MN Healthcare News Oct 2015

October 2015 • Volume 13 Number 10

Lifelong exercise Mike Dixey, PT

Organ donation

By Susan Gunderson and William Payne, MD

Male osteoporosis

By Catherine B. Niewoehner, MD

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Minnesota Health care news October 2015

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October 2015 • Volume 13 Number 10

4 7 8 10 12

News

PEOPLE

PERSPECTIVE

Take Care

Dietary supplements— read the label

FORTyFOURTH SESSION

Jr., PhD

University of Minnesota School of Public Health

10 QUESTIONS Steven D. Stein, MD Minneapolis Clinic of Neurology

Physical Fitness A lifelong guide to exercise

Community Health

Organ, eye, and tissue donation

By Susan Gunderson and William Payne, MD

16

MINNESOTA HEALTH CARE ROUNDTABLE

By Marsha K. Millonig, John R. Finnegan MBA, BPharm

By Mike Dixey, PT, DPT, Cert. MDT, PES, CSCS

14

18 20

cALENDAR

22 24

Wo men’s Health Hysterectomy

By Jon Nielsen, MD, FACOG

Environ mental Health Issues with indoor mold

By Kelly Smeltzer, MPH

26

Oncology

Cancers of the neck and head

By Deepak Kademani, DMD, MD, FACS

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M en’s Health

Behavioral Health Integration New pathways to care

Thursday, November 12, 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 new pathways to behavioral health care. We will introduce new ideas and discuss how to incorporate them into our health-care delivery system. We will examine the value they can bring and the challenges they 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.

Male osteoporosis

Panelists include:

By Catherine B. Niewoehner, MD

• Lee Beecher, MD, President, Minnesota Physician-Patient Alliance

• Sarah Anderson, MSW, LICSW, CEO, Psych Recovery, Inc. • Timothy P. Gibbs, MD, FAPA, DFAACAP, Chief Medical Officer, Natalis Counseling and Psychology Solutions • Martha Lantz, MSW, LICSW, MBA, Executive Dir., Touchstone Mental Health

Dermatology

• Judge Kerry W. Meyer, Hennepin County Criminal Mental Health Court

What is eczema?

• Jane Pederson, MD, Medical Affairs Director, Stratis Health

By Charles E. Crutchfield III,

• Jeff Schiff, MD, MBA, Medical Director, MN Dept. of Human Services

MD

• L. Read Sulik, MD, Chief Integration Officer, PrairieCare Sponsors include: • MN Community Healthcare Network • MN Dept. of Human Services • Natalis Outcomes • PrairieCare • Psych Recovery, Inc. • Stratis Health 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.

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October 2015 Minnesota Health care news

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News

PrairieCare to Leave Medica/Optum Network PrairieCare has announced that it will not be an in-network provider with Medica/Optum for hospitalbased psychiatric services as of October 20.

spends more than 80 percent of their time struggling with Medica/Optum utilization management staff, fighting to get authorization for critical psychiatric care,” said Joel Oberstar, MD, PrairieCare CEO. “In our opinion, their utilization management approach is well outside the community standard and creates a real barrier to care.”

“PrairieCare leadership believes that Medica/Optum has burdened members and clinicians with un­ reasonable barriers to accessing/ receiving care and has made no meaningful efforts to resolve sub­ stantive concerns raised regard­ing unreasonable utilization manage­ ment policies,” according to a PrairieCare statement.

PrairieCare is sending notices to current and recent patients with Medica/ Optum insurance letting them know their plans will no longer cover services at PrairieCare starting October 20 and that while they will still be able to receive care at PrairieCare, costs to them will likely be higher.

The organization claims that reviewers with Medica/Optum pushed for patients to be discharged sooner than their treating psychologists deemed medically appropriate.

Minnesota’s Uninsured Rate Dropped in 2014

“Although about 20 percent of our patients have Medica/Optum insurance, our utilization review staff

Minnesota’s uninsured rate fell 28 percent from 2013 to 2014, according to data recently released from

4

Minnesota Health care news October 2015

the U.S. Census Bureau. The uninsured rate was 8.2 percent in 2013 and 5.9 percent in 2014, meaning 123,000 people who were previously uninsured gained health insurance in one year.

Minnesota had the fifth-lowest uninsured rate and was one of only six states to reduce its rate to about 7 percent or less, along with Massachusetts, Vermont, Hawaii, Iowa, and Connecticut.

“This dramatic drop in the number of Minnesotans without health insurance is an indisputable success of MNsure and the Affordable Care Act,” Gov. Mark Dayton said in a statement. “It means better, more affordable health care for them and their families, and lower, indirect health care costs for everyone else.”

About 317,000 Minnesotans still don’t have health insurance, according to the data. Uninsured rates varied widely among different populations—the uninsured rate was 15 percent among black Minnesotans,

23 percent among American Indians, and 29 percent among Hispanics.

Minnesota’s decrease in uninsured rates reflects a nationwide trend. There were decreases in rates across all 50 states and the District of Columbia. Overall, the U.S. uninsured rate fell 2.9 percentage points, from 13.3 percent in 2013 to 10.4 percent in 2014, meaning 33 million Americans did not have health insurance. Massachusetts had the lowest rate of uninsured in 2014 (3.3 percent), followed by Vermont (5 percent) and Hawaii and the District of Columbia (both at 5.3 percent). Texas had the highest uninsured rate (19.1 percent), closely followed by Alaska (17.2 percent) and Florida (16.6 percent). Kentucky showed the greatest improvement, decreasing its uninsured population by 41 percent from 2013 to 2014.

The data shows that states that elected to expand Medicaid and/or developed their own health insurance marketplaces had the greatest decreases in uninsured.

MDH Investigating Impact of Medications in Water The Minnesota Department of Health (MDH) has determined screening values for 119 of the most commonly prescribed medications in order to better evaluate potential health concerns for humans from pharmaceuticals in Minnesota waters.

Traces of a variety of pharmaceuticals have been found in Minnesota’s wastewater, lakes, rivers, and groundwater, according to MDH. This has caused concern about the health of aquatic life. In addition, some of this water may be used as a source for drinking water, which has also caused concern about the pharmaceuticals’ effect on humans.

The first step in evaluating potential human health impacts is to determine the level of each pharmaceutical in drinking water that poses no expected risk, according to MDH. The values can be monitored to determine which pharmaceuticals need to be evaluated more closely, as well as to help prioritize future monitoring and risk assessment efforts.

They can also help determine needs for improved laboratory techniques.

“It is important that we know more about the presence of pharmaceuticals in water,” said Pam Shubat, supervisor of the Contaminants of Emerging Concern Program at MDH. “Pharmaceuticals are designed to affect the health of people and may harm aquatic life.

This work will aid in understanding which pharmaceuticals may be of greater or lesser concern to Minnesotans.”

According to MDH, only a portion of the pharmaceuticals they developed screening values for have been found in Minnesota waters.

And they haven’t been detected yet in the water from public water systems. They hope the newly determined screening values will help keep the pharmaceutical levels below health concerns.

The Minnesota Pollution Control Agency (MPCA) conducts some of the surface and groundwater testing, and is working with MDH to evaluate the potential impact of pharmaceuticals and other contaminants on aquatic life.

“Given the number of pharmaceuticals being detected in Minnesota’s surface and groundwater, it is very helpful for MPCA and others to have some context with which to review the monitoring results we’ve gotten,” said Katrina Kessler, water assessment section manager at MPCA. “This information will help advance the MPCA’s work to protect Minnesota’s environment.”

n is o i t s e u lq The re a m ake n who c a e e asier? r M edic althPartners Freedeocmt palnadn to Hea perf Turn to p you find the get. d el let us h needs and bu r u meet yo

Essentia Health Allows Patients to See Caregiver Notes

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Essentia Health has announced that as of July 1, it began allowing patients who have access to their medical records through MyHealth to also access notes made by their caregivers during clinical appointments and urgent care visits.

“Research shows that patients value this type of transparency and partnership with their healthcare team,” said Tom Wiig, MD, chief medical information officer at Essentia Health. “It’s in the best interest of our patients’ health to make this information easily accessible to them.”

To access the information, patients or caregivers with MyHealth accounts may log in and click “Visit Notes.” This allows them to revisit what was covered at each visit and better understand their health and medical condition, according to Essentia Health. It can also improve communication and patient education.

Blue Cross Partnering to Offer Dental Plans Blue Cross and Blue Shield of Minnesota has announced an agreement with Pennsylvania-based United Concordia Dental to offer dental products to Minnesotans in 2016.

The new dental portfolio is called Blue Cross Dental and will include a variety of products to individuals and businesses. Details for 2016 coverage options will be released later this fall after regulatory review and approval by the Minnesota Department of Commerce.

H2462_72596_01 Accepted 9/25/2013. HealthPartners is a Cost plan with a Medicare contract. Enrollment in HealthPartners depends on contract renewal. ©2013 HealthPartners

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INFORMATION Job Number

245-13124

Trim

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September 10, 2014 10:08 AM

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Terry Thomas

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Minnesota Optometric Notes Association

Description

Doctors on the frontline of eye and vision care

[­­­­]

AS

Mark Jenson

[­­­­]

AM

Linda Gogolin

[­­­­]

PM

Krista Kraabel

[­­­­]

PA

Tera Gilmore

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

News to page 6 October 2015 Minnesota Health care news

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News from page 5

Conference Addresses Prescription Pain­ killer Problem More than 1,000 Minnesota law enforcement officials, public health officials, health care professionals, attorneys, drug court representatives, medical students, government staff, and recovering addicts gathered in Minnesota on Aug. 25 to discuss the state’s prescription painkiller problem and develop solutions to address it.

The conference, called Pain.Pill.

Problem, featured six panels on the topics of the impact of opioid addiction; prescribing and pain culture; pharmacy and distribution; law enforcement; opioid treatment; and recovery, prevention, and the role of the community. Several speakers took the floor, including Gov. Mark Dayton, Minnesota Department of Human Services Commissioner Lucinda Jesson, Sen. Amy Klobuchar,

Rep. Tom Emmer, U.S. Attorney Andrew Luger, Hennepin County sheriff Rich Stanek, former Rep. Mary Bono, University of Minnesota President Eric Kaler, and others.

Some recommended developing a system to more closely monitor patients who are using painkillers as well as utilizing alternative pain management techniques such as acupuncture, massage, exercise, and nutrition more often.

“Narcotic painkillers are being over-prescribed in Minnesota, leading to addiction, abuse, and serious consequences,” said Jesson. “In the last decade, overdose deaths have more than doubled. Painkillers now cause more deaths than heroin and cocaine combined. We need to have a conversation as a society about how we can treat pain in ways that restores function and this conference is a step in the right direction.”

“This gathering today proves we’re all in this together,” said Nick Motu, vice president of the Hazelden Betty Ford Institute

for Recovery Advocacy. “We’ve made addressing the opioid crisis a bedrock of the advocacy efforts at our organization, and by coming together with others around solutions like we did today, we can make real progress against this epidemic.”

St. Therese and North Memorial Team Up on Transitional Care Saint Therese and North Memorial Medical Center have announced that they are partnering on a program to help transition patients from the hospital to their homes.

Transitional Care by Saint Therese will open on the fourth floor of North Memorial Medical Center in Robbinsdale in spring 2016 and will include about 32 private rooms for patients transitioning from hospital to their homes after illness, injury, or surgery.

Patients will receive care from a team of care professionals, including

specialized physicians, nurse practitioners, dieticians, and physical, occupational, and speech therapists.

Senior Memory Care Neighborhood to Open in Burnsville The Rivers and its managing part­ ner, Des Moines, Iowa-based Life Care Services, have announced the grand opening of a memory care neighborhood within its senior living community in Burnsville on August 29. The neighborhood, called the Rivers Landing, is an alternative to at-home care for people with Alzheimer’s and other forms of dementia.

The memory care neighborhood is specially designed for adults with progressive cognitive disorders, offering a memory care program and staff who have undergone training to help residents manage dementia symptoms like sundown syndrome, wandering, or combativeness.

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Learn more about the benefits of UCare for Seniors in our new eGuide to Medicare at ucareplans.org. Or call (toll free) 1-877-523-1518 (TTY) 1-800-688-2534, 8 a.m. to 8 p.m. daily.

UCare for Seniors is an HMO-POS plan with a Medicare contract. Enrollment in UCare for Seniors depends on contract renewal. ©2015, UCare H2459_101512 CMS Accepted (10202012) 2015 Boomer MPP MN Health Care News_Hippie.indd 1 6 UC693 Minnesota Health care news October 2015

9/14/15 9:03 AM

People Stephanie Krejcarek Childs, MD, has joined Radiation Oncology at the Maplewood Cancer Center. Childs earned her medical degree at Harvard Medical School, completed an internship at Brigham and Women’s Hospital in Boston, and completed a residency in the Harvard Radiation Oncology Residency Program. Childs was awarded a FulStephanie bright Fellowship from the Fulbright Foundation of Krejcarek Childs, Sweden. Previously, she was an assistant professor MD of radiation oncology at the Mayo College School of Medicine and senior associate consultant in the Mayo Clinic Department of Radiation Oncology.

Amy Hammers, MD, has joined Clinic Sofia, an OBGYN clinic with offices in Edina and Maple Grove. Hammers earned her medical degree at Creighton University School of Medicine in Omaha, Neb. and completed her residency at the University of Florida College of Medicine in Jacksonville, Fla. She is a member of the American Congress of Amy Hammers, Obstetricians and Gynecologists (ACOG) and the MD American Medical Association. Hammers will see patients primarily in Clinic Sofia’s Maple Grove location but will also be available for appointments in Edina one day a week.

Peter Polski, DC, has joined Hennepin County Medical Center (HCMC) in the department of integrative health. Polski earned his doctorate of chiropractic from Northwestern Health Sciences University. In addition to his chiropractic education, Polski has pursued additional training in acupuncture, rehabilitation, and neuromuscular retraining.

Peter Polski, DC In addition to spinal and extremity complaints, Polski treats conditions such as headache disorders, TMJ dysfunction, Bell’s Palsy, and mechanical foot problems. Laura Schrag, MD, has also joined HCMC in the department of emergency medicine. Schrag earned her medical degree at Chicago Medical School and completed Laura Schrag, an internship and residency in emergency medicine MD at HCMC. Jean Wood, executive director of the Minnesota Board on Aging and director of the Aging and Adult Services Division at the Minnesota Department of Human Services (DHS), has received the first Executive Director’s Award from the National Association of States United for Aging and Disabilities (NASUAD) for her national leadership and commitment Jean Wood to the association. She first served as a staff member, then as a long-standing member of the NASUAD Board of Directors.

Her work helped the association move from serving only state aging agencies to serving state agencies on disabilities and aging.

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Visit us online at www.minneapolisclinic.com October 2015 Minnesota Health care news

7

P e r s p e ct i v e

The Triple Aim A prescription for health care

F

or more than 30 years—long before the 2010 Affordable Care Act (ACA)—the U.S. has spent more on health care than any other nation, but achieved less. Of the trillions spent on health, more than 85 percent has gone to medical services, yet other forces, including environment, genetics, and social determinants, account for some 80 percent of the factors that create and sustain health. Investment in prevention and health promotion has been painfully inadequate.

John R. Finnegan Jr., PhD University of Minnesota School of Public Health Dr. Finnegan is professor and dean of the University of Minnesota School of Public Health. Founded in 1944, the school is ranked among the top five public schools in the U.S. in research, learning, and community engagement.

It graduates some 300 students each year serving the public health workforce in Minnesota, the U.S., and all over the world.

The Triple Aim, articulated by Donald Berwick, former head of the Centers for Medicare and Medicaid Services, set a three-part agenda for health reform in 2008: improve population health, improve the health care experience, and reduce cost.

The subsequent journey has been one of enormous uncertainty, major change, and dysfunctional national politics.

The Triple Aim

Access. Emphasized more than other Triple Aim components under the ACA, access to care has been a roaring success. Only Texas has an uninsured rate higher than 20 percent. Almost 90 percent of Americans now have health insurance, with large but improving disparities among the poor, young, and minorities. Until now, the U.S. has historically been among the few developed nations unwilling to provide affordable basic health care.

There is also some good news regarding increases in health insurance rates. States like Minnesota that require pre-approval of rate increases have seen their costs rise 10 percent less than states without such regulation.

Population health. The ACA mandated some $14.5 billion be spent over a ten-year period for prevention and for programs to improve health and restrain increases in health care costs. But that funding has taken some major hits. With Congress and the president trading off population health for protecting physician cuts in Medicare payments, less than half of the original amount remained for population strategies in 2015.

Nationally, we’re still spending only about 3 percent of health dollars on public health.

Minnesota Health care news October 2015

The road in Minnesota

Two years before the ACA, Minnesota passed a health reform law aspiring to the Triple Aim. Long a bellwether for health innovation, Minnesota has been more efficient in spending health care dollars and in its focus on public health.

Driving this in part is the state’s tradition of not-for-profit health care and its Institute for Clinical Systems Improvement (ICSI) and Minnesota Community Measurement, both launched by the state’s major health plans. Data and evidence sharing, performance transparency, and innovation have been vital to Minnesota’s leadership in health.

We must all contribute to building a culture of health and wellness.

Cost containment. There also has been progress on cost. New incentives nudge health care from “fee-​ for-​service” to “fee-for-performance”; for some, this means home-based outpatient care, not the more costly hospital-based inpatient care. The ACA imposes Medicare penalties for patient readmissions within 30 days for conditions such as heart failure. Penalties started at 1 percent and are now up to 3 percent. In fiscal 2016, more than 75 percent of subject hospitals could be penalized for readmissions within 30 days.

8

Health care organizations with hospitals are required by the end of fiscal 2015 to conduct and publish a Community Health Needs Assessment (CHNA) or face an excise tax from the IRS. They must follow with a three-year action plan, mandating that they focus on everyone in their primary market areas, not just their own patients. It also drives them toward community, organizational, and public health partnerships to address the neglected factors that shape community health and wellness.

Another vital component has been Minnesota’s greater focus and investment in public health. The Minnesota Department of Health runs the Statewide Health Improvement Program (SHIP) that makes grants to communities for projects designed to change factors driving preventable illness and foster smarter choices.

The program has stimulated community partnerships across the state.

Nearly all of the state’s major health care organizations engage with communities in health improvement initiatives. For example, Allina Community Benefit and Engagement is well known for its Backyard Initiative and New Ulm Heart Health Program.

Minnesota may have an advantage in health reform by history and politics, yet all is not rosy. Longevity and health outcomes are generally better for whites.

Disparities in health are among some of the worst in the U.S. for American Indians, people of color, and all who live in poverty, offending our Minnesota values of fairness and equity. The health reform solutions that have eluded us so far will require even greater collaboration and partnership. We must all contribute to building a culture of health and wellness, both rural and urban. This crosses public health and health care, public and private sectors, professional and disciplinary boundaries, and all the ways we have siloed ourselves unintentionally and reduced our joint effectiveness.

It will be a continuing journey, not a destination.

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Get plan details now for coverage beginning in January 2016 at EssentiaCare.org, or call 218-722-4783, 1-855-432-7027 toll free, or TTY 1-800-688-2534 toll free, 8 a.m. to 8 p.m. daily. *Paid Actor Portrayal

Limitations, copayments, and restrictions may apply. This information is not a complete description of benefits. Contact the plan for more information. Benefits and/or copayments may change on January 1 of each year. EssentiaCare is a PPO plan with a Medicare contract.

Enrollment in EssentiaCare depends on contract renewal. © 2015, UCare H0735_091515_2 CMS Accepted (09202015) October 2015 Minnesota Health care news

9

10 Questions

Neuropathy Steven D. Stein, MD Dr. Stein is a neurologist with the Minneapolis Clinic of Neurology, practicing in Edina, Minn. He is boardcertified in electrodiagnostic medicine. He received his medical training at the University of Minnesota, and his neurology training at the Mayo Clinic.

What is neuropathy? Neuropathy refers to a disturbance in the function of a nerve or multiple nerves. It is a broad, descriptive term and does not refer to a single, specific disease. The expression “peripheral neuropathy” refers to an alteration in the function of the peripheral nerves, which typically would start in the feet and then start moving up the legs.

What are the classifications of neuropathy? Neuropathy can be classified in many different ways. For example, it may be classified as to whether it involves a single nerve or whether groups of nerves are affected. It may be classified as to causation, if a specific cause can be determined. For neurologists, it is often helpful to classify based upon which portion of the nerve is primarily affected.

For example, the two prime components of a nerve consist of the central portion known as the axon, and an insulating portion known as myelin. Conditions that affect axon versus myelin can display different types of clinical symptoms and often respond to different treatment regimens.

What causes neuropathy? There is a very long list of conditions that may cause neuropathy.

Some neuropathies may be due to a compression of the nerve, such as carpal tunnel syndrome, where there is a pinched nerve at the wrist. Activities that include repetitive use of the hands and wrists may lead to the development of carpal tunnel syndrome. Some neuropathies may be related to other medical conditions—diabetes would be a common example. There are some individuals who may develop neuropathy several years before diabetes becomes manifest. Some neuropathies may be related to vitamin deficiencies, including vitamin B deficiencies.

Some neuropathies may be related to infections such as Lyme disease. Some neuropathies may be related to inflammation of the nerves. Some neuropathies may be related to hereditary conditions. Some neuropathies may be

10

Minnesota Health care news October 2015

caused by medications, including some antibiotics used to treat infections. Individuals who receive chemotherapy as part of cancer treatment may develop neuropathy. Some neuropathies may be caused as a remote effect of certain cancers. Certain “toxins” may contribute to the development of neuropathy. This could include the excessive use of alcohol. Finally, there are a large number of individuals with neuropathy for whom a specific cause may not be identified.

What are the signs and symptoms?

The typical symptoms of neuropathy may include numbness, tingling, and pain. If nerves that supply muscles are involved, weakness can also be a symptom.

When the nerves in the feet and legs are involved, common symptoms can include loss of balance and coordination.

Sometimes neuropathy can cause very painful symptoms, sometimes described as burning or electric-like shocks. If neuropathy involves nerves that help control blood pressure, symptoms may include lightheadedness upon standing.

Occasionally, certain types of neuropathy may also affect bowel and bladder function. The signs of neuropathy that a physician may find on examination often include abnormalities when testing sensation in the arms or legs as well as changes in the deep tendon reflexes.

How do you test for and diagnose neuropathy? The evaluation always begins with the medical history, looking for clues of possible exposure history, medications, other medical conditions, or hereditary factors that may be relevant.

The findings on physical examination may provide further clues as to the type of neuropathy that may be involved and can sometimes narrow down diagnostic possibilities. Blood tests and urine tests can be performed to look for specific causative factors.

A spinal fluid examination may be considered, particularly if an inflammatory cause is suspected.

A test that is often useful for getting more objective information about nerve function is called an electromyogram or EMG. This test can sometimes help confirm the presence of neuropathy and may occasionally provide clues as to causation. Finally, in select cases, a biopsy may be considered as there are some causes that may be apparent under microscopic examination.

How is neuropathy treated? If a specific cause, such as a vitamin deficiency, can be identified, treatment would often focus on correcting that cause. In situations of compressive neuropathies, such as carpal tunnel syndrome, surgical decompression may be required. In circumstances where the cause of a

neuropathy cannot be determined, or if the cause is not treatable, treatment focuses primarily on symptoms. There are several medications available to treat nerve-related discomfort, including amitriptyline, gabapentin, pregabalin, and duloxetine. These medications are typically most beneficial for pain and discomfort that may be associated with neuropathy. Individuals who have significant neuropathy in their feet must be very careful to prevent further damage as a result of lessened sensation. Toenails should be cut by a professional, and special stockings and shoes may also be of benefit. As a rule, it is best to avoid going barefoot to avoid damage to the feet due to the loss of sensation.

medical conditions that produce inflammation in the body or are associated with alterations in the body’s immune system. This would include conditions such as rheumatoid arthritis or lupus. Neuropathy can be associated with various infections, either as a direct effect or as an indirect effect. The presence of neuropathy may also be associated with certain types of cancer.

Why did it take so long for medical science to recognize neuropathy as a legitimate disease?

Because the symptoms of neuropathy may sometimes be fairly vague and subjective, the presence of neuropathy may not always be easily recognized. Also, since there has often been a conception that little can be done to help neuropathy, it has sometimes been pushed aside or ignored as a diagnosis.

In some situations, people may assume that the development of numbness or pain in the feet is simply a normal phenomenon of aging.

Individuals with diabetes will often develop neuropathy.

Are there ways to reduce the likelihood of acquiring neuropathy?

In most cases, there may not be preventive tactics to avoid the development of neuropathy. Consuming adequate vitamins and other nutrients can help guard against nutritional deficiencies. If an individual is predisposed towards diabetes, weight loss and exercise may help limit the development of some of these conditions, and may be of some benefit in minimizing symptoms.

How is neuropathy linked to other diseases? As noted above, neuropathy may be associated with other medical conditions.

For example, individuals with diabetes will often develop neuropathy. The precise mechanism by which this occurs is not well understood. In fact, peripheral neuropathy may develop even before the diagnosis of diabetes. Neuropathy may also be associated with other

BILATERAL KNEE REPLACEMENT HELPS FARMER GET HIS

Can neuropathy be cured? Neuropathy may be “cured” if a treatable cause is found. Compressive neuropathies, such as carpal tunnel syndrome, may be “cured” as long as the degree of nerve damage has not been overwhelming. This involves decompressing the nerve at the wrist. In most circumstances, we may not be able to cure the neuropathy but our treatment focuses on controlling the symptoms of the neuropathy.

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.”

Watch Tim’s story online. Go to http://bit.ly/183Vlpc Appointments: Online or call 651-439-8807 | Multiple clinics in Minnesota and Wisconsin

www.stcroixortho.com

October 2015 Minnesota Health care news

11

Physical Fitness

A lifelong guide to exercise Goals and precautions for all ages

By Mike Dixey, PT, DPT, Cert. MDT, PES, CSCS

W

ith the seasons changing, you may be eager to show everyone the body you’ve worked on all summer.

Haven’t been sculpting, lifting, spinning, and hiking as often as you had planned? Well, then, let’s get to it!

Federal guidelines recommend that adults get at least 2.5 hours of moderate-intensity aerobic activity or 1.25 hours of vigorous-intensity activity each week, or a combination of both. According to the Centers for Disease Control and Prevention (CDC), the people most likely to exercise are between 18 and 24 years of age (almost 31 percent of total exercisers). Those least likely to engage in physical activity are ages 65 and older (only 16 percent of exercisers). That leaves 53 percent of total exercisers in the 25 to 64-year-old range.

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We’re looking for people over 18 years of age to take part.

We’d especially like to hear from migraine sufferers with at least one of the following cardivascular risk factors (But aLL migraine sufferers are welcome to contact us): • High blood pressure • High cholesterol • A smoker • Overweight • Diabetes

• Family history of coronary artery disease • Female and post-menopause • Male and over 40 years of age

Contact the study team or ask your physician about SAMURAI to learn more.

radiant Clinical research

www.radiantresearch.com 12

Minnesota Health care news october 2015

After a long day of work, caring for the family, and taking the kids to their sporting events, where’s the time left for exercise?

Surely, that reasoning has to do with the fact that 80 percent of Americans do not fit the recommended times for exercise into their daily and weekly schedules. As a result, we may try to cram our exercise program into a shorter period of time. We might skip a few meals because we’re not exercising as we should. Or we might start an exercise program that’s more intense than our current program.

Whatever it is, we want the changes to occur tomorrow, and we often do drastic things to make that happen. This article addresses the steps needed to prevent injuries from occurring, the focus of exercise based on your age, and the signs that you are overdoing it. Let’s start at the beginning, the warm-up, and work our way through the entire workout.

Warming up Athletes, weekend warriors, and gym rats all need to perform some sort of dynamic (moving) warm-up to improve performance and decrease risk of injury. Gone are the days of walking on the treadmill for five minutes or doing a few stretches before exercising and telling yourself that you did a good warm-up! As a matter of fact, static stretching (holding a stretch for a length of time) has been shown to weaken the muscle for a period of time following the stretch. Therefore, it is not recommended to perform this type of stretching until after your workout (when the body temperature is elevated and the muscles can stretch better). Instead, movements such as High-Knee Skipping, Butt Kicks, Frankenstein Walks, and Cariocas should be utilized as part of a thorough dynamic warm-up.

How many exercises should you do and for how long? Research tells us that a dynamic warm-up consisting of various exercises lasting 10–15 minutes is adequate to increase performance and get the body ready for activity. A good starting program is as follows (all exercises—descriptions and videos—can be found online with a simple search or by visiting www.youtube.com): • Skipping: 20 meters • High-Knee Marching/Running: 20 meters • Butt Kicks: 20 meters • Small Two-Footed Jumps: 20 meters • Cariocas: 20 meters • Frankenstein Walk: 20 meters • Lunges: 20 meters When first starting this type of program, the “warm-up” may be more difficult than your previous or current exercise routines.

That’s OK. Work into it slowly. Before you know it, you’ll be able to complete the warm-up without much difficulty and still have the energy you need to crush your workout.

As we age How intense should your exercise program be? When people see me in my clinic, I often hear, “I used to be able to do that program, no problem. Why is it so difficult now?” Or, “Why did I get hurt?” While there is no clear-cut answer, the truth is that we are not who we once were. As we age, our fitness levels, quality of muscle, and body composition all change. In our 20s, we have a great ability to perform intense, heavy, frequent exercise. Our 20s represent the best time to build muscular power (generate maximum force as quickly as possible).

The 30s are a time when we learn from what we did in our 20s and design better routines based on what worked and what didn’t work.

We exercise smarter and, as a result, see great improvement.

Find a physical activity you enjoy.

Look at professional athletes: for most, the 30s are the prime years of their careers. Endurance athletes also do very well in their 30s. A 2007 analysis of marathon times by German researchers revealed that runners don’t slow down at all in their 30s, even though their hearts start losing stroke volume and their VO2 max levels, which measure the maximum rate of oxygen consumption during exercise, and reflect aerobic fitness, begin to even out. Our 40s

should be the time when we start caring more for our bodies when exercising. According to research, our nerve fibers lose their effectiveness, which diminishes coordination and can lead to injury if we are not careful. Our hearts also beat more slowly, cutting down the blood flow that delivers nutrients to and removes waste from our joints and muscles.

If that’s not enough, we’re also losing 0.5 percent of our muscle mass each year. Beyond age 50, the focus should move away from looking good (although that’s still a goal) to staying functional. Exercising regularly is very important during this time.

Exercise protects the heart, relaxes the arteries, builds muscle, strengthens bones, fights cancer, and boosts the immune system. To break it down, exercise program goals, based on age, should look something like this:

Decade of life

Goals

20s

Power & Agility

30s

Strength & Stamina

40s

Flexibility & Strength

50s+

Balance & Mobility

Focusing on this chart can help take advantage of what our bodies need. It can also remind us not to overdo it.

A lifelong guide to exercise to page 34

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www.OakdaleOBGYN.com October 2015 Minnesota Health care news

13

Community Health

Organ, eye, and tissue

donation

Giving and receiving the gift of life

By Susan Gunderson and William Payne, MD

W

hen Christopher Spears received his driver’s license at the age of 16, he chose to register as an organ, eye, and tissue donor. Like most teenagers in Minnesota, Christopher had received vital information about this decision thanks to a state law requiring 30 minutes of instruction about organ, eye, and tissue donation during driver’s education classes.

The bill that made this 2007 law possible was introduced and championed by Minnesota teenagers, who insisted that the way to create a culture of organ donation in our community was to provide education to young people who would be making this important

decision for the first time. The impact has been far-reaching and sustained: 16- to 24-year-olds have the highest rate of organ donor designation in the state, according to data from the Minnesota Department of Public Safety.

Christopher’s mom, Luann, remembers being with her son as he was filling out his driver’s license application. When they got to the donation question she asked him, “Are you sure you know what that means, to be an organ donor?” In typical teenage fashion he responded with “Well, duh, mom. Of course I do!”

Saving lives through tragedy Sadly, Christopher’s decision to be a donor was fulfilled much too soon. In March of 2010, Christopher was on his way to an intramural basketball game when he was involved in an accident that ended his life. But as an organ, eye, and tissue donor, Christopher’s story continues in new and powerful ways. His kidneys and liver saved the lives of three people and his gifts of tissue will potentially help dozens more.

Do You Suffer from 3 to 8 migraineS per month?

If so, consider joining Samurai–a clinical study to assess a potential new migraine medication for people like you.

We’re looking for people over 18 years of age to take part.

We’d especially like to hear from migraine sufferers with at least one of the following cardivascular risk factors (But aLL migraine sufferers are welcome to contact us): • High blood pressure • High cholesterol • A smoker • Overweight • Diabetes

• Family history of coronary artery disease • Female and post-menopause • Male and over 40 years of age

Contact the study team or ask your physician about SAMURAI to learn more.

radiant Clinical research

www.radiantresearch.com 14

Minnesota Health care news October 2015

Each of those individuals have received life, hope, and healing through the generosity of a quiet kid who made everyone laugh and who loved his friends, his family, and his faith. Christopher’s family is on a new journey as well, sharing the message of donation and how it has impacted their grief journey and subsequent healing. His mother, Luann, and his sisters volunteer as Donate Life Ambassadors, sharing their story in their community to inspire others to support donation. (LifeSource, a Minnesota nonprofit organization dedicated to saving lives through organ and tissue donation in the Upper Midwest, posts videos about Christopher and other Minnesotans on its YouTube channel at YouTube.com/LifeSourceMN.) The tragic reality is that there are many more people waiting for a life-saving organ transplant than there are organs available.

According to the United Network for Organ Sharing (UNOS), there are some 122,445 people waiting for an organ transplant in the U.S., including 3,171 in Minnesota alone. On average, 22 people die each day while waiting for a life-sustaining organ transplant.

The need is great and the disparity alarming. The good news is that everyone can help address this critical health issue by learning more about what it means to be a donor and making the choice to support giving the gift of life. If more people registered as a donor, more lives would be saved.

Minnesotans have an incredibly high donor designation rate, with about 63 percent of adults registered as organ, eye, and tissue donors on their driver’s license or state identification card. This is much higher than the national average of 51 percent, according to Donate Life America.

Facts and figures Although the state ranks high when compared nationally, there is room for improvement. LifeSource’s goal is to reduce deaths on the transplant waiting list by saving lives and offering hope and healing by facilitating organ and tissue donation. Here are the top ten facts about organ, eye, and tissue donation.

Your decision will be honored. When you register to become an organ and tissue donor you are making a legal decision and, even after your death, your decision will be honored. It’s important to talk with your family to make sure they are prepared to honor your decision at the time of your death.

If you don’t make a decision, your family will. If you haven’t registered to be an organ and tissue donor, your family will be asked to make a decision about donation on your behalf. Therefore, it is important that you have a conversation about donation and share your wishes with your loved ones.

On average, 22 people die each day while waiting for a lifesustaining organ transplant.

Your life is always first. If you are taken to the hospital after an accident or injury, it is the hospital’s number one priority to save your life. Your status as a donor is not even considered until every effort has been made to try to save your life and death has been declared.

Anyone can register to be a donor. Your age or health should not prevent you from registering to be an organ, eye, and tissue donor. Most health conditions do not prevent donation and age is not a factor— the oldest organ donor in the U.S. was 92.

Become a donor Registering to be an organ, eye, and tissue donor is simple. You can register online at www.DonateLifeMN.org or you can check the box to register to be a donor when you apply for or renew your driver’s license, state identification card, or learner’s permit.

Susan Gunderson is chief executive officer of LifeSource, a Minnesota nonprofit that has provided organ and tissue donation services to more than 8,000 families for 26 years. William Payne, MD, is medical director for LifeSource.

All faiths agree. All major U.S. religions support organ and tissue donation and consider it a generous act of caring. Individuals looking for specific guidance should talk with their clergy or religious leader.

There is no cost to your family. If you decide to be an organ, eye, and tissue donor, your family will not have to pay for any medical expenses associated with the donation.

One donor can save up to 60 people. One person can save and heal up to 60 lives through organ, eye, and tissue donation. Solid organs that can be donated include heart, lungs, liver, kidneys, pancreas, and intestines. Tissues include eyes, bone, skin, veins, connective tissue, and heart valves.

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Can I keep my doctor?

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Everyone is equal. When it comes to waiting in line for an organ transplant, we are all created equal. Wealthy or famous individuals cannot and do not get bumped up higher on the national transplant waiting list. Factors such as blood type, body size, location, severity of illness, and length of time on the waiting list are used to determine the best candidate for an organ.

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You’ll be treated with respect. Organ, eye, and tissue donors are heroes and are treated as such. The medical professionals who perform the recovery surgeries treat donors with the utmost respect, just as they would for any other patient. An open casket funeral or viewing should not be affected by organ and tissue donation.

Your family will be well supported. Donor families receive compassionate care at the time of donation and in the months and years following their loved one’s death. LifeSource offers a comprehensive donor family aftercare program, providing grief resources, the ability to participate in remembrance events, and the opportunity to connect with other grieving families whose loved ones gave the gift of life.

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3

INFORMATION October

2015 Minnesota Health care news

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245-13124

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HealthPartners

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MN Health Care News

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Dermatology

What is

eczema?

A focus on allergic reactions

By Charles E. Crutchfield III, MD

E

czema is a term for “inflammation of the skin.” Inflamed skin is itchy, red, swollen, and flaky. In extreme cases it can even crack, weep, and blister. Dermatitis is another name for eczema. Eczema and dermatitis are synonyms and are used interchangeably.

Dermatitis can have many causes. These include allergic reactions, irritation, prolonged exposure to heat and moisture, prolonged exposure to dryness (especially in winter), and genetic

factors. For now, we will focus on rashes caused by allergic reactions, often referred to as “Allergic contact dermatitis.”

Allergic contact dermatitis The intense itching and blistering of allergic contact dermatitis can occur after contact with a substance that causes an allergic reaction.

This substance is referred to as an “allergen.” These reactions typically appear within a few days of exposure. The person experiencing the allergic reaction must be exposed on a prior occasion for the first reaction to occur. As one ages, the reactions to specific allergens may lessen.

Common allergens include: nickel, rubber, antibiotics, poison ivy, hair dyes, preservatives, chemicals used in clothing manufacturing, natural oils, ingredients in skin care products, and many others.

Common allergens Nickel. Found in many metal products, nickel is a common cause of skin allergy. Chrome-plated objects may also contain enough nickel to produce an allergic rash in people sensitive to nickel. Nickel is also in stainless steel, but the metallic structure of stainless steel keeps the nickel from being released and the rash from forming in nickel-sensitive people. Perspiration may exacerbate nickel allergy.

Earrings, watch strap buckles, and clothing fasteners such as belt buckles, jean buttons, zippers, and metallic clips that contain nickel can cause earlobe, lower-stomach, and wrist dermatitis. These are very common problems in people allergic to nickel. Only stainless steel earrings should be worn, and nylon accessories and plastic buttons can be used instead of nickel for many clothing items.

Rubber. Rubber products, including latex, are a common offender that is well known to cause allergic contact dermatitis. Chemical components required to process rubber usually cause the allergic reaction. Latex gloves have become a real problem, and those with a latex allergy can experience a life-threatening condition called anaphylactic shock. Vinyl or other synthetic gloves may be substituted for those with a rubber or latex allergy.

16

Minnesota Health care news October 2015

Additionally, elastic in clothing (spandex in clothing is a common offender) can be problematic. Allergic contact dermatitis from

shoes are commonly caused by ingredients used in rubber processing or any number of materials used in the construction of the shoes, such as glues, dyes, or certain fabrics that are chemically processed.

Hair and clothing dyes. Most people can dye their hair without any problem. Paraphenylenediamine (PPD), a common ingredient in many permanent hair colors, acts as a potent allergen. PPD is commonly mixed with peroxide to activate. Be sure to always do a small spot test with any permanent dye to make sure that you are not allergic. Most temporary colorants can be tolerated, but still need a pre-test. Some people may also react to dyes found in some clothing. Also, a distant relative to PPD is the anesthetic lidocaine. About 20 percent of people allergic to PPD have allergy problems with anesthetics like benzocaine. Henna tattoos may also now contain PPD and may cause allergy problems.

Skin care products. Perfumes, fragrances, creams, lotions, and cosmetic products may cause allergic contact dermatitis. Some allergies are a result of the chemical used as fragrance; others may be from the ingredients used as preservatives. Although many products will proclaim that they are “fragrance free” “or “unscented,” they rarely are. It is easy to determine if you can tolerate such products: put a small amount, twice daily, on your forearm for three to five days; if no rash forms, it is a good indicator that the product is safe to use without an allergic reaction. Your dermatologist can perform more extensive allergic contact testing.

Chromates. Chromates contain chromium and are common sources of allergic contact dermatitis. Chromates are found in cement, match tips, leather tanning, some paints, and products that combat rust. Because chromates are found in so many products, people in many occupations can experience chromate allergies.

(Eczema) can have many causes.

Antibiotic ointments. Triple antibiotic ointment contains bacitracin, neomycin, and Polymyxin B. All of these can cause allergic reactions, but reactions to bacitracin and neomycin are most common. The longer one uses these antibiotics, the more likely one is to develop an allergy to them. Consult with your dermatologist before using any over-the-counter topical antibiotic, especially on a longterm basis.

Tattoo inks. There are now hundreds of pigments used in the tattoo industry, but some of the common color pigments in tattoo ink that cause allergies are: • Red: cinnabar

• Yellow: cadmium

• Blue: cobalt

• Green: chromic oxide

• Purple: manganese

• White: titanium and zinc oxide

What is eczema? to page 19

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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technoloGY

breast cancer

Robot

weight loss surgery (bariatrics)

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Gallbladder hernia endocrine (parathyroid, thyroid and adrenal) Gastric Reflux bowel (colon resections) oncology/cancer

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

17

Calendar Oct.-Nov. 2015 Oct.10

Food Allergy Resource Fair & Trick-or-Treating

The Food Allergy Support Group of Minnesota presents this free activity for families with food allergies. Learn how to have a safe Halloween for your child with food allergies and bring them in costume to trick-or-treat at information booths for allergy-friendly candy. Free, but a $5 donation per family is encouraged. For more information, visit www.foodallergysupportmn.org Saturday, Oct. 10, 9 a.m.–12 p.m., Eisenhower Community Center, 1001 Hwy. 7, Hopkins

20

Pancreas Cancer Support Group

Allina Health hosts this free support group for those living with pancreas cancer and their families. Come share information and gain support from others on a similar path.

Meetings are facilitated by a nurse coordinator and oncology social worker. No registration required; call (612) 863-7553 with questions or to learn about other meeting dates.

Tuesday, Oct. 20, 4–6 p.m., Abbott Northwestern Hospital, Piper Building, 913 E 26th St., Ste. 602, Minneapolis

23

Advance Care Planning Class

Park Nicollet presents this free class for those who are ready to start the advance care planning process. Come learn how to select a health care agent, begin a family conversation, and complete a health care directive. Registration required. Call (952) 993-3454 to sign up or for more information.

Friday, Oct. 23, 1–2:30 p.m., Park Nicollet Clinic—St. Louis Park, Senior Services Conference Room, 3850 Park Nicollet Blvd., St. Louis Park

26

National Depression Screening Day An estimated 6.7 percent of adults in the U.S., or about 14.8 million people, experience major depression, according to the National Alliance on Mental Illness.

Depression and other mood disorders are the third most common cause of hospitalization for youth and adults ages 18 to 44.

Symptoms vary for everyone, but the most common warning signs include changes in sleep and eating patterns, lack of concentration, loss of energy, low self esteem, feelings of hopelessness, and physical aches and pains. Depression can be caused by trauma, genetics, life circumstances, or other medical conditions.

It can affect people of any gender, age, or ethnicity.

Depression is a serious mental health condition. However, it responds very well to treatment. Early detection and diagnosis, and an individual treatment plan consisting of medications, therapy, and lifestyle changes, help many people improve.

Seizure Recognition & Response Class

The Epilepsy Foundation of Minnesota offers this free class to teach how to recognize the four main types of seizure, first aid response for someone experiencing a seizure, and basic information on epilepsy, seizure triggers, and more. Call (651) 287-2300 to register or for more information.

Monday, Oct. 26, 6:30–7:30 p.m., Southwest High School, 3414 W 47th St., Minneapolis

Online

Screening for Depression

Screening for Mental Health is a nonprofit that first introduced the concept of large-scale mental health screenings in 1990 in conjunction with its first National Depression Screening Day. To take an anonymous online depression screening and educate yourself on the signs and symptoms of mental illness, visit helpyourselfhelpothers.org.

Nov. 2

Growth Through Grieving

HealthEast offers this group to anyone who is grieving the loss of a loved one. While grieving can be painful and lonely, sharing experiences and support with others going through similar losses can help. Contact Ted at (651) 232-7397 or thein@healtheast.org for more information.

Monday, Nov. 2, 4–5:30 p.m., Maplewood Professional Building—St. John’s Hospital, Watson Education Center, Ste. 202, 1575 Beam Ave., Maplewood

4

Memory Screenings

7

Brain Injury Conference

The Alzheimer’s Foundation of America is offering free 10-minute memory screenings for those concerned about memory loss, experiencing warning signs of dementia, at risk due to family history, or those who want to check their memory for future comparisons.

Call (763) 277-1008 to set up an appointment.

Wednesday, Nov. 4, 8 a.m.–12 p.m., Copperfield Hill, 4200 40th Ave. N, Robbinsdale

The Minnesota Brain Injury Alliance hosts this free “Journey to Wellness” conference for individuals with a brain injury, family members, and loved ones. Come participate in workshops and sessions focusing on innovations in the world of brain injury care, therapy, and rehabilitation. Registration required by Nov. 3.

For more information or to RSVP, call (612) 378-2742.

Saturday, Nov. 7, 1–4 p.m., New Life Presbyterian Church, 965 Larpenteur Ave. W., Roseville

17

Heart Safe

Hennepin County Library and the Rotary Club of Plymouth offer this free class for anyone who would like to learn the symptoms of cardiac arrest and receive training for CPR and the use of an automated external defibrillator (AED). Call (612) 543-5825 to sign up or for more information.

Tuesday, Nov. 17, 7–8 p.m., Plymouth Library, 15700 36th Ave. N., Plymouth

Send us your news: We welcome your input. If you have an event you would like to submit for our calendar, please send your submission to MPP/Calendar, 2812 E. 26th St., Minneapolis, MN 55406.

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

America’s leading source of health information online 18

Minnesota Health care news October 2015

What is eczema? from page 17

Poison ivy and its relatives. Every year 30 million people in the U.S. experience dermatitis from poison ivy. Poison ivy, poison oak, and poison sumac are three related American plants of the genus Rhus. They contain an oil (urushiol) which is the allergen and cause of allergic contact dermatitis. A hint for diagnosis is that often the very itchy rash is composed of linear blisters, marking the area where the plant brushed up against the skin. Allergies to these three plants may make people sensitive to certain tree oils, mango husks, pistachios, and cashew shells from overseas. The skin has enzymes that naturally break down the oils over four to six hours after exposure. After that, you can’t spread the dermatitis by rubbing it or breaking blisters. The only exception: if it gets on animal fur or clothing that does not contain the enzyme to break it down, it can be touched later and cause the reaction.

• Substitute products that do not cause allergic reactions. Your dermatologist can provide you with a comprehensive list of suggested alternatives.

• Treatment is directed to relieve symptoms. Topical or oral steroids, cool compresses, and other non-steroidal anti-itch medicines will be recommended by your dermatologist. Next, it is important to investigate, identify, and remove/avoid the cause of the allergic skin reaction. Your dermatologist may recommend skin patch tests containing different allergens to test for reactions.

This information can be employed to avoid future skin reactions.

Most allergic reactions need to be treated for three weeks.

Treatment People with allergic contact dermatitis should: • Avoid the allergen that causes the reaction and chemicals that cross-react with it. Your dermatologist can help you identify items to avoid.

• Dermatologists may initiate more aggressive treatments using prescription strength anti-itch medicines, topical and oral steroid treatments, and light (phototherapy) treatments if the rash is severe.

• Note that most allergic reactions need to be treated for three weeks.

If you suspect an allergic contact dermatitis, see your dermatologist for the appropriate evaluation and treatment.

Charles E. Crutchfield III, MD, is a board-certified dermatologist and Clinical Professor of Dermatology at the University of Minnesota Medical School. He also has a private practice in Eagan, Minnesota.

October 2015 Minnesota Health care news

19

Take Care

Dietary supplements—

read the label

A look at an unregulated industry

By Marsha K. Millonig, MBA, BPharm

M

ore than half of all Americans take a vitamin, dietary, or mineral supplement each day, driving annual sales of these products to more than $30 billion. Consumers may believe these supplements will improve their health, but that doesn’t mean they heard it from their doctor; indeed, many consumers do not even discuss or disclose their supplement usage with health care providers. If they did, they might hear that supplements may be ineffective, may interact negatively with other over-the-counter (OTC) and prescription medicines, and may present health risks if overused. Many consumers would be surprised to learn that such supplements are not subject to the same government oversight and regulation as OTC and prescription drugs.

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Minnesota Health care news October 2015

Buy now Supplement makers spend more than $1 billion advertising their products through a variety of media channels, and studies show that this advertising spurs consumer sales. At the same time, more than 40 percent of consumers say they are confused by the number and variety of supplements on the market, nearly 40 percent believe they all work the same, and nearly one-third say they switch supplement brands frequently based on news reports.

Health care professionals, including pharmacists, physicians, and nurses, could provide valuable information on choosing quality supplements, but many consumers do not ask. In a 2010 survey of Americans over age 50 conducted by the American Association of Retired Persons (AARP) and the National Institutes of Health (NIH), 37 percent said that they used herbs and dietary supplements, yet 67 percent never discussed their use with a health care provider. A 2011 Harvard Opinion Research Program study of more than 1,500 U.S. adults found that 36 percent did not tell their physician about their use of supplements, while 5 percent had been told to stop using the supplement by their health care provider. One-fourth of these respondents said they would stop using the supplements if they were found to be ineffective. The U.S. Preventive Services Task Force doesn’t recommend regular use of any multivitamins or herbs, citing lack of evidence from numerous long-term studies.

Claims, evidence, and regulation In spite of these findings, supplement makers often make claims that cannot be backed up by research, and industry oversight can be lacking. While supplement makers must follow manufacturing practices mandated by the U.S. Food and Drug Administration (FDA), they do not have to prove that their product is safe and effective prior to marketing—a fact likely unknown by many consumers.

Finished dietary supplement products and dietary ingredients are regulated under the Dietary Supplement Health and Education Act (DSHEA) of 1994, not by the FDA regulations that cover foods and drug products. Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded, and are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of DSHEA and FDA regulations. The FDA is responsible for taking action against adulterated or misbranded dietary supplement products only after they reach the market.

For the most part, the FDA relies on post-market surveillance efforts, such as adverse event reporting, consumer complaints, and

facility inspections, to identify potential safety concerns for dietary supplements. One report notes the FDA only conducts spot-tests on 1 percent of the 65,000 dietary supplements on the market. If a concern is identified, the FDA must demonstrate that the dietary supplement presents a significant or unreasonable risk, or is otherwise adulterated, before that product can be removed from the market.

Because this approach has fallen short in the past, the Food, Drug, and Cosmetic Act was amended by the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006 to tighten oversight. Manufacturers are now required to notify the FDA of supplement-related serious adverse events. These are defined as any health-related events that result in, for example, a death, a life-threatening experience, an inpatient hospitalization, or a birth defect, or which require, based on reasonable medical judgment, a medical or surgical intervention to prevent those serious outcomes.

The FDA received more than 6,000 reports between 2008 and 2011, according to a March 2013 report from the Government Accountability Office (GAO), with most of those coming from industry. The GAO said it believes these are probably under-reported because some consumers appear to report these events to poison control centers instead of the FDA.

Pharmacopeial Convention (USP) provides a Dietary Supplement Verification Program that allows manufacturers to affix product labeling with the USP mark if the tested product meets specific requirements. The requirements include verification of product ingredients and amounts, effective disintegration and dissolution for absorption, absence of harmful contaminants, and safe, sanitary, well-controlled manufacturing. Consumers should look for the USP mark on vitamin and mineral supplement labels. Consumers should also consult their pharmacist or other health care provider to share why they are seeking to use a supplement, ask what studies show about the product’s effectiveness, and seek advice on high quality USP mark supplement brands and how to use them correctly.

The NIH’s Office of Dietary Supplements provides an overview on supplement use at https://ods.od.nih.gov/factsheets/ MVMS-HealthProfessional/. This site has consumer updates on dietary supplements, including new warnings and tips for spotting health fraud.

Many consumers do not even discuss or disclose their supplement usage with health care providers.

In spite of these efforts, regulating dietary supplements remains problematic, and many consumers are unaware of factors that can affect the safety and efficacy of these products. The Council for Responsible Nutrition (CRN), a Washington, D.C.-based trade association representing dietary supplement manufacturers, says that 85 percent of American adults were confident in the safety, quality, and effectiveness of supplements. Yet, an analysis published

by JAMA Internal Medicine in 2013 found that dietary supplements represented more than 50 percent of the FDA’s Class I Pharmaceutical recalls between 2004 and 2012. Most of these substances were for bodybuilding, weight loss, or sexual enhancement products that contained unapproved medicinal ingredients, and almost 25 percent were manufactured outside of the U.S.

Information about medicine and supplement interactions may be found at: http://acsh.org/2000/11/whats-​the-​ story-​drug-​supplement-​interaction/.

Marsha K. Millonig, MBA, BPharm, is interim executive director of the Minnesota Pharmacists Association. An associate fellow at the University of Minnesota Center for Leading Healthcare Change, she is also president and CEO of Catalyst Enterprises, LLC.

And in February 2015, the New York State Attorney General had four major retailers—GNC, Target, Walgreens, and Walmart— pull herbal products bearing each store’s brand from their shelves following an investigation. Authorities purchased 78 bottles of the leading brands of herbal supplements across New York State, then conducted DNA analysis to determine whether they contained herbs listed on their labels. Four out of five products did not contain any of these herbs, and testing further revealed that pills often contained little more than cheap fillers. One product marketed as ginseng contained only powdered garlic and rice, while another one labeled as ginkgo biloba contained little more than powdered radish, houseplants, and wheat. The investigation also stated that pills sold as St. John’s wort and valerian root tested negative for the herbs on their labels. Critics of the investigation said that herbal DNA could have been destroyed in the manufacturing process, rendering the tests inaccurate, although DNA was detected for other ingredients used as fillers.

Read the labels The large number of recalls and lack of safety and efficacy requirements underscore the need for consumers to choose quality supplements and to use them appropriately. The United States

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21

Women’s Health

Hysterectomy Alternative surgical approaches

By Jon Nielsen, MD, FACOG

T

echnological advances have benefitted our lives in many ways. As a long-time ob-gyn physician, I can attest that this is true in gynecologic surgery, particularly with regard to minimally invasive laparoscopic hysterectomy. While many individual surgeons, as well as the American College of ObGyn Committee (ACOG), prefer an alternative vaginal surgical approach, I prefer the laparoscopic procedure, for reasons stated below.

the vaginal canal; cancer of the uterus, cervix, or ovaries; endometriosis, in which uterine tissue attaches and grows elsewhere; adenomyosis, a condition similar to endometriosis that affects the muscles of the womb; abnormal vaginal bleeding; and chronic pelvic pain.

These conditions may require a hysterectomy to remove the upper part of the uterus; the entire uterus, cervix, and surrounding tissue; and, in some instances, the ovaries.

Background Hysterectomies are among the most common gynecologic surgeries.

As many as 20 percent of women undergo a hysterectomy by the age of 55, for reasons including fibroids, or benign lumps in the uterus; uterine prolapse, a sliding of the uterus from its normal position into

There are several ways to perform a hysterectomy, and often the reason for the hysterectomy dictates what type of surgery is best. In the past, all hysterectomies required a large abdominal incision and lengthy recovery time. Today, women who have a normal-sized uterus, have no history of abdominal surgeries, and do not have cancer, are good candidates for an alternative: minimally invasive hysterectomy.

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Minnesota Health care news October 2015

“Minimally invasive hysterectomy” is performed in two ways.

The first type, done through the vaginal canal without any other abdominal incisions, has been performed for years and has historically been the alternative to large abdominal incisions. The other method is the laparoscopic hysterectomy, which is performed through small incisions in the abdomen using scopes (like telescopes), video monitors, and long instruments. Both of these procedures offer an easier recovery for the patient with fewer complications when compared with the abdominal hysterectomy, although ACOG, in its 2009 Committee Opinion, advocated strongly in favor of vaginal hysterectomies.

Weighing the choices Why do ACOG and some surgeons recommend the vaginal approach over the minimally invasive laparoscopic approach? One reason is that the data used for ACOG’s conclusion predates major advances in laparoscopic hysterectomy that have occurred since 2005. Since that time, extensive data supporting use of laparoscopic hysterectomy demonstrates its success. Another likely reason is the preference and training of the surgeon. The laparoscopic hysterectomy is generally considered more technical and difficult than the other forms of hysterectomy, and requires additional training.

In practice since the early 80s, I have personally taken part in the transition away from the abdominal approach to hysterectomy.

My initial approach was the vaginal hysterectomy, but, like many other surgeons, I now prefer the laparoscopic hysterectomy. My experience is that patient outcomes and satisfaction are improved with the laparoscopic approach, and that patients have more rapid return to normal activities and to work (usually within two weeks), as well as less pain. In fact, I’ve performed hundreds of laparoscopic hysterectomies and have not done a vaginal hysterectomy for more than five years.

The case for laparoscopic hysterectomy Here, I make my case for laparoscopic hysterectomy as the new “gold standard” for hysterectomy.

No recent data. The main source of information used to create the ACOG Committee Opinion was the latest 2009 Cochrane review of 34 randomized trials of abdominal hysterectomy, laparoscopic hysterectomy, and vaginal hysterectomy, including 4,495 patients. This report highlighted comparisons with abdominal hysterectomy and confirmed the opinion that when a minimally invasive procedure could be performed rather than an abdominal approach, it should be done.

pelvis is limited, especially the upper pelvis, limiting comprehensive treatment of such conditions as endometriosis or other concomitant disease processes. There are very few conditions that preclude the use of the laparoscopic hysterectomy.

Call for more studies. I recommend a reevaluation of all the current data regarding the relative value of these two techniques.

A likely outcome from such a study would be that both procedures are safe, cost effective, and produce good outcomes. While some surgeons have strong preferences—and some insurance companies favor one procedure over another—the final decision should be determined by the patient and the surgeon, and informed by scientific evidence.

“Minimally invasive hysterectomy” is performed in two ways.

Comparative data: time, cost.

The ACOG Committee Opinion focuses on cost effectiveness and efficiencies of the vaginal hysterectomy. Unfortunately, most of the comparisons are to abdominal hysterectomy rather than laparoscopic hysterectomy. To date, there is still a scarcity of data comparing vaginal and laparoscopic hysterectomy. Older studies found that laparoscopic hysterectomies took longer than the vaginal hysterectomy, but as surgeons and teams have mastered these newer, more technical procedures, laparoscopic hysterectomy operating time has shortened. Technological surgical advances, including the use of the barbed suture, newer energy systems, laparoscopic entry techniques, and the focus on doing these procedures in efficient and consistent outpatient facilities have further reduced operating time.

Conclusion Women for whom a hysterectomy is recommended should be clear why the hysterectomy is recommended and be educated on alternatives. If a minimally invasive procedure is not being considered they should ask, why not? Questions about the surgeon’s experience with different types of hysterectomy are not inappropriate. If the rationale for recommendations does not seem to be clear, then a second opinion may be appropriately sought.

Jon Nielsen, MD, FACOG, is a fellow of the American College of Obstetrics and Gynecology. He practices with Oakdale Ob-Gyn, a division of Premier Ob-Gyn of Minnesota.

Those factors have also driven down the costs of laparoscopic hysterectomies, one of the issues cited by the ACOG Committee Opinion in 2009. Use of disposable instruments was also cited as a reason for increased cost with laparoscopic hysterectomy. Today, these same devices are now often used with the vaginal approach, which likewise increases cost.

Moreover, same-day discharge or surgery in ambulatory surgery centers is more common with laparoscopic than vaginal hysterectomy, subsequently decreasing cost. At Oakdale ObGyn, our practice performs more than 90 percent of laparoscopic hysterectomy as outpatient surgeries. We are comfortable with that approach and would not be as comfortable with same-day discharge following vaginal hysterectomy.

Training and safety. A strong, consistent trend has been away from vaginal hysterectomy in the last 20 years, with less than 15 percent of hysterectomies now being done vaginally. Most residency training programs are not focusing on training vaginal hysterectomy. In fact, surveys show that most residents are more comfortable with the total laparoscopic hysterectomy or laparoscopic hysterectomy.

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Of note: there were no differences in complication rates between vaginal and laparoscopic hysterectomy. However, studies have shown that laparoscopic hysterectomy demonstrated less post-operative pain and shorter hospital stays.

Deciding what’s best for patients. A concluding recommendation from the ACOG 2009 Committee Opinion was that in cases where a vaginal hysterectomy was not feasible, then the laparoscopic hysterectomy was an appropriate alternative to the abdominal hysterectomy. The problem is that there are many limitations that exist with the vaginal approach, which in turn limit the type of cases that can be done vaginally. Visualization and access to the

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October 2015 Minnesota Health care news

23

Environmental Health

Issues with

indoor mold Risks and remediation

By Kelly Smeltzer, MPH

M

old is truly everywhere in our environment. Oftentimes, fungi are a great thing—without them, we wouldn’t have natural decomposition of plants, and we wouldn’t have things such as penicillin, bread, and wine. However, when mold starts growing in our buildings, it isn’t so beneficial. Not only is indoor mold growth unsightly, smelly, and destructive, but exposure to mold can cause negative health effects. Building owners should not tolerate any indoor mold growth. It doesn’t matter if the mold is green or black, fuzzy or slimy; all indoor molds can cause health effects and should be removed as soon as possible.

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Minnesota Health care news October 2015

Mold has three simple requirements for growth: moderate temperatures, nutrients, and moisture. The first two are present in every indoor environment. “Room temperature” happens to be great for mold growth. Common building materials—everything from wood and drywall to upholstery and carpet—are excellent food sources.

Since we can’t control temperature and building materials much, the third requirement is key: moisture. Cozy, dry homes resist mold growth, so if building owners can quickly solve water and condensation issues, they can prevent mold problems.

Health concerns For most people, the health problems associated with mold exposure can be summed up with one word: allergies. According to the American Academy of Allergy, Asthma & Immunology (AAAAI), about 5 percent of the general population will suffer an allergic reaction to mold. Typical allergy symptoms include irritated eyes, runny nose, sore throat, and sneezing. Mold and dampness are a well-known trigger for attacks in asthma patients. The Institute of Medicine (IOM) stated in 2004 that there is sufficient evidence of an association between damp indoor environments and upper respiratory tract symptoms, cough, wheeze, and asthma symptoms. Treatment of allergies and asthma should begin with a primary care provider and include discussion of environmental exposures and history of symptoms. Referrals may be made to ear, nose, and throat (ENT) specialists, pulmonologists, or allergists/immunologists.

A very limited segment of the population is at risk for opportunistic mold infections. For the most part, these infections will only occur in patients with weakened or impaired immune systems.

These immunocompromised patients include those with uncontrolled diabetes or HIV/AIDS, or those undergoing treatment with chemotherapeutic drugs or organ transplant drugs. The Centers for Disease Control and Prevention (CDC) recommends that individuals with these conditions protect themselves by avoiding areas with a lot of dust or with bird and bat droppings, by wearing gloves when handling soil, and by taking other steps. Good communication with your health care provider is necessary if you are immunocompromised.

Serious respiratory fungal infections can also occur in people with fully functional immune systems, but are quite rare. According to the CDC, lung infections such as valley fever or histoplasmosis

can occur in people who visit and live in certain areas, and most are contracted from certain soils. Birds and bats can carry these fungi, as well, so people exposed to their droppings should wear the appropriate personal protective equipment to minimize the risk of infection.

Many mold species produce a chemical byproduct known as mycotoxins, some of which are actually beneficial. Penicillin, for example, is a derivative of a mold toxin, but other toxins can cause severe illness in humans. While evidence links ingestion of these toxins to severe illness, there is little research available to show toxic effects from inhalation of these compounds in the home or the workplace. It is important to remember that mold species do not always produce mycotoxins, and that the amount of toxins found in our buildings is typically well below the amount that could cause a toxic effect.

or underneath carpet, furniture, or cabinets. If you smell an earthy or musty smell, assume there is mold growing somewhere. Visible mold growth can be a variety of colors or textures, but often it will appear as discoloration or a fuzzy growth. Tools such as moisture meters, infrared cameras, and boroscopes (thin snaking cameras) can be useful in these investigations.

In most situations, environmental mold testing is unnecessary.

If you can see or smell the mold, then you know you have a mold issue. The CDC, U.S. Environmental Protection Agency (EPA), and most state health departments discourage the routine use of mold testing for several reasons. Currently there are no health-based standards available to define unsafe amounts of mold. Everyone reacts differently, and insufficient research has been done to determine these standards.

As stated earlier, the type of mold does not usually matter—all molds have the potential to cause health effects, so if you find mold it needs to be removed.

Finally, mold testing is expensive and has some inherent problems.

No single mold test is going to detect all types of mold, and levels of spores can vary greatly throughout a day. In almost all cases, the money spent on testing is better used to identify and solve the moisture problems in the building.

No indoor mold growth should be tolerated.

Addressing indoor mold Building occupants with symptoms of a mold allergy must find the mold source and solve the problem. Searching indoor mold need not be complicated—the most practical investigative tools available are your eyes and nose. Take a walk through the building and look for signs of extra moisture. If you see evidence of water damage from leaking pipes or water intrusion, look there first for mold. Interview the building owner, service providers, and occupants, if necessary, and review previous records, such as real estate disclosure statements. Evaluate rooms such as bathrooms and kitchens that might have condensation problems. It might be necessary to look behind

Remediation of mold begins with one extremely important step: solve the moisture problem. No building owner wants to clean up Issues with indoor mold to page 29

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25

Oncology

Cancers of the neck and head Detection and treatment

By Deepak Kademani, DMD, MD, FACS

T

he American Cancer Society estimates that 39,500 people will be diagnosed with oral or oropharyngeal cancer (affecting the part of the throat just behind the mouth) this year, and that 7,500 people will die of these cancers in 2015. Historically, oral cancer has been associated with males over the age of 60 who regularly consume tobacco and alcohol products. However, statistics now show that in certain populations—especially younger individuals, white males, and people infected with the human papilloma virus (HPV)—the incidence of oral cancer is increasing, and that a

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significant number of these cases are not diagnosed until they reach the advanced stages. These trends are of particular concern, since oral cancer can often be detected early during routine dental and medical exams.

Background Tumors of the head and neck are among the top ten most common malignancies for both men and women. An estimated 291,108 people living in the U.S. had oropharyngeal cancer in 2012, according to the National Cancer Institute’s Surveillance, Epidemiology, and End Results Program (SEER). In Minnesota, rates of oral cavity and pharynx cancer in 2015 were higher than rates of both cervical and ovarian cancer. Across the globe, oropharyngeal cancer is the 11th most common cancer, according to the World Health Organization (WHO).

Rates of oral cavity and pharynx cancer in 2015 were higher than rates of both cervical and ovarian cancer.

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Minnesota Health care news october 2015

Some 50 percent of all head and neck tumors originate within the oral cavity. Approximately 90 percent of cancers in the oral mucosa originate in the thin, flat (squamous) cells lining the mouth, lips, and oral cavity. Other possible head and neck cancers include salivary gland tumors, sarcomas (tumors of bone, nerve, cartilage, fat, muscle, or blood vessels), and mucosal melanomas. Cancers within the oral cavity most often occur on the tongue, the tonsils, and oropharynx (throat region), and along the gums or floor of the mouth.

Although once associated with tobacco and alcohol consumption, the patient demographic for head and neck cancer is changing.

There has been an alarming and steady increase in the incidence of oral cancers occurring in patients below the age of 40, and in particular females, without identifiable risk factors. Researchers have also focused on the role of viruses, specifically those associated

with HPVs, which are now considered an independent risk factor for the development of oral cancer. Fortunately, the prognosis for treating cancers associated with HPV is favorable, as these tumors show better responsiveness and survival rates when compared to HPV-negative tumors.

Oral cancer is often preceded by precancerous lesions or abnormal tissue changes. Patients may not be aware of these lesions and may not experience symptoms, and many lesions are only identified during dental exams or oral screenings.

It is important to find, monitor, and manage such precancerous lesions, because with time they may develop into oral cancer. Oral lesions are typically categorized according to color and include white (leukoplakia), red (erythroplakia), and red/white (erythroleukoplakia) characteristics. White lesions are associated with a malignant change in only 1 to 3 percent of cases, while red/white lesions are associated with a 50 percent incidence of malignant change. Individuals with any lesion should alert their health care provider to ensure ongoing surveillance and to assess the need for a biopsy or surgical removal.

Oral cancer can often be detected early during routine dental and medical exams.

Detection and treatment Unfortunately, despite advances in screening tools, imaging technology, and access to primary care physicians, a significant number of these cancers are not diagnosed until they reach the advanced stages.

As noted above, 90 percent of oral cavity cancers originate in the squamous cells lining the lips and oral cavity. It is widely believed that tobacco and alcohol create an irritated and thinned environment conducive to oral cancer. Studies have shown that the death rate from oral cancer is about four times higher for cigarette smokers. Additionally, younger patients who use smokeless tobacco are also being diagnosed with oral cancer in significantly growing numbers. Other possible contributing factors include poor oral hygiene, irritation caused by ill-fitting dentures and rough surfaces on teeth, poor nutrition, some chronic infections, and combinations of these factors.

Patients with a history of smoking, alcohol consumption, or smokeless tobacco or snuff usage should perform monthly self-examinations of their tongues and oral cavities. For all individuals, annual or biannual dental examinations are critical to early detection of oral cancer. If a lesion looks suspicious, a biopsy may be recommended to help establish a diagnosis and treatment plan. If the lesion is dysplasia, or precancerous, ongoing monitoring may be recommended.

Patients diagnosed with oral cavity cancer should have their treatment planned by a team of doctors specializing in head and neck cancer. Early-stage cancer is typically managed with either surgery or radiation therapy. While these two approaches have almost equal success in the control of recurrence, the side effects of radiation Cancers of the neck and head to page 28

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Symptoms that could indicate oral cancer include jaw or dental pain, changing or growing lesions, loose teeth, bleeding, difficulty in speech articulation, pain or difficulty in swallowing, ear pain, sensory and motor nerve compromise, mass lesions at the primary site, or cervical lymphadenopathy (affecting the lymph nodes in the neck).

If a cancer diagnosis is confirmed, then further imaging may be indicated. Computerized tomography (CT) scans and/or magnetic resonance imaging (MRI) provides three-dimensional views of the tumor and the surrounding anatomy. These images may show if lymph nodes are enlarged or if there are other areas of concern. A more sensitive test, the positron emission tomography (PET) scan, may identify possible areas of cancer involvement, including metastasis to the lymph nodes, the lungs, and other parts of the body. Additional tests may include blood work or a chest X-ray. Since no single, reliable test will determine if the cancer has spread, clinical examination and surveillance after surgery are very important.

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27

Cancers of the neck and head from page 27

often make this a less appealing option. Advanced-stage tumors require additional modes of treatment, often including surgery, radiation, and chemotherapy. An individualized approach, developed by a multi-disciplinary team, will ensure the best treatment options.

Ultimately, the goal of treatment is to remove the primary site of the cancer, along with a margin of noncancerous tissue one to two centimeters in all directions surrounding the tumor. This uninvolved region, which varies by location, may include bone, tissue, and teeth. As with other cancers, squamous cell carcinoma tends to spread through the lymphatic system. The head and neck contain more lymph nodes than other body parts, with some 700 located above the collarbone.

Therefore, it may be necessary to remove the lymph nodes in the neck to prevent the spread of malignant cells.

of the major advances in the treatment of patients with oral and maxillofacial cancers has been the use of vascularized bone and/or tissue transplantation.

The death rate from oral cancer is about four times higher for cigarette smokers.

After the surgical removal of oral cancer lesions, reconstructive surgery is often desirable to address both functional and cosmetic changes.

The goal of reconstruction is to reestablish normal functions such as speaking, eating, and appearance as quickly as possible. One

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Following up After any diagnosis of cancer, follow-up care and surveillance is essential to evaluate for recurrence. The overall five-year prognosis for oral cancer is determined by the site of the cancer and the presence or degree to which the malignancy has spread. A relatively small, localized cancer has a 75 to 90 percent survival rate over five years. This is far lower if there has been any spread of the cancer beyond the neck. Ultimately, the best opportunity for a cure in the oral cancer patient is at the time of initial diagnosis, making detection and management critical. The greatest improvement in survival from oral cancer will be due to increased public and provider awareness, resulting in diagnosis at an earlier stage.

Deepak Kademani, DMD, MD, FACS, is a board-certified oral and maxillofacial surgeon. He is the fellowship director of the Oral, Head and Neck Oncologic Surgery and Reconstructive Surgery Program at North Memorial Medical Center and The Humphrey Cancer Center.

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Minnesota Health care news October 2015

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Issues with indoor mold from page 25

mold and have it return because the water is still present. Once the moisture problem is repaired, it is important to remove the mold growth. Physical pieces of mold—spores and hyphae—are the elements that cause the allergic reaction. Even dead mold can cause health reactions. Removing the mold can be done in two ways: cleaning or removing the building material. The approach used depends on the type of material. For hard, non-porous materials, scrub the mold off with water and detergent. In most cases, bleach isn’t needed, since detergent will work fine without the hazards of bleach. More absorbent materials, such as carpet, drywall, and upholstered furniture, need to be bagged up and thrown away. It is nearly impossible to remove mold growth from these porous materials. After cleaning up mold, dry the area completely before beginning to rebuild.

A competent and prepared homeowner can tackle a mold cleanup project, but it is important to think about safety first. Individuals who are highly sensitive to mold might be better off leaving the job to someone else. Anyone who cleans up mold should wear personal protective equipment (PPE), including gloves, eye protection, and respiratory protection. Additional PPE might be necessary if the mold growth is extensive or covers a large area. When contamination exists in areas with many potentially sensitive individuals (e.g., hospitals, clinics, schools, and senior housing), or if it exceeds 100 square feet, it might be time to bring in professionals. Mold remediation companies can contain the work area and use special air cleaners to prevent the movement of mold spores around the building.

Conclusion Indoor mold issues can be frustrating but it is important to remember one simple thing: no indoor mold growth should be tolerated.

The color, texture, or species of mold doesn’t matter, since all mold can cause health effects for the occupants. If a person suspects a mold allergy or reaction, it is best to consult a primary care physician for advice on treating the symptoms, then remove the indoor mold growth. Find the mold with a thorough investigation for water damage and consider environmental testing as a last resort. In nearly all cases it is better to save that money and use it to repair the source of moisture in the building. The good news is that by controlling moisture and keeping our buildings dry, it is possible to keep indoor mold growth to a minimum.

Kelly Smeltzer, MPH, is an Indoor Air Quality Specialist with the Minnesota Department of Health, Indoor Air Unit. She holds a Master of Public Health (MPH) in Environmental Health from the University of Minnesota.

Additional Reading: U.S. Environmental Protection Agency: http://www.epa.gov/mold/index.html Centers for Disease Control and Prevention: http://www.cdc.gov/mold/default.htm Minnesota Department of Health: http://www.health.state.mn.us/divs/eh/indoorair/mold/index.html

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5/25/11 10:58 AM October 2015 Minnesota Health care news 29

Men’s Health

Male osteoporosis Preventing fractures as we age

By Catherine B. Niewoehner, MD

O

steoporosis is the combination of low bone quantity and poor bone quality, making fractures more likely with minimal trauma—coughing hard, leaning over to pick up a newspaper, going over a bump in the road, or falling from a standing height. Among individuals with osteoporosis, just 20 percent are male, but 30 to 40 percent of osteoporotic fractures occur in men.

Bone quantity depends on the amount of bone made during adolescence and early adulthood and the amount lost due to aging and illness. The male sex hormone testosterone stimulates bone growth in puberty and helps maintain bone density in adults. Men

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Minnesota Health care news October 2015

also need some estrogen, the main sex hormone in women, for normal bone accrual and maintenance. Spine bone density peaks around age 18–20; peak hip bone density usually develops by the mid to late 20s. As we get older, new bone formation does not keep up with bone loss, which begins between 30 and 40 years, and in men usually progresses steadily, although superimposed illness can increase the rate.

Fracture risk increases significantly after age 50. The major increase in spine and hip fractures occurs ten years later in men than in women. Men generally develop larger bones and higher peak bone density and lose less bone with age. Testosterone declines gradually, but most men do not suffer a marked loss between ages 40–55 while post-menopausal women see a loss of estrogen.

Diagnosis Osteoporosis does not cause symptoms until a fracture occurs. Early clues include more loss of height than expected with aging or low bone density on routine X-rays, although significant bone loss often isn’t apparent until one-third of bone is gone.

Dual-energy X-ray absorptiometry (DXA) measures bone mineral density, a major indicator of fracture risk, by determining the amount of calcium in a given area of bone. DXA usually measures bone density at the lower (lumbar) spine and the hip, the major sites of osteoporotic fractures. DXA can measure forearm sites, but men have far fewer wrist fractures than women because their wrist size is larger. The upper (thoracic) spine can be assessed by an extension of DXA called vertebral fracture analysis or by X-rays.

Other methods, such as quantitative CT scanning, provide excellent detail but involve too much radiation, expense, and expertise for routine clinical use. Ultrasound of the heel is inexpensive but does not predict hip and spine bone density reliably.

Risk factors Risk factors for fractures are less well-documented for men than for women. The Endocrine Society’s Guideline for Osteoporosis in Men summarizes research and expert opinion. The Osteoporotic Fractures in Men Study (MrOS), carried out at six centers including Minneapolis, enrolled 5,995 men at least 65 years old who could walk unassisted and who did not have both hips replaced between 2000 and 2002 and followed them through 2007. All had initial

DXA scans, and 4,720 had subsequent scans. They filled out questionnaires about race, marital history, education, diet, family history, health problems including joint pain and back pain, physical activity, medications, smoking, and alcohol. They filled out questionnaires about falls and fractures every four months, and were tested for strength and cognition.

Many provided blood, urine, and DNA samples to measure sex hormone levels, blood glucose, thyroid hormone, vitamin D levels, and more.

During the study, 24 percent of new non-spine fractures were rib fractures. Nearly half involved falling from a standing height or lower. Rib fractures were associated with old age, especially over age 80, low hip bone density, and previous rib fracture.

Based on the above studies and many others, major risk factors for fractures in men include: • Age (over 70) • Current smoking • Prior fracture • Parental fractures • Low testosterone • Falls within the last year • Stroke history • Diabetes mellitus • Dementia • Rheumatoid arthritis • Alcohol (more than 10 drinks per week)

or sardines with bones, collard greens, and calcium-supplemented foods such as soy milk, almond milk, orange juice, tofu, and supplemented cereals. Most supplements are absorbed better when taken in divided doses with food.

A blood vitamin D level of at least 20 to 30 ng/L. Vitamin D can be made from the action of sunlight on bare skin (no sunblock or clothing) by exposing bare arms and face or arms and legs to sunlight for 30-minute intervals from April to October. Minnesotans are too far away from the sun the rest of the year.

Elderly men have thinner skin and make less vitamin D from the same amount of exposure. Many vitamin D supplements are available. Individual needs vary, but common doses range from 400–2,400 units daily.

Weight-bearing exercise for 30 to 40 minutes three to four times weekly. This is suggested for bone strength, muscle mass, and fall prevention, but there are no studies showing this amount of exercise actually prevents fractures.

As we get older, new bone formation does not keep up with bone loss.

Risk factors related to specific systems include: • Starvation, poor calcium intake, or vitamin D deficiency • Immobilization from stroke, spinal cord injury, or prolonged bed rest • Poor gastrointestinal absorption, especially celiac disease, inflammatory bowel disease, or bariatric surgery • Rheumatoid arthritis • Chronic obstructive pulmonary disease (emphysema) • Cancer: multiple myeloma or metastases to bone • Endocrine: Cushing syndrome (high cortisol), diabetes, hyperthyroidism, and low testosterone Men with low testosterone from a very young age who never develop a normal peak bone mass are particularly vulnerable—for example, men with delayed puberty, Klinefelter syndrome, or Kallmann syndrome. Men with prostate cancer being treated with drugs such as bicalutamide or lupron and others to suppress testosterone as completely as possible are at especially high risk.

Drugs associated with osteoporosis include: • Glucocorticoids (prednisone and others) • Anti-seizure medications • Treatment for HIV/AIDS • Drugs suppressing testosterone production or action Prevention Recommendations include: Daily intake of 1,000 to 1,200 milligrams of calcium from diet or supplements. Diet sources include dairy products, canned salmon

Limiting alcohol to two drinks per day or less and not smoking. Excess alcohol inhibits formation of new bone.

DXA scans of spine and hip. These are recommended for all men over 70, and for men at ages 50 to 69 years if other risk factors Male osteoporosis to page 32

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Male osteoporosis from page 31

• Bisphosphonates, taken orally or intravenously, inhibit osteoclasts, the cells that break down bone. Oral forms can cause gastrointestinal distress. They accumulate in bone and can cause problems with healing of injury to the jaw. This is rare with osteoporosis doses.

are present. Bone density at the forearm can be helpful if other sites are impossible due to osteoarthritis, surgery, or weight over 300 pounds. Medicare pays for the initial DXA only in men who already have vertebral fractures, have low bone density on X-ray, are treated with a glucocorticoid such as prednisone, or men with hyperparathyroidism. Medicare will pay for follow-up DXA scans, usually at intervals of at least 24 months.

Treatment Additional treatment is recommended for those who have had osteoporotic fractures, and for men with bone density more than 2.5 standard deviations below the mean bone density scans for 30-year-old males.

• Denosumab, given subcutaneously, also decreases the formation of osteoclasts. It also is usually well-tolerated, but has the same potential for rare non-healing of jaw injury as bisphosphonates.

•

Teriparatide is a form of parathyroid hormone given by daily subcutaneous injection. It prolongs the life of osteoblasts, the bone-forming cells. It is the only treatment that builds new bone, although nothing restores significant lost bone completely.

Men also need some estrogen.

Other risk factors should be considered, and tools have been developed that assess combinations of risk factors. The World Health Organization’s FRAX diagnostic tool assesses risk in 40- to 90-year-old patients who have not yet been treated. Based on age, sex, race/ethnicity, height, weight, previous fracture, family history, smoking, alcohol, and bone density, it calculates fracture risk for the next 10 years.

What about testosterone replacement? Testosterone increases bone density, but we have no data showing that testosterone actually decreases the number of fractures. Benefit for bone density in older men has not been shown unless the testosterone level measured in early morning is less than 200 ng/dL. Several promising new approaches are undergoing clinical trials.

Several drugs or classes of drugs are FDA-approved for prevention and treatment of osteoporosis in men. These reduce fracture risk at both hip and spine.

Catherine Niewoehner, MD, is a staff physician in the Endocrinology/ Metabolism Section at the VA Medical Center, Minneapolis, and a professor of Medicine at the University of Minnesota.

September 2015 Survey

M I N N E S OTA H E A LT H C A R E

CO N S U M E R A S S O C I AT I O N

Each month, members of the Minnesota Health Care Consumer Association are invited to participate in a survey that measures opinions around topics that affect our health-care delivery system. There is no charge to join the association, and everyone is invited.

1. I, or a member of my family, has become ill from household mold.

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2. I am aware of the physical symptoms of household mold-related illness.

80

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Strongly agree

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No opinion

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4. I am aware of how to detect household mold.

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5. I am aware of how to remediate household mold problems.

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Strongly disagree

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Minnesota Health care news October 2015

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For more information, please visit www.mnhcca.org.

We are pleased to present results of the most recent survey.

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Be heard in debates and discussions that shape the future of health care policy. There is no cost to join this informed and informative online community.

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

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A lifelong guide to exercise from page 13

When starting a new program or returning to a previous one, most people overestimate their fitness level and partake in a program that’s too difficult. Overtraining can quickly set in.

How do you know you’re doing too much, too fast? Here are some signs of overtraining: difficulty elevating your heart rate, feeling of simultaneous tightness and stiffness, discomfort in your tendons, Delayed Onset Muscle Soreness (DOMS) even after low-intensity or low-volume training, changes in appetite, decreases in body weight, mental fuzziness, loss of focus during exercise, loss of motivation to exercise, sleep disturbances, mood-related issues or general irritability, persistent feelings of fatigue, and loss of libido. Ignoring these signs often leads to injury and a visit to the physician, physical therapist, or chiropractor.

and decreases unhealthy triglycerides. This helps keep the blood moving freely and prevents cardiovascular diseases.

• Exercise improves mood. Physical activity stimulates brain chemicals that leave you feeling more happy and relaxed. xercise boosts energy. Exercise and phys• E ical activity deliver oxygen and nutrients to the tissues and help the cardiovascular system function more efficiently.

• Exercise promotes better sleep.

Most people overestimate their fitness level.

Benefits The benefits of exercise and staying in shape are numerous. The Mayo Clinic cites seven ways exercise can improve your life: • Exercise controls weight. Routine exercise can help facilitate weight loss and/or prevent weight gain.

• Exercise combats health conditions and diseases. Exercising boosts high-density lipoproteins (HDL’s) or good cholesterol

xercise puts the spark back into your sex • E life. xercise can be fun. Physical activity can • E get you outdoors, connect you with friends, and allow you to spend more quality time with your family.

The key is to find a physical activity you enjoy. Whether it’s working out at a gym, hiking a Minnesota trail, or playing in community sports, as Nike says, “Just Do It.” If you get bored, try something new. There’s plenty to do year-round in Minnesota, indoors and outdoors…no excuses!

Mike Dixey, PT, DPT, Cert. MDT, PES, CSCS, is a clinical specialist physical therapist at the Institute for Athletic Medicine in Savage. He is also a credentialed McKenzie spine therapist and a certified strength & conditioning specialist with the National Strength and Conditioning Association.

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Minnesota Health care news october 2015

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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 ® Victoza 1.8 + Metformin Placebo + Metformin + Glargine + Metformin + + Glimepiride N = 230 Glimepiride N = 114 Glimepiride N = 232 (%) (%) (%) Adverse Reaction Nausea 13.9 3.5 1.3 Diarrhea 10.0 5.3 1.3 Headache 9.6 7.9 5.6 Dyspepsia 6.5 0.9 1.7 Vomiting 6.5 3.5 0.4 Add-on to Metformin + Rosiglitazone ® 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 pharmaceuticals, patients treated with Victoza® may develop anti-liraglutide antibodies. Approximately 50-70% of Victoza®-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment. Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 8.6% of these Victoza®-treated patients.

Sampling was not performed uniformly across all patients in the clinical trials, and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies. Cross-reacting antiliraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 6.9% of the Victoza®-treated patients in the double-blind 52-week monotherapy trial and in 4.8% of the Victoza®-treated patients in the double-blind 26-week add-on combination therapy trials. These cross-reacting antibodies were not tested

®

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

b

A 52-week, double-blind, double-dummy, active-controlled, parallel-group, multicenter study. Patients with type 2 diabetes (N=745) were randomized to receive once-daily Victoza® 1.2 mg (n=251), Victoza® 1.8 mg (n=246), or glimepiride 8 mg (n=248). The primary outcome was change in A1C after 52 weeks.

The change begins at VictozaPro.com.

Indications and Usage

Victoza (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans, prescribe Victoza® only to patients for whom the potential benefits are considered to outweigh the potential risk. Victoza® is not recommended as firstline therapy for patients who have inadequate glycemic control on diet and exercise.

Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victoza®. Victoza® has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victoza®. Other antidiabetic therapies should be considered in patients with a history of pancreatitis.

Victoza® is not a substitute for insulin. Victoza® should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.

Victoza® has not been studied in combination with prandial insulin. ®

Important Safety Information

Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies.

Victoza® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Based on the findings in rodents, monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials, but this may have increased the number of unnecessary thyroid surgeries. It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors. Patients should be counseled regarding the risk and symptoms of thyroid tumors.

Do not use in patients with a prior serious hypersensitivity reaction to Victoza® or to any of the product components.

Postmarketing reports, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. Discontinue promptly if pancreatitis is suspected. Do not restart if Victoza® is a registered trademark of Novo Nordisk A/S. © 2013 Novo Nordisk All rights reserved.

pancreatitis is confirmed. Consider other antidiabetic therapies in patients with a history of pancreatitis.

When Victoza® is used with an insulin secretagogue (e.g. a sulfonylurea) or insulin serious hypoglycemia can occur. Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemia.

Renal impairment has been reported postmarketing, usually in association with nausea, vomiting, diarrhea, or dehydration which may sometimes require hemodialysis. Use caution when initiating or escalating doses of Victoza® in patients with renal impairment.

Serious hypersensitivity reactions (e.g. anaphylaxis and angioedema) have been reported during postmarketing use of Victoza®. If symptoms of hypersensitivity reactions occur, patients must stop taking Victoza® and seek medical advice promptly.

There have been no studies establishing conclusive evidence of macrovascular risk reduction with Victoza® or any other antidiabetic drug.

The most common adverse reactions, reported in ≥5% of patients treated with Victoza® and more commonly than in patients treated with placebo, are headache, nausea, diarrhea, dyspepsia, constipation and anti-liraglutide antibody formation.

Immunogenicity-related events, including urticaria, were more common among Victoza®-treated patients (0.8%) than among comparator-treated patients (0.4%) in clinical trials.

Victoza® has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patients.

There is limited data in patients with renal or hepatic impairment.

In a 52-week monotherapy study (n=745) with a 52-week extension, the adverse reactions reported in ≥ 5% of patients treated with Victoza® 1.8 mg, Victoza® 1.2 mg, or glimepiride were constipation (11.8%, 8.4%, and 4.8%), diarrhea (19.5%, 17.5%, and 9.3%), flatulence (5.3%, 1.6%, and 2.0%), nausea (30.5%, 28.7%, and 8.5%), vomiting (10.2%, 13.1%, and 4.0%), fatigue (5.3%, 3.2%, and 3.6%), bronchitis (3.7%, 6.0%, and 4.4%), influenza (11.0%, 9.2%, and 8.5%), nasopharyngitis (6.5%, 9.2%, and 7.3%), sinusitis (7.3%, 8.4%, and 7.3%), upper respiratory tract infection (13.4%, 14.3%, and 8.9%), urinary tract infection (6.1%, 10.4%, and 5.2%), arthralgia (2.4%, 4.4%, and 6.0%), back pain (7.3%, 7.2%, and 6.9%), pain in extremity (6.1%, 3.6%, and 3.2%), dizziness (7.7%, 5.2%, and 5.2%), headache (7.3%, 11.2%, and 9.3%), depression (5.7%, 3.2%, and 2.0%), cough (5.7%, 2.0%, and 4.4%), and hypertension (4.5%, 5.6%, and 6.9%).

Please see brief summary of Prescribing Information on adjacent page.

1013-00018617-1

December 2013