May 2016 â€˘ Volume 14 Number 5
Medicare and financial counseling Deb Taylor
Pediatric sports injuries Michael J. Priola, DO
Cystic fibrosis Terri Laguna, MD, MSCS
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MAY 2016 • VOLUME 14
MINNESOTA HEALTH CARE ROUNDTABLE
HEALTH CARE BENEFITS
Medicare and financial counseling Reduce costs, maximize coverage
Value - Based Purchasing:
By Deb Taylor
Medical education A focus on social accountability Pedro Joe Greer, MD, FACP, FACG
Cystic fibrosis New hope for a devastating disease
Chief, Dept. of Emergency Medicine, HCMC
The reality of “chemo brain” A treatment phenomenon James R. Miner, By Michaela Tsai, MD MD, FACEP
Emergency department care
S PORTS MEDICINE
Pediatric sports injuries Risks from a focus on stardom
By Michael J. Priola, DO Alzheimer’s disease Not a normal part of aging
By George Schoephoerster, MD
A new way to pay for health care
By Terri Laguna, MD, MSCS
Florida International University Herbert Wertheim College of Medicine
2 016 COMMUNITY CAREGIVERS
Making a difference in Minnesota and the world Recognizing Minnesota’s Volunteer Physicians and Health Care Providers By Lisa McGowan
Thursday, November 3, 2016 • 1:00-4:00 PM
Symphony Towers Symphony Ballroom, Downtown Minneapolis Hilton and Towers
Background care Background and Focus: As initiatives driven by federal health care reform reform move forward, the term “Value-Based Purchasing” (VBP) is is being applied to a wide spectrum of issues. But what does this mean? mean? CMS is developing measurements, well over 150 to date, to to define what “value” means in health care. It is proposed that these these metrics will be used to create incentives that pay more for better better care in every element of health care delivery. Hospitals, physician physician practices, home care, and long-term care will all be reimbursed reimbursed by an emerging new math. Objectives: Objectives: We will explore the motivations behind this changing approach approach to purchasing health care. We will examine what is being the being measured and what value really means. We will discuss the arguments arguments that claim VBP is a bad idea and those that believe it is transparis the best solution. We will discuss how a collaborative, transparent ent system, that integrates care teams, health information technology nology and improved reimbursement methods will help achieve increased increased access to high-quality, cost-effective care for patients. Please tickets at $95.00 per ticket. Tickets may be ordered ordered by by Please send me phone (mppub. phone at (612) 728-8600, by fax at (612) 728-8601, on our website (mppub. com), Publishing. com), or by mail. Make checks payable to Minnesota Physician Publishing. Mail note: Mail orders to MPP, 2812 East 26th Street, Mpls, MN 55406. Please note: tickets tickets are non-refundable.
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MAY 2016 MINNESOTA HEALTH CARE NEWS
Most Patients Don’t Disclose Alternative Medicine Use More than 40 percent of U.S. adults who use complementary and alternative medicine (CAM) don’t disclose that information to their primary care providers, according to a study from the University of Minnesota School of Public Health and Center for Spirituality and Healing. “Not telling primary care providers about using CAM can be dangerous, especially if the type of CAM being used creates adverse interactions with any medical treatments that a patient might be undergoing concurrently,” said Judy Jou, MA, a PhD candidate in the Division of Health Policy and Management in the School of Public Health and lead author of the study. Some herbs and supplements can interact with prescription drugs, which can lead to complications. The study showed that 25 percent of people using them did not disclose that information to their primary care provider.
“Encouraging discussion of CAM use can help prevent medical complications that may arise from simultaneous use of conventional and CAM treatments,” said Jou. Researchers analyzed patient data from the 2012 National Health Interview Survey. They focused on about 7,500 people who indicated using CAM in the past year and analyzed their reasoning for disclosing or not disclosing that information to their providers. Previously, studies had shown that patients were hesitant to tell providers about their CAM therapies due to fear of discouragement or disapproval. The results of this most recent study show that may not be the case. The study showed that less than 5 percent of the patients studied didn’t tell their provider about CAM use due to past or potential physician discouragement. “Our findings suggest that non-disclosure is most often due to lack of provider-initiated conversation about CAM, rather than patients’ concerns about providers discouraging the use of CAM,” said Jou.
Next, the researchers say they hope to explore how communication about CAM could affect health and whether health outcomes differ significantly when patients do or do not disclose CAM with their primary care providers.
HealthEast Opens Dedicated Center for Wellness Program HealthEast has opened a new facility to house and expand its Ways to Wellness program on the Woodwinds Health Campus in Woodbury. The program started within the health system about 10 years ago on a small scale, led in part by Brenda Navin, now the director of health and wellness at HealthEast. The goal is to help people live a healthier lifestyle overall, from nutrition and fitness to mental health and managing stress. The new wellness facility is about 11,245 square feet. It includes space for a pilates studio, gym and physical therapy center, and a full kitchen for nutrition classes. Patients can choose
from personal training, nutrition coaching, chef consultations, personal training, health psychology care, and health and wellness coaching in one-on-one settings or group sessions. Services such as metabolic calorie testing or body composition are also available. The Ways to Wellness program has gained 812 new members in the last year.
Mastectomies that Preserve The Nipple are Safe, Study Shows A study from Mayo Clinic has found that for women with a genetic mutation that raises the risk of developing breast cancer, protective mastectomies that preserve the nipple and surrounding skin prevent breast cancer just as effectively as traditional mastectomies. Women with the mutation, called BRCA, can have a breast cancer risk of 50 to 60 percent by age 70, and up to 80 percent over their lifetime. “Nipple-sparing mastectomy is gaining wide acceptance because of its superior cosmetic results, but
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pockets of the medical community remain skeptical that it is the right choice for the BRCA population,” said James Jakub, MD, breast surgeon at Mayo Clinic and lead author of the study. “This is the largest study of its kind to address the controversy, and to show that nipple-sparing mastectomy is as effective at preventing breast cancer as traditional mastectomy.”
Statewide Coalition Forms to Reduce Youth Tobacco Use
Researchers studied outcomes among 348 women who had a total of 551 mastectomies performed between 1968 and 2013. Of those, 203 women had bilateral mastectomies, where both breasts are removed completely, and 145 had one breast removed preventively after developing cancer in the other breast. They found that none of the women who had a bilateral mastectomy developed breast cancer after an average of three to five years when they followed up. No breast cancer developed in the retained skin, nipples, or lymph nodes on the side of the prophylactic procedure.
The coalition, called Minnesotans for a Smoke-Free Generation, supports policies that reduce youth smoking and will help end the health issues and deaths caused by tobacco use. Its four strategic priorities are: increasing the tobacco purchase age to 21; restricting the sale of flavored tobacco products; increasing tobacco prevention funding; and keeping tobacco prices high. According to the coalition, tobacco use is responsible for more than 5,100 deaths and almost $3 billion in preventable health care costs each year in Minnesota.
“The BRCA population has a genetic mutation in all the cells of their body that predisposes them to breast cancer,” said Jakub. “We know that a majority of breast cancers originate in the breast ducts, so it might seem counterintuitive to leave behind the nipple and the ducts associated with the nipple when you are trying to reduce the risk of this disease.” About 8 percent of mastectomies performed at Mayo Clinic in 2009 were nipple-sparing. That rate jumped to about 30 percent in 2014 and continues to increase. However, Jakub says there is still controversy about the procedure. “There is no question that this option of nipple-sparing mastectomy can often provide an outstanding cosmetic result and may make it easier for women who are at risk to take this preventive measure,” said Jakub. “Though the nipple is preserved, it unfortunately will not have stimulation or arousal. Despite that, studies looking at the impact of risk-reducing surgery on quality of life, sexual satisfaction, and intimacy, suggest that being able to preserve aesthetics and body image can improve all of these factors.”
ClearWay Minnesota has joined 30 other organizations in forming a statewide coalition to support policies that reduce youth smoking and will help end the health issues associated with tobacco.
Fairview Announces Plan to Acquire UCare Fairview Health Services and UCare have signed a letter of intent to combine their provider and payer operations. UCare will become a wholly owned subsidiary of Fairview under the agreement, and Jim Eppel will remain in his position as president and CEO of the health insurance company. It will combine with PreferredOne, which came under Fairview’s sole ownership in January, to form Fairview’s health insurance division. The two insurers are the fourth and fifth largest in Minnesota. The organizations are finalizing details of the transaction, including the new operational model and relationship between Fairview, UCare, and PreferredOne, and hope to secure regulatory approval by mid-summer. However, they have agreed that Fairview will continue to collaborate with other health plan administrators and UCare will continue to do the same with other health care providers and systems. Workforce reductions are not anticipated as a result of the change. News to page 6
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News from page 5
Apple Valley Medical Clinic Adds Direct Primary Care Model Apple Valley Medical Clinic has announced it is now offering PrimaCare Direct, a health membership that allows patients to pay a monthly fee of $75 for unlimited primary care access. “Many individuals are searching for a way to lower their health care costs without sacrificing access or quality,” said Victoria Champeau, chief executive officer of Minnesota Healthcare Network. “This innovative health care model is not based on insurance. There are no copays or deductibles. The result is greater access to health care for patients, especially in areas related to primary and preventive care.” Care covered by PrimaCare Direct includes physician services, throat cultures, casts and splints, blood pressure checks, cholesterol screenings, well child check-ups, nutritional counseling, Pap smears, lab, and X-ray services.
“With PrimaCare Direct’s unlimited access to primary care, individuals with chronic conditions, such as diabetes or asthma, are more likely to see a physician before their situation becomes acute,” said Champeau.
Minnesota’s 2015 STD Rates Highest Ever Recorded The number of sexually transmitted disease (STD) cases reached an alltime high of 25,986 in 2015, according to a report from the Minnesota Department of Health (MDH). The STDs that health care providers are required to report include chlamydia, gonorrhea, and syphilis. The 2015 rate reflects an increase of 6 percent from 2014 and 33 percent from 2010. “This disturbingly high rate of growth in the number of STD cases shows the need for improved education about STDs among both the general public and health care providers,” said Ed Ehlinger, MD, Minnesota commissioner of health. “These rates also provide further
evidence that eroding basic local public health services not only hurts our ability to respond to intractable problems like STDs, but also to emerging infectious diseases like Zika virus.” The most commonly reported STD was chlamydia, reaching a high of 21,238 cases in 2015—a 7 percent increase from 2014 when 19,897 cases were reported. Most of the cases were in teens and young adults ages 15 to 24. At least three cases were reported in every Minnesota county. The second most commonly reported was gonorrhea, with 4,097 cases—a 1 percent increase from 2014 when 4,073 cases were reported. Nearly half of the cases occurred in those ages 15 to 24 and more than three-quarters occurred in the Twin Cities metro area. Cases of syphilis rose by 4 percent, from 629 cases in 2014 to 654 in 2015. However, within the new cases there was a 70 percent increase in cases among women from 2014 to 2015, primarily among those of childbearing age in all racial and ethnic groups, including pregnant women. Most new infections were
in the Twin Cities metro area and among men who have sex with men. The report showed additional disparities—there were higher rates of chlamydia and gonorrhea among communities of color and American Indians than among whites and rates of syphilis were higher among American Indian and African American women and men who have sex with men. “Addressing disparities is a health department priority, particularly among those racial and ethnic groups with limited access to STD testing and prevention programs due to longstanding social, medical, or income disadvantages,” said Ehlinger. “Expanding our partnerships within these communities will help ensure that these services are available and culturally acceptable.” MDH is taking several action steps and partnering with community agencies to address the alarming trend and is recommending that health care providers assess risks for all patients and provide any STD testing that may be necessary.
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MINNESOTA HEALTH CARE NEWS MAY 2016
PEOPLE Anne Stern, BS Pharm, RPh, and Tom Reutzel, PharmD, pharmacists at Abbott Northwestern Hospital, have received the Minnesota Hospital Association’s Good Catch for Patient Safety Award in recognition of their commitment to keeping patients safe by speaking up to prevent potential harm. Stern and Reutzel took action when an atypical pharmacy Anne Stern, BS order was received for a drug called alteplase, a drug Pharm, RPh that helps break down blood clots. Reutzel noticed that while the dose was typical for a stroke patient, the form in which the product was ordered was not. He called the pharmacist working in the patient care area to clarify it was the correct order. Stern answered Reutzel’s call and said she had been looking into the same issue. Stern clarified with the provider that the intended order was a dose to clear a clot in the patient’s IV catheter and not to treat a stroke. The pharmacists were applauded for their willingness to question an abnormal order and their knowledge of medication therapy that prevented the patient from receiving a 40-fold dose of the medication. Mary Thompson, a registered public health nurse at Houston County Public Health, has been named a Centers for Disease Control and Prevention (CDC) Childhood Immunization Champion for her work promoting childhood immunization in Minnesota. Thompson has worked as a nurse for over 40 years. Seeing the effects of preventable Mary Thompson diseases drove her dedication to improving immunization rates. She has worked to make immunizations a priority and has used innovative strategies to reach parents, such as setting up a station at the county fair where parents can look up their child’s, or their own, immunization records. In addition, her work at Houston County Public Health has included a focus on strengthening relationships with local partners to improve immunization rates in the county and region. She has worked with local clinics to review immunization practices and with schools to institute school-based immunization clinics. Thompson also served as an advisor on a Wisconsin-based regional immunization coalition. Molly Magnani, DC, lead chiropractor at Allina Health, and Vivi-Ann Fischer, DC, chief clinical officer at Chiropractic Care of Minnesota, Inc. (CCMI), were recognized at the 2016 Women’s Health Leadership TRUST Forum for their innovative contributions to health care. Fischer, a finalist for the TRUST’s Emerging Company Leader in Molly Magnani, Health Care Award, was recognized for her contriDC butions in the development and launch of CCMI’s distinguished ChiroCare Centers of Excellence program, which consists of chiropractic clinics in the ChiroCare network that demonstrate the use of standardized clinical protocols and an integrated, collaborative approach to achieving positive outcomes, lower cost of care, and high-quality experiences for patients. Magnani, a finalist for the Health Vivi-Ann Fischer, DC Care Innovative Leader Award, was recognized for her work in collaboratively developing the University of St. Thomas’ Chiropractic Leadership Institute, an executive education program that empowers chiropractors to effect transformation in today’s health care environment.
MAY 2016 MINNESOTA HEALTH CARE NEWS
Medical education A focus on social accountability
Pedro Joe Greer, MD, FACP, FACG Florida International University Herbert Wertheim College of Medicine Dr. Greer, a gastroenterologist and hepatologist and a recipient of the Presidential Medal of Freedom and MacArthur Fellowship’s Genius Award, is associate dean of community engagement and founding chair of the Department of Medicine, Family Medicine, and Community Health at the Florida International University Herbert Wertheim College of Medicine.
oday, it is widely accepted that 80 percent of disease is caused not by biological factors, but by economic and social conditions. According to the World Health Organization, these Social Determinants of Health (SDOH) range from lifestyle, food, education, and employment, to transportation, gun and police violence, and racism. Communities are also a critical factor; in America, ZIP codes are a better predictor of health outcomes than genetic codes.
student rotations, this approach reinforces competencies in population health, SDOH, and effective teamwork—all of which are key to the future health care workforce.
These realizations have deep implications for leaders in medical education and health care delivery. Medical students who are exposed to the relationship between health, culture, and economics — as my students are — are better equipped to address the impact of the SDOH and to provide quality care for all segments of society.
Building social accountability
A new approach
Our curriculum centers on a novel service-learning program—the Green Family Foundation Neighborhood Health Education Learning Program (NeighborhoodHELP)—that immerses medical students in the community for most of their medical education. Community partners identify households for referral to the program, and outreach teams assess individual needs. Medical students are then assigned to teams, generally comprised of medical, nursing, and social work students, all under the supervision of HWCOM faculty, with law and education students also available. Working directly with households, these teams not only address medical issues, but provide primary, social, and behavioral health services intended to help individuals navigate and manage health and social services. Unlike conventional 6–12 week medical MINNESOTA HEALTH CARE NEWS MAY 2016
I describe this major shift in medical education and health care delivery as a movement toward “social accountability,” which is distinct from social responsibility or social responsiveness. Medical schools that are committed to the welfare of society and that direct their programs to explicitly identified health priorities are considered socially responsible and socially responsive, respectively. Schools that demonstrate social accountability take it a step further, working with all parties to positively impact people’s health and to provide evidence that their work is “relevant, of high quality, equitable, and cost-effective,” according to a 2012 article entitled The Social Accountability of Medical Schools and its Indicators.
In America, ZIP codes are a better predictor of health outcomes than genetic codes.
When I went to medical school, I was never trained in the construction and maintenance of health. I was trained, as were most physicians, to identify and treat diseases. Today, I tell my students at the Florida International University Herbert Wertheim College of Medicine (HWCOM) that throughout almost 25 years of practicing as a gastroenterologist and hepatologist, I’ve never seen a liver walk into my office. They smirk, but they get the point. We need to prepare health care providers to address the entire spectrum of needs, and this will require major shifts in medical school education.
One such shift is already underway here at HWCOM. As a relatively new medical school (formed in 2006), we had the opportunity to design a new curriculum from the ground up that fully integrates the SDOH, ethics, and population health into established medical training.
The program has already benefited households in our region, and a heightened awareness of the SDOH has sparked national interest in both medical education and individual care.
The shift from responsibility to accountability requires an outcome-based approach that includes assessments performed by an external evaluation team of peers and a focus on the impact of the school’s products (i.e., graduates, clinical and research programs, and service models) on meeting people’s health needs, with health partners being part of the assessors.
Making a difference
The only way to improve America’s health is to have professionals from different sectors working together. Five main players must take part in socially accountable medical education: policy makers, health professionals, health administrators, communities, and academic institutions. We all have a role to play in making medical education more socially accountable and in improving America’s health. Whether it’s the underlying determinants of the Ferguson riots or the gaps in life expectancy between neighboring ZIP codes, the medical industry needs to take responsibility for addressing the SDOH that burden the health of Americans. Health care providers should take responsibility for making our nation better and healthier, by improving the quality of lives of all.
rehabilitate T oowith rehabilitate aa body, body, we we start start with the the mind mind and and soul. soul.
If you or someone you know needs rehabilitation after an accident, surgery, illness or stroke, we have a If you or someone you know needs rehabilitation after an accident, surgery, illness or stroke, we have a simple premise for you to consider: To recover physically, you need support mentally and emotionally. How simple premise for you to consider: To recover physically, you need support mentally and emotionally. How positive and how determined someone is can make all the difference. We believe the most effective therapy positive and how determined someone is can make all the difference. We believe the most effective therapy treats your body, mind and soul. That’s our approach. treats your body, mind and soul. That’s our approach. Post-acute rehabilitation services from the Good Samaritan Society are offered at multiple inpatient and Post-acute rehabilitation services from the Good Samaritan Society are offered at multiple inpatient and outpatient locations throughout Minnesota and the Minneapolis/St. Paul area. outpatient locations throughout Minnesota and the Minneapolis/St. Paul area. To make a referral or for more information, call us at To make a referral or for more information, call us at (888) GSS-CARE or visit www.good-sam.com/minnesota. (888) GSS-CARE or visit www.good-sam.com/minnesota.
The Evangelical Lutheran Good Samaritan Society provides housing and services to qualified individuals without regard to race, color, religion, gender, disability, familial status, national origin or other protected statuses according to applicable federal, stateGood or local laws. Some services may housing be provided a thirdtoparty. All faiths or beliefs are welcome. 2015color, The Evangelical Lutheran Goodfamilial Samaritan Society. All rights 15-G1553statuses according The Evangelical Lutheran Samaritan Society provides and by services qualified individuals without regard to©race, religion, gender, disability, status, national origin reserved. or other protected to applicable federal, state or local laws. Some services may be provided by a third party. All faiths or beliefs are welcome. © 2015 The Evangelical Lutheran Good Samaritan Society. All rights reserved. 15-G1553
MAY 2016 MINNESOTA HEALTH CARE NEWS
Emergency department care James R. Miner, MD, FACEP Dr. Miner is chief of the Department of Emergency Medicine at Hennepin County Medical Center (HCMC) and professor of Emergency Medicine at the University of Minnesota. What are the most common reasons people go to the emergency department (ED)? Generally, it’s because something about their health has changed suddenly and they don’t know why. The three most common causes are chest pain, back pain, and headache. These are followed closely by trauma, which can range from minor falls and abrasions to major car accidents. What factors affect volume? The two big determinants are time of year and weather. In Minnesota, we see a huge increase in the summer, starting the first weekend in April that’s over 70 degrees, peaking the weekend closest to July 4th, and then starting to slow down after the first fall frost. The other busy time is the six weeks of flu season, which is usually around January. Busy holidays include St. Patrick’s Day, Memorial Day weekend, July 4th, Labor Day weekend, Halloween, and New Year’s Eve. Other holidays, like Christmas and Thanksgiving, tend to be pretty slow. As it gets hotter, we also get busier, and the bigger the change, the larger the increase. This is true whether the temperature is going from 0 to 30 degrees, or from 60 to 90 degrees. Volumes decrease when it gets colder, unless we have icy roads at rush hour. How does emergency training differ from other medical specialties? Emergency physicians complete a three- or four-year residency after medical school, focusing specifically on emergency patient care. This includes resuscitation of cardiac arrest, stabilization of critically ill and injured patients, and evaluation of acute and unstable conditions. The training is very rigorous and challenging, but ensures the broad skill set necessary to address any imaginable emergency. Specific skills include endotracheal intubation, wound repair, fracture management, and vascular access. Far more difficult, however, is developing the decision-making
MINNESOTA HEALTH CARE NEWS MAY 2016
skills necessary to make the best decisions possible despite the limited information and time available during emergencies. Resident physicians develop these skills alongside experienced emergency physicians, and their responsibilities gradually increase as they develop technical and decision-making skills. What other kinds of professionals are involved? The ED requires many skilled professionals. Firstline paramedics are specifically trained in the rescue and initial stabilization necessary to transport patients with emergencies, and work closely with the emergency medical services director to develop protocols for pre-hospital care. The largest single group of professionals are the emergency nurses, who are generally very experienced in critical care skills. Emergency physicians are trained to take care of any medical condition the moment the patient arrives, but complex medical conditions require specialized medical care. As emergency physicians stabilize and diagnose the patient, they also determine whether the patient will require specialized care, and assess how to get them to that care at the right time. Trauma surgeons are usually in the hospital or close by. Sometimes they are called to the bedside even before the patient arrives, if we know that the patient is injured badly. Interventional cardiologists and cardiac catheterization lab teams—usually in the hospital or close by— can be called when paramedics see the first EKG and recognize a heart attack. Neurologists are also in the hospital or close by to treat stroke patients, who, like heart attack patients, are treated more often in the ED than they were a decade ago. Other surgical specialists, such as orthopedic surgeons; ear, nose, and throat surgeons; oral surgeons; urologists; Ob/Gyn physicians; cardiothoracic surgeons; and neurosurgeons are frequently called to provide expert care. Emergency physicians interact most with the radiologist, who interprets images performed during the diagnostic evaluation of emergency patients and works with them to determine a patient’s diagnosis. The radiologist is a critical part of emergency care. Patients rarely get to meet them (unless they need treatment from an interventional radiologist) but as many as 50 percent of patients require a test that they interpret.
What kinds of emergency preparedness measures are in place between you and other area emergency departments? HCMC has robust emergency response plans for mass casualty, hazardous materials, and infectious diseases, and conducts frequent training and exercises. As a Level 1 trauma center and accredited burn center, we are a key receiving facility for disaster victims. HCMC also is the host of the Regional Hospital Resource Center, which helps coordinate activities of all metro-area hospitals during a disaster, and our West Metro Medical Resource Control Center coordinates emergency medical services (EMS) communications during disasters. HCMC coordinates disaster planning and response activities closely with Minneapolis and Hennepin County Emergency Management, Public Health, and EMS.
you’re not sure whether or not it’s an emergency, then you should be seen in the ED. With so many popular TV shows based on emergency medicine, what are some of the most common misperceptions? The biggest difference between television EDs and real EDs is the expressed level of anxiety and stress. Experienced emergency physicians, nurses, and paramedics learn how to stay calm in a crisis; panic and anxiety get in the way of good decision making and skilled work. I’ve been in multiple medical crises larger and more complex than anything I’ve seen on TV, but the staff in my ED look calm and focused as they work, with the only clue to the seriousness of the crisis being the lack of background conversation and careful attention to repeating back what we say to one another to avoid mistakes.
If your health changes suddenly and you don’t know why, you should be seen in an ED.
What are some of the most exciting new technologies being used in emergency medicine? Emergency ultrasound is just one of many. Radiologists have long used ultrasound to perform diagnostic imaging, but recent advances now allow rapid bedside ultrasounds, which greatly reduce the time to diagnose a variety of medical conditions, especially in trauma patients. HCMC has been a leader in this since the 1980s, and the pace of advancement has not slowed. Other new technologies include peripheral and brain tissue perfusion monitors, which allow us to see how much oxygen is delivered to the brain and body and to treat critically ill patients more precisely and rapidly than we could in the past.
What do you find most satisfying about your work? I love practicing emergency medicine. I can honestly say, after 20 years at HCMC, that I still look forward to every shift in the ED. I never know what is in store on any given day, and I’ve never had a day I wasn’t challenged. By far my favorite part, however, is all the great patients I get to meet. Each time I work I get to be a part of the life of 30–40 people I’ve never met before, and the gift of having shared experiences with so many people is the greatest reward of my career.
Looking to the future, big advances are coming in our ability to start the sickest patients on extracorporeal membrane oxygenation (ECMO), which provides oxygen and blood pressure to patients when the heart and/or lungs can’t do it. This technology has been used frequently in intensive care units (ICUs), but technological advancements now allow us to start patients on this treatment earlier than we could in the past. It has already improved our ability to care for patients with a really low blood pressure from hypothermia, and holds great promise for patients with cardiac arrest, who have conditions that could be reversed if we keep them alive long enough. What will HCMC’s expanded heliport services mean for patient care? HCMC serves as a referral hospital for a wide area, with patients coming from all over the upper Midwest. Besides being updated to handle most helicopters, the HCMC heliport is connected by elevator to our ED, the operating rooms, and the ICUs, allowing the rapid transfer of patients to care the moment they arrive at HCMC. What advice do you have for patients who are unsure whether they should go to the emergency room? Too many patients in my career weren’t sure whether they should come into the ED. They would have benefited from early intervention, but they waited until hours after their symptoms started. If your health changes suddenly and you don’t know why, you should be seen in an ED. This is especially true of chest pain and stroke symptoms (weakness, numbness, trouble speaking). For ongoing medical problems, you’d be better off seeing your regular physician, but if things are changing and you don’t know why, or if something new occurs and
Early Childhood Education • Autism Services Pediatric Speech, Music and Occupational Therapy Children’s Mental Health • Foster Care Services for Individuals with Lifelong Special Needs More than 2,400 families have found a place to belong at St. David’s Center. MAKE A REFERRAL. MAY 2016 MINNESOTA HEALTH CARE NEWS
Alzheimer’s disease Not a normal part of aging By George Schoephoerster, MD
even slowed. Every 66 seconds someone is diagnosed with Alzheimer’s, and more than 5.4 million people nationwide live with the disease, including 91,000 people ages 65 and older right here in Minnesota.
This is a unique disease—among the top 10 leading causes of death in the U.S., it’s the only one that can’t be prevented, cured, or
What is Alzheimer’s disease? Alzheimer’s—a disease of the brain that causes problems with memory, thinking, and behavior—is the most common type of dementia. Scientists believe Alzheimer’s disease prevents parts of a brain cell’s “factory” from running well. They’re not sure where the trouble starts, but just like a real factory, backups and breakdowns in one system cause problems in another. As damage spreads, cells lose their ability to do their jobs and eventually die, causing irreversible changes in the brain.
or some, Alzheimer’s disease is a daily reality that brings life-altering challenges, memory loss, confusion, and, at times, beautiful moments with family and loved ones. For others, it’s a story unfolding piece by piece, continuously changing their life as the disease changes the person they knew. For many, however, Alzheimer’s disease can be a foreign, intimidating, or confusing topic that often receives less attention than it deserves.
It’s a progressive disease, where symptoms gradually worsen over a number of years. In its early stages, Alzheimer’s often starts with short-term memory loss, but with late-stage Alzheimer’s, individuals lose the ability to carry on a conversation and respond to their environment. The average life expectancy is eight years after symptoms become noticeable to others, but survival can range from three to 20 years, depending on age and other health conditions.
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Visit us online at www.minneapolisclinic.com 12
MINNESOTA HEALTH CARE NEWS MAY 2016
Alzheimer’s is not a normal part of aging. Even though the greatest known risk factor is increasing age, and the majority of people with Alzheimer’s are 65 and older, it’s not just a disease of old age. Up to 200,000 people with the disease have younger-onset Alzheimer’s, which appears under the age of 65. Differences between Alzheimer’s and dementia Dementia is not a specific disease—it’s an overall term that describes a wide range of symptoms associated with a decline in memory severe enough to interfere with daily life. For example, you can compare the word “dementia” with the word “cancer.” Both are umbrella terms describing a group of distinctive diseases. If someone says they have cancer, you’d want to know what type of cancer they have. Similarly, when someone says they have dementia, your next question should be about what kind of dementia they have, like vascular dementia, Huntington’s disease, or Alzheimer’s disease.
While Alzheimer’s accounts for 60 to 80 percent of all cases of dementia, a diagnosis of dementia doesn’t necessarily mean that you have or will develop Alzheimer’s disease. A diverse disease Alzheimer’s doesn’t discriminate—it can affect anyone, anywhere. While the greatest known risk factor is advancing age, statistics show that some individuals are more likely to develop the disease. Almost two-thirds of American seniors living with Alzheimer’s are women, and researchers have identified some genetic factors that could heighten risk. If you have a family history of Alzheimer’s, have suffered serious head injury, or have heart or vascular conditions, you may be more likely to develop the disease. Variations in health, lifestyle, and socioeconomic risk factors across racial groups likely account for most differences in risk of Alzheimer’s disease and other dementias by race. According to the Alzheimer’s Association, a review of many studies by an expert panel concluded that older African-Americans are about twice as likely to have Alzheimer’s and other dementias as older whites, and Hispanics are about one and one-half times as likely as older whites. Currently, there isn’t enough evidence to estimate the prevalence of Alzheimer’s disease and other dementias in other racial and ethnic groups.
exhibiting confusion and memory loss, they would want to know if Alzheimer’s was the cause. Too many patients and their families either ignore or downplay warning signs out of fear or lack of awareness. Tragically, diagnosis is frequently triggered by a health crisis that might have been avoided with earlier diagnosis. While a definitive diagnosis of Alzheimer’s is possible only after death—when the brain can be studied to reveal the plaques and tangles characteristic of the disease—it is possible to rule out other factors, such as depression, drug interactions, thyroid problems, excess use of alcohol, or certain vitamin deficiencies, that may contribute to symptoms of memory loss or dementia. By conducting tests of memory, physical and neurological exams, blood tests, and brain imaging, skilled physicians can diagnose Alzheimer’s with more than 90 percent accuracy.
The majority of people with Alzheimer’s are 65 and older.
Ten warning signs People with possible signs of Alzheimer’s may find it hard to recognize they have a problem; warning signs may be more obvious to family members or friends. According to the Alzheimer’s Association, there are 10 warning signs that may mean a person is developing Alzheimer’s disease:
Determining an Alzheimer’s diagnosis early on allows for: • A better chance of benefiting from treatment • More time to plan for the future
• Lessened anxieties about unknown problems Alzheimer’s disease to page 34
Life. Worth. Living.
1) Memory loss that disrupts daily life 2) Challenges in planning or solving problems 3) Difficulty completing familiar tasks at home, work, or leisure 4) Confusion with time or place 5) Trouble understanding visual images and spatial relationships 6) New problems with words in speaking or writing
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7) Misplacing things and losing the ability to retrace steps
Rogers Behavioral Health is making mental health treatment even more accessible with the opening of our Eden Prairie location in May.
8) Decreased or poor judgment 9) Withdrawal from work or social activities 10) Changes in mood and personality Every individual may experience one or more of these signs in different degrees. If you notice any of them, contact your doctor, visit www.alz.org for information and resources, or call their 24/7 Helpline (800-272-3900). Importance of early diagnosis Today, less than half of those living with Alzheimer’s disease are diagnosed. Yet almost 90 percent of Americans say that if they were
Offering specialized outpatient treatment for OCD and anxiety, posttraumatic stress disorder, depression and other mood disorders. Call 844-599-8959 for a free screening or visit rogersbh.org. 6442 City West Parkway, Suite 200, Eden Prairie, MN 55344
MAY 2016 MINNESOTA HEALTH CARE NEWS
HEALTH CARE BENEFITS
MEDICARE and financial counseling Reduce costs, maximize coverage By Deb Taylor
Telephone Equipment Distribution (TED) Program
hen Tammy Hughes retired, she dreaded the paperwork ahead. She easily applied for Social Security, but reviewing the many Medicare supplemental and Part D insurance options was overwhelming. She was not alone. Many people begin the Medicare process only when they’re about to retire because of the anxiety-producing complexities of the programs. Factor in the phone calls and mail from businesses pitching their own insurance products, and consumers like Tammy can be left confused and bewildered by the many available choices. “It’s hard to know where to begin,” she said. “I’m sure there are others, just like me, who don’t understand the process and need assistance.”
Do you have patients with trouble using their telephone due to hearing loss, speech or physical disability? If so…the TED Program provides assistive telephone equipment at NO COST to those who qualify. Please contact us, or have your patients call directly, for more information.
1-800-657-3663 www.tedprogram.org Duluth • Mankato • Metro Moorhead • St. Cloud The Telephone Equipment Distribution Program is funded through the Department of Commerce Telecommunications Access Minnesota (TAM) and administered by the Minnesota Department of Human Services
MINNESOTA HEALTH CARE NEWS MAY 2016
A path through the paperwork Like many retirees, Tammy turned to an independent Medicare counselor. A trained volunteer from the Medicare & Health Insurance Counseling Program, operated by Minnetonka-based nonprofit Senior Community Services, met with her at home and patiently went through the process to explain options and reach decisions based on her health care needs. Tammy wound up saving money by finding the best plan to cover her particular prescription medications. The program is one of several initiatives (see sidebar) that can help older adults sort through the mountains of official documents— and, in some cases, the boxes of mail solicitations sent to those at retirement age. Those solicitations might include options that are ideal for the individual’s needs, but trained Medicare counselors often have access to the same choices, and can help to identify unique circumstances that meet a client’s needs even better. For example, veterans and government employees may qualify for additional coordinated benefits. By changing the insurance of one retired veteran to reduce duplication of coverage with a military plan, program counseling led to annual savings of $600. The right choices can often save hundreds—and, in some cases, thousands—of dollars each year. Timing is everything For older adults already on Medicare, and for Baby Boomers about to sign up, the annual Medicare open enrollment period runs from October 15 to December 7. It’s important to review options before you sign up, and to reevaluate your health coverage each year thereafter, because costs, scope of coverage, and the providers and pharmacies in your network may change. Shopping around for the best Medicare and prescription Part D drug plans can often save you money. You can do your own research, of course, but a trained Medicare counselor with unbiased expertise might point out unexpected wrinkles. Sometimes a plan will look best because it offers a lower
Questions and answers
lder adults and their caregivers have a wealth of resources to help navigate Medicare. Among the many services available online:
For details about Senior Community Services, the organization mentioned in this article, visit http://seniorcommunity.org. See the “Programs” tab for links to Medicare and health insurance counseling, financial counseling, management of complex care situations, and volunteer and low-cost home maintenance initiatives. Medicare’s official federal site, www.medicare.gov, explains programs and costs, with tools to help users compare and select insurance plans, supplemental coverage, and prescription drug options. Users may sign up for coverage, file claims and appeals, locate physicians and providers, and download forms. Visit the Minnesota Board on Aging’s Senior LinkAge Line at www.mnaging.org/Advisor/SLL.aspx to get in touch with six Area Agencies on Aging throughout the state. The Senior LinkAge Line can help answer questions about Medicare and prescription drug programs, help you find a trained Medicare counselor, and help navigate other issues facing seniors and their loved ones.
The Minnesota Board on Aging’s home page also provides information and links to legal, financial, and community resources under the “Advisor” tab on its home page at www.mnaging.org.
As you narrow the field of prospective health care plans that match your needs at the most affordable cost, be sure to check benefit levels to determine the maximum amount each insurer agrees to pay for specific covered benefits. Visit the official Medicare site at www.medicare.gov for a complete overview, including a search page for those who wish to keep their favorite physicians. Visit www.medicare. gov/physiciancompare/ search.html to see which doctors are covered by the insurance plans you’ve identified. As with prescription drug formularies, authorized physicians and providers may change each year.
The annual Medicare open enrollment period runs from October 15 to December 7.
Picking the best strategy See the “questions and answers” sidebar for additional local and national resources, and, if you do seek a Medicare counselor, pick one that meets your individual needs. In Tammy’s case, that meant finding a trained counselor who was not an insurance agent, and MSA - MN Healthcare July 2013.pdf
Medicare and financial counseling to page 32
Visit the state’s Senior Services webpage at www.mn.gov/ portal/social-services/senior-services/ for links to senior services, including MinnesotaHelp.info and listings of Medicare savings programs from the Minnesota Department of Human Services (DHS). The DHS also hosts an “Aging” page at bit.ly/1USVvFt.
premium, for example, but read the fine print; the copays may be higher and more frequent. If that’s the case, then a higher premium with fewer copays could actually be cheaper in the long run. Your strategy—with or without Medicare counseling—should include: • Picking a Medicare supplement • Picking a Part D drug plan • Selecting a Medicare Advantage plan • Addressing Social Security Administration concerns • Deciding if long-term care is right for you • Comparing and analyzing medical plans • Understanding Medicare benefits • Seeking medical assistance and other resources Start thinking about health coverage several months before retirement and before the fall election period. First, check with your existing health plan(s) to see if there will be any changes in existing coverage in the coming year. Check your medications to ensure they’ll continue to be covered, since providers can and do change their lists of formularies.
MAY 2016 MINNESOTA HEALTH CARE NEWS
Cystic fibrosis New hope for a devastating disease By Terri Laguna, MD, MSCS
avin is an amazing 6-year-old boy living with cystic fibrosis (CF). I met Gavin and his parents, Jen and Casey, when he was 10 days old. When Gavin was born, he had his heel pricked to collect a small sample of blood, which was sent to the Minnesota Department of Health and analyzed for a number of congenital diseases, including CF. Gavin’s CF screening test came back positive, and he was referred to the Minnesota Cystic Fibrosis Center at the University of Minnesota for an appointment with the Pediatric CF multidisciplinary team. Telling Gavin’s parents that their beautiful, perfect son had CF was difficult; there is never an ideal way to deliver such shocking
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MINNESOTA HEALTH CARE NEWS MAY 2016
news. However, Gavin was born at a time of increased excitement and hope within the CF community—a time when the possibility of a potential cure to this devastating disease was getting closer to reality. About CF Cystic fibrosis is a genetic disease affecting primarily Caucasians with central and northern European ancestry. In the U.S., approximately 35,000 adults and children live with CF. Among this population, it is considered the most common autosomal recessive life- limiting illness—meaning that both parents must possess and pass on a specific bad gene. That gene—CFTR, for cystic fibrosis transmembrane conductance regulator—causes a genetic mutation in the CFTR protein, which makes a chloride channel responsible for regulating the salt and water balance of multiple organs in the body. With this function disrupted, thick, sticky secretions of mucus accumulate, making it difficult for organs to function normally. For example, mucus that is normally coughed out of the lungs easily by most people develops the consistency of wet concrete, and is almost impossible to remove. Because this bad gene is recessive, some individuals inherit it but remain asymptomatic, showing no sign of CF throughout their lives. They are still considered carriers, however, and have a 25 percent risk of having a child with CF if their mate is also a carrier of the disease. In the case of Gavin, both parents were unaware that they each carried a CF mutation, making their son’s diagnosis a shock and a surprise. New developments As recently as 1940, life expectancy for those with CF was less than one year. Today, because of significant advances in medical care, it has increased dramatically to almost 41 years. Most die due to damage to the lungs, but the disease also affects almost every other organ in the body, including the sinuses, liver, pancreas, GI tract, sweat glands, and reproductive organs. Babies born with CF often lag in growth and develop challenging lung problems early in life. By diagnosing CF as soon after birth as possible, physicians can improve growth and development; keep the lungs healthier; decrease the need for early hospitalization; and provide early genetic counseling, education, and support resources.
Newborn screening such as Gavin’s is available in all 50 states, but this has not always been the case. Colorado was the first state to implement newborn screening for CF in 1982, and nationwide screening was not universal until 2010. Minnesota started to screen for CF in 2006. Minnesota utilizes a two-step testing approach to screen infants. The first analyzes a dried sample of blood for an elevation of the IRT protein, which is a marker of damage to the pancreas that often occurs to infants during pregnancy. If an increased level of the protein is detected, follow-up molecular testing looks for specific changes, such as mutations, to the DNA in the gene responsible for making the CFTR protein. While thousands of mutations can cause CF, Minnesota’s test screens for the most common 39 mutations and four variants.
medical complications. The Minnesota CF Center has both a pediatric and an adult CF program with dieticians, respiratory therapists, nurses, social workers, genetic counselors, pharmacists, physicians, and nurse practitioners who focus on aggressive, preventive care and treatment of complications as they arise. One of the biggest hurdles people with CF face is difficulty in gaining weight. The disease destroys the ability of the pancreas to release enzymes necessary to digest fat, protein, and sugar, so CF patients must take capsules containing digestive enzymes with every meal, in addition to daily vitamins. CF patients often need to eat 50–100 percent more daily calories than a person without CF in order to maintain and gain weight appropriately. Under the guidance of a CF dietitian, our patients are expected to grow and gain weight at a similar rate as their peers.
Cystic fibrosis is a genetic disease affecting primarily Caucasians.
If the first test shows elevated IRT and the second shows at least one mutation—as was the case with Gavin—it is considered a positive newborn screen and the infant is referred to an accredited CF Center for a follow-up test. If this “sweat test” shows elevated concentrations of chloride in the perspiration, then the infant is diagnosed with CF and treatment and education begins. A lifetime regimen Accredited CF programs with multidisciplinary teams dedicated to CF care are best equipped to address the multitude of potential
Aggressive, daily treatment for the lungs is another cornerstone of CF care. Using a nebulizer—a device that delivers drugs in mist form—patients inhale medications to open up their air tubes, thin out their mucus, and treat infections in their lungs. In addition, each CF patient uses an inflatable jacket that shakes at different frequencies, creating vibrations that break up and help clear mucus from the lungs. They use this device twice daily, in conjunction with nebulized medications, as part of a complicated, Cystic fibrosis to page 19
MAY 2016 MINNESOTA HEALTH CARE NEWS
Calendar May-June 2016 May 12
Varicose Vein Seminar
Abbott Northwestern Hospital is hosting this free seminar for anyone interested in learning more about varicose veins. They are relatively common and only a cosmetic concern for most people. However, they can also be a sign of a more serious health condition. Come learn what causes them and what options are available. Call (952) 925-4321 to sign up. Thursday, May 12, 5: 30 – 7: 30 p. m., CRAVE Restaurant, 3530 W. 70th St., Edina
Pregnancy After Loss HealthEast hosts this free support group that meets twice a month for parents who have experienced a loss and are now expecting a child. Come receive guidance on grieving, healing the past, and moving through the normal feelings of fear and anxiety to look forward to the future. No registration necessary; check in at the front desk. Call Joann at (651) 326-3733 or (612) 788-6903 for more information. Tuesday, May 17, 5: 30 – 6: 45 p. m., St. John’s Hospital, 1575 Beam Ave., Maplewood
Making Healthy Choices Class Park Nicollet offers this free class to explore the association between screen time/ technology and child behaviors, and how this leads to unhealthy choices and decisionmaking. Children will have the opportunity to explore alternative activities. A light dinner will be provided. To register, call (952) 993-3454. Thursday, May 19, 5 – 7: 30 p. m., Park Nicollet Clinic—Naegele Auditorium, 3800 Park Nicollet Blvd., St. Louis Park
Health Screenings UCare, Hennepin County Medical Center, and KARE 11 TV host this opportunity for free basic health screenings. Nurses will perform the health checks in a mobile RV unit. Other dates and locations are available across the metro area through October. The events are open to the public and screenings are performed on a first-come, first-served basis. For more information, call (763) 797-7299. Wednesday, May 25, 9: 30 a.m. – 1: 30 p. m., YMCA, 1761 University Ave. W., St. Paul
Mental Health Awareness Month In May, organizations and participants across the country work to fight the stigma associated with mental health issues, provide support to those affected, and educate the public about mental health conditions. There are more than 200 classified forms of mental illness. The most common forms include depression, bipolar disorder, dementia, schizophrenia, and anxiety disorders. One in five adults in the U.S. — 43.8 million—will be affected by a mental health condition in a given year. One in 25, or about 10 million, live with a serious mental illness that substantially interferes with their life. Some symptoms of mental illness include changes in mood, personality, personal habits, and social withdrawal. However, mental illness does not affect everyone in the same way. It is important to reach out to someone you trust, such as friends or family members, to create a support network. Therapy and support groups can also be helpful for people affected by mental illness as well as their family members. Many people with mental illness return to a productive and fulfilling life.
Minnesota Warmline The Mental Health Association of Minnesota offers the Minnesota Warmline, a safe, confidential phone line for people working on recovery. Calls are answered by professionally trained staff that have firsthand experience dealing with a psychiatric diagnosis. Call (877) 404-3190 for support or information, answers to questions, local referrals for treatment, or just to talk about what’s important to you.
Diabetes Support Group Hennepin County Library and Nokomis Healthy Seniors present this free support group for people with diabetes or prediabetes. Come share your experiences and get advice on blood sugar management, diet, and exercise from a health care professional. Free transportation is available. To arrange a ride, call (612) 729-5499. Friday, June 3, 1 – 3 p. m., Nokomis Library, 5100 34th Ave. S., Minneapolis
Car Seat Clinic HealthPartners offers this free child and booster seat safety clinic. Certified car seat technicians from Regions Hospital will teach you how to install and use child care restraints correctly. Other dates and locations are available. Call (651) 357-2798 for more information or to make an appointment. Monday, June 6, 4 – 7 p. m., Regions Hospital, South Ramp, 640 Jackson St., St. Paul
Maximizing Meds for Lupus Lupus Foundation of Minnesota hosts this free seminar for people living with lupus. Come learn how to use your medication wisely, including ways to minimize the risk of side effects and increase the effectiveness of commonly used medications for lupus. Call Sandy at (952) 746-5151 to register by June 7. Wednesday, June 8, 3: 30 – 5 p. m., Center for Changing Lives, 2400 Park Ave., Minneapolis
Memory Loss Discussion Group The Amherst H. Wilder Foundation offers this free memory loss discussion group for family and friend caregivers of people with memory loss. Come connect with other caregivers to gain support and share advice. On-site respite is available with pre-approval. For more information, call (651) 280-2273. Thursday, June 9, 10 – 11: 30 a.m., Wilder’s Community Center for Aging, 650 Marshall Ave., St. Paul
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 email@example.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 MAY 2016
Cystic fibrosis from page 17
approximately half of the CF population. The medication combines the potentiator mentioned above with a “corrector” to allow the chloride channel to function correctly. Lumacaftor/ivacaftor (sold under the brand name Orkambi) is now approved for CF patients older than 12 years, with clinical trials underway to assess its efficacy for younger patients. Patients on these medications still must follow their daily treatment regimen, but the restoration of chloride function has resulted in improved Carrier – lung health, fewer hospitalizations, and improved mother weight gain.
time-consuming regimen necessary to remain healthy. Unfortunately, the sticky mucus means that they are always at risk of lung infections, which can lead to coughing, sputum production, and decreased lung function, all of which may require antibiotics and even hospitalization. Hope for a cure Until four years ago, the goal was to keep the lungs as healthy as possible for as long as possible, and then consider lung transplantation as an option. The treatment of CF has focused on treating the complications of the disease, but never has been able to target the dysfunctional chloride channel at its root—until now.
Carrier – father
Some individuals inherit it but remain asymptomatic.
In 2012, the U.S. Food and Drug Administration (FDA) approved ivacaftor (sold under the brand name Kalydeco) for treatment of patients older than 2 years having at least one copy of a specific mutation of the CFTR gene (G551D). This medication is a “potentiator” of the CFTR, meaning that it binds to a dysfunctional chloride channel and allows it to work. Unfortunately, only 4 percent of the entire CF population has this specific mutation. In 2015, the FDA approved a medication to treat the most common CFTR mutations (F508del/F508del), which account for
Don’t Suffer Alone
CF and NHL Gavin carries one copy of the G551D mutation and now uses Kalydeco to treat his CF. He has been amazingly healthy, with a normal weight and normal lungs. He has never been hospitalized. Gavin is an avid hockey player, and would love to be the first National Hockey League player with CF. He was born during a time of active research, as scientists have devoted their careers to improving CF care and seeking an eventual cure.
Terri Laguna, MD, MSCS, a pediatric pulmonologist, is director of the Pediatric CF Program at the University of Minnesota and assistant professor in the University of Minnesota Medical School’s Division of Pediatric Pulmonology and Sleep Medicine. She specializes in pediatric lung disease and pediatric cystic fibrosis.
Gambling Addiction Is Lonely
RecoveRy is Not
For most, gambling is a fun-filled adventure enjoyed in the company of others. But for a gambling addict it is often a lonely pursuit as they become more and more withdrawn and desperate.
Don’t suffer alone. Treatment is free and confidential. And it works.
Gambling addicts don’t need to suffer alone. A full life can be restored with treatment and support.
Call 1-800-333-HOPE • Or visit www.NorthstarProblemGambling.org MAY 2016 MINNESOTA HEALTH CARE NEWS
2016 Community Caregivers Making a difference in Minnesota and the world Recognizing Minnesota’s Volunteer Physicians and Health Care Providers Each year, Minnesota Physician Publishing recognizes physicians and health care providers who have volunteered their medical services. Whether volunteering at home or overseas, these caregivers help people in need and come away with a revitalized sense of their work. Their compassion, commitment, and generous spirit reflect the deeply held values in Minnesota’s medical community. By Lisa McGowan
Carol Nelson, MD Boynton Health Service
he chance to improve the high maternal and child mortality rate in rural Tikonko, Sierra Leone inspired Dr. Carol Nelson, a primary care physician at Boynton Health Service at the University of Minnesota, to volunteer. Sierra Leone is extremely poor and still recovering from a civil war and last year’s Ebola outbreak. There are only 120 doctors in the entire country and a lack of adequate health care. One in 17 women die related to pregnancy or childbirth, and life expectancy is only 46. Malnutrition and stunting is very common among the children. Nelson traveled to Tikonko in 2013 and 2015 through the Rural Health Care Initiative (RHCI), which was founded by Alice Karpeh, a nurse at Boynton, who was born in Tikonko, and is determined to improve health care in her village. RHCI’s mission is to partner with the Tikonko Community Health Center to give the health care workers the knowledge and resources they need to provide quality, life-saving care especially for pregnant women and their children. RHCI has donated a solar suitcase that supplies power, and much needed medication and medical supplies to the Health Center.
MINNESOTA HEALTH CARE NEWS MAY 2016
between the villages in the chiefdom and the Health Center, so RHCI chose to focus on training them because they have little or no formal medical training. In July and August 2015, Nelson was part of a collaborative team from RHCI and Midwives on Missions of Service to train TBAs to become community health workers. Thirty TBAs passed a certification exam after taking a three-and-a-half week course on basic anatomy, physiology, nutrition, infection prevention, antenatal and postnatal care, labor, delivery, and newborn care. The course also stressed that women can be agents of change in their communities. Long-term sustainable
They are currently raising funds to build a birth waiting home for pregnant women so the women are close to care and can avoid walking long distances while in labor. Nelson pointed out, “The birth waiting home is one part of the plan to reduce maternal and newborn morbidity and mortality.” RHCI is also collaborating with the Health Center to operate an outreach motorbike clinic that goes to one of four villages each Friday to provide vaccines and primary care.
work in developing countries is critical.
The Health Center has no doctors or advanced health care professionals, but is staffed by a nurse midwife, health aids, a community health worker, a health assistant, and unpaid traditional birth attendants (TBAs). TBAs are a critical link
Inspired by her volunteer work, Nelson is earning an MPH degree at the University of Minnesota School of Public Health. According to Nelson, “My volunteer work gives me a stronger sense of purpose in my life. I’ve learned that doing long-term sustainable work in developing countries is critical, as opposed to limited short trips. Medical volunteering in low-resource countries is about understanding the culture and the importance of community involvement. That makes a real difference.”
Vibhu Kshettry, MD Minneapolis Heart Institute at Abbott Northwestern Hospital
wenty years ago, Dr. Vibhu Kshettry began going on cardiac surgery missions to India and Ethiopia to operate on indigent children and young adults. The death rate in these developing countries is high because of a lack of trained medical personnel and limited access to medical care. Cardiovascular disease is a leading cause of death globally and there is a great need for cardiac care in India and Ethiopia. Kshettry realized that surgical mission trips helped a lot of children, but did not solve the overall problem of a lack of medical providers. “These missions were saving lives, but the sustainability and impact on the host country was limited,” said Kshettry. In 2005, Kshettry established the International Cardiac Outreach Research and Education (ICORE) program at the Minneapolis Heart Institute Foundation in an effort to train nurses, technicians, and physicians in developing countries. ICORE partnered with the Institute of Cardiac Sciences in Bangalore, India to educate medical staff on the latest in cardiac care.
Training in India is cost effective and the trainees gain experience in treating diseases that are common in their countries such as congenital and rheumatic valvular heart diseases. ICORE has trained 250 nurses, 60 technicians, and 30 physicians so far.
the personnel shortage. Last year, the CHFE sponsored six Ethiopian trainees to spend three years at the Institute of Cardiac Sciences in Bangalore to become cardiologists, cardiac surgeons, and anesthesiologists. Once their training is complete, they will return to Ethiopia ready to practice
It’s amazing how much you can do with limited resources in other parts of the world. on their own. The CHFE also sponsored a study to track the pattern of cardiac diseases in Ethiopia.
In 2009, Kshettry was approached by the Minnesota Ethiopian community to help staff the Cardiac Centre of Ethiopia in Addis Ababa, the only such center in the country. The Cardiac Center had the necessary equipment to perform cardiac surgery but no trained personnel. In response, Kshettry began the Children’s Heart Fund of Ethiopia, Minnesota (CHFE) in 2013 to address
During his childhood in India, Kshettry saw his father, a surgeon, treat all patients who came to him even when they were unable to pay. His father stressed how important it was to make a difference in these people’s lives. Kshettry continued his father’s philosophy by volunteering as a boy and throughout his career as a surgeon. According to Kshettry, “Working with underserved populations offers valuable insight into their lives. It’s amazing how much you can do with limited resources in other parts of the world.” 2016 Community Caregivers to page 22
MAY 2016 MINNESOTA HEALTH CARE NEWS
2016 COMMUNITY CAREGIVERS
Mark Marshall, PA-C Thomas Bracken, MD Mille Lacs Health System
week after the earthquake hit Haiti in 2010, Mark Marshall traveled to a field hospital in the Dominican Republic and then to an orphanage in Haiti to tend to earthquake victims. Haiti is the poorest country in the Western Hemisphere and the need for medical care is great even under normal circumstances. Many Haitians have little or no access to health care, so Marshall returned to Haiti a few months after the earthquake to help establish an outpatient clinic affiliated with the Mercy Village Orphanage in the Santo region of Port-au-Prince. Initially he ran the clinic under tarps in the orphanage yard, and managed to immunize and treat a large number of people. After the orphanage closed in 2013, the clinic moved to the House of Presence, run by a Catholic charity on the outskirts of Croix-des-Bouquets. Dr. Thomas Bracken first went to work with Marshall in Haiti in 2011 after hearing him talk about the lack of care, food, and sanitation that most people experience.
Both work at Mille Lacs Health System in Onamia, where Marshall works as an emergency medicine physician assistant and Bracken as a family physician. They are very humble about their work in Haiti. According to Marshall, “Our desire to provide medical services to the Haitian community is unwavering.”
System donating all medication, the Girl Scouts making gifts for the children, local churches donating clothing and shoes, and Lion’s Clubs gathering donations of eyeglasses. Marshall started the Santo Clinic organization to raise funds for their work in Haiti.
Our desire to provide medical services to the Haitian community is unwavering.
A strong dedication to providing regular care brings Marshall back to Haiti four times a year and Bracken twice a year along with other volunteers from Mille Lacs Hospital. The community of Mille Lacs also contributes to the trips that occur every three months, with the Mille Lacs Health
Three patients. Who is at risk for diabetes?
In an effort to reach more people, pop-up clinics are set up in churches in the rural areas, plus they make house calls to homebound patients. With the help of translators, the volunteer providers can see up to 140 patients a day. They conduct general exams, and treat people with parasites or infections and chronic ailments. In 2014, they brought and placed 100 mosquito nets in homes in an effort to prevent dengue, malaria, and chikungunya. Bracken said, “Haiti is a place where you can actually make a difference. It is reassuring to see the same families when we come back. We have learned to trust each other.”
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MINNESOTA HEALTH CARE NEWS MAY 2016
Katherine Clinch, MD Twin Cities Anesthesia Associates
r. Katherine Clinch volunteers by providing anesthesia for the surgical repair of cleft lip and palate deformities in China and Peru. According to Clinch, an anesthesiologist at Twin
the unique perspective of seeing the world close up and the opportunity to meet people from different countries in a much more personal way. At the beginning of a trip, Clinch works with both local and volunteer staff to set up a workflow for patients coming in for sur-
A volunteer physician must be flexible and able to adapt to the environment. Cities Anesthesia Associates, “My passion lies in pediatrics, so I look for opportunities to work with children in my mission travels.” She generally spends one week in Peru through Programa San Francisco de Asis who focuses on cleft lip and palate repair and two weeks in China through Love Without Boundaries who helps orphaned and impoverished children. Now that both of her daughters are in college, Clinch wants to expand her volunteering and is looking at other international opportunities. Clinch’s first mission trip to Zimbabwe was an incredible experience and she found the work addicting. Volunteering gives her
Ayham Moty, MD HCMC Whittier Clinic
o matter where Dr. Ayham Moty ends up volunteering in the Philippines, hundreds of patients are always lined up and waiting for medical care well before the physicians arrive. The patients either cannot afford medical care or do not have access to a medical facility. The people have left a lasting impression on Moty, “The Filipino people are some of the most resilient people I have ever met. They remain positive through great hardship, natural disasters, and illness.” Moty, a family physician, is medical director of HCMC’s Whittier Clinic in Minneapolis and a faculty member of the HCMC Family Medicine Residency Program. He offered his services to the Philippine Minnesotan Medical Association (PMMA) after hearing his colleagues talk about the need for medical support and services there. Every two years, the PMMA sends medical and dental teams to a different part of the Philippines. Off years are spent raising funds and gathering supplies for the next trip. Moty wanted to volunteer
gery and for their care after the operation. She also assesses the anesthesia equipment and organizes the supplies. The team physicians carefully screen potential patients by reviewing medical histories and any
for a long time and finally did it with no regret. “I have been very blessed in my life and to be able to help those less fortunate is a true privilege.”
available lab work. The medical teams work 12 to 14 hour days in order to complete as many surgeries as possible, and they often operate on 10 to 15 patients a day. The variation and complexity of the defects determines the complexity of the surgery and the anesthesia required. Clinch advises other providers who may be thinking about volunteering abroad, to be aware of the environments they are going to be working in because that impacts the selection of patients. “A volunteer physician must be flexible and able to adapt to the environment,” noted Clinch. Tough decisions have to be made, and the team often decides against operating on young or underweight children. The physicians have to consider whether a health care facility can care for a child after surgery once the volunteers have gone home or if the surgery is too risky. Saying no seems heartless, but teaching the family how to effectively feed the child in a way that allows them to gain weight despite their physical defects is better than risking complications from the surgery. Her final advice to others, “Mission work is an incredible opportunity and will change your life in the most positive way imaginable.”
procedures beginning at 7 a.m. and continuing until 6 p.m. According to Moty, “It’s amazing that despite the long hours, you still feel energized after helping so many people.”
Despite the long hours, you still feel energized after helping so many people.
Moty provides primary care and also performs ambulatory surgical procedures where there is no need for general anesthesia or overnight observation. Many of these patients have not seen a medical provider for years and come in with advanced skin growths, subcutaneous tumors, and malignancies. He also provides primary medical care. A typical mission day in the Philippines starts at 5:30 a.m., with medical
In January 2016, he traveled with a team to Mariveles in Bataan, because the city did not have a hospital to meet the needs of a growing population. The closest hospital was two hours away. There was a basic building structure in place, but it was not fully functional because it lacked plumbing, electricity, and furniture. PMMA sent an advance team of electricians, plumbers, medical facility experts, and other volunteers to Mariveles a week before the medical team arrived to get the building operational. Moty provided some insight to get the building up and running. The people and governor of Bataan were very appreciative for the help in completing a fully functional medical center. 2016 Community Caregivers to page 24 MAY 2016 MINNESOTA HEALTH CARE NEWS
2016 COMMUNITY CAREGIVERS
Betsy Schwartz, MD, MS Park Nicollet
r. Betsy Schwartz has been volunteering since she was in high school when she walked dogs for The Humane Society. “As an environmentalist, my dad taught me to do whatever I can to make the world a better place,” said Schwartz, a pediatric endocrinologist at Park Nicollet. She continued to volunteer while in college at two hospitals and during medical school as a tutor to inner city youth struggling in school. She wants to instill the importance of volunteering in her own children. Schwartz volunteers for One Heartland, a non-profit organization in Minnesota that runs summer camps for youth facing health challenges or social isolation. One Heartland runs Camp 5210 in Willow River, Minn., a camp for children who struggle with their weight. One Heartland approached Park Nicollet and HealthPartners seven years ago to help them develop Camp 5210 and its curriculum. Schwartz was part of that team and noted, “Through the years, we have learned what kinds of activities motivate the kids to make healthy changes.”
The camp staff includes physicians, dieticians, health educators, physical therapists, and mental health providers and they provide social and emotional support for the campers. Kids help with vegetable gardening, meal planning, and food preparation and stay active with lots of outdoor activities. She also teaches the campers and their parents about better eating habits and increasing their physical activity.
Croix River and has lots of activities such as tennis, basketball, swimming, sailing, and horseback riding to keep the kids busy. The campers benefit from the peer support of other campers and counselors with diabetes. Schwartz works with doctors and nurses to manage the campers’ diabetes by reviewing blood glucose levels and insulin dosing, which allows the kids to concentrate on having fun. Volunteer providers
My dad taught me to do whatever I can to make the world a better place. also staff the health office where they care for typical camp-related health issues like bee stings, poison ivy, and homesickness.
For the past 10 years, she has also volunteered for Camp Needlepoint, a camp for kids and teens with type 1 diabetes run by the American Diabetes Association. The camp is south of Hudson, Wis. on the St.
Schwartz pointed out, “I enjoy being part of a team that creates positive experiences for children.” Working in the camps lets her promote health in a more creative, fun, and interactive way. She discovered that her camp work has an unexpected bonus, “Volunteering gives me a different set of tools to use to motivate kids when I’m back in the clinic.”
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MINNESOTA HEALTH CARE NEWS MAY 2016
Shelly Strong, MD Central Pediatrics
n 2010, after a number of teen suicides in Woodbury, Cottage Grove, and Stillwater left these communities in shock, Dr. Shelly Strong and Renee Penticoff knew they needed to do something. According to Strong, “We knew that somehow we needed to prevent suicides and help teens with mental health issues.” Strong, a pediatrician with Central Pediatrics and Penticoff, a psychologist in private practice, who have worked together for years, met to share their grief and thoughts about the rash of suicides. They decided to gather a group of professionals so they could work together to help at-risk teens. As a result, the Suicide Prevention Collaborative (SPC) was born.
and concerned parents all came together. “Collaboration is empowering and can make a difference right here in our community,” said Strong. The energy and determination of those who attended that first meeting set an action plan in motion that included forming several task forces to focus on resources, needs, and goals. As a first step, support groups were set up to help grieving students and a Facebook page was created.
Collaboration is empowering and can make a difference right here in our community. The response was overwhelming as community mental health professionals, pediatricians, social workers, teachers, principals, school counselors, faith leaders,
Pankaj Timsina, MD Essentia Health St. Mary’s– Detroit Lakes Clinic
SPC’s goal is to encourage schools, workplaces, and communities to make
On April 25, 2015, a massive earthquake hit Nepal killing and injuring thousands of people. Timsina and his wife still have relatives living in Kathmandu and thankfully they were all safe. Timsina decided to drop everything, gather supplies, and fly to Nepal, along with Dr. Jared Aelony, to help earth-
orn and raised in Nepal, Dr. Pankaj Timsina has seen suffering, poverty, and pain firsthand. He considers himself fortunate that his family could afford health care and an education for him when he was growing up. The majority of people that he knew in Nepal, one of the poorest countries in the world, were not so lucky. Life is too short “I have grown and achieved a and I want to lot during my make a difference short career, but my life will in people’s lives. not be complete until I help those people and bring a smile to their faces,” said Timsina, a primary care physician, quake victims. For two weeks, they treated bariatrician, and hospitalist at Essentia thousands of injured victims and traveled to Health St. Mary’s–Detroit Lakes Clinic. He seven remote areas. They treated infections, is dedicated to helping those who cannot broken bones, pneumonia, and gastroenteriafford medical services and who have been tis as well as chronic conditions that were deprived of basic health needs. not earthquake related. Timsina was there
mental health a priority. They want to educate the community to reduce the stigma of mental illness and teach them how to recognize and respond to the signs of a suicide crisis. They also want to reach teens who are at risk before they start having suicidal thoughts. “SPC is committed to increasing awareness about depression and other mental illnesses,” said Strong. SPC sponsors a 5K race/fun run to raise money every year. The money is used to bring in well-known speakers to educate and raise suicide awareness in the community. SPC works to explore the impact that suicide has on a community and to inform people about area mental health resources and how to access them. The SPC also provides QPR training (question, persuade, and refer) to groups, which gives people the tools they need to talk about and confront suicide. Strong said, “I see my work with SPC as an extension of my daily work as a pediatrician.” She feels that as teens learn to navigate through life, a healthy mind is important. Strong and Penticoff both feel that encouraging people to talk about suicide goes a long way to saving lives.
which was quite scary. Timsina remembers his time in one village that was completely devastated, “A patient I treated who had lost her whole family in the quake gave me a small scarf as a token of appreciation. Her selflessness brought tears to my eyes.” After returning from Nepal, Timsina and some of his friends started the ASK (Aspire to Serve with Kinship) Foundation dedicated to helping earthquake victims in Nepal. ASK recently diversified its services and started operating a telemedicine program thanks to a team of physicians, software engineers, and people with an expertise in business. Timsina is in the process of setting up telemedicine clinics in five remote areas of Nepal. He is also conducting telemedicine training for both medical and non-medical personnel in these remote areas and has set up online case forums for doctors to access specialists here. Timsina tries to volunteer in Nepal once a year. He is planning on traveling to Ecuador and Guatemala next year to begin volunteering there. According to Timsina, “Life is too short and I want to make a difference in people’s lives.”
when the second earthquake hit on May 12, MAY 2016 MINNESOTA HEALTH CARE NEWS
The reality of
“chemo brain” A treatment phenomenon By Michaela Tsai, MD
nn was a 36-year-old married mother of two elementary school children working full time as an executive assistant when she was diagnosed with an aggressive Stage 2 breast cancer. She underwent surgery with minimal pain and no complications, and was able to return to work after two weeks. She continued to work during her chemotherapy treatment, missing only the days when she came to the office for treatment. She then received additional chemotherapy with a less intense weekly regimen. Unfortunately, this was just the start of her story. Treatment and challenges During what should have been kinder and gentler rounds of therapy, Ann had progressive anemia and fatigue. However, she did continue
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MINNESOTA HEALTH CARE NEWS MAY 2016
After finishing radiation, she started an anti-estrogen treatment, at which point she really fell apart. She had severe hot flashes, especially at night, causing her to wake up frequently and rise each morning feeling exhausted. It wasn’t until she attended a support group with other cancer survivors and shared her symptoms that she ultimately realized she was suffering from what many call “chemo brain.” She was referred to occupational therapy and began a series of cognitive exercises. Over the next six months, her hot flashes diminished and she was able to sleep better at night. She took steps to eliminate distractions at work and set up alerts on her mobile phone for upcoming events. By the time she was one year out from completion of her chemotherapy treatment, she finally felt as if she was back to “normal.” Living with cancer According to the American Cancer Society, there were 14.5 million children and adults with a history of cancer living in the United States as of Jan. 1, 2014. By 2024, that number is expected to reach 19 million U.S. cancer survivors.
Soon Ann discovered that she was often too tired to get to work on time. While at work, she found that she couldn’t focus well enough to complete her usual daily tasks. She began to miss appointments and other events as she simply forgot when and where she was supposed to be.
Jeffrey Mil ler, MD, and Timothy Schacker, MD
to work during most of this treatment course and was able to attend all of her children’s school and sporting activities. Once chemotherapy was finished, she had a short break before starting radiation. She had been looking forward to radiation, thinking this would be easy compared to chemo.
“Cancer survivor” refers to those at any stage during the journey from initial diagnosis, treatment, active surveillance, and longterm survival. Survivorship care, a rapidly evolving field of oncology, helps these patients cope with the physical, mental, and emotional consequences of their cancer diagnosis and related treatments. For men, the three most common such cancers are prostate, colorectal, and melanoma; for women, it is breast, uterine, and colorectal. The goal with any newly diagnosed cancer is to cure if at all possible. When this cannot be achieved, the focus changes to living as long as possible with the best quality of life possible. It is important for the physician and patient to have ongoing dialogue about the short- and long-term side effects and consequences of potential treatments, especially when cure is not likely.
Cancer treatment may involve surgery, radiation, chemotherapy, endocrine (hormone suppressive) therapy, targeted therapy, immunotherapy—or some combination of these modalities. There are shortand long-term side effects potentially associated with all of these treatments. Some, while distressing, are short-lived, such as hair loss, nausea, and low blood counts. Others can be long term or even permanent, such as pain, neuropathy, and infertility.
with concentration and focus. Anxiety and depression are common in cancer survivors and may be contributing factors. Radiation treatment, especially to the brain, can also cause memory problems and fatigue. Hormone therapy (used to treat breast and prostate cancer) can cause mood changes, fatigue, and difficulty sleeping. These issues can ultimately impair cognitive functions. Other complications of cancer treatment, such as anemia, fatigue, nutritional deficiencies, and menopause, likely play a role. Thus, chemo brain is likely a much more complex, multifactorial problem.
Symptoms can vary among individuals and within the same person over time.
Several names, one phenomenon For many years, there has been increasing awareness and concern regarding the phenomenon of “chemo brain,” which describes the difficulty with thinking and memory that some patients experience after cancer treatment. Survivors may also call this “chemo fog,” while oncology providers may use clinical phrases such as chemotherapy-related cognitive impairment or cognitive dysfunction.
While symptoms can vary among individuals and within the same person over time, patients with chemo brain most commonly report difficulty with concentration and memory. Other symptoms may include feeling disorganized or confused; having difficulty with finding words, learning new skills, multi-tasking, or remembering names or appointments; and fatigue. It is not clear whether these issues are a direct result of chemotherapy treatment, or are related to other aspects of the cancer diagnosis and treatment. Simply hearing the words “you have cancer” can be stressful enough to cause issues
Some patients are at higher risk of cognitive impairment than others. These include patients with brain cancer, patients receiving chemotherapy directly into the spinal fluid or brain, patients receiving combined chemotherapy and radiation, patients receiving high-dose chemotherapy, and patients at both ends of the age spectrum (very young and very old). Many studies have tried to define the exact nature of the memory problems that occur with chemo brain. This has proved challenging as the severity and duration of cognitive deficits that occur vary greatly from one person to the next, even if given the same treatment for the same type of cancer. Some cancer survivors are able to work full time during and after their treatment without any difficulty. Others find that it takes extra concentration and time to get through The reality of “chemo brain” to page 31
WHO’S A BIGGER BASEBALL FAN, YOU OR ME? You’ll find that people with Down syndrome have a passion for knowledge and learning that can rival anyone you’ve met before. To learn more about the rewards of knowing or raising someone with Down syndrome, contact your local Down syndrome organization. Or visit www.dsamn.org today. It is the mission of the Down Syndrome Association of Minnesota to provide information, resources and support to individuals with Down syndrome, their families and their communities. We offer a wide range of services, programs and materials at no charge. If you are interested in receiving one of our information packets for new or expectant parents, please email Kathleen@dsamn.org or For more information please call:
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©2007 National Down Syndrome Congress MAY 2016 MINNESOTA HEALTH CARE NEWS
Pediatric sports injuries Risks from a focus on stardom By Michael J. Priola, DO
e have all heard it: No pain, no gain. But this is not the case for young athletes. Children today face increasing pressure when pursuing athletic endeavors. America is no longer the land of sandlot baseball games or touch football on the street corner. Children are now growing up in a world plastered with pictures of a young Tiger Woods holding a golf club before he could walk. And what young female athlete hasn’t seen the victorious Brandi Chastain tearing off and waving her shirt to celebrate scoring the winning goal at the Women’s World Cup soccer final?
In the next issue... Your Guide to Consumer Information
• Genomic research • Mosquitoborne illness • Understanding body mass index 28
MINNESOTA HEALTH CARE NEWS MAY 2016
Over 30 million children between 6–21 years of age engage in sports programs held outside of school—and forget the days of playing two or three sports. Almost half of young athletes today focus solely on one sport with hopes that this will give them an edge for college scholarships and beyond—with little regard for the risk of pediatric sports injuries. Playing the odds and risking injury What are the chances of going pro? Take basketball as an example. Out of 540,000 male high school basketball players, only 17,500 will land on a college team, and only 48 of those will be drafted into the pro leagues. Simply put, even single-sport children have just a 0.3 percent chance of making the jump from high school to college to the NBA (and that’s just getting drafted, not actually playing in the NBA or landing a multimillion dollar advertising campaign). But many kids will still risk injury for a shot at the front of the Wheaties box or schoolyard stardom, and the risks are as varied as the sports themselves. Despite commonly held beliefs, girls in cross-country have the highest frequency of sports injury, followed by football, wrestling, girls’ soccer, and boys’ soccer. During their quest for glory, repetitive stress and trauma on young skeletal systems is causing lifelong debilitation. Add societal pressures that drive some boys to use performance-enhancing substances and some girls to extreme dieting, and you have a recipe for disaster. The smaller they come, the harder they fall As we like to say in medicine, kids are not “little adults.” The growing skeleton is weakest at the “physis” or growth plate, the segment of bone responsible for growth. Composed of cartilage, this “weak link” is the most prone to injury and will generally fail before surrounding tendons or bone. The growth plate may not be involved in an acute injury (a hard tackle or sudden blow, for example), but a skilled surgeon must avoid damaging the physis during any number of surgeries. One such operation that poses special demands for young patients involves surgical repairs to the knee’s anterior cruciate ligament (ACL), which connects the femur (thighbone) to the tibia (shinbone). Female soccer and basketball players have the highest rate of ACL tears in high school sports, and the average age of injury
continues to fall. However, standard ACL reconstructive techniques can cause damage to the physes of the knee joint’s top part (distal femur) and upper shinbone (proximal tibia), the areas responsible for over 90 percent of the leg’s growth. In response to this dilemma, multiple ACL reconstructive surgeries have been developed and studied over the years to avoid permanent damage and deformity in a young athlete’s knee. An estimated 40 percent of all traumatic shoulder dislocations occur in patients under 22 years of age. The majority of these occur in young athletes participating in collision or contact sports. The younger the age of the first dislocation, the more likely subsequent shoulder dislocations will occur. It has been estimated that pediatric athletes who sustained a traumatic shoulder dislocation have a 90 percent chance of recurrent dislocations. This is because pediatric shoulder dislocations stretch the shoulder capsule (the strong connective tissue surrounding the joint) more than adult dislocations. For older adults experiencing first-time dislocations, a monitored physical therapy program to help restore strength and range of motion is the mainstay of treatment, but this is not the case for young patients. It is becoming more and more accepted that even first-time pediatric shoulder dislocations should undergo shoulder surgery to repair the damaged anatomy and prevent future dislocations.
Other acute injuries include, but are not limited to, meniscal (knee disc) injuries, patellar (kneecap) dislocations, fractures, and ankle sprains. Each one of these injuries requires someone familiar with the pediatric musculoskeletal system in order to guide the child through rehabilitation and possible surgery; one size does not fit all. Many of the injuries child and adolescent athletes sustain are from repetitive trauma. In most cases, rest, ice, and NSAIDs (nonsteroidal anti-inflammatory drugs, such as aspirin, ibuprofen, and naproxen) will relieve discomfort and alleviate the problem, but these athletes face additional hurdles: parents and coaches who encourage them to play through the pain. Their injuries run the gamut from minor injuries like shin splints and tendonitis to chronic exertional compartment syndrome (pain, swelling, and disability in leg and arm muscles) and avulsion fractures, in which the tendon or ligament pulls off a piece of the bone. Even with restrictions on “spear tackling” in high school football, teenage football players have a much larger incidence of cervical neck arthritis than the general population.
Girls in cross-country have the highest frequency of sports injury.
Pediatric sports injuries to page 30
Player stats Young athletes who race for glory may be headed for injury as well. Of the 46.5 million U.S. children participating in sports each year:
• 1.24 million visit emergency rooms with sports-related injuries. • 90 percent report some type of injury while playing a sport. While many of these are minor, the tally also includes concussions and brain injuries, dehydration, broken bones, and sprains and strains. • 42 percent hide or downplay injury so they can continue playing, and 62 percent know another young athlete who has done so. At the same time, only 27 percent of coaches report the practice. • 53 percent of coaches say that parents or players have pressured them to put an injured child athlete back into the game. • 54 percent of athletes have played with injuries, often out of team spirit, a desire to win an important game, or a fear of being benched.
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• 33 percent of those playing team sports miss practice or games because of injury. • 62 percent of injuries occur during practice, not games. Source: Safe Kids Worldwide MAY 2016 MINNESOTA HEALTH CARE NEWS
Pediatric sports injuries from page 29
Additional concerns While earlier we discussed traumatic shoulder dislocations in young athletes, it is important to note that most shoulder injuries in the young athlete are caused by subtle, non-traumatic instability. Sports with overhead movements (swimming, volleyball, baseball, tennis, basketball, etc.) are the main culprits. Eighty percent of growth in the arm’s upper bone (humerus) occurs at the shoulder region (humeral proximal physis). Repetitive stress, especially in young pitchers, can actually cause physeal widening and changes in the metaphyseal bone (Little Leaguer’s Shoulder). This overuse syndrome typically resolves with rest, and is then followed by an individualized throwing program. Therapy focusing on stretching the posterior shoulder capsule, rotator cuff strengthening, capsular stabilization, and core strengthening are often enough, but further training may also be necessary. Repetitive stress can also cause capsular stress leading to excessive motion of the humeral head within the shoulder joint. Multiple studies have demonstrated bone remodeling resulting from overuse, including increased external rotation and loss of follow-through. Usually a period of rest will help, but many young athletes require up to 6–9 months of supervised therapy. In rare cases, surgery may be necessary to stabilize the shoulder.
The best game plan Children and adolescents recovering from a sports injury will rebound faster when examined by a full team of pediatric specialists that includes pediatricians, occupational therapists, physical therapists, orthotists, radiologists, social workers, surgeons, and nutritionists. Sometimes, there are underlying problems that predispose children to injuries, so taking a step back and evaluating the whole patient before zeroing in on the one acute injury is also very important. But remember that kids are more active than ever and are being pushed by their parents harder than ever—and for what? We owe it to today’s young athletes to treat them with patience and respect. If an injury occurs, they should see a specialist immediately. Continuing to play through pain can lead to lifelong consequences and disability. For all of our children, the lights and glory will eventually fade. And when they do, everyone deserves a life free from the pain of adolescent sports injuries.
Continuing to play through pain can lead to lifelong consequences.
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Michael Priola, DO, is a board-certified pediatric orthopedic surgeon who specializes in sports medicine for Shriners Hospitals for Children–Twin Cities, where all care is provided regardless of ability to pay or insurance coverage limitations. Visit www.twincitiesshrinershospital.org for more information.
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The reality of “chemo brain” from page 27
their usual daily tasks. Some are so debilitated that they are unable to return to work at all. Fortunately, such severe cognitive dysfunction is rare. Patients who do have moderate to severe changes or persistent changes may be referred to an occupational therapist or a neuropsychologist. It is important to rule out a treatable medical cause of these symptoms, such as anemia, depression, or thyroid dysfunction. Sometimes blood tests or brain imaging may be recommended. The long-term picture As yet there is no standard treatment for chemo brain. Memory tests such as neuropsychiatric testing often show normal, but may still identify deficits for which specific interventions may be helpful. Memory and thinking exercises, done repetitively, may be able to retrain the brain in areas lacking normal function. Coping strategies, such as making lists, setting calendar reminders, timing important meetings during periods of the day when patients feel at their best, and avoiding work while hungry or extremely tired can be helpful.
these two potential underlying contributors. Correcting anemia and low thyroid levels can also help. Other medications, such as Ritalin or Concerta (used to treat attention deficit hyperactivity disorder, or ADHD), have been tried with varying success. Aricept and Namenda, more commonly used to treat Alzheimer’s disease, may be appropriate for use in some patients. More research is needed to see if these and other treatments are truly beneficial for patients with chemo brain.
Some patients are at higher risk of cognitive impairment than others.
While there is no specific medication available to treat chemo brain, antidepressants or antianxiety medications may help treat
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Progress in oncology and in survivorship care depends on medical research. Every treatment and intervention we use in the clinic today has been proven in clinical trials to be safe and effective. If we are to better understand this perplexing phenomenon, we will need to invest more time and resources into studying cancer-related cognitive dysfunction. In the meantime, we must work to better identify patients suffering this long-term effect of cancer treatment and help them find effective rehabilitation strategies.
Michaela Tsai, MD, is a medical oncologist and hematologist with Minnesota Oncology’s Minneapolis Clinic, specializing in breast cancer and clinical research.
the benets of yoga.
This amazing medical-grade infrared heating mat can change your life for the better. It is used in homes and professional healing practices all over the world. The BioMat provides immediate and dramatic relief for people suffering from a wide variety of chronic conditions that have not responded well to medication therapy.
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A brief overview of benefits from using the BioMat: • Stress and anxiety relief
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866.689.7336 For more details please visit: www.crystalbiomat.com MAY 2016 MINNESOTA HEALTH CARE NEWS
Medicare and financial counseling from page 15
was part of a team representing multiple professional disciplines such as law and accounting. Her counselor researches individual options, based on information forms completed in advance by clients, and reviews recommendations during confidential appointments. All financial information is strictly confidential, addressing privacy concerns of some older adults who may be reluctant to seek Medicare counseling. In addition to its individualized Medicare counseling, available by phone and at more than a dozen locations in Hennepin and Wright counties, Senior Community Services hosts “Navigating Medicare” community education classes at public and corporate venues. Classes are held throughout the year, and you can request a customized class for your group or business.
older Minnesotans whose income falls between 100 percent and 200 percent of the Federal Poverty Guidelines. These are seniors who are on Medicare, do not qualify for Medicaid, and are frequently unable to pay the balance of their health care costs after Medicare has paid its portion. Most of these at-risk seniors typically cannot afford supplemental insurance. The situation grows more dire if they avoid seeking needed medical attention because of the costs, only to later need expensive emergency room treatment or hospitalization. Fortunately, there are resources and services to address these concerns. Under the Senior Partners Care program, for example, certain health care costs can be waived thanks to agreements maintained with hundreds of health care providers throughout Minnesota that have agreed to consider a waiver of Medicare deductibles, coinsurance, and copays. See sidebar for links.
Start thinking about health coverage several months before retirement.
Additional help for seniors and caregivers Seniors interested in Medicare counseling often desire more information on reducing medical debt that has grown unmanageable. Assistance with medical debt is especially critical for thousands of
Deb Taylor is CEO of Senior Community Services and the Reimagine Aging Institute, a nonprofit that advocates for older adults and helps seniors and caregivers maintain their independence through free or low-cost services.
M I N N E S OTA H E A LT H C A R E
April 2016 Survey 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 understand what is meant by the term “Health Care Literacy”.
2. I consider myself to be health care literate.
3. I have a clear understanding of my health status and treatment options after I see my doctor. 60 60 50 50
20 20 10 10 00
00 Strongly agree
4. I understand the benefits and limitations of my health care insurance plan. 60 60
5. If simple tools were available to increase my health care literacy I would take advantage of them. 50 50
50 50 40 40
40 40 30 30
10 10 00
MINNESOTA HEALTH CARE NEWS MAY 2016
For more information, please visit www.mnhcca.org. We are pleased to present results of the most recent survey.
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.
www.mnhcca.org MAY 2016 MINNESOTA HEALTH CARE NEWS
Alzheimer’s disease from page 13
• Increased chances of participating in clinical drug trials, which helps advance research • An opportunity to participate in decisions regarding future care, transportation, living options, and financial and legal matters • Arranging care and support services to help manage the disease Unfortunately, most people living with Alzheimer’s are not aware of their diagnosis. According to the 2016 Alzheimer’s Disease Facts and Figures report, only 46 percent of people with Alzheimer’s disease or their caregivers report being told of their diagnosis, partly due to fears of causing emotional distress. By contrast, more than 90 percent of people with the four most common types of cancer are told of their diagnosis.
Direct costs of health care and long-term care for people living with Alzheimer’s and other dementias are substantial, making Alzheimer’s the most expensive disease in America. In 2016, Alzheimer’s and other dementias will cost the nation an astonishing $236 billion. Unless something is done, by 2050 these costs are projected to reach as high as $1.1 trillion. Everyone with a brain should be concerned about Alzheimer’s disease. Currently, 91,000 Minnesotans over age 65 are living with the disease, and more Minnesota families are going to be touched by Alzheimer’s at a frightening rate. Alzheimer’s is the public health crisis of this century and the defining disease of the baby boom generation.
Alzheimer’s doesn’t discriminate—it can affect anyone, anywhere.
Alzheimer’s has no cure, but certain medications can relieve some memory symptoms, and antidepressants and anti-anxiety medications may provide relief from behavioral changes.
The impact Alzheimer’s takes a devastating toll on the people diagnosed, their families, and their friends. For millions of Americans, watching a loved one struggle with Alzheimer’s is a pain they know all too well. In addition to the human suffering caused by this disease, Alzheimer’s creates an enormous strain on the health care system and significant burdens on family, state, and federal budgets.
Help is available Alzheimer’s disease brings enormous cost and burden to everyone it touches. While it may seem like an overwhelming health crisis, there is much being done to combat this public health issue. People across the globe are working tirelessly to advance research, care, and support for those impacted. Visit the local Alzheimer’s Association Minnesota-North Dakota Chapter website at www.alz.org/mnnd for more information about the disease, clinical trials, and the Association’s 24/7 Helpline. George Schoephoerster, MD, is a geriatrician with Genevive Long Term Care. He is chair of the Alzheimer’s Association Minnesota–North Dakota Medical and Scientific Advisory Council.
Now accepting new patients
A unique perspective on cardiac care Preventive Cardiology Consultants is founded on the fundamental belief that much of heart disease can be avoided in the vast majority of patients, and significantly delayed in the rest, by prudent modification of risk factors and attainable lifestyle measures. Elizabeth Klodas, M.D., F.A.S.C.C is a preventive cardiologist. She is the founding Editor in Chief of CardioSmart for the American College of Cardiology www.cardiosmart.org, a published author and medical editor for webMD. She is a member of several national committees on improving cardiac health and a frequent lecturer on the topic.
We are dedicated to creating a true partnership between doctor and patient working together to maximize heart health. We spend time getting to know each patient individually, learning about their lives and lifestyles before customizing treatment programs to maximize their health. Whether you have experienced any type of cardiac event, are at risk for one, or
are interested in learning how to prevent one, we can design a set of just-for-you solutions. Among the services we provide • One-on-one consultations with cardiologists • In-depth evaluation of nutrition and lifestyle factors • Advanced and routine blood analysis • Cardiac imaging including (as required) stress testing, stress echocardiography, stress nuclear imaging, coronary calcium screening, CT coronary angiography • Vascular screening • Dietary counseling/Exercise prescriptions
To schedule an appointment or to learn more about becoming a patient, please contact: Preventive Cardiology Consultants 6545 France Avenue, Suite 125, Edina, MN 55435 phone. 952.929.5600 fax. 952.929.5610 www.pccmn.com
MINNESOTA HEALTH CARE NEWS MAY 2016
Victoza® (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY. Please consult package insert for full prescribing information. WARNING: RISK OF THYROID C-CELL TUMORS: Liraglutide causes dose-dependent and treatmentduration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies. Victoza® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Based on the findings in rodents, monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials, but this may have increased the number of unnecessary thyroid surgeries. It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors. Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions].
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
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