monthly cash benefits. If your loved one is housebound, these benefits may be even higher.

Medicare is the principal provider of home health care.

Medicaid Medicaid covers short-term in-home care for acute conditions, usually following stays in a hospital or rehabilitation/skilled nursing facility. In Minnesota, Medicaid covers a limited amount of longterm in-home care for those who qualify. However, Medicaid rules often limit coverage to people whose physical or mental condition is severe enough to qualify them for Medicaid nursing home coverage. Also, Medicaid only pays for inhome care provided by a Medicaid-certified home care agency, not by an independent paid caregiver or family member.

Talk with your doctor Home care is designed to provide care wherever you call home, and to keep you from having to go back into the hospital or long-term care facility. Talk with your doctor to see if you qualify. Julie Endres-Spray, RN, PHN, MA, is clinical director of home health for the Minnesota Visiting Nurses Association.

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.

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To schedule an appointment at any of our 13 locations, please call 763-780-6699 or visit www.sgsmn.com April • May 2015 Minnesota Health care news

POLICY

A long-term plan for long-term care

Addressing the growing crisis By Rep. Joe Schomacker

ndy Rooney, the 60 Minutes commentator, best summed up our greatest health care challenge when he said, “It’s paradoxical that the idea of living a long life appeals to everyone, but the idea of getting old doesn’t appeal to anyone.” Rooney’s comment is quite relevant when considering the aging demographic landscape in Minnesota.

www.mppub.com

Workforce shortages In the year 2020, Minnesota will have more citizens over the age of 65 than it will have children starting kindergarten. In fact, the number of aging Minnesotans needing long-term care is expected to increase annually until the year 2035—a so-called silver tsunami— with the next generation’s workforce paying the bill. Already today, 15 percent of skilled nursing facilities consider closing their doors each year due to inadequate funding. Last year alone, one out of five Minnesota nursing homes reported turning seniors away because staff resources were insufficent to meet the demands of an aging population. Minnesota is not alone in this conundrum, as baby boomers continue to age and retire. Each state must deal with long-term care issues, but statistics show that Minnesota’s elderly population is larger than many other areas of the country. Addressing the crisis So how has the Legislature handled this oncoming crisis? Both Democrats and Republicans have done just enough over the years to state that they’ve begun addressing long-term care needs. That may work for the suits in St. Paul, but it doesn’t help the workforce in our care centers.

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I’ve seen the problems firsthand. Long-term care is the top employer in my Minnesota district, whose counties border both South Dakota and Iowa. I have heard heart-wrenching stories concerning low reimbursement rates and the difficulty our long-term care facilities have attracting and retaining quality and experienced caregivers. Similar stories are shared with lawmakers from all corners of Minnesota, including the Twin Cities and surrounding metro area. This year, our new Minnesota House leadership has decided to address the long-term care dilemma with a sense of urgency. To this end, we created the Aging & Long-Term Care Policy Committee with the charge of making wholesale improvements to our senior care funding and long-term care regulation problems. As a simple value statement, aging Minnesotans should receive the care they need to preserve their quality of life as long as possible

Minnesota Health care news April • May 2015

in a place they can call home. Seniors should be able to live safely and independently as long as they can. Legislative leaders should respond by reforming our system to provide more flexibility and choices as we age. We have a duty to ensure that all aging Minnesotans receive safe and quality care from experienced caregivers. We have a responsibility to be a guardian of quality care through funding and a fresh, bottom-up approach to regulations. Finally, we need to do more to encourage partnerships with seniors, their caregivers and their families.

people should turn to Medicaid to pay for long-term care. Not only does that drive down more cost-effective solutions, but it also puts the burden on the state of Minnesota. The committee’s focus Not only will the Aging & Long-Term Care Policy Committee focus on longterm care solutions, but it will provide the information that all lawmakers need to know. More than $1 billion currently is spent on long-term care in Minnesota each year, and that could grow to $5 billion in the next decade. This means that our state needs to do what it can to help the greatest generation and upcoming baby boomers in a way that’s efficient, effective and sustainable. And that means lawmakers have to start planning now.

In the year 2020, Minnesota will have more citizens over the age of 65 than it will have children starting kindergarten.

In the past, the Minnesota Legislature has debated health care issues in health care committees, debated tax and estate bills in tax committees, and debated workforce initiatives in a jobs committee. No committee has ever had the sole focus of addressing aging and long-term care issues head on. As chairman of the new Aging & Long-Term Care Policy Committee, I eagerly look forward to working toward generational improvements in long-term care. Goals for reform The committee’s goals include funding reform for the care our senior citizens receive. A recent survey indicates that, on average, facilities receive reimbursements that are more than $30 per bed per day short of the actual cost of care, which is clearly unsustainable. With the aging demographic shift we face over the next two decades, and the fact that 80 percent of all health care costs come during the final two years of life, we need to adopt a new service plan that ensures that our home health care workers, assisted living facilities and nursing homes have adequate reimbursement for the tasks and services they provide. We also need to strengthen the long-term care workforce. Those who take care of our elderly won’t get rich; in fact, they often are underpaid. Most people working in a nursing home do not view it as a career. They take the job to help their family make ends meet, or they use it as a stepping stone before taking another job in the health care field. The demand for long-term care is so great that we must make the profession desirable and worthwhile to those who seek a rewarding career opportunity. Those who plan to utilize home health care options in the future should have opportunities to set money aside for this purpose. Many adamantly oppose living in a nursing home, and it’s costly to have health care services provided in their homes. So why not let people plan ahead? Why not allow them to save and take charge of their lives as they grow older? We should explore health-care savings account funds, or even 401K proceeds, to help cover long-term care expenses. People would rather plan their own funeral than plan for their potential long-term care needs. A November 2014 study from the Center for Retirement Research at Boston College found that only 20 percent of Americans can afford and benefit from long-term care insurance and can make it work for them. Insurance will not work as the only solution. Neither will the recent recommendation that

When it comes to the impending challenges of elderly care, the Legislature has reflected the same values that Andy Rooney identified years ago. It is time to do what appeals to no one, but is imperative for everyone. Long-term care needs a long-term plan in Minnesota. Rep. Joe Schomacker (R-Luverne) is the chair of the Minnesota House Aging & Long-Term Care Policy Committee. He was recently elected to his third term in the Minnesota House of Representatives.

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Digestive health

Diverticular disease Rampant—but it doesn’t need to be By Mark Y. Sun, MD

y mother always warned me that not eating my fruits and vegetables would eventually come back to haunt me, but what kid wants to eat broccoli or an apple when they could be eating a cheeseburger and fries instead? The transition of Western and developed nations to a highly processed, low-fiber diet may be exactly the problem that has led to one of the most common and costly gastrointestinal disorders in the U.S.: diverticular disease.

In the next issue...

• What’s new in PAP guidelines • Poison prevention in children • Twincities food deserts

Minnesota Health care news April • May 2015

How widespread has this disease become? Well, here are some figures. The prevalence of diverticular disease in this country in the 1930s was only 5 percent to 10 percent. Presently, 33 percent of all Americans are affected by age 50, 50 percent by age 60, and 66 percent by age 80. Data from 2004 showed that diverticular disease accounted for more than 800,000 patients requiring hospitalization, 3.2 million outpatient clinic visits, and more than $3 billion U.S. health care dollars spent each year. As the American population ages, the burden of diverticular disease will only increase. Because diverticular disease is so rampant, most Americans are either personally affected by it or know someone who is. But what, exactly, is this disease and why does it happen? What is it? Diverticular disease is characterized by the presence of diverticula, which are outpouchings on the surface of the colon due to increased pressure within the colon. The cause of diverticula remains debated, but suspects include structural abnormalities of the colon wall; a deficiency of dietary fiber; and disordered intestinal motility, which refers to abnormal contraction of the muscles that mix and propel intestinal contents along the intestinal tract. The colon has natural weak points in its wall where blood vessels penetrate its muscular layer. When pressure inside the colon rises, either due to impaired motility or irregular stool consistency from lack of fiber, this causes the wall of the colon to bulge through those natural weak points. The bulge then may become an outpouching, or diverticula. Causes Although some people may have a genetic predisposition to the development of diverticula, they are in the vast minority. Many patients think that they have diverticulitis because their parents had it, but a more likely explanation is that families share the same dinner table and likely eat a similar diet. The influence of diet is shown by the fact that diverticulitis in Asia and nonindustrialized countries is significantly lower than in the West, but studies have shown that within a generation of emigrating to a westernized country, the incidence of diverticulitis in immigrants mirrors that of native-born residents. This is a fairly convincing argument that diverticular disease is an acquired condition rather than an inherited one. Both

men and women appear equally affected by diverticular disease. Smoking, alcohol use, and eating red meat do not seem to increase the incidence of diverticular disease, but there is some evidence that obesity and higher percentages of intra-abdominal fat increase an individualâ&#x20AC;&#x2122;s risk for it. Types Diverticular disease exists in two forms: diverticulosis and diverticulitis. The presence of diverticula is the condition known as diverticulosis but does not necessarily mean a person will have a problem. However, when one of the diverticula becomes inflamed or infected, then the condition becomes known as diverticulitis. Only 10 percent to 25 percent of people with diverticulosis will have an episode of diverticulitis during their life.

diverticulitis (infection contained within the colon) or one episode of complicated diverticulitis (infection extending outside the colon wall or to adjacent organs). What we discovered was that this recommendation was likely overly aggressive and exposed more patients to surgical risks than was probably necessary. We now approach surgery on a more individualized basis. Prevention For someone who has had an episode of diverticulitis, it is currently not possible to predict whether he or she will have another one. Researchers in our field are working to identify patients at risk of recurrent attacks so we can offer them elective surgery in hopes of avoiding emergency surgery and a potential colostomy. Unfortunately, we are still unable to identify this patient population accurately.

Diverticular disease is an acquired condition rather than an inherited one.

Symptoms and diagnosis Most people with diverticulosis never have symptoms. When diverticulitis occurs, however, patients commonly report pain in the left lower quadrant of their abdomen, fever, chills, and changes in bowel habits. This should prompt a visit to a doctor, who often can diagnose diverticulitis based on symptoms and a physical exam, although confirming the diagnosis usually requires a CT scan and blood tests. Treatment Outpatient Most episodes of diverticulitis can be managed on an outpatient basis with oral antibiotics and by following a clear liquid or low-fiber diet. Once symptoms have disappeared, adherence to a low-fiber diet is usually recommended for an additional four to six weeks to allow the colon to heal completely and the inflammation to subside. Patients then transition to a high-fiber diet to help prevent further diverticula from forming as well as to prevent future episodes of diverticulitis. Patients commonly ask whether they should avoid certain foods like popcorn, seeds, or nuts because they may have heard from friends, family, or even other doctors that these foods can get trapped in diverticula and cause inflammation. Research has not demonstrated a higher risk of developing recurrent episodes of diverticulitis from eating popcorn, seeds, or nuts so it appears that these foods are safe. Hospitalization Occasionally, episodes of diverticulitis can be severe enough to require admission to the hospital for intravenous antibiotics and prolonged periods of bowel rest. In cases where a significant perforation of the colon or abdominal infection has occurred, emergency surgery may be necessary. Emergency surgery often results in the need for a temporary colostomy, which is construction of a pouch that collects the personâ&#x20AC;&#x2122;s solid waste outside the body. This, understandably, can be distressing to patients and families. Fortunately, with improved antibiotics and techniques for draining abdominal infections, the need for emergency surgery is decreasing. The surgical management of diverticular disease is constantly evolving. As recently as 10 years ago, elective surgery was recommended for any patient who had experienced two episodes of simple

So in the end, was mom right? Can eating that extra piece of broccoli keep you out of my office talking about surgery for your diverticular disease? Possibly. But what I can say for certain is that eating a healthy, well-balanced, high-fiber diet, along with portion control and routine exercise, is the best way to help minimize the risks of developing most medical conditions, including diverticular disease. Mark Y. Sun, MD, is board-certified in colon and rectal surgery and practices with Colon and Rectal Surgery Associates.

Participants Diagnosed with Type 2 Diabetes Needed Prism Clinical Research is conducting several studies for participants diagnosed with type 2 diabetes. Financial compensation is provided for study participation time. Plus, volunteers receive: X Study related medications X Study related medical and laboratory evaluations X Screening laboratory results for personal records

Qualifications, scheduling, and compensation amounts vary from study to study. For more details, contact Molly at: 651-274-5046 or visit www.prismresearchinc.com April â&#x20AC;˘ May 2015 Minnesota Health care news

Balloon sinus dilation from page 15

camera is inserted into the nose and the image is projected onto a monitor. The low-profile deflated balloon is inserted into the narrow or blocked sinus opening so that it is seen on the monitor, and then inflated to a fixed diameter. When the balloon is inflated, it widens the opening by creating microfractures in the eggshell-thin bones of the sinus. Patients may hear a faint crackling noise and feel slight sinus pressure, but they experience very little, if any, discomfort. The actual inflation procedure takes only a couple of minutes, and the doctor watches the whole process on the monitor. Then, the balloon is deflated and removed. The bones that were fractured by the procedure heal in that open position. The pathway for mucous to drain is thus remodeled in a more open fashion so that it permanently improves drainage. Most patients find the 20- to 30-minute procedure comfortable and tolerable, and many report immediate improvement. I’ll have people stand up from the chair and tell me they can sense their sinus pressure easing right then and there. Many of them return to work the same day or the next. Most patients resume full, normal activity within 48 hours. The extended postoperative discomfort and bleeding so common with FESS is rare with balloon dilation. Success rate What’s most important, of course, is that the sinuses stay open for good. We’ve found in our practice and in published results that this procedure has a success rate comparable to that of FESS. Further-

more, patients who undergo balloon dilation tend to stay healthier after their procedure because it’s less invasive than FESS. A recent study found a more than 75 percent long-term reduction in subsequent sinus infections among patients who received balloon dilation (American Journal of Rhinology & Allergy, February 2014). That means an end to the unpleasant merry-go-round of pressure headaches, antibiotics, decongestants, and nasal steroids that some patients have been riding for decades. Insurance All this makes balloon dilation highly attractive to health insurers, most of whom cover this procedure. A brief office procedure is far less expensive than an operating room procedure requiring a general anesthetic, and the effectiveness of this procedure reduces subsequent postoperative costs as well. Considerations It’s important to note that not everyone is a candidate for balloon sinus dilation. Much depends on the extent of the patient’s problem, particularly what’s blocking the opening and where the blockage is located. FESS may be the procedure of choice for more complicated cases involving polyps, anatomic abnormalities of the sinus, or fungal infections. But for people who have simple but chronic sinus blockages, the balloon dilation procedure can be a welcome breath of fresh air. Theodore O. Truitt, MD, is a board-certified otolaryngologist and a Fellow of the American College of Surgeons. He practices at St. Cloud ENT.

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. For more information, please visit www.mnhcca.org. We are pleased to present results of the most recent survey. 1. I, or a member of my family, has been affected by substance abuse.

2. I, or a member of my family, have benefited from treatment for substance abuse.

Strongly agree

Agree

No Disagree Strongly opinion disagree

4. I believe research should be done to create more effective treatments for substance abuse.

Strongly agree

Agree

No Disagree Strongly opinion disagree

5. I believe substance abuse should be viewed as a public health issue. 60

10 0

3. I believe the current methods for treating substance abuse are effective.

Strongly agree

Agree

No Disagree Strongly opinion disagree

Minnesota Health care news April • MAy 2015

Strongly agree

Agree

No Disagree Strongly opinion disagree

Strongly agree

Agree

No Disagree Strongly opinion disagree

Minnesota

Health Care Consumer Association

Welcome to your opportunity to be heard in debates and discussions that shape the future of health care policy. There is no cost to join and all you need to become a member is access to the Internet.

Members receive a free monthly electronic newsletter and the opportunity to participate in consumer opinion surveys.

www.mnhcca.org

Join now.

“A way for you to make a difference” April • May 2015 Minnesota Health care news 33 NOVEMBER 2012 MINNESOTA HEALTH CARE NEWS 33

Proton pump inhibitors from page 13

Side effects/complications All PPIs show the similar and common side effects of headaches and diarrhea. However, they are typically very well tolerated and very few people stop taking them due to side effects. Concern arises because of the potential for serious complications when PPIs are overused or are used for longer than recommended.

Drug interactions PPIs may interact with other medications. One of the most common and significant interactions is the concurrent use of the PPIs omeprazole or esomeprazole with clopidogrel (Plavix), which is a blood thinner used to prevent clots after heart attacks and stent placement. This combination of medications may decrease the efficacy of clopidogrel. PPIs also may interact with the blood thinner warfarin (Coumadin), thereby increasing the risk of bleeding. However, the effects of PPIs on anticoagulation caused by warfarin appear to be small and the interaction is of doubtful clinical significance. Nonetheless, be sure to alert your pharmacist or health care provider if you notice bleeding gums or an increased tendency to bruise in a loved one who is taking both warfarin and a PPI.

Almost every American experiences some degree of heartburn

Complications from long-term use of PPIs include an increased risk of infection, particularly for higher risk individuals with lung disease or a compromised immune system. Such infections include pneumonia and/or infection by Clostridium difficile (also referred to as “C. diff.”), which causes severe diarrhea and fevers. Increased susceptibility to infection is likely due to the decreased amount of acid in the stomach, which would otherwise act as a line of defense by killing infectious organisms.

Other complications include an increased risk of bone fractures in older patients who have been using a PPI for more than one year, due to this drug’s side effect of decreased calcium absorption. Longterm use of PPIs may also decrease absorption of magnesium over time, which may lead to serious conditions such as muscle spasms or changes in heartbeat.

Use wisely PPIs are the most potent inhibitors of stomach acid available. They are not without risk, and should be reserved for heartburn symptoms occurring more than twice per week. Starting with the lowest effective dose and using this class of medication for the shortest duration possible is important to prevent long-term complications. Andrea Rosenberg, PharmD, is a pharmaceutical care leadership resident at the University of Minnesota College of Pharmacy, Minneapolis. Anita Sharma, PharmD, BCACP, is a pharmacist at HealthEast Grand Ave. Clinic, St. Paul.

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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

Minnesota Health care news April • May 2015

S:9.75”

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].

VICU3X1498_B_2_0_Journal_Ad_Tabloid_Resize_BS_r5.indd 1

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

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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 Placebo + Glimepiride Rosiglitazone + All Victoza® + 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 ® 1.8 + Metformin Placebo + Metformin + Glargine + Metformin + Victoza + 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 Placebo + Metformin + Rosiglitazone All Victoza® + Metformin + 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 pharma® ceuticals, 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

Victoza —a force for change in type 2 diabetes. 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

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