Your Guide to Consumer Information November 2017 â€¢ Vol. 15 No. 11
Speech-language pathology By Cara Benoit, MA, CCC-SLP
Medicare: Knowing your options By Dan Tarjano, MD
Anesthesiology By Tjorvi E. Perry, MD
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The Newborn Foundation: Saving lives worldwide Annamarie Saarinen
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Anesthesiology Tjorvi E. Perry, MD
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Speech-language pathology: Helping children communicate By Cara Benoit, MA, CCC-SLP
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Congenital heart disease: Diagnoses and treatments By Jamie L. Lohr, MD, and S. Kimara March, MD
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Knowing your options By Dan Trajano, MD
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Polycystic ovary syndrome: A common hormone disorder By Amy Hammers, MD
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Your vagus nerve: New treatments and possibilities By Tacjana K.E. Friday, MD
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Tendonopathies: Common and treatable By Julie Anderson, MD, FAAFP, CIC
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Transitional care units: A bridge from hospital to home By Dan Johnson
REGENERATIVE MEDICINE: Efficacy, Economics, and Evolution
Tuesday, December 12, 2017, 1-4 pm 14
The Gallery, Downtown Minneapolis Hilton and Towers
About, objectives, background and focus: 16
The Minnesota Health Care Roundtable is a semi-annual conference featuring a panel of stakeholder group experts in a moderated discussion before a live audience covering topics that affect the evolution of health care policy.
We will define regenerative medicine and trace its development. We will explore what the pharmaceutical, device, and insurance industries are doing now with regenerative medicine and how they can work together moving forward. We will discuss the challenges that face regenerative medicine and offer potential solutions. We will look ahead so that, as we enter the third decade of the 21st century, the pace of innovation can expand in a way that is accessible, affordable, and sustainable.
Several recent studies have reached troubling conclusions. A huge percentage of prescription medications produce little to no therapeutic benefit for many patients. In large part this relates to a drug development paradigm and medical care model centered more on treating symptoms than curing root causes. An emerging solution to this problem is the field of regenerative medicine—an approach that directly repairs or replaces damaged tissues and organs. Though initial research and development costs present significant upfront investment, the promise of better outcomes and eventual savings are impossible to ignore.
Blake Johnson, MD Center for Diagnostic Imaging
Roger Hogue, MD Minnesota Regenerative Medicine
David R. Brown, MD Children’s Minnesota
David Largaespada, PhD Institute for Molecular Virology
Meri Firpo, PhD Stem Cell Institute
Mathew Thorson, MD Stem Cell Centers
Sponsors include: Center for Diagnostic Imaging · Recombinetics Minnesota Regenerative Medicine · Stem Cell Centers
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Our address is 2812 East 26th Street, Minneapolis, MN 55406; phone 612.728.8600; fax 612.728.8601; email firstname.lastname@example.org. We welcome the submission of manuscripts and letters for possible publication. All views and opinions expressed by authors of published articles are solely those of the authors and do not necessarily represent or express the views of Minnesota Physician Publishing, Inc., or this publication. The contents herein are believed accurate but are not intended to replace medical, legal, tax, business, or other professional advice and counsel. No part of this publication may be reprinted or reproduced without written permission of the publisher. Annual subscriptions (12 copies) are $36.00/ Individual copies are $4.00.
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Minnesota Joins HIV Prevention Campaign
as treatment as prevention. People living with HIV need to take their medications daily as prescribed and The Minnesota Department of receive regular viral load screening Health (MDH) has joined an inter- from their health care provider to national HIV prevention campaign ensure it remains undetectable. called Undetectable=Untransmitta“In addition to supporting HIV ble, also known as U=U. treatment as prevention, we must The campaign is a growing community of HIV advocates, activists, researchers, and nearly 400 community partners from 60 countries that are uniting to clarify and disseminate the revolutionary but largely unknown fact that people living with HIV on effective treatment do not sexually transmit HIV. It was launched in 2016 by a group of people living with HIV who created a consensus statement with global experts to clear up confusion about the science of U=U. The scientific consensus says that people living with HIV who take antiretroviral therapy daily and are able to get and keep undetectably low levels of HIV in their blood effectively have no risk of transmitting HIV to their sex partners. The concept is also known
continue to support consistent and correct condom use, regular HIV screening, pre-exposure prophylaxis (PrEP), and post-exposure prophylaxis (PEP) to prevent sexual transmission of HIV,” said Kristen Ehresmann, infectious disease director at MDH. “One or more of these methods may be appropriate depending on individual circumstances, and only condoms also protect against other STDs and pregnancy.” Minnesota is the third state health department to participate in the campaign, joining the New York Department of Health and the Michigan Department of Health and Human Services. The Centers for Disease Control and Prevention and the National Institutes of Health endorse the science behind the campaign.
MDH is currently developing a campaign to educate people about the benefits of HIV treatment as prevention, with the idea that public awareness can decrease HIV stigma, improve the quality and length of life for people living with HIV and their partners, and provide additional incentive for people living with HIV to achieve and maintain an undetectable viral load. Minnesota’s rate of people known to be living with HIV who are virally suppressed was 63 percent in 2016, compared to a national rate of 49 percent in 2014. The United Nations has set a goal of reaching 90 percent by 2020.
Study Shows Low Awareness of Breast Cancer Screening Risk
The results showed that only approximately 16 percent of the women were aware of the potential risk of overdiagnosis from breast cancer screening and 18 percent were aware of the concept of overtreatment. Women under the age of 40 were the least likely to have heard about overdiagnosis.
Most women in the U.S. aren’t aware that routine mammograms can lead to overdiagnosis and overtreatment of breast cancer, according to results of a new study conducted in collaboration with the University of Minnesota School of Public Health.
When presented with statements about overdiagnosis and overtreatment, most women had negative perceptions of the messages—one in four agreed with and found statements about overdiagnosis and overtreatment to be believable.
QUALIFYING MEDICAL CONDITIONS NOW INCLUDE PTSD Some patients with PTSD have described noticeable improvement in sleep, anxiety, and other PTSD symptoms from use of medical cannabis. Patients interested in enrolling in the program are encouraged to talk with their health care provider. Qualifying medical conditions as of August 1, 2017 include: • Cancer, Glaucoma, Tourette Syndrome, HIV/AIDS, and ALS
• Inflammatory bowel disease, including Crohn’s disease
• Seizures, including those characteristic of Epilepsy
• Terminal illness, with a probable life expectancy of less than one year • Intractable Pain • Post-Traumatic Stress Disorder
• Severe and persistent muscle spasms, including those characteristic of MS
Cannabis Patient Centers are now open to approved patients in Minneapolis, Eagan, Rochester, St. Cloud, Moorhead, Bloomington, Hibbing, and St. Paul. Information on the potential of medical cannabis for treatment of PTSD is available on the Office of Medical Cannabis web site. mn.gov/medicalcannabis
OFFICE OF MEDICAL CANNABIS
email@example.com (651) 201-5598: Metro (844) 879-3381: Non-metro P.O. Box 64882, St. Paul, MN 55164-0882
MINNESOTA HEALTH CARE NEWS NOVEMBER 2017
A survey was conducted to assess women’s awareness and perceptions of two of the main potential harmful effects of breast cancer screening— overdiagnosis, which refers to detection of cancers that grow so slowly that they will never cause health problems during a woman’s life, and overtreatment, which refers to unnecessary treatments such as surgery or medications that expose women to various potential complications and side effects while offering minimal health benefits.
Even fewer women evaluated them as strong arguments to consider in their own decisions about mammograms. Those who recently had a mammogram were even less convinced by the statements. In addition, women with a routine source of medical care, such as a family doctor or neighborhood clinic, were less likely to believe statements regarding overdiagnosis.
families’ access to affordable care; and expanding the Return to Community initiative, which helps people in nursing homes or hospitals or those who may be candidates for nursing homes to return to their homes with supports. Legislation passed this year for the initiative provides a stipend to people who are caregiving to help pay for respite or other necessary help.
The researchers say there is a growing expert consensus that the phenomenon of cancer overdiagnosis is real and may require a re-evaluation of aggressive breast cancer screening strategies. They also believe their findings have implications for communicating with patients about the potential harms of breast cancer screening and emphasize that women with a strong history of following advice to get mammograms may be an important target for interventions to improve informed decision-making.
The foundation uses data from the AARP LTSS State Scorecard and the prize is awarded across four of the scorecard dimensions— affordability and access; choice of setting and providers; support for family caregivers; and effective transitions. Minnesota improved in three of the measures and overall ranked sixth in the country for support for family caregivers. On this year’s AARP scorecard (the third of its kind) Minnesota ranked second after ranking first in 2011 and 2014.
Minnesota Recognized for Family Caregiver Support
Teen Birth Rate Declines in Hennepin County
The birth rate among teenagers fell 12.4 percent in Hennepin The SCAN Foundation has awarded the Pacesetter Prize County in 2016, outpacing the to Minnesota in recognition of statewide decrease of 11.3 percent. its efforts to improve long-term An analysis of Hennepin County services and supports for older birth records showed that 418 feadults, people with disabilities, males ages 15 to 19 gave birth in 2016, compared to 477 in 2015. and their caregivers. The decrease in Hennepin Minnesota was recognized for County continues a trend of deproviding services including coachcreasing teen birth rates—there has ing to help people care for those been a 66 percent decline in the last with dementia; consultation, indecade. In addition, the number of formation, and assistance through repeat births among teens is at a Senior LinkAge Line; and services that give caregivers a respite. In 10-year low of 13.4 percent of all addition, the SCAN Foundation teen births. recognized Minnesota for success including the passage of the CARE (Caregiver Advise, Record, Enable) Act that requires health care facilities to notify family members when an older adult is being discharged and instruct them on how to provide care; expanded employee sick leave benefits for absences due to caring for a relative; the Working Caregiver Initiative, which educates employers about caregiving issues and promotes workplace flexibility; allowing Advance Practice nurses to work at the top of their education and training, which increases
“This has been a long-term focus of Hennepin County, to arm youth to make informed decisions about their sexual health, and to assure access to reproductive health care and caring, approachable adults who can answer their questions and provide guidance,” said Kathy Wick, manager of Better Together Hennepin, the county’s teen pregnancy prevention program. The program’s $1.5 million, five-year grant was recently reduced by the Trump Administration
News to page 6
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THE BEST CHOICE FOR WOMEN’S HEALTH CARE
COORDINATED OBGYN CARE VLow- and high-risk obstetrics, including advanced maternal age. V Certified nurse midwifery. V Gynecologic care, including well-woman screenings and in-office procedures V Menopause Clinic, including management of peri-menopause
V Gynecologic surgeries, including minimally invasive surgeries and robotics for conditions such as endometriosis and pelvic organ prolapse V Center for Urinary and Pelvic Health, including urodynamics. V Nutrition and wellness consultations. V Infertility evaluation and treatment.
Early, late, and Saturday appointments. Consults available. Call 763-587-7000 • OakdaleOBGYN.com MAPLE GROVE • BLAINE • FRIDLEY • CRYSTAL • PLYMOUTH NOVEMBER 2017 MINNESOTA HEALTH CARE NEWS
News from page 5
to three years. It will now end June 30, 2018. The cut was part of $213 million in funding that was cut from the Health and Human Services Teen Pregnancy Prevention Program. The decrease spanned all racial demographics, but there remained distinctive disparities—the teen birth rate is eight to 13 times higher for African Americans, Native Americans, and Latinos. Hennepin County focused its efforts on five cities with the highest birth rates. Four of the five (Brooklyn Park, Richfield, Robbinsdale, and Minneapolis) continued to show a decline, while the fifth city (Brooklyn Center) experienced an increased teen birth rate of 7.5 percent between 2015 and 2016.
more to do. Outperforming the rest of the state is nice, but all indicators tell us that children born to adults who are ready to accept the awesome responsibility of being a parent are more likely to thrive.”
Fairview Clinic Recognized for Midwife Care Fairview Clinics–Riverside has been recognized with the Triple Aim Award by the American College of Nurse-Midwives for providing excellent care to pregnant and laboring mothers.
breastfeeding within 48 hours rate of 94.3 percent. “We’ve developed and use a wide variety of labor support techniques that help us achieve our low C-section rates, such as upright birthing guidelines, labor slings and water birth,” said Jennie Ramsey, CNM, lead certified midwife at Fairview Clinics–Riverside. “Our overall midwifery philosophy contributes to our low pre-term birth rates—we take time to listen to the individual woman, watching for risks of pre-term labor closely and catching issues early enough to intervene. We also are a designated Baby Friendly Hospital, which means breastfeeding is encouraged and patients receive a lot of education and support.”
To receive the award, a hospital or clinic must qualify for three exceptional ratings—low primary cesarean rates (less than 23.9 percent), low pre-term birth rates (less “The Hennepin County Board than 11.4 percent), and high exclu- St. Francis Opens Clinics has long realized that teen preg- sive breastfeeding within 48 hours At Hy-Vee Locations nancies are devastating to all con- rates (greater than 81 percent). St. Francis Regional Medical cerned,” said Mike Opat, Hennepin Fairview Clinics–Riverside midCounty Commissioner. “We have wives have a primary cesarean rate Center is partnering with Hy-Vee made prevention our priority and of 6.9 percent, a pre-term birth- to open two express care clinics at the work is paying off, but we have rate of 4 percent, and an exclusive its Savage and Shakopee grocery
MINNESOTA HEALTH CARE NEWS NOVEMBER 2017
stores. The clinics will include two exam rooms, lab services, and selfserve kiosks. The clinic at the Shakopee location is expected to open in November at the same time that the grocery store opens, and the clinic at the Savage location is expected to open later this year. The express care clinics are accredited by the Joint Commission. “St. Francis and Hy-Vee have a lot more in common than one might think because we’re both making an intentional effort to provide services for modern society, which in one word means convenience,” said Mike McMahan, president of St. Francis Regional Medical Center. “People today want to buy groceries, grab a coffee and get a flu shot all under the same roof.”
PEOPLE TONI STRAND, RN, house charge nurse at Avera Marshall Regional Medical Center, has received the Caregiver of the Year award from the Minnesota Hospital Association. In her role at the Critical Access Hospital, she oversees day-to-day staffing and all associated nursing operations for behavioral health, medical/surgical, obstetrics/postpartum, emergency, and the intensive care unit. She is in charge of code teams, is a super user for the electronic medical record system, and led Avera Marshallâ€™s medication reconciliation improvement project. She began caregiving at age 16 as a certified nursing assistant before progressing to LPN and then RN. Hospital leaders describe her as engaged, eager to help, supportive, and a good problem-solver. JAMES GARRITY, MD, oculoplastics and neuro-ophthalmology practitioner at Mayo Clinic, has received the 2017 George T. Tani, MD, Humanitarian Award from the Minnesota Academy of Ophthalmology. The award is given annually to a member who demonstrates a pattern of humanitarian service involving charitable activities, indigent care, and community service. Garrityâ€™s contributions include founding and directing a monthly eye care clinic for people without insurance at the Rochester Salvation Army, where many of his volunteers are ophthalmic technicians, medical students, and residents at Mayo Clinic who are interested in ophthalmology. In 2016, the clinic served approximately 110 patients in need of eye care or glasses; dispensed 70 pairs of glasses; performed 96 refractions tests; and saw 32 referrals from the Good Samaritan Medical Clinic. Garrity earned his medical degree at the University of Minnesota Medical School. DEBORAH KRAHL, MD, has joined Clinic Sofia, an OBGYN practice with offices in Edina and Maple Grove. She will be based in the Edina clinic and care for patients at Fairview Southdale and Maple Grove Hospital when on call. Krahl has 20 years of experience in the field and has consistently ranked in the top 95 percent nationally in patient satisfaction scores. She specializes in high-risk pregnancies as well as performing minimally invasive and robotic surgeries. She received her medical degree from University of Minnesota Medical School. SANTO CRUZ, JD, has been appointed to the position of deputy commissioner for external relations at the Minnesota Department of Human Services. In his new role, Cruz will oversee the Office of Inspector General, which manages financial fraud and abuse investigations; licenses programs such as family child care, adult foster care, and mental health centers; and conducts background studies on people who apply for jobs in those settings. He has previously held positions at the Minnesota Department of Agriculture and the Minnesota Department of Commerce. He has also served as a prosecutor and press secretary for Hennepin County Attorney Mike Freeman. Cruz earned his juris doctor degree from the University of St. Thomas School of Law.
NOVEMBER 2017 MINNESOTA HEALTH CARE NEWS
The Newborn Foundation Saving lives worldwide
t just two days old, my daughter, Eve, was diagnosed with an asymptomatic critical heart defect—in other words, she showed no signs of her life-threatening condition. Eve survived because of early detection in the hospital and access to life-saving treatment. Inspired by Eve’s success story, I co-founded the Newborn Foundation and advocated for expanded infant screening. Today, all 4 million newborns born each year in the U.S. are screened using a simple, noninvasive monitor.
A little red beam Annamarie Saarinen
The Newborn Foundation Ms. Saarinen is a Humphrey Policy Fellow and co-founder of the Newborn Foundation | Newborn Translational Research Institute. She currently serves on two workgroups under the United Nation’s Every Woman, Every Child initiative, is a member of the Minnesota Newborn Screening Advisory Committee, and was appointed by the U.S. Secretary of Health and Human Services in 2016 to the federal Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC). She has drafted more than 40 pieces of health legislation, authored more than 200 briefing reports, and published six manuscripts on the importance of technology in advancing prevention, early detection, and treatment of pediatric health conditions. Ms. Saarinen is the recipient of the 2016 Global Humanitarian Award from the Patient Safety Movement Foundation and the Betty Hubbard Maternal and Child Health Leadership Award.
Pulse oximetry has been around for more than a quarter century—if you’ve been in the hospital, you may have experienced it in the form of a small meter clipped to the end of your finger. Newborns who otherwise appeared healthy, including some with congenital defects, were not evaluated with this technology at the time Eve was born, but the simple screening test can identify heart abnormalities before any signs are shown. The noninvasive pulse oximeter uses a “little red beam of light” to read both the amount of oxygen in the blood and the pulse rate. The sensor is placed on the newborn’s right hand and either foot, providing a reading within seconds. The American Academy of Pediatrics’ screening protocols determine whether the newborn passes or fails. This pre-hospital-discharge test has also proven to be highly sensitive in picking up other conditions associated with low concentrations of oxygen in the blood (hypoxemia), including pneumonia, persistent pulmonary hypertension, and neonatal sepsis.
Here at home In 2010, Eve’s physicians, in collaboration with the Minnesota Department of Health (MDH), launched the nation’s first multi-hospital pilot project to evaluate newborn pulse oximetry screening on more than 8,000 babies. That same year, following federal evidence review, the U.S. Department of Health and Human Services (HHS) recommended that all 4 million babies born in the U.S. each year should be screened. Within a year, this screening was added to the Recommended Uniform Screening Panel (RUSP). Starting with New Jersey in 2011, states have implemented the screening, which has been shown to reduce the rate of delayed diagnosis of critical congenital heart defects by more than 30 percent. Newborn heart screening now covers 47 states and the District of Columbia. Starting just 7 years ago with one little baby right here in Minnesota, more than 15 million U.S. newborns have now been screened, and nearly 5,000 lives have already been saved or improved thanks to earlier diagnosis of serious heart defects and other serious but “hidden” medical conditions.
MINNESOTA HEALTH CARE NEWS NOVEMBER 2017
Across the globe To expand upon this initial work, the Newborn Foundation co-launched the Newborn Translational Research Institute—a public/private forum to pursue and collaborate on groundbreaking research in newborn and pediatric health. The Newborn Foundation helped co-develop the world’s first low-cost, medical grade, mobile-phone capable pulse oximeter in collaboration with Masimo, and was awarded a grant from the Bill and Melinda Gates Foundation aimed at reducing preventable deaths from pneumonia in babies and young children. Pneumonia remains the top international killer of children under the age of 5, and is a major cause of newborn mortality—lives that could be saved through early detection using low-cost tech. The grant will be used to provide training and educational support and public policy advocacy for screening babies and young children in Ethiopia, Nigeria, and India over a 17-month pilot period.
All 4 million newborns born each year in the U.S. are screened using a simple, non-invasive monitor. The Newborn Foundation was among the first round of investments from the London-based Global Innovation Fund (GIF) for its BORN Project (Birth Oximetry Routine for Newborns) work in rural China and the Philippines. The BORN Project was one of only 14 innovation projects chosen from 100 countries to be presented at the Solutions Summit before the 70th United Nations General Assembly. It was the only U.S.-based project selected. As part of a project funded by the University of Minnesota’s Pediatric Device Innovation Consortium, the Newborn Foundation is working on a proof of concept for what would be the first automated echocardiography for infants and pediatric patients in low-resource health settings. Our newborn screening public health funding bill, the SHINE Act, was recently introduced in Congress. Modeled after the newborn hearing screening (EHDI) legislation, this funding bill will help support state public health programs in the implementation and improvement of point-of-care newborn heart screening.
Summing up “A little red beam of light” is just one of our tools to address critical heart defects and infant mortality. Collaborating with public, private, and governmental entities, the Newborn Foundation has expanded its early initiatives to reach newborns across the globe.
rehabilitate a body, we start T owith the mind and soul. 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 positive and how determined someone is can make all the difference. We believe the most effective therapy treats your body, mind and soul. Thatâ€™s our approach. 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.
To make a referral or for more information, call us at (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, state or local laws. Some services may be provided by a third party. All faiths or beliefs are welcome. ÂŠ 2015 The Evangelical Lutheran Good Samaritan Society. All rights reserved. 15-G1553
NOVEMBER 2017 MINNESOTA HEALTH CARE NEWS
Anesthesiology What can you tell us about the many subspecialties of anesthesiology?
TJORVI E. PERRY, MD, is Abbott Northwestern’s director of Cardiac Anesthesia Services.
Patients have varying medical needs throughout their lifetimes. Anesthesiologists—medical doctors who have received additional training and have completed residency programs in anesthesia— may partner with nurse anesthetists to address needs throughout a patient’s lifetime, from pediatrics to geriatrics, obstetrics to patients with cardiac disease, and from patients in need of joint replacement surgery to patients with chronic pain.
He is boardcertified by the American Board of Anesthesiology.
How do you describe the role of the anesthesiologist? Anesthesiologists care for patients throughout the perioperative period, which covers the times before, during, and after surgery. We optimize patients prior to surgery, support patients and their families during the surgery, and enhance their recovery throughout the hospital stay. The days of anesthesiologists simply putting people to sleep and waking them up at the end of the operation are gone.
Please tell us about the work you do with patients in advance of administering anesthesia. My colleagues and I at the Minneapolis Heart Institute at Abbott Northwestern Hospital specialize in caring for patients with heart and vascular disease. While life expectancy in the United States continues to grow, Americans are eating worse, sleeping less, and spending more time on the couch, and many of them have very serious heart and vascular disease. As anesthesiologists, we try to make sure our patients are mentally, emotionally, and physically ready for surgery. We spend time with our patients and their families before surgery setting realistic expectations for their hospital stay. We also make sure all their organ systems are working as well as can be expected. Sometimes we have to delay or even cancel a procedure or surgery because a patient has uncontrolled diabetes or a blood pressure that may be too high, for example.
How did you train for your career? I was lucky to train at the Brigham and Women’s Hospital and Harvard Medical School in Boston, where we learned to usher patients through their perioperative period in an efficient but safe manner. Today, anesthesiologists take more and more responsibility for running the perioperative setting, from preoperative optimization clinics to operating rooms to postoperative and intensive care units.
Please describe the different types of anesthesia. Depending on the type of operation, we can administer varying doses of medication to achieve the three components of anesthesia: amnesia, analgesia, and muscle relaxation. During general anesthesia, sedatives ensure that patients remain asleep and will be unable to remember the procedure. These patients will not be able to breathe on their own, so we use a breathing tube to ensure safety. During monitored anesthesia care (MAC), we administer precise levels of sedation to leave patients awake and able to respond, even though they may not remember the procedure. Patients receiving MAC can breathe without a breathing tube. Analgesia, or pain control, may include narcotics as well as nonnarcotic pain medications to ensure that patients wake up comfortably after surgery. We may also give pain medications after the surgery to keep them comfortable. Finally, we give muscle-relaxing medication during general anesthesia to make sure the patient’s muscles are relaxed during the operation. These three components ensure the patient’s comfort and safety during surgery.
MINNESOTA HEALTH CARE NEWS NOVEMBER 2017
What is conscious sedation and how is it used? Conscious sedation is an anesthetic technique whereby we administer a sedative medication—enough to relax the patient, but not put them to sleep. The patient breathes on their own and does not need a breathing tube. In contrast with a general anesthetic, the patient is usually up and out of bed a little faster after the procedure. In the Minneapolis Heart Institute, we have started using a conscious sedation technique on our older patients. We have found that, compared with general anesthesia, many of our older patients recover more quickly after conscious sedation, and can sometimes even go home sooner.
How do anesthesiologists work with other members of a surgical care team? Collaboration, communication, and coordination between all members of a patient’s care team—namely surgery, cardiology, radiology, critical care, nursing, and perfusion—has never been more important. All members of the team bring their own expertise. My cardiac and vascular-trained anesthesiology colleagues understand how to monitor blood pressure, heart rate, and blood oxygen levels, among many other vital signs, and will administer all the medications needed to keep patients safe during a large, complicated operation. The other members of the patient’s care team rely on us to know these things, while we rely on their separate expertise to ensure safe and effective care to all our patients.
What are some potential complications a patient might encounter while recovering from anesthesia? Some common complications after anesthesia include nausea and even vomiting. We do our best to give medications during and after surgery to avoid these complications. Itâ€™s also not uncommon to have some shivering after anesthesia, not because patients are cold necessarily, but because of the anesthesia itself. Post-surgical pain, of course, is common, so our job is to predict how much pain the surgery will entail and to administer an appropriate amount of pain medication. Sometimes we also need to give additional pain medication during the recovery period. Other complications, unrelated to the anesthesia, include bleeding and surgical site infections, so we work with our surgical and critical care colleagues to minimize these complications.
The use of anesthesia goes back thousands of years. What have been some of the most important breakthroughs? Anesthesiologists have a long tradition of ensuring a safe environment in and around the operating room. In my opinion, our most important contribution to this tradition has been to leverage technology. For example, our monitors allow us to monitor blood pressure, the electrocardiogram, blood oxygen content, the anesthesia gases we deliver, brain activity, and ventilator settings, to name just a few. More importantly, however, our monitors are all programmed to alarm if the patientâ€™s vital signs wander out of range. When that happens, an alarm goes off and we are able to immediately treat that vital sign. As
technology improves and we continue to innovate, anesthesiologists are committed to improving patient safety.
We try to make sure our patients are mentally, emotionally, and physically ready for surgery.
What advances does the future hold for the field of anesthesia? In my opinion, anesthesiologists will lead the way, in collaboration with the entire surgical team, to standardize how we deliver perioperative care. In many ways, my colleagues and I practice anesthesia the way we trained in our respective institutions. Because many of us trained in different institutions, the way we deliver our care may differ significantly. We are starting to understand that this variability in care delivery may result in variability in how patients fare after their surgery and after their hospitalization. One of the things my anesthesia colleagues and I focus on is standardizing care in a way that allows us to take a unified approach to caring for our patients. We have started a number of promising efforts to standardize our care, and we are hopeful that these efforts will result in better patient outcomes.
NOVEMBER 2017 MINNESOTA HEALTH CARE NEWS
Speech-language pathology Helping children communicate
By Cara Benoit, MA, CCC-SLP
any people associate speech therapy with elementary school: the creative therapist who used fun alliterations with the “s” sound, or the boy who said “wed” instead of “red.” I remember my school’s speech therapist fondly. She sang the “banana fanna fo fanna” song with a level of speed and precision that was incredibly impressive to her young audience. Today, speech-language pathologists (SLPs) employ a much wider range of exercises to help nurture language development.
A broad approach To help improve articulation, speech-language pathologists will work on these “speech sound production skills.” Parents may ask SLPs about lisps, tongue ties, stuttering, and language milestones: when do those first words really need to appear? But SLPs cover much more ground. The increase in autism diagnoses, for example, often leads to questions about eye contact, scripted speech, and social interactions. For children on the autism spectrum, therapy might initially focus on pre-linguistic skills that help build social communication skills, such as using gestures, eye contact, and early vocalizations. Over time, therapy might address pragmatic language skills—how we use both verbal and nonverbal language for different purposes with different partners—as well as expressive language goals such as signing, talking, reading, or even writing. Language influences our overall cognitive development, and vice versa, so SLPs may focus on attention, memory, problem solving, and executive functioning— all cognitive skills. We also address disorders involving voice (characteristics of sound produced by the larynx, or voice box) and resonance (the airflow of speech through the oral and nasal cavities), as well as feeding and swallowing disorders. Some parents are surprised to learn that SLPs can help children develop conflict resolution skills to improve relationships with friends, or teach impulsecontrol strategies to help children maintain focus and participate in classroom group activities. Speech-language pathology is much more than articulation. When is it time for a speech and language evaluation? You don’t need a specialist to identify your child’s developmental milestones—a trip to the library or an online search could provide that information. But this is only part of deciding to seek an evaluation.
MINNESOTA HEALTH CARE NEWS NOVEMBER 2017
Your own level of concern and family history, as well as your child’s level of frustration, birth order, gender, ability to communicate across different settings, and cultural influences are just a few of the factors to be weighed in considering whether intervention is needed. Where do you begin? If you are concerned about your child’s speech and language development, start with a trusted pediatrician. Write down your questions in advance, and keep a log of behaviors that concern you. These specific examples will help guide your consultations with professionals. Follow your instincts. If you have concerns, an evaluation is a great place to start. You can have your questions answered by a professional, gain peace of mind, and, if treatment is recommended, get a full range of options. Your options might include treatment in a variety of different locations. SLPs work in schools, in private practice, and in health care settings. Your pediatrician—and your own evaluation of your child’s needs—can help you determine what would work best for your situation. Common questions When new clients start therapy, their parents often ask some common questions: Why are you just playing with my child? Should we be ordering these flashcards? Will this app help my child learn to talk? Speech therapy often looks like play—but play is one of the best ways for children to learn. By joining the children on the floor or at a child-sized table, we let them take the lead, allowing the session to be driven by their strengths and interests, rather than what we think they should be interested in. We get a feel for the child’s preferences, creating a supportive foundation for building new skills. It’s like climbing a ladder: with each step, we decide if the child has the ability to stay at that step, or if they need to take a step back until they are ready to try again.
Children with language delays may struggle with reading and writing down the road. We use prompts and cues to support each subsequent step, based on what we know about typical development and what we learn about that individual child’s development. For example, one of the most basic steps in starting an interaction is having the child get our attention. We wouldn’t necessarily begin with having them speak a word to get our attention; instead, we would work on setting up the environment with preferred items that allow them to have several opportunities to get our attention. We then might accept a tug on
Speech-language pathology to page19
Try this at home Here are four suggestions to encourage your toddler to talk:
Get on their level 4 Position yourself face-to-face, with good eye contact. It’s important for your child to see your face as you talk. Be on their level metaphorically, too—let go of your agenda, and do what they are doing, rather than what you want them to do.
Limit toys 4 Having too many toys overwhelms kids, distracts them from paying attention to you, and takes away the opportunity for them to ask for more. The fewer the toys, the higher the chance of your child requesting something new!
Use routines and repetition 4 Use everyday activities to build opportunities for communication. For example, when you buckle them into their car seat, sing a funny song or say a phrase that is repetitive so they can start to use the same song or words. Repeat what they say and add one or two steps more— if they make a sound, repeat the sound and add a word. If they say, “go car,” say, “go fast blue car.”
Use sabotage 4 Yes, you read that right. If something is hard to get to or is broken, your child will need to ask for assistance. Why ask for the car if you don’t have to? But if the car is out of reach, the child will have to ask. Put things in a container that they can’t open, have pieces of toys “missing,” or do part of a well-known routine incorrectly. Have them ask for what they need, or name what is different.
NOVEMBER 2017 MINNESOTA HEALTH CARE NEWS
Congenital heart disease Diagnoses and treatments By Jamie L. Lohr, MD, and S. Kimara March, MD
pproximately one in 100 live born babies enter the world with structural heart changes—defects that physicians call congenital heart disease (CHD). About one-third of these abnormalities are life threatening, requiring both early diagnosis and treatment. Many are diagnosed by pre-birth ultrasound, while others are detected through newborn screening by physical examination or pre-discharge pulse oximetry. Some very young children display few symptoms, and their CHD is not detected
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MINNESOTA HEALTH CARE NEWS NOVEMBER 2017
until later in childhood or adulthood. Thanks to recent medical and surgical advancements, most people with CHD live long and healthy lives. The normal heart Twelve weeks into pregnancy, the normal heart is fully formed and beating, utilizing its four separate chambers to collect and pump blood: Collecting chambers, or atria, sit at the top right and top left of the heart, receiving blood from the body and from the lungs and then passing it into the pumping chambers. Pumping chambers, or ventricles, also appear on both sides of the heart, separated from the atria by thin tissue valves that open and close with each beat to prevent backflow. The two ventricles contract rapidly and circulate blood. After our working muscles and organs draw oxygen from our blood, it is returned to the heart’s right atrium. This oxygen-poor blood then passes into the right ventricle, where it is pumped at low pressure through the pulmonary artery to the lungs to be reoxygenated. This oxygen-rich blood then passes from the lungs to the left atrium and on to the left ventricle. The left ventricle pumps blood at high pressure into the aorta, the main blood vessel supplying blood to the body. Thin but strong valves between both ventricles and the blood vessels they supply keep the blood moving forward through the heart. The right and left atria are separated by a thin muscular partition. The ventricles are separated by a thicker, more muscular structure called the “ventricular septum,” or divider. The ventricular septum completes the separation of the high-pressure left ventricle containing oxygen-rich red blood, and the low-pressure right ventricle containing oxygen-poor blue blood. The amazing heart has its own electrical system that beats an average of 70 times every minute, or about 100,000 beats per day. That’s over 2.5 billion beats in an average lifetime. The pumping chambers circulate about 2,000 gallons of blood through the cardiovascular system every day in adults—it’s a little bit less in
children, but not much less. Regular activity does not “use up” these beats, but keeps the heart going stronger, longer!
Complete atrioventricular canal defect, a complex form of septal defect, involves a loss of the heart’s center structures, leading to a low ASD, a posterior VSD, abnormally formed mitral and
Common types of CHD
tricuspid valves, and an abnormal conduction system. AV canal
Although the heart is formed in early pregnancy, it continues to grow
is common in patients with Trisomy 21 (Down syndrome), but
and mature through early infancy. In the United States, about 8–9
can also affect patients with normal genetic findings. It requires
newborns per 1,000 live births have some form of congenital heart
surgical repair in infancy, and often leaves long-term issues with
disease. One-fourth of CHD patients will require surgical repair as
the heart’s valves and electrical system.
a newborn, most of them during their first year. A small number of children and adults will not be diagnosed until later in life. Septal defects may affect the ventricles or the atria. Ventricular septal defects (VSDs), the most common type of CHD, involve a
CHD with cyanosis Although much less common than many other forms of congenital heart disease, CHD with cyanosis (low oxygen levels) can be an
hole in the thick muscular septum separating the ventricles. These
emergency for newborns, often requiring medications or surgery to
holes can occur in different parts of the septum, but the two most
maintain normal blood flow. Tetralogy of Fallot (TOF), the most
common, perimembranous VSDs and muscular VSDs, close off on
common form, represents 5–7 percent of all CHD, and cases can
their own or are too small to require treatment in 80–90 percent
vary in severity. It requires surgical repair and often at least one
of instances. Holes between the thinner-walled atria, or atrial
follow-up surgery due to residual pulmonary valve abnormalities,
septal defects (ASDs), are also common. They are less likely than
as well as lifelong follow-up with congenital cardiologists.
VSDs to close spontaneously, but small defects often do not require
Other cyanotic lesions with two ventricles include total
treatment. If necessary, both surgical and non-surgical (catheter-
anomalous pulmonary venous return (TAPVR), in which blood does
based device insertion) procedures help most patients with septal
not enter the heart normally after picking up oxygen in the lungs;
defects live healthy, normal lives. Abnormalities of the pulmonary valve, which separates the right ventricle from the main lung artery (pulmonary artery), are
Congenital heart disease to page 20
the most common congenital form of valve disease. They can most often be treated with balloon dilation, but very severe types may require a surgical procedure or prolonged hospitalization due to low oxygen levels (cyanosis). Abnormalities of the aortic valve, the valve between the left ventricle and main blood vessel to the body, or aorta, are also common, and severe forms may require surgical relief. Unlike septal defects, valve abnormalities almost always leave patients with some residual abnormalities that need to be closely watched. Isolated CHD limited to the other two valves in the heart,
Most CHD occurs in children that otherwise appear healthy. the mitral and tricuspid valves that keep blood flowing forward between the atria and ventricles, are rare, but often very challenging when they need treatment—which is most often surgical. Coarctation of the aorta, another common CHD associated with the left side of the heart, is caused by a narrowing of the main blood vessel leading from the heart to the body—usually quite far from the aortic valve. It can be associated with other types of heart disease (VSD and aortic valve abnormalities). Most forms
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require surgical repair in infancy and lifelong monitoring for late complications, including high blood pressure. Late detection and late repair are associated with high blood pressure and increased risk of stroke and heart failure.
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NOVEMBER 2017 MINNESOTA HEALTH CARE NEWS
HEALTH INSUR ANCE
Medicare Understanding your options
By Dan Trajano, MD
ealth care policy is in the headlines more than ever and you might wonder how those changes affect your Medicare options. Rest assured that most proposed policy changes are for the individual and Medicaid markets and do not impact Medicare. Whether you are just becoming eligible or you are simply reviewing your coverage, here are some basics to get you started and ease any uncertainty. To start, keep these important dates in mind:
Initial enrollment period: the seven–month window. Most people become eligible for Medicare at age 65. The enrollment
period for those newly eligible is the three months before, the month of, and the three months after your 65th birthday. It’s important to enroll during this specific 7-month window to avoid paying future penalties. If you are still working and covered by your employer’s health insurance, your benefit manager can advise you if you can delay enrolling in Medicare. Annual Election Period: October 15 to December 7. Each year between October 15 and December 7 is the annual election period for certain types of supplemental Medicare plans, such as Medicare Cost, Medicare Advantage, or a Part D plan. This is the timeframe when you can make changes or additions to your current Medicare plan. Plans chosen at this time would start January 1 of the following year. Special enrollment periods. You may be able to enroll at other times of the year if you qualify for a special enrollment period. Events that trigger this include changes to where you live, losing existing coverage, or becoming eligible for different coverage (such as Medicaid or an employer plan). Exceptions. Medigap plans—private insurance policies that can be added to Original Medicare—are open for initial enrollment all year. However, you may have to wait until the annual election period to change from one Medigap plan to another. It’s also worth mentioning that if you are already enrolled in a Medicare plan, your plan may be renewed automatically if you take no action. For example, Blue Cross Blue Shield of Minnesota’s Medicare Cost plan, Platinum Blue, will continue to be available in 2018 and existing members will be renewed automatically if they don’t desire a change.
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MINNESOTA HEALTH CARE NEWS NOVEMBER 2017
Key considerations Before sorting through your options, take some time to review your medical conditions, medications, and certain lifestyle factors. Are you healthy and only looking for basic medical and prescription
drug benefits? Do you have any major procedures or surgeries coming up? Do you need hearing and vision benefits? Do you travel frequently? Also, before making your final decision, verify that your preferred physician is “in-network” for the plan you choose, as it isn’t uncommon for networks to change from year to year.
your out-of-pocket maximum. Medicare Part C, or Medicare Advantage plans, combine Medicare Part A and Part B benefits, so your hospital and medical coverage are provided under one plan. Medicare Advantage Plans are usually HMOs or PPOs. HMOs (health maintenance organizations) typically provide greater cost savings through lower premiums and affordable copays. You are generally required to use a specific provider network and to choose a primary care provider to coordinate your care and provide you with referrals. PPOs (preferred provider organizations) give you a network of preferred providers. They offer more flexibility and choice as you can generally choose any doctor or specialist without a referral, as long as they are in the PPO network. But you may pay more for those services. Because coverage is offered by private health plans, benefits and provider networks differ from plan to plan. Some Medicare Advantage plans include prescription drug, preventive, dental, vision, hearing, and wellness benefits.
ABCDs (and more) of Medicare The two primary components of Medicare are Part A and Part B, often referred to as Original Medicare. Medicare Part A covers most hospital costs. It also covers some nursing home, home health, and hospice care. Most people do not pay a monthly premium for Part A. If you (or your spouse) worked, then you likely paid toward the Part A premium through payroll taxes. With Part A, you pay a deductible and copayments. Most people sign up for Part A when they first become eligible.
With a Medicare Advantage plan, you must continue to pay your Part B premium in addition to any monthly premium. And while you’ll pay a percentage of some costs, these plans can save you money when you use providers in your plan’s network.
Your plan may be renewed automatically if you take no action. Medicare Part B includes most doctor visits, lab tests, medical supplies, and some outpatient expenses. However, Part B does not cover all costs. With Part B, you pay monthly premiums and an annual deductible. Medicare Part B pays 80 percent for most eligible services and supplies, and you pay the rest. There is no out-of-pocket maximum. You will likely have to pay for things like an annual physical exam, routine vision care, hearing aids, most prescription drugs, routine dental care, and extended longterm care. If you are still working and receive health insurance from your employer, check to see if it is primary coverage that pays before Medicare. In that case, you may decide to opt out of Part B. But delaying or declining Part B may trigger penalties later on, so carefully evaluate your options, seek advice, and determine if you’ll be eligible for a special enrollment period later. Beyond Parts A and B, private insurers offer additional coverage options to help pay for costs not covered by Original Medicare. Medicare Cost plans are a popular option in Minnesota. Cost plans are offered through private insurance companies approved by Medicare and include all the benefits of Medicare Part B. In addition, they help pay deductibles, copays, and coinsurance that Original Medicare doesn’t cover. You can choose from medical-only Cost plans or Cost plans with prescription drug coverage built in. You will continue to pay your Part B premium, along with monthly Cost plan premiums, deductibles, copays, and coinsurance. Cost plans are a great choice if you spend part of the year in another state, because you can receive in-network coverage for medically necessary services from any provider that accepts Medicare. These costs will apply toward
Medicare Supplement, or Medigap, plans are designed to
Medicare to page 21
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CALENDAR NOVEMBER CALENDAR ALZHEIMER’S DISEASE AWARENESS MONTH An estimated 5.5 million Americans are living with Alzheimer’s dementia in 2017. It is the sixth leading cause of death in the U.S. and rising, as deaths from the disease have increased by 89 percent between 2012 and 2014. It is the only top 10 cause of death that cannot be prevented or cured. Alzheimer’s is the most common type of dementia, a general term for memory loss and mental ability that impairs daily activity. A progressive disease beginning in the part of the brain that affects learning, Alzheimer’s and its symptoms become increasingly severe as the disease advances through the brain. Other early Alzheimer’s symptoms include challenges in planning or solving problems, difficulty completing familiar tasks, confusion with time or place, misplacing things, decreased or poor judgment, and changes in mood or personality. It is most common in people over the age of 65, and is twice as likely to affect African Americans and one and a half times as likely to affect Hispanics. Anyone experiencing these symptoms should contact their physician as soon as possible. Though no cure currently exists for Alzheimer’s disease, there are treatments available that can temporarily slow the worsening of dementia symptoms. If you or a loved one has been diagnosed with Alzheimer’s, you are not alone. Find more information at www.alz.org, or by calling the Alzheimer’s Association 24/7 Helpline: (800) 272-3900.
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 firstname.lastname@example.org 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.
9 Better Breathers Club
Park Nicollet and the American Lung Association in Minnesota hosts these bimonthly meetings for anyone living with chronic lung disease. Come meet others facing similar issues and learn ways to cope with the challenges that come with chronic lung disease. No registration required. Call Kris at (952) 993-7022 for more information. Thursday, Nov. 9, 1:30–3 p.m., Park Nicollet—Methodist Hospital, Heart and Vascular Center—Conference Rm. B, 6500 Excelsior Blvd., St. Louis Park
Autism Society of Minnesota (AuSM) hosts this monthly support group for parents and caregivers of children ages 4–21 affected by autism spectrum disorder. Come meet others in similar situations and gain insights from their experiences. For more information or to RSVP, call (651) 647-1083.
The Alzheimer’s Association and Coventry of Mahtomedi hosts this monthly support group for people living with memory loss and their family, friends, and caregivers. Come develop a support system, exchange practical information, share feelings, and learn about community resources. Call (651) 528-8442 to RSVP or for more information. Tuesday, Nov. 21, 6–7 p.m., St. Jude of the Lake Parish–Kohler Hall, 700 Mahtomedi Ave., Mahtomedi
Saturday, Nov. 11, 10:30 a.m–12 p.m., AuSM Office, 2380 Wycliff St. #102, St. Paul
14 Cancer Support Group
Minnesota Oncology hosts this monthly support group for anyone with esophageal, gastric, or head and neck cancers and their loved ones. Come share questions and concerns with others who are experiencing a similar diagnosis. The group is led by a licensed psychologist and an oncology registered nurse. For more information, call Jessica at (612) 863-4648. Tuesday, Nov. 14, 3–4:30 p.m., Abbott Northwestern Hospital—Piper Building, 6th Flr., Ste. 602 Conference Rm., 913 E. 26th St., Minneapolis
30 Melanoma Support Group
Allina Health hosts this twice-monthly support group for people affected by fibromyalgia and associated chronic pain conditions. Come share your experiences and gain support and resources from others. No registration required; call (763) 236-5607 for more information. Thursday, Nov. 30, 4:30–6:30 p.m., Courage Kenny Rehabilitation Institute–2nd Flr. Boardroom, 3915 Golden Valley Rd., Minneapolis
Dec.13 Health Care Directives
The National Ataxia Foundation offers this free social group for people living with ataxia, their family members, and friends. Join others who understand to make new connections and gain new insights. Call Lenore at (612) 724-3784 for more information. Saturday, Nov. 18, 10 a.m–12 p.m., Langton Place, 1910 Cty. Rd. D W., Roseville
HealthEast hosts this free support group for brain tumor survivors and their loved ones. Join the informal group discussion for support, education, and a source of hope and encouragement. Free dinner provided. Call Kathy at (651) 232-3987 to sign up or for more information. Monday, Nov. 20, 6:30–8 p.m., St. Joseph’s Hospital, 3M Conference Center, Rms. A/B, 45 W. 10th St., St. Paul
21 Memory Loss Support Group
11 Autism Family Support Group
18 Ataxia Social Group
20 Brain Tumor Support Group
Hennepin County Library presents this free class for anyone wanting to learn more about advance care planning. Come complete or review your own health care directive based on your values, beliefs, goals, and health status. Registration not required. To learn more, call (612) 543-5900. Wednesday, Dec. 13, 1–2:30 p.m., Walker Library, 2800 Hennepin Ave., Minneapolis
America’s leading source of health information online 18
MINNESOTA HEALTH CARE NEWS NOVEMBER 2017
Speech-language pathology from page 13
our shirt as a means of communicating their need for help. Those efforts would be praised, and we would then model use of a word such as “help” or “open” so they can learn how and when to use the word before we actually expect them to use it themselves. Why is early intervention so important? Another common question is, “will my child outgrow their communication problem?” We don’t always know the answer, but we do know that early intervention is important, since communication
Speech and language delays are very common, and very treatable. impacts all areas of development, including social and cognitive development. Children who are not effective communicators may avoid interacting with others because they are frustrated when they are misunderstood; eventually, their ability to make and maintain friendships will be impacted negatively. A lack of solid early language skills can initiate a domino effect: children with language delays may struggle with reading and writing down the road, which can impact their willingness to participate in activities
within a classroom setting, which in turn can impact their overall self-esteem and confidence as they experience perceived failures as a learner. Amy Wetherby, PhD, a Fellow of the American SpeechLanguage-Hearing Association, sums it up this way: “The younger the child is, the more malleable or plastic their brain is.” She also notes that the symptoms of autism can create secondary challenges to social interaction and communication, as well as future behavior problems. Early intervention may address these challenges for all children. Parting words If you have questions about speech development, from language delays to feeding issues to attention span problems, speech-language pathology can provide the answers—or at least point you in the right direction. The sooner the issue can be addressed, the more successful the outcome is likely to be. Speech and language delays are very common, and very treatable—especially if you catch them early, and engage with an appropriate treatment plan. Cara Benoit, MA, CCC-SLP, is the senior program director of pediatric therapies at St. David’s Center for Child & Family Development, where she has served as a speech-language pathologist, outpatient therapist, member of the Multi-Disciplinary Assessment Team, and clinical supervisor.
NOVEMBER 2017 MINNESOTA HEALTH CARE NEWS
Congenital heart disease from page 15
truncus arteriosus, in which there is a single outflow vessel from the heart; and transposition of the great arteries (TGA), in which the great vessels switch positions, leading to severe cyanosis early in life. All of these conditions require early surgical repair for the best outcomes, and all patients may face follow-up surgery or complications. CHD with one ventricle The most complex forms of CHD are the forms with only one pumping chamber. These include complex single ventricles and patients with hypoplastic left heart syndrome (HLHS). These patients often require early surgery for survival and they typically require more than one additional surgery to reach a workable,
appear healthy. CHD can be associated with abnormalities of the kidneys, lungs, digestive system, brain, and development. Some medications used during pregnancy, infections, and health conditions of the mother, including diabetes, increase the risk of having a baby with CHD. Researchers are working to determine the exact causes of different forms of CHD so that it can be prevented or treated more effectively. Conclusion Today, most children with CHD survive to adulthood and lead productive lives. Over two million adults in the U.S. live with CHD, with new adult cases diagnosed each week. Early diagnosis and excellent catheter-based and surgical options have improved the outlook for patients of all ages.
long-term circulation. Outcomes continue to improve, especially in HLHS, although these patients are at risk for long-term complications, including heart failure, arrhythmias, and damage to other organ systems. Why does congenital heart disease happen? About 15 percent of CHD occurs in newborns with genetic conditions, including Trisomy 21 (Down syndrome) and 22q deletion syndrome (DiGeorge syndrome). These infants often have other health concerns. Most CHD occurs in children that otherwise
Don’t Suffer Alone
Jamie L. Lohr, MD, is an Associate Professor of Pediatrics in Pediatric Cardiology and in the Adult Congenital and Cardiovascular Genetics Center at the University of Minnesota. She is board-certified in Pediatrics, Pediatric Cardiology, and Adult Congenital Cardiology. She sees both children and adult patients at the University of Minnesota Hospitals and Clinics and the Fairview Burnsville Specialty Clinic for Children. S. Kimara March, MD, is board-certified in General Cardiology, Interventional Cardiology, and Adult Congenital Cardiology. She treats patients at University of Minnesota Health Heart Care clinics, including locations in Minneapolis, Edina, and Wyoming, Minn.
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Medicare from page 17
“close the gaps” in Original Medicare and pay for costs Original Medicare doesn’t cover. You’ll also have the freedom to travel or live anywhere in the United States and receive plan benefits from
Cost plans are a great choice if you spend part of the year in another state. any provider that accepts Medicare. You can choose from a range of plans and each will have a different set of benefits and premiums. Costs vary and you must continue to pay your Part B premium. Medigap plans do not include prescription drug coverage. It is important to know that if you apply for a Medigap plan more than six months after the month your Part B coverage begins, you may be required to submit a health history with your application. You may not get the plan you want or you may have to pay more. Medicare Part D plans help pay for your medications. You can add standalone Part D coverage to Original Medicare and some other plans that don’t have prescription drug benefits. If you add a standalone Part D plan, you will pay a monthly premium. You may also pay a prescription drug deductible and a copayment.
If you don’t sign up for a Medicare Part D plan when you’re first eligible, and you don’t have other coverage that’s as good as or better than a standard Part D plan, you’ll pay a late enrollment penalty if you sign up later. The penalty is added to your monthly premium and you must pay it as long as you have Part D coverage. So, even if you don’t take prescription drugs now, consider enrolling when you’re first eligible. Need additional help? Medicare can be confusing but luckily there are many resources to help. Your existing health insurance carrier or an independent insurance agent is a natural first step for more information on your options. Blue Cross offers free workshops to learn about Medicare; read more at bluecrossmn.com/medicare. Additionally, you can contact any of the seven Area Agency on Aging sites in Minnesota (http://mn4a.org/aaas/), the official U.S. government site for Medicare at medicare.gov, or by calling 1-800-Medicare. Dan Trajano, MD, serves as Blue Cross’ senior medical director for the STARS and Risk Adjustment Center of Excellence. He is responsible for medical leadership on strategic initiatives to improve quality of medical care, health outcomes, and member experience within the Medicare STARS Center for Excellence.
NOVEMBER 2017 MINNESOTA HEALTH CARE NEWS
Polycystic ovary syndrome A common hormone disorder By Amy Hammers, MD
hile many people don’t know much about polycystic ovary syndrome (PCOS), more than half of women may suffer from it in varying degrees. It is the most common hormone disorder among women of reproductive age, according to the American College of Obstetricians and Gynecologists, affecting more than 5 million women of childbearing age. Particularly for women struggling with infertility, it is important to ensure that PCOS does not affect their chances of conception.
Overview A big name for small cysts on the ovaries, polycystic ovary syndrome is characterized by elevated levels of androgen hormones—male sex hormones such as testosterone that are also present at lower levels in women—as well as abnormal ovulation and multiple small cysts on the ovaries. While these ovarian cysts are not harmful themselves, they can spur hormone imbalances in the body. Patients with PCOS often experience: • Abnormal hair growth on the face
Telephone Equipment Distribution (TED) Program
• Severe acne
• Insulin resistance and difficulty losing weight • Long or infrequent periods • High blood pressure 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.
While the exact cause of PCOS is still unknown, potential causes include excess insulin, genetics, and low-grade inflammation in the body. And even though PCOS is relatively common, many women are still altogether unfamiliar with this syndrome.
Many patients come to me with concerns about getting pregnant or difficulty losing weight but have no idea what PCOS is until they are diagnosed. For instance, one patient came in for her annual exam and mentioned that her periods were very irregular. She asked for advice on how to time intercourse to improve her chances of getting pregnant. Due to her irregular periods, we completed an ultrasound and blood work, which revealed that she had PCOS and was not ovulating very regularly. She was able to start fertility treatments and conceived very quickly, going on to have a normal pregnancy and delivery.
Duluth • Mankato • Metro Moorhead • St. Cloud
The silver lining with PCOS is that doctors are now better than ever at diagnosing the condition and can help women suffering from it to enjoy healthier, happier lives.
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
Risk factors and symptoms PCOS has a genetic component and can run in families. Studies
Please contact us, or have your patients call directly, for more information.
MINNESOTA HEALTH CARE NEWS NOVEMBER 2017
have shown that first-degree female relatives of women with PCOS are more likely to have the disease.
with PCOS; a weight loss of simply 5 percent can normalize ovulation and menstrual cycles in many women with polycystic ovary syndrome.
While there is no particular age range where it is more prevalent, PCOS is often diagnosed during women’s reproductive years, when women experience irregular menstrual cycles or fertility problems. However, PCOS can be diagnosed as soon as girls start menstruating and showing symptoms.
Unfortunately, since we don’t know what exactly causes polycystic ovary syndrome in the first place, all of these treatments are based upon treating the symptoms and seeking to prevent worsening of the outcomes of PCOS.
The presentation and symptoms of PCOS vary greatly from woman to woman. Most women have irregular menstrual cycles— anything from no periods at all to heavy and frequent periods—and many struggle with getting pregnant. Severe acne and dark hair growth are other common characteristics, although, again, not every woman with PCOS faces the same issues. In addition, about 80 percent of women with PCOS are overweight and can have an increased risk of diabetes, high blood pressure, and elevated cholesterol levels. What to do if you suspect PCOS Polycystic ovary syndrome is not something that you can easily diagnose yourself. If you have concerning symptoms, discuss them during your annual exam or with your family doctor. After discussing the clinical symptoms caused by PCOS, a trained doctor, including your obstetrician-gynecologist, may order laboratory tests for elevated androgens in your blood, followed by ultrasound imaging to identify polycystic ovaries. Typically, these ultrasound and lab work evaluations are only ordered after a patient has physical signs of PCOS or a complaint that is consistent with PCOS symptoms. An ultrasound can help to confirm if there is either enlarged ovarian volume or the presence of 12 or more small follicular cysts measuring 2–9 millimeters in diameter. A finding in just one ovary is sufficient to meet the diagnostic criteria for PCOS. Early diagnosis is especially important, since polycystic ovary syndrome can eventually lead to heart disease, endometrial (uterine) cancer, high blood pressure, diabetes, asthma, depression and anxiety, and other significant health complications. Sometimes the symptoms can be mistaken for other hormone abnormalities such as thyroid disorders, which is why a discussion of your symptoms and menstrual cycle, as well as a physical exam, ultrasound, and lab work, are all typically required for a proper diagnosis.
PCOS and pregnancy Sometimes women have no idea they have polycystic ovary syndrome until they try to conceive and struggle to get pregnant. The multiple Polycystic ovary syndrome to page 34
R E H A B I LITATI V E C A R E N E V E R LO O K E D B E T TE R Look noA further than your V own REH B I LITATI E backyard C A R Efor exceptional rehabilitative therapy or acute care. N E V E R LO O K E D B E T TE R Look no further than your own backyard for exceptional rehabilitative therapy or acute care.
The Birches is a stunning community for those in need of short-term rehabilitative care or specialized memory support. Designed to complement its natural surroundings and enhance the warmth of natural light, very own health careincaRe Hospitality-RicH suppoRtive The Birches is aPlymouth’s stunning community for those community feels more like a soothing need of short-term rehabilitative care resort. or specialized Our mission is providing resident-centered, memory support. Designed to complement its Our individualized care is delivered in athat setting that brings compassionate and competent carethe maximizes natural surroundings and enhance warmth the outdoors in...and brings out the best in each resident. quality of life for both residents and their families. of natural light, Plymouth’s very own health care community feels more like a soothing resort. Our mission is providing resident-centered, compassionate and competent care that maximizes H O S P ITA L IT Y- R I C H S Uquality P P OofRTI V Eboth CA R E and their families. life for residents
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However, lifestyle modifications are the most important treatment for polycystic ovary syndrome. These include regular exercise and healthy eating to lower blood pressure and cholesterol levels, and quitting smoking. All of these habits can decrease hormonal abnormalities. In particular, diet and weight loss can significantly decrease the risk of diabetes and heart disease in women struggling
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For women who are not trying to get pregnant, combined hormonal contraceptives are usually very effective in treating abnormal periods and decreasing acne and bothersome hair growth. Medication can also be used to treat high blood pressure, diabetes, and high cholesterol, and to help the ovaries ovulate to support conception.
Balance System®™, VitalStim® Therapy and
14585 59th Avenue North | Plymouth, MN 55446 MAG/PlymouthCommGuide/2016-17
The Birches is a stunning community for those in need of short-term rehabilitative care or specialized memory support. Designed to complement its natural surroundings and enhance the warmth BY health care of natural light, Plymouth’s very own community feels more like a soothing resort. 14585 59th Avenue North | Plymouth, MN 55446 Our mission is providing resident-centered, compassionate and competent care that maximizes quality of life for both residents and their families.
H O S P ITA L IT Y- R I C H S U P P O RTI V E C A R E Our individualized care is delivered in a setting that brings the outdoors in… and brings out the best in each resident.
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Your vagus nerve New treatments and possibilities
By Tacjana K.E. Friday, MD
he vagus nerve is the longest cranial nerve and has the widest distribution in our body, which is why it is referred to as the “wandering nerve.” It emerges from the medulla in the lower brainstem and descends into the neck and thorax, and travels to our visceral (internal) organs in our abdomen. The vagus nerve plays a role in multiple body functions, including digestion and cardiac functions. Physicians now have a new set of tools to address complications related to this vital part of the nervous system.
From brain to body At just over three inches long, the brainstem contains important sensory and motor tracts that allow the brain to communicate information to the spinal cord and peripheral nervous system. Located at the base of the brain and connected to the spinal cord, it consists of three regions: midbrain, pons, and medulla. Despite its small size, the brainstem is one of the body’s most vital areas, coordinating reflexes responsible for cardiac and breathing functions as well as maintaining consciousness. It helps regulate our level of alertness, arousal, heart rate, blood pressure, breathing, and sleep, and is also responsible for autonomic functions such as digestion, sweating, and salivation. Emerging from both sides of the brainstem, the vagus nerve is part of the body’s parasympathetic nervous system, which regulates involuntary and reflexive functions—sometimes referred to as the “rest and digest” functions. The vagus nerve contains two types of fibers:
Compassionate, Comprehensive, & Personalized care for adult and pediatric patients with neurological conditions, including:
Head Injury/Concussion Epilepsy/Seizures Headache/Migraine Neck/Back Pain Sleep Disorders Movement Disorders Parkinson’s Disease Tremors Alzheimer’s Disease Dementia Muscle Weakness Carpal Tunnel Syndrome
Sciatica Neuromuscular Disease Muscular Dystrophy Dizziness Numbness Stroke Multiple Sclerosis ALS And other neurological disorders
Efferent, or motor fibers, carry impulses away from the central nervous system. In the case of the vagus nerve, these efferent components target the muscles of the larynx (voice box) and pharynx (part of the throat), which is responsible for speech and swallowing. They also target the thoracic and abdominal viscera, which are responsible for various sympathetic (“flight or fight”) effects on organs. Some of vagus nerve’s motor fibers inhibit heart rate and adrenal (hormone) secretion, and stimulate the contraction and relaxation of intestinal muscles (peristalsis). They also stimulate glands in the stomach, liver, and pancreas. Afferent, or sensory fibers, transmit information from the
sensory organs to the central nervous system. Approximately 80 percent of the vagus nerve fibers are afferent. These sensory components of the vagus nerve target the external ear, pharynx, larynx, aortic arch (the curved portion of the heart’s main artery), and the thoracic and abdominal organs. Afferent fibers aid in
Blaine | Edina | Lake Elmo/Woodbury | Lakeville | Minneapolis | Plymouth
MINNESOTA HEALTH CARE NEWS NOVEMBER 2017
the function of taste, and help carry the sensations of abdominal
distention and nausea as well as the impulses regulating our breathing and controlling our blood pressure. If the vagus nerve is injured, patients may suffer from weakness or paralysis of the vocal cord, and often display hoarseness. Vagus nerve injuries can lead to difficulty with swallowing, loss of gag reflex, or cardiac arrhythmias. Stimulating the vagus nerve Because of its extensive connections, the vagus nerve can modulate the function of higher brain centers, forming the basis for its potential use in treating many disorders. Vagus nerve stimulation (VNS), an approach often used in conjunction with medications, can help treat drug-resistant epilepsy as well as depression that has not responded adequately to therapy. Researchers are also exploring its utility to treat several other conditions. Patients with epilepsy experience unprovoked, recurrent seizures. Epilepsy is considered drug resistant when an individual has tried two or more appropriate anti-seizure medications, but the seizures are not adequately controlled. In the United States, VNS therapy is indicated in adults and adolescents over the age of 12 and for focal onset epilepsy. VNS therapy is not brain surgery and is delivered by a small device resembling a pacemaker, which is implanted in the chest. Extending from the device is a thin, flexible wire that sends mild impulses to the left vagus nerve in the neck. The right vagus nerve is not chosen because it innervates the heart.
throat or neck, coughing, and shortness of breath. These side effects typically improve over time. Surgical risks include infection, change in heart rate, or injury to the vocal cord during implantation. There is also research underway for implantable VNS devices in the treatment of Alzheimer’s disease, multiple sclerosis, heart failure, headache, gastric motility disorders, and asthma. Expanding VNS technology Vagus nerve stimulation technology is now finding its way into new devices. The CardioFit VNS system, an implantable VNS device, is being investigated to treat heart failure. By activating the vagal efferent (motor) fibers, the stimulation is designed to correct autonomic imbalances that can cause worsening of heart functions, especially in patients with heart failure. Two newer, noninvasive VNS therapies do not require surgery—thereby improving safety and tolerability—and permit patient-administered treatment, when it is needed: NEMOS is an external device that provides transcutaneous (passing through the skin) vagus nerve stimulation (tVNS). Using a handheld controller, the patient can deliver a pulse through an earbud-like device to stimulate a branch of the vagus nerve located
Your vagus nerve to page 32
After being stimulated by the device, the vagus nerve sends these electrical pulses through the brainstem to areas of the brain. Timed pulses are frequently delivered throughout the day to help reduce the duration, frequency, and severity of seizures. It can also help shorten the recovery period after a seizure. The goal of the vagus nerve stimulator is to improve one’s quality of life. For example, it can help reduce the number of hospitalizations related
The vagus nerve plays a role in multiple body functions.
to complications from seizures, and can result in fewer missed days of work. Individuals with the device have also reported feelings of well-being, alertness, improved memory and thinking, and heightened mood. The vagus nerve stimulator can also help individuals with depression who have not been adequately treated after trying at least four antidepressant medications, therapy, counseling, and electroconvulsive therapy (ECT). While there are many benefits, side effects from VNS therapy can occur when stimulating the device. These can include hoarseness or changes in the tone of one’s voice, a tickling sensation in the
NOVEMBER 2017 MINNESOTA HEALTH CARE NEWS
Tendinopathies Common and treatable By Julie Anderson, MD, FAAFP, CIC
y dad, an avid golfer in Arizona, called me the other day frustrated about his golf game. Over the past month, he had been having pain on the inner part of his elbow, which was significantly impacting his handicap. Further questioning revealed that he had fairly localized pain just where the tendon entered his inner elbow, difficulty moving the elbow, mild swelling, and a crackling sound with movement. We discussed the likelihood of medial epicondylitis, or Golferâ€™s Elbow, a type of tendinitis caused by repetitive strain.
Use and overuse As a family physician, I see a lot of overuse injuries, many of which involve injury to a tendon, which is the thick cord that attaches a muscle to a bone. These types of injuries are commonly referred to as tendinitis or, more accurately, tendinopathies. Although most tendon injuries are from repetitive stress leading to inflammation and irritation, they can also be due to acute trauma, causing rupture or laceration of the tendon. Regardless of the cause, these tendinopathies account for nearly 7 percent of all injury-related physician office visits in the U.S., and can have a significant impact on workability and lifestyle. I instructed my dad to see his family physician, but provided him with a little background information before his visit. It is important for patients to understand the causes and symptoms of tendinopathy, as well as the options for treatment and preventive measures to avoid repetitive injury. What is tendinopathy, and why does it hurt so much? Our tendons get used when we exert force on our muscles, and this force then gets transmitted to our bones at the point where the tendon inserts into the bone. Problems can occur anywhere along the tendon, but this junction is the most common site of an overuse injury. The area just before this insertion point receives less blood flow, which may also predispose the tendon to degeneration. The most commonly seen overuse tendinopathies involve the rotator cuff of the shoulder, medial and lateral epicondyles of the elblow, patellar tendon of the knee, and the Achilles tendon of the ankle. Tendinopathy causes pain at the site of the injured tendon and often the surrounding area as well. The pain may build gradually or be quite sudden in onset, and can even be associated with loss of motion in some joints, like a frozen shoulder if a rotator cuff injury is neglected for too long. Typically, pain increases in intensity and duration with time, and can be present while resting during the later stages of the inflammatory process. Most people describe the pain
MINNESOTA HEALTH CARE NEWS NOVEMBER 2017
as sharp and stabbing during the aggravating activity, but they may also have dull aching immediately with rest. Occasionally, swelling may be present, particularly in acute trauma injuries. X-rays may rule out bony abnormalities like fractures and osteoarthritis, but they don’t demonstrate the soft tissue changes of tendinopathy. If further imaging is necessary, an MRI or ultrasound may help delineate the source of the injury if it is not improving as expected. How did this happen? —or, “This can’t be my golf swing!” When we diagnose repetitive stress injuries, we focus on recurrent stress loads on the tendon, which can be caused by all sorts of activities. Some of the more common are:
hopefully avoid the need for additional office visits. However, if symptoms are not improving, physical and occupational therapy is often extremely helpful in getting patients back to full speed. Other conservative treatments include orthotics for foot and knee pain, massage, and ultrasound. My dad would do well to not play golf for a few weeks, wear an elbow compression sleeve, and start stretches when the pain
Patients over 65 tend to have tendons that tolerate less stress.
• Chores: gardening, raking, carpentry, cleaning house, shoveling, painting • Sports: tennis, golf, skiing, throwing, running • Work: typing, factory assembly, line work, repetitive lifting/ pushing/pulling While certain activities may be directly to blame, there are other risk factors that contribute to tendon injury. Patients over 65 tend to have tendons that tolerate less stress because they are less elastic and more susceptible to injury. Other risk factors include: physical limitation, incorrect posture, improper or inadequate exercise or stretching prior to activity, and physical stress from medical conditions like rheumatoid arthritis or diabetes. Some antibiotics are known to affect tendon health, so it is important for patients to notify their physician of any medical issues and medications they are taking.
subsides. If his pain persists, he may want to consider—gasp— visiting with his golf pro to try modifying his technique. For patients who do not improve after a few weeks to months of the above conservative measures, I may offer an injection with a corticosteroid. Great caution should be taken with this approach, as there are potential side effects and risks with the
Tendinopathies to page 31
How do I fix this? —or, “I play in golf league on Tuesday!!” The good news is that most tendon injuries recover with treatment and time. Initially, the most appropriate treatment for overuse tendinopathy is rest, ice, compression of the involved area, and elevation. I typically advise the patient to avoid aggravating activities, particularly the one that caused the injury if it is known. This advice is easier to give than to follow, since most tendons are involved in our daily activities. Therefore, a period of relative rest is probably more appropriate. This helps prevent ongoing damage, reduce pain, and promote healing. There are no great studies proving what duration of rest is most appropriate. Unless there is trauma involved, complete immobilization of the area is avoided as this can lead to atrophy of surrounding muscles and could lengthen healing time by causing deconditioning of the affected area. Once the pain has improved, most patients can start doing some light stretching and strengthening exercises. I often recommend reputable websites with video instructions for patients to access and
NOVEMBER 2017 MINNESOTA HEALTH CARE NEWS
Transitional care units A bridge from hospital to home
By Dan Johnson
magine your Aunt Betty had major surgery and needed a level of post-op care before she could return home—care that the hospital wasn’t ideally suited to provide. Or consider a scenario where your neighbor suffering from Parkinson’s disease required special therapy after a stay at another medical facility. For loved ones in such situations, a Transitional Care Unit (TCU) is an essential but temporary stop—and a real catalyst for recovery. A bridge for patients Think of a TCU as a bridge between hospital and home. A relatively
new health care development in the past 25 years, TCU admissions are now commonplace, offering patients comfortable, healing environments at rates that are more cost-effective than remaining in the hospital. The American Geriatrics Society (AGS) defines transitional care as “a set of actions designed to ensure the coordination and continuity of health care as patients transfer between different locations or different levels of care.” In other words, TCU patients require focused interim care because they are not yet well enough to be transferred to their ultimate discharge destination, which could be a private home, senior residence, or assisted living facility. Average stays in TCUs are about 18 days. Many of these facilities exist as stand-alone centers. Others can be adjacent to senior living communities or hospital campuses. Most modern TCU facilities will have generously sized private room options and other appealing features, such as intimate and/or casual dining options, hydro spas, sunlit therapy spaces, state-of-the-art health care equipment, Wi-Fi coverage throughout, meeting areas for family and visitors, and spaces for faith counseling and worship. Of course, not just the elderly benefit from a stay in a TCU. Patients of all ages can benefit from the wide range of services and specialties most TCUs have to offer, as well the philosophy underlying these facilities. The AGS describes this as a comprehensive plan of support coupled with the availability of health care practitioners who are well-trained in chronic care and have current information about the patient’s goals, preferences, and clinical status. The care model includes logistical arrangements, education of the patient and family, and coordination among the health professionals involved in the transition. Spanning the time that the patient leaves the hospital, settles in to the TCU, and prepares to return home, this model ensures quality care for patients of all ages who have complex health care needs. Comprehensive teams, specialized equipment Those complex needs might include post medical-surgical conditions, orthopedic conditions, neurological conditions, wounds,
MINNESOTA HEALTH CARE NEWS NOVEMBER 2017
pulmonary conditions, diabetes, pain, and other issues that must be addressed before patients will be ready to return to their prior residences. The TCU model provides specific services tailored to each patient, with progress assessed throughout the stay—whether that involves memory care, occupational therapy, physical therapy, speech therapy, post-acute care, or other patient needs.
Average stays in TCUs are about 18 days.
While some TCUs have more resources than others, the standard for most facilities includes personal contact and a nurse-led, interdisciplinary team approach involving physical therapists, occupational therapists, speech-language pathologists, dietitians, social workers, physicians, and nurse practitioners. Therapeutic equipment plays an important role in implementing the medical team’s individualized care plans. At our Catholic Eldercare facility, we offer NuStep recumbent cross trainer and zero gravity gait training, a ceiling track system, and a treadmill to support ambulation training for those with weight-bearing restrictions on one or more lower extremities. The equipment also helps those who may be missing a lower extremity or overcoming weakness. The D2 Dynavision, a leading-edge visual motor and
neurocognitive rehab tool, is used to improve cognitive function, balance, and mobility, all of which are important for improving function and preventing future falls. First steps to recovery Upon admission, TCU staff will conduct a thorough evaluation of the patient’s condition and needs, carefully reviewing their health history and, for many patients, recommendations from the hospital or facility that discharged them to transitional care. If someone comes in with knee pain, for example, the entire team will assess the patient, evaluating foot, hip, and ankle, functional skills like walking, getting in and out of a chair, dressing and toileting, and then will put together a plan to target the necessary areas of focus. Once needs are identified, goals are set and a personalized treatment plan is created. The TCU model of care stresses the need for patients and their families or other loved ones to understand the symptoms, related anatomy, the treatment plan and the rationale behind it, and the reasons for symptoms, so that everyone understands why the rehabilitation experience might be challenging at first and that things may be uncomfortable for them. Then it’s down to work! And if pain is a factor, that becomes a particular focus. Pain control
Transitional care units to page 30
NOVEMBER 2017 MINNESOTA HEALTH CARE NEWS
Transitional care units from page 29
is the gateway to achieving optimal function. This is frequently accomplished through targeted strengthening exercises, or the use of modalities like electrical stimulation and hot/cold therapy. TCUs are skilled at monitoring progress and adjusting the pain plan accordingly so the individual knows that if the first solution doesn’t work, there’s always an alternative. Most TCUs also draw on the latest research to inform the care plan, offering the attendant therapeutic modalities to improve patient outcomes. For Parkinson’s patient care, for example, Lee Silverman’s Voice Treatment is considered state of the art, while lymphedema-certified therapists can effectively reduce the swelling commonly encountered after cancer surgery to remove lymph nodes. What’s covered, what’s not Hospitalizations are, of course, expensive. An important goal of an admission to a TCU is to disrupt or end patterns of frequent rehospitalizations, to reduce costs of care, and yet provide excellent quality care, all with a view to improving the patient’s overall health status. After learning about the advantages that a TCU can deliver, patients and their families often turn to the critical questions: what it will cost, and whether it is covered by Medicare, Medicaid, or private insurance.
MINNESOTA HEALTH CARE NEWS NOVEMBER 2017
An average day’s stay in a TCU can cost $600 and up. It is important to discuss coverage of a TCU stay with your hospital discharge planner or TCU admissions staff. Private insurance, Medicare, and Medicaid may cover a qualifying stay, but it is always smart to avoid surprises. Ask what will be covered and what will not be covered before being admitted to a TCU. Realize, too, that authorization of payment can be discontinued once the goals of treatment have been realized. They will be working with you from day one to plan for the day you will be discharged from the TCU. Staff will alert you as that moment approaches, so plan ahead to avoid rapidly mounting out-of-pocket costs for you or your loved one. Remember, the goal is a successful return home and at the highest level of function possible. It takes an effective team to accomplish this. Your understanding of how it all works can make the difference for you or your loved one. Finally, if you are exploring options for a family member, friend, or yourself, ask lots of questions and, if possible, take the time to tour the TCU ahead of time to make the best decision you can for you or your family member. Dan Johnson is president and chief executive officer of Catholic Eldercare in Northeast Minneapolis, a not-for-profit community of five residential nursing facilities offering senior services such as assisted living, independent living, skilled nursing, and memory care. It opened its own TCU late last year to fill a gap in patient recovery services in Northeast, downtown Minneapolis, and surrounding areas.
Tendinopathies from page 27
procedure. Not all tendons respond to these injections and, in fact, some can lead to rupture of the tendon. Surgical removal of the abnormal tissue is another effective treatment, but should be reserved for patients who have failed conservative therapy. Prognosis for surgery is 70–85 percent, and recovery typically takes 4–6 months. The Key is Prevention —or, “I’m signing up for a golf swing analysis” It is important to remember that most tendinopathies will resolve with time and proper care. In fact, about 80 percent of patients with tendon injuries can expect a full recovery within 3–6 months. Although injury is sometimes unavoidable, there are some actions that patients can implement to help prevent a future tendon injury. My typical prevention strategy focuses on the patient’s individual routine. For athletes, I discuss specific warm-up routines before exercise and stretches afterward. It is important to gradually build up to an ideal activity level, especially after an injury. Patients should take care to not over-exercise tired muscles. To avoid workplace injuries, limiting repetitions is paramount. I will often encourage patients to stop the aggravating activity if
pain occurs (if this is feasible), and to take regular breaks. For patients who have had prior injury, I consider requesting a worksite ergonomic evaluation. Often, human resource staff is equipped to handle these requests, although larger businesses may have specific personnel for this assessment. If a patient does not have access to this evaluation internally, many occupational and physical therapists are trained to come to the job site and offer suggestions to modify repetitive behaviors. For the weekend warriors, many of these same preventive measures will apply. Proper footwear and equipment should be utilized for a given activity, and additional lessons or assistance should be considered for those patients who are prone to injury. Summing up Tendon injuries are common and, fortunately, most resolve with rest and time. Most tendinopathies are preventable if patients become more aware of their repetitive and overuse activities and are able to modify them. My dad continues to golf. He rested for a week. He was able to “fix” his swing and has limited pain in his elbow. I’m sure I will hear from him again soon! Julie Anderson, MD, FAAFP, CIC, is a board-certified family physician at St. Cloud Medical Group. She is a past president of the Minnesota Academy of Family Physicians and a trustee on the American Academy of Family Physicians Foundation.
NOVEMBER 2017 MINNESOTA HEALTH CARE NEWS
Your vagus nerve from page 25
within the ear. The patient controls the VNS stimulation intensity with self-treatment sessions lasting one to four hours and averaging a few times per day. It can also be used as needed while experiencing symptoms prior to a seizure, otherwise known as a seizure aura. This device is approved in Europe for epilepsy.
Your vagus nerve is the largest nerve extending directly from your brain.
Another new device, gammaCore, utilizes non-invasive vagus nerve stimulation (nVNS) to treat certain types of headache. A hand-held device delivers mild electrical stimulation to the vagus nerve through the skin. The patient places the device on the neck on the same side as the pain, at the onset of discomfort or before it occurs. The device stimulates the sensory fibers of the vagus nerve, resulting in modification of pain signals. It has recently been approved by the FDA for acute treatment of pain associated with episodic cluster headaches in adults who have not responded to
conventional treatments. Cluster headaches are rare but extremely painful headaches characterized by recurring attacks on one side of the head. These headaches are also known as “suicide headaches” due to the severity of pain and frequency or clustering of the headaches. In Europe, the device is also used for acute and/or prophylactic treatment of migraines. In addition, gammaCore is under investigation for treatment of multiple other conditions, including depression, epilepsy, gastrointestinal disorders, metabolic syndrome, and inflammation. Summing up Your vagus nerve is the largest nerve extending directly from your brain. It descends through your neck and throat, reaching internal organs throughout your abdomen. A key part of your body’s nervous system, it can affect functions as diverse as digestion, cardiac functions, and breathing and swallowing. Researchers and physicians are now exploring treatments that employ electrical stimulation of the vagus nerve, delivered through both implantable and handheld devices.
Tacjana K.E. Friday, MD, practices at the Minneapolis and Blaine offices of Noran Neurological Clinic. She is board-certified in neurology, sleep medicine, and epilepsy.
AUGUST 2017 SURVEY MINNESOTA HEALTH CARE CONSUMER ASSOCIATION 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 healthcare delivery system. There is no charge to join the association, and everyone is invited. 1. I, or a member of my family, has been prescribed opioid-based pain medications.
2. When I received this prescription I feel I was given adequate information about the dangers of use.
40 30 20 10
30 25 20 15 10 5 0
4. I feel that as a result of this prescription a need to take increasing amounts was developed.
5. I support increased government funding for treatment of opioid use disorder.
Percentage of respondents
Percentage of respondents
Percentage of respondents
Percentage of respondents
Percentage of respondents
30 20 10 0
3. When I received this prescription I feel I was given clear instructions about how to safely dispose of unused medication.
30 25 20 15 10
MINNESOTA HEALTH CARE NEWS NOVEMBER 2017
40 30 20 10 0
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 NOVEMBER 2017 MINNESOTA HEALTH CARE NEWS
Polycystic ovary syndrome from page 23
birth, and cesarean deliveries. When you take the right measures for your baby’s health as well as your own, you can ensure a safe
cysts on the ovaries and elevated androgen hormones can cause women to not ovulate at all or to ovulate very irregularly, which can make timing intercourse to get pregnant very difficult. Many times, these women require medication to help with regular ovulation. If needed, your doctor can share information on options including fertility medications, artificial insemination, and in vitro fertilization (IVF).
and healthy pregnancy and breastfeeding. Take charge of your health If you have polycystic ovary syndrome, or suspect that you do, make sure you see a health professional who can address all of the aspects of this syndrome. It is not simply about abnormal bleeding or the inability to get pregnant. If you have polycystic ovary syndrome, you should have a full evaluation, screening, and/or treatment for all the associated metabolic and hormonal abnormalities that can
Lifestyle modifications are the most important treatment for polycystic ovary syndrome.
significantly affect your overall health and wellness. Taking care of your health will help to mitigate symptoms and enhance your quality of life. Medical professionals can ensure that you receive the support and treatment you need and to help you with any
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Amy Hammers, MD, sees patients at the Maple Grove location of Clinic Sofia, an ob-gyn clinic known for its personalized approach to women’s health care. She is a member of the American College of Obstetrics and Gynecology.
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MINNESOTA HEALTH CARE NEWS NOVEMBER 2017
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
11/19/13 8:09 PM
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
Published on Nov 9, 2017
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