Your Guide to Consumer Information April 2017
Vol. 15 No. 4
Genetic counseling and testing By S. Kimara March, MD, FACC, FSCAI, and Sarah Kreykes, CGC
Understanding gout By Umbreen Hasan, MD, MBA
Autism spectrum disorder By Stuart Steichen, DO
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Radon: Protect yourself and your family Øyvind Birkenes
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Public health Marina McManus
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Genetic counseling and testing: Assessing risk for heart disease By S. Kimara March, MD, FACC, FSCAI, and Sarah Kreykes, CGC
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Alzheimer’s disease and dementia: A growing worldwide epidemic By Debbie Richman
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Autism spectrum disorder: Changing perceptions of a developmental disability By Stuart Steichen, DO
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Sciatica: A symptom, not a diagnosis By Tacjana K.E. Friday, MD
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Prosthetics and orthotics: Improving the “new normal” By Charles W. Kuffel, MSM, CPO, FAAOP
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Understanding gout: Diagnosis and treatment By Umbreen Hasan, MD, MBA
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Understanding your health care coverage: Ways to minimize out-of-pocket costs By Alison Renneke
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APRIL 2017 MINNESOTA HEALTH CARE NEWS
Evidence of Viruses and Bacteria Found in Some Public Water Supply Wells Scientists with the Minnesota Department of Health (MDH) have reported that one year into a twoyear study, they are finding evidence of genetic material from viruses and bacteria in water from some of the state’s public water supply wells. The tests show how much of a microbe’s DNA or RNA is in the water, but do not tell scientists how long they may have been in the water or if the microbe is capable of causing illness. According to the report, the results so far do not mean that people that consume this water will become ill, but do show that the water systems may be vulnerable to contamination. They are now working to determine how to reduce potential contamination.
includes two components—a monitoring study divided into two phases and a community illness study. For the first phase of the monitoring study, scientists collected 478 samples from 82 water systems between May 2014 and April 2015. They found that 8 percent of samples tested positive for human viruses and 11 percent tested positive for salmonella. However, 37 percent of systems had evidence of human viruses and 89 percent had evidence of microbes detected at least once during the study period, showing that water contamination can come and go quickly.
“We don’t know exactly how viruses and bacteria might be getting into wells,” said Anita Anderson, project coordinator at MDH. “That’s part of the work we still have to do: looking at the wells, potential sources of contamination and other factors, and figuring out how the contamination is occurring and what The project began after the 2014 can be done about it.” Minnesota Legislature directed The second phase of the moniMDH to conduct a groundwater virus monitoring project. The project toring study will be completed this
MINNESOTA HEALTH CARE NEWS APRIL 2017
summer, along with the community illness study, which is designed to see if there is an association between viruses in the water supply and illness in the community. A final report including recommendations will be submitted to the Minnesota Legislature several months from now.
Minnesotans Uncertain About Costs and Strategy for Long-Term Care as They Age
Half of respondents also said their biggest concern about retirement is worsening health and needing care. The second biggest concern was not having enough money (40 percent) and being a burden to family (11 percent). About 25 percent answered that they don’t know how they could pay for long-term care and others said they would use personal savings or investments (28 percent), long-term care insurance (21 percent), or government programs (10 percent). “In 13 years, the oldest baby boomers turn 85 and the youngest will be 65,” said Loren Colman, assistant commissioner for Continuing Care for Older Adults at DHS. “We estimate that more than half of these people will need help after age 65 with daily activities such as bathing and dressing as well as housekeeping and other everyday tasks. Yet many people have not planned for and are unprepared to pay for that help.”
A survey conducted by the Minnesota Department of Human Services (DHS) shows that half of respondents said they are not prepared to deal with the help they and their loved ones are expected to need after age 65. The Own Your Future survey was conducted at the 2016 Minnesota State Fair and had more than 2,500 participants. It was designed to provide the state with a snapshot of Minnesotans’ current thoughts According to DHS, the total lifeabout their retirement and long-term time cost for the average person who care planning. uses long-term care is $259,000.
About half of that will be paid out of pocket and the rest will be paid for by Medical Assistance (34 percent), Medicare (10 percent), private insurance (3 percent), and other sources.
care clinics, with 7,200 employees. Currently, HealthEast serves the east metro area and Fairview serves the south, west, and north metro area as well as northern Minnesota.
Currently, family caregivers provide an estimated 92 percent of longterm care in Minnesota. Among the survey respondents, 80 percent said they have provided care for a parent, in-law, or another older relative, but 60 percent said they would not expect their children or other family members to play an active role in their long-term care or that they would not want them to be involved in their care.
The organizations plan to begin integrating once they receive regulatory and legal approval, which they expect to get this spring. Hereford will lead the combined system and it will be governed by the existing Fairview Board of Directors, with the addition of three HealthEast board members. The new name of the combined system has yet to be decided and it is not clear whether the merger will result in layoffs.
“The survey results indicate a need for more Minnesotans to plan with their families how they will manage their needs as they age,” said Colman. “While we explore new financing products, we also have resources to help older adults and their families now.” DHS and other state agencies will use the survey results to gauge how concerns and behavior about retirement and long-term care planning are changing over time and how these trends could potentially influence policy, public information, and outreach efforts.
Fairview, HealthEast Plan to Merge Fairview and HealthEast have announced plans to merge in a move that would create the largest health system in the metro area. “Bringing Fairview and HealthEast together will create a world-class health system committed to serving our communities and the region,” said James Hereford, president and CEO of Fairview. “Our organizations are stronger together. By joining forces, we can expand clinical services and combine our expertise to serve patients where they live and work, giving them access to the widest range of care choices available.”
HealthPartners Developing Online Tool to Lower Prescription Costs HealthPartners is collaborating with GoodRx, a website that allows consumers to compare prescription drug prices at pharmacies and provides online coupons for prescription medications, to develop a personalized cost-saving tool for its health plan members. According to HealthPartners, studies show that up to half of prescriptions aren’t filled or taken as prescribed, often due to the cost of the drugs. The new tool will allow HealthPartners’ members to compare prescription prices at nearby pharmacies while getting information based on their specific health plan, including whether a certain prescription is covered. Members will also be able to track their spending and transfer prescriptions between pharmacies.
“When prescribed and used appropriately, drugs can contribute to lower overall health care costs,” said Scott Schnuckle, senior vice president of pharmacy and business development at HealthPartners. “They can also help people live longer lives and provide a better quality of life. These things can’t happen if people Fairview has seven hospitals and can’t afford to pay for them. This 42 primary clinics with 26,000 emtool will help us remove that barrier ployees on staff. HealthEast operates for our members.” Bethesda Hospital, St. John’s Hospital, St. Joseph’s Hospital, Woodwinds Health Campus, and 14 primary News to page 6 APRIL 2017 MINNESOTA HEALTH CARE NEWS
News from page 5
University of Minnesota Reverses Decision to Close Dental Clinic The University of Minnesota has reversed its decision to close its dental clinic on the West Bank in the Cedar-Riverside neighborhood. The announcement that the dental clinic would close came in November. The University of Minnesota said budget cuts and low reimbursement rates for patients enrolled in Medical Assistance led to losing nearly $800,000 last year. The clinic was scheduled to shut its doors when the building’s lease was up at the end of June. It serves nearly 7,500 patients annually. Since that decision, the University of Minnesota received input from community members and state leaders that led to the decision to keep the clinic open. Todd Thierer, associate dean for clinical affairs for the University of Minnesota School of Dentistry, said they have been in
talks with legislators about ways to maintain the clinic without losing so much money. The clinic’s goal now is to break even.
Summit Orthopedic Surgery Center Receives Prestigious Certification
hip and knee replacement surgeries performed at both locations to 800 in 2017.
Summit Orthopedics’ Vadnais Family Medicine Clinic Heights Surgery Center has earned Adds Substance Abuse CentraCare Opening New The Joint Commission’s Gold Seal of Recovery Specialty Locations Approval for Advanced Certification The University of Minnesota PhyCentraCare Health has opened a for Total Hip and Total Knee Re- sicians Broadway Family Medicine neurosciences facility in Baxter. Cen- placement. It is one of only two am- Clinic has launched a new Substance traCare Neurosciences will provide bulatory surgery centers in the U.S. Use Recovery Clinic for highly comminimally invasive brain and spine to receive this certification. plex pain patients, those struggling care for patients in the Brainerd area The facility has performed more with chemical dependency, and those with acute back and neck pain, brain than 1,800 total hip and total knee who may be concerned about their use tumors, aneurysms, and other vascu- replacements since it opened in 2014. of substances. It opened on Feb. 8. lar malformations. The average satisfaction level for paThe clinic treats patients over the In addition, CentraCare’s St. tients undergoing the procedures at age of 18 and takes appointments on Vadnais Heights Surgery Center was Cloud Hospital Behavioral Health Wednesday afternoons. It is staffed 96.2 out of 100; the average infection by physicians from the University Clinic– Sartell is now open for patients rate was between 0.1 and 0.5 perof Minnesota Medical Schools’ Dein need of therapy to treat depression, cent; and the average time between partment of Family Medicine and anxiety, trauma, domestic violence, surgery and ambulation was between Community Health as well as resand behavioral problems. The facility three hours and 10 minutes and three idents who have additional trainis the only clinic in the state to offer hours and 23 minutes, with patients ing in addiction medicine. Services “warm handoffs” from the nearby traveling an average of 95 to 98 feet. include comprehensive addiction Central Minnesota Child Advocacy medication-assisted Summit opened a new Eagan Sur- assessments, Center, a community partnership that therapy, and substance abuse during launched in October to serve children gery Center in late March, which it anwhen there is a concern of child abuse. ticipates will raise the number of total pregnancy.
MINNESOTA HEALTH CARE NEWS APRIL 2017
PEOPLE JOANIE LENNICK-GOULART , executive director of Ebenezer Tower Apartments in Minneapolis, has received the Caregiver of the Year award from LeadingAge Minnesota. The award honors individuals in older adult services who demonstrate exceptional commitment to older adults and enhance and enrich the quality of life of those in their care. Lennick-Goulart has been with Ebenezer Tower for five years, where she started as a resident services coordinator after completing a graduate school internship. She coordinates the direct care and social well-being of the 192 residents at the facility, which provides housing options for low-income older adults. She also served as construction project manager for a $10.2 million renovation of the building, a role in which she managed communication between the construction crew, staff, and residents to cause as little disruption as possible. Lennick-Goulart earned her master’s degree in counseling and psychological services at St. Mary’s University.
BOB DAHL, president and CEO of Elim Care in Eden Prairie, received LeadingAge Minnesota’s Kal Michels Outstanding Leadership Award. The award recognizes a leader in older adult services who has provided excellent leadership to their employees and organization, enhances the quality of life for the residents in the community, and provides exceptional community service. Dahl began his career at Elim Care in 1981 where he first held the position of a summer administrative intern. He returned as president and CEO in 1994 and has since grown Elim Care from a small, regional, multi-facility organization to a full continuum service provider with 27 facilities in Minnesota, North Dakota, and Iowa. He also serves as a board member for LeadingAge Minnesota, CareChoice, and North Memorial Health Care.
MARY MESNER, RN, nurse at Murray County Medical Center, has received the Good Catch for Patient Safety award from the Minnesota Hospital Association (MHA) for speaking up to prevent a potential patient safety issue. Mesner prevented a medication error before it reached her patient in the emergency room. She noticed that an order was placed for a diabetes medicine that helps control blood sugar levels to be administered to a patient with a blood sugar level of 100. After verifying with the patient that he was not diabetic, Mesner contacted the pharmacy and the provider regarding the order. The provider had intended for the medication to be ordered for another patient whose blood sugar level was 295. The incorrect order was discontinued and reentered for the correct patient. Mesner’s willingness to question a medication order helped prevent her patient from potentially experiencing a hypoglycemic reaction. Because the order was questioned, no error or harm occurred.
APRIL 2017 MINNESOTA HEALTH CARE NEWS
Protect yourself and your family
e take many precautions to keep ourselves healthy. We read the labels on food items and personal care products, we install smoke detectors and carbon monoxide monitors, we get a flu shot before flu season. But there’s one healthy action that many of us miss: testing our homes for radon gas.
An invisible cancer threat
Øyvind Birkenes Airthings Mr. Birkenes is chief executive officer of Airthings, whose mission is to ensure that people around the world take control of their air quality through simple, affordable, and accurate technology solutions.
Produced by the natural decay of uranium, radon is an invisible, odorless, tasteless gas that enters buildings through cracks in floors or walls, construction joints, or gaps in foundations around pipes, wires, or pumps. This deadly gas can build to dangerous levels, particularly in homes that are sealed up tight for the winter. Decreased ventilation means that we breathe more radon into our lungs, increasing our risk of cancer. Approximately 21,000 Americans die each year from lung cancer caused by radon exposure, according to the Environmental Protection Agency (EPA). That’s more than 10 times the number of deaths attributed annually to carbon monoxide poisoning and house fires combined. Additionally, the American Cancer Society recently linked radon exposure to an increased risk of blood cancers in women.
of whether testing or mitigation of the home has been done. There is no disclosure or notification requirement when signing a lease, unlike when buying a home. (The MDH describes common radon mitigation options at http://tinyurl.com/HCN-Radon.)
Testing for radon These laws targeting real estate transactions will help raise awareness of the risks, but there still isn’t broad awareness of the need to measure radon on an ongoing basis. This is imperative to protect yourself and your family. Short-term kits, commonly used at the time of a home purchase, provide a quick snapshot of your home’s radon level, but to monitor long-term fluctuations due to time of year, level of ventilation, and other factors, look for a digital detector that provides continuous, year-round measurements. Some tips:
4 Look for detectors with both short-term and longterm readings, so you can monitor current radon levels as well as average radon levels over an extended period. For convenience and accuracy, opt for a digital display rather than a product that requires mailing your test kit and awaiting results. 4
Two in five homes have radon levels that pose a significant health risk.
Close to home While radon is present to some degree in all locales, high levels of radon are especially prevalent in Minnesota, due to our region’s geology and climate. The Minnesota Department of Health (MDH) says that two in five homes have radon levels that pose a significant health risk, and nearly 80 percent of counties are rated as high radon zones. But until recently, Minnesota had no mandatory radon testing in place for homes, schools, or day care centers; no requirement that homeowners test for radon before selling a house; and weaker real estate disclosure rules than many other states. The Minnesota Radon Awareness Act, implemented in 2014, now requires sellers to inform home buyers whether their home has been tested for radon and, if so, what the levels are and whether the home has been mitigated for radon. In addition, sellers must provide a warning statement and a two-page publication about radon to the buyer. However, the law does not require radon testing or mitigation, only disclosure
MINNESOTA HEALTH CARE NEWS APRIL 2017
Place your radon detector in the room where you spend the most time. Make sure the detector is at breathing height and away from direct sunlight and high humidity, placed at least 20 inches above the floor, 10 inches from the nearest wall, and 60 inches from any doors, windows, or ventilation. Remember to test bedrooms and playrooms on all levels of your home, including the basement, where radon frequently enters the home.
Test year-round to ensure an accurate reading. While you need to monitor your home for radon exposure during every season, you’ll find the most accurate test results in the winter months, when doors and windows are closed and your home lacks ventilation.
Breathe safely Taking action in your own home is simply the first step to reduce the impact of radon exposure. Share the dangers of radon with friends and family, and reach out to school officials and local legislators to ensure proper radon testing is in place throughout public areas. It also is critical to stress the importance of long-term testing for the most accurate view into exposure potential. With the elevated levels of radon in Minnesota, it poses a serious health risk not to take measures to ensure that you and your family are protected from this deadly gas.
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&#x20AC;&#x2122;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
APRIL 2017 MINNESOTA HEALTH CARE NEWS
Public health MARINA MCMANUS retired last November as director of Saint Paul–Ramsey County Public Health. She recently received the Betty Hubbard Leadership Award for her work on behalf of maternal and child health.
What changes have you seen in public health services? As a public health leader in Minnesota for over 40 years, I have experienced significant changes affecting public health policy and practice. Federal programs such as the Maternal and Child Health Program; the Women, Infants and Children (WIC) program; and the Maternal, Infant and Early Childhood Home Visiting Program all provide funding and support to reach high-risk mothers, children, and youth. These programs have improved healthy birth outcomes and beginning years of life, and have produced significant cost savings and long-term societal benefits. The prevention and control of infectious disease has taken on a much broader and deeper role, first with HIV/AIDS, and then with the emergence of the influenza H1N1 virus, West Nile, and, more recently, Ebola and Zika. Bioterrorism has become a significant concern, with public health becoming a vital participant in emergency planning, training, and response at the local, regional, and state level. We adapt and change services based on a comprehensive assessment or in response to short-term issues or critical incidents. Our services expand or contract depending on the availability and affordability of other community resources. For example, we no longer sponsor large routine flu clinics because immunizations are readily available in the community.
What are the most common avoidable health problems you have seen? Many of today’s chronic and costly health issues can be prevented, or the effects significantly reduced, through healthier behaviors and lifestyle. Health statistics clearly show how tobacco use, substance abuse, being overweight, lack of physical activity, poor diet, and mental health concerns can lead to chronic diseases such as diabetes, heart disease, certain cancers, and respiratory disease. Seat belts, bike helmets, child car seats, and safe driving habits can reduce unintentional injuries. Teaching parents to place their infants on their backs to sleep reduces sudden infant death syndrome (SIDS).
What are some programs that might surprise people? Traditional local government planning—land use, transportation, housing, parks and open spaces, community facilities, etc—now includes a public health perspective that goes beyond basic design to include cultural considerations, authentic community engagement, social connectedness
MINNESOTA HEALTH CARE NEWS APRIL 2017
for all ages, access to healthy foods, opportunity and access for physical activity, air and water quality, safety, and community aspirations. There is a health aspect in all policy and planning, since our built environment reflects and affects the “health” of our community.
Which of your initiatives have made the biggest difference? Many of our programs and services make a difference, whether at a primary prevention level—educating and promoting healthy behaviors— or through direct care, such as identifying and treating infectious disease, including tuberculosis and sexually transmitted diseases. Our public health nurse-led home visiting services serve pregnant women (including teens), newborns, infants, and young children and parents. Using evidence-based models, we have increased healthy births, improved high school graduation rates of teen moms, addressed family violence and mental wellness within different cultures, and created a model of practice for African American mothers and fathers. The Saint Paul–Ramsey County home visiting program has received national and state recognition. Our Healthy Homes model protects children and their families from housing-related health and safety hazards. We take a comprehensive approach to assess and address health hazards, rather than focusing on a single hazard. Lead, mold, hazardous chemical storage and use, allergens, radon, and home safety issues are included in the assessment. Family education is critical to the success of this approach in reducing asthma triggers, emergency room and acute care treatments, and loss of time at school and work. A pilot project is underway to evaluate this model, which pairs an environmental health specialist with a public health nurse to conduct assessments and create an improvement plan with the family.
Please tell us about your department’s new efforts to offer Pre-Exposure Prophylaxis (PrEP)—a pill taken once a day to reduce the chance of getting HIV. Under a grant from the Minnesota Department of Health, our Clinic 555 offers PrEP for individuals wanting to protect themselves against HIV. We see both insured and uninsured clients and provide assistance with insurance and affordability. Clinic 555 accepts referrals from health care agencies for PrEP services.
What challenges face local public health departments? Challenges include the loss of experienced and skilled public health professionals through retirements and job changes; attracting and maintaining a culturally and professionally competent workforce; adequate and stable funding and continuing policies; and structures that focus on prevention rather than higher cost intervention and treatment.
How does your department address health disparities? Saint Paul–Ramsey County Public Health has a long-standing commitment to addressing health equity and health disparities through the design and implementation of its programs and services, as well
photo credit: Greg Christensen
as partnering with other community-based systems and organizations. We have staff from many cultures that effectively connect and work with individuals and communities. We have community advisory committees or action teams for our overall programs, and on specific topics of violence prevention, mental health, home visiting, solid waste management, nutrition and active living, and health care access and utilization.
Many of todayâ&#x20AC;&#x2122;s chronic and costly health issues can be prevented.
We conduct client surveys and quality improvement analysis to evaluate whether our delivery of services is appropriate and effective. We provide staff and other resources to support culturally specific health information and education through various media. This past year, we partnered with the Institute for Clinical Systems Improvement (ICSI) to develop culturally appropriate health care guidelines for Hmong populations.
How is your department involved with the health-related issues of climate change? We have completed a community vulnerability assessment for Ramsey County that has generated national interest from the Centers for Disease Control and Prevention (CDC). We have provided education to our staff,
presented the findings to local elected officials, and held policy discussions with our primary advisory committees on future planning and community.
What role can public health play in addresing gun violence? The public health community has been a strong advocate for addressing the growing problem of gun violence. It is a public health issue because of the numbers of intentional and accidental injuries and deaths caused by firearms across all populations, as well as the high costs of immediate and long-term care (physical and psychological) for individuals and families. Successful health policy decisions and approaches are based on research. It was research into understanding the impacts on childrenâ&#x20AC;&#x2122;s health and the need for protection that resulted in reduced second-hand exposure to smoking tobacco and to lead in our environment. Research on gun violence has been blocked at the federal level, hampering our ability to understand and address this issue. However, existing data on premature deaths and injuries in younger populations warrants a renewed effort on the part of all health professionals, along with family and community involvement and support, to advocate for stronger policies and approaches.
How do you assure taxpayers and elected officials that public health programs and services are of high quality and efficient? The department last year received national accreditation from the Public Health Accreditation Board (PHAB), demonstrating that it meets or exceeds rigorous national standards and is committed to continuous quality improvement. Currently, just 163 state and local health departments across the country are accredited.
APRIL 2017 MINNESOTA HEALTH CARE NEWS
Genetic counseling and testing Assessing risk for heart disease By S. Kimara March, MD, FACC, FSCAI, and Sarah Kreykes, CGC
any of us know that a healthy lifestyle can help ward off heart disease, but are less familiar with the role of genetics. If your family tree includes a history of heart trouble, you may have inherited risk factors for some genetic cardiovascular conditions. Until recently, patients were not always sure whether they carried—or would pass on—these risk factors, but advances in genetic testing and counseling have changed that. Genetic testing
and counseling can be life saving, identifying people and fetuses at high risk and pointing the way to earlier treatment options, preventive measures, and changes in lifestyle. The ABCs of DNA Each cell in your body contains 20,000–30,000 DNA-bearing genes packaged into 46 chromosomes (23 pairs). You inherit pairs because one copy of each chromosome, and therefore one copy of each gene, comes from each of your parents. One of these pairs of chromosomes determines sex. The remaining 22 pairs are labeled autosomal chromosomes, shared by both males and females and bearing genetic information unique to each individual. The exact combination of genes is determined randomly at conception, which is why one sibling might have red hair and another have black hair. But not all variations are merely cosmetic. Some genetic heart conditions develop when a parent has one autosomal gene that is normal and one that is abnormal or broken—a condition that geneticists call an autosomal dominant (AD) pattern. (Coronary artery disease and heart attacks are rarely AD.) The broken gene prevents normal development and leads to cardiovascular disease, and a parent with this AD pattern has a 50 percent chance of passing the abnormal gene on to each of his or her children. If a person inherits one normal and one abnormal gene, they will develop the AD condition and have a 50 percent risk of passing it on to their own offspring. If a person inherits two normal genes (one from each parent), then they are not at increased risk for disease and cannot pass it on. Sometimes, a family history of heart disease can appear to be negative or to “skip” a generation. This can happen for two reasons: reduced penetrance and variable expressivity. “Reduced penetrance” means that not everyone who inherits the gene develops symptoms. “Variable expressivity” means that the age of onset and severity of disease can differ, even within the same family.
MINNESOTA HEALTH CARE NEWS APRIL 2017
Assessing risk Genetic counselors do not treat heart conditions, but they can assess your familial risk factors and “read” the genetic code of your cells, offering invaluable tips to protect your health and that of your direct relations. Genetic testing is most commonly available for these cardiac conditions: • Familial hypercholesterolemia, a genetic condition that leads to high levels of LDL (“bad”) cholesterol • Hypertrophic cardiomyopathy, in which heart muscles thicken, diminishing pumping ability • Dilated cardiomyopathy, an enlargement and weakening of the heart’s chambers, particularly the left ventricle • Arrhythmogenic cardiomyopathy (AC), in which muscle in the ventricle is replaced by fat or connective tissue • Long QT syndrome, a heart rhythm disorder that can cause fainting, seizures, and even death • Brugada syndrome, marked by potentially dangerous irregular heartbeats in the lower chambers • Thoracic aortic aneurysm or dissection, a bursting or rupture of the major heart artery • Family history of sudden cardiac or unexplained death at a young age (<50 years)
patient, it may encourage at-risk family members to be tested as well, before they even have symptoms. Learning your genetic status can allow for earlier treatment options, preventive measures, and changes in lifestyle. For example, a person who carries a gene for a genetic arrhythmia condition, such as long QT syndrome, will be monitored more frequently, be assessed for medications to reduce risk of a cardiac event, and may have a defibrillator placed to reduce risk of sudden cardiac arrest. What happens at a genetic counseling appointment? Genetic counseling is a communication process to discuss a genetic condition and the associated risk of inheritance, as well as to collect a detailed family history. Typically, genetic counseling happens before genetic testing. The genetic counselor will discuss testing options, as well as the limitations, capabilities, potential risks, and logistics of testing. Genetic counselors provide support and guidance on the testing process. However, since genetic testing has practical implications, including cost and insurance issues different from those of other medical tests, the patient and/or family must choose whether to proceed with testing. Genetic counseling and testing to page 34
Patients bearing a gene mutation related to these and other genetic cardiovascular conditions are at increased risk for developing the disease. However, genetic testing cannot predict when symptoms will occur or how severe symptoms will be. Symptoms and the course of the disease can vary widely, even within the same family. With some conditions, such as AC, competitive athletes face a greater risk for cardiac events, including sudden cardiac arrests. Therefore, a cardiologist may recommend that they restrict their activities.
Genetic testing and counseling can be life saving. It is important to note that many common cardiac conditions, such as coronary artery disease, are caused by a combination of genetic and non-genetic factors. Genetic testing is not available for common cardiac conditions that have both genetic and non-genetic causes. For example, coronary artery disease can be familial, but lifestyle factors play a significant role in the course of the disease. These factors include diet, exercise, diabetes, and smoking. Acting on test results Confirming these risks by genetic testing can be extremely beneficial and potentially life saving, and not just for the individual patient. When genetic testing identifies a disease-causing variant in one
APRIL 2017 MINNESOTA HEALTH CARE NEWS
Alzheimer’s disease and dementia A growing worldwide epidemic By Debbie Richman
esearch studies showing a drop in dementia rates made headlines last fall, but the full story is much more complicated. The age-specific risk of Alzheimer’s disease and other dementias may indeed have declined, perhaps due to increased levels of formal education and improved heart health, but the actual number of Americans with dementia continues to rise as our population ages. And the raw statistics overlook the costs—emotional, financial,
A diagnosis of
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It raises many questions few of us are prepared to answer, such as: • How can I take time off from work? • Can I get help paying bills? • What is the difference between a health care directive and a power of attorney? • Can I keep my health insurance even if I lose my job? • And many others. If you or a loved one is facing cancer, we are here to help.
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and practical—of each individual case. To understand these factors, as well as the proactive steps you might take to reduce your risk, it helps to learn more about this disease. Distinguishing between Alzheimer’s and dementia Dementia is not a specific disease—it’s an overall term that describes a wide range of symptoms associated with a decline in memory severe enough to interfere with daily life. For example, you can compare the word “dementia” with the word “cancer.” Both words are used to describe a group of distinctive diseases. Both are umbrella terms. When someone says they have cancer, you’d want to know what type of cancer they have, like skin cancer, breast cancer, etc. Similarly, when someone says they have dementia, your next question should be about what kind of dementia they have, like vascular dementia, Huntington’s disease, Alzheimer’s disease, or any of a number of other forms. Alzheimer’s is the most common type of dementia, accounting for 60 to 80 percent of all cases. However, a diagnosis of dementia doesn’t guarantee you have or will develop Alzheimer’s disease. Numbers and costs Each new instance of Alzheimer’s disease adds to a problem that’s rapidly growing out of control. According to the Alzheimer’s Association “2017 Alzheimer’s Disease Facts and Figures” report, an estimated 5.5 million Americans are living with Alzheimer’s, with someone developing this disease every 66 seconds. Since 2000, deaths from Alzheimer’s have increased 89 percent. In 2016, nearly 16 million family and friends provided over 18 billion hours of unpaid care to those with Alzheimer’s and other dementias, a contribution to the nation valued at $230 billion. If it doesn’t impact you directly, it will financially. Alzheimer’s is the most expensive disease in America. For the first time in history, Alzheimer’s is estimated to cost our nation over a quarter of a trillion dollars, even before factoring in the impact on employers and communities.
Alzheimer’s disease cannot be cured, but we may be able to slow the impact of dementia—both Alzheimer’s dementia and some other forms—and maintain brain health. Understanding dementia rates In its November 2016 issue, JAMA Internal Medicine cited research showing that the percentage of American seniors with dementia (which statisticians call the dementia prevalence rate) had decreased from 11.6 percent in 2000 to 8.8 percent in 2012. More years of education, higher net worth, and late-life obesity were significantly associated with lower risks of dementia (mid-life hypertension and obesity are much more likely than late-life obesity to increase the risk of dementia).
dementia risk factors such as high blood pressure, diabetes, and high cholesterol. Eating a heart-healthy diet benefits both your body and brain. In general, this is a diet lower in saturated fats. Research targeting the relationship between diet and cognitive functioning is somewhat limited, but it does point to the benefits of two diets in particular: the DASH (Dietary Approaches to Stop Hypertension) diet and the Mediterranean diet. These diets can help reduce heart disease and may also reduce risk of dementia.
Alzheimer’s disease and dementia to page 32
It’s important to distinguish between this prevalence rate (the percentage of the population with dementia) and the prevalence number (the total number of people with the condition). As the number of Americans 65 and older continues to swell, the total number of people with dementia—which includes those diagnosed in prior years—continues to rise. Figures appearing in the Alzheimer’s Association “Facts and Figures” report also support this trend.
Alzheimer’s is the most expensive disease in America. The good news is that a half-dozen research studies on dementia incidence consistently indicate a measurable decrease in incidence of dementia in highly developed countries. Researchers almost unanimously suggest that this change is due to increasing levels of formal education and better control of heart health risk factors (e.g., blood pressure, diabetes, and smoking) in these countries. At the same time, we must acknowledge the growing worldwide Alzheimer’s and dementia epidemic. The drop in rates is encouraging, but the swelling numbers of people with Alzheimer’s or another dementia is still expected to grow dramatically in the coming years and decades. Acting on the data These and other research studies suggest that good nutrition, combined with mental, social, and physical activities, may have a greater benefit in maintaining or improving brain health than any single activity. One two-year clinical trial of older adults at risk for cognitive impairment showed that a combination of physical activity, nutritional guidance, cognitive training, social activities, and effective management of heart health risk factors slowed cognitive decline. If it’s safe for you, engage in cardiovascular exercise to elevate your heart rate. This will increase the blood flow to your brain and body, providing additional nourishment while reducing potential APRIL 2017 MINNESOTA HEALTH CARE NEWS
BEHAVIOR AL HEALTH
Autism spectrum disorder Changing perceptions of a developmental disability By Stuart Steichen, DO
utism spectrum disorder (ASD) is the term now used for a range of conditions previously classified separately as autism, Asperger’s syndrome, pervasive developmental disorder, and childhood disintegrative disorder. Symptoms range in severity along this spectrum, from mild and easily managed to severe and intensely debilitating. This neuropsychiatric disorder affects about 1 in every 68 children, mostly boys, and occurs in all racial, ethnic, and
socioeconomic groups. It is considered a developmental disability, often present from birth. While ASD can present challenges to individuals and families, ongoing research has paved the way to improved diagnosis and effective early intervention. Symptoms of ASD Children with ASD struggle with varying degrees of learning, social interaction, verbal skills, and non-verbal communication. They may have repetitive interests or restrictive behaviors. They may have a wide range of intellectual abilities, sensory impairments, or lack of motor skills. ASD also can affect a child’s imagination and self-regulation. Speech difficulties are quite common. Some children start to build a small vocabulary but stop between the ages of one and two. Children with ASD may seem tougher than others—for example, they may not cry when they fall. They may fail to make eye contact, but seek a separate visual stimulus, such as waving a stick in front of their eyes. Many parents are surprised by the challenging behaviors that arise in children with ASD. These children can be violent to others, damage property, or engage in fecal smearing. Eating and sleep patterns are often disrupted, with some children ready to start their day at 3 a.m. Holidays and large gatherings—especially those filled with the sensory issues that trigger ASD sensitivities—can be particularly stressful. Triggers may include strong smells from foods or perfume, excessive hugging and touching, crowded rooms, loud noises, and unfamiliar faces. Some people avoid these situations; others prepare for them ahead of time by role-playing. Not all forms of ASD are severe, however, and children with milder forms may not be diagnosed early. These children may play baseball, join Cub Scouts, and seem perfectly normal until they get a little older. They may communicate, but poorly. These children may function well in a supported school or employment setting.
MINNESOTA HEALTH CARE NEWS APRIL 2017
Other children display signs as newborns. In one such instance, a parent noticed during their first week of infancy that one of her twin sons—later diagnosed with ASD—seemed so much less alert and so much more relaxed than his brother. He made no eye contact while nursing, and did not like to snuggle much. The boy’s fine motor skills seemed overly developed, with a greater focus on detail. At six months, he sat in the middle of the carpet, picking up tiny rocks or bits of dirt and setting them aside on a tissue. As a one-year-old, he entertained himself by carefully turning pages in a dictionary or Bible for an hour. He was determined to learn to ride a tricycle and practiced constantly in a gym to the exclusion of other activities or other children. He began to toilet train himself at 18 months, but did not speak until after the age of two. Then, he woke one morning and began speaking in entire paragraphs. Before the age of three, he had memorized several children’s books. He had an unusual tolerance to pain, never crying during infant vaccinations or after bumping his head while learning to walk. This high-functioning child is now doing well in school, practices his violin five days a week, sings in his school choir, and reads at his church once a month. Occasionally, ASD is not diagnosed until a person is older. According to the Autism Science Foundation, signs of ASD in adolescents or adults can include anxiety in social settings, trouble forming and maintaining relationships, difficulty in making conversation, trouble practicing socially appropriate behaviors, and difficulty making eye contact. Adults with ASD may develop restricted or unique interests, such as obsessions with dictionaries or encyclopedia facts, as well as an obsession with rigid routines or trouble planning for the future.
contact or respond to their names. In a recent article appearing in the journal Nature, University of Minnesota assistant professors Jed Elison and Jason Wolff, together with other researchers, state that physicians may soon be able to diagnose infants at a much younger age, by tracking their brain growth using MRI technology and neurobiological data. Excessive brain growth between six and 12 months of age is a significant predictor of ASD, according to Elison. According to the website of the university’s Institute of Child Development, “researchers found that brain differences at six and 12 months of age in infants with older siblings with autism correctly predicted eight out of 10 infants who would later meet criteria for autism at 24 months of age in comparison to those infants with older ASD siblings who did not meet criteria for autism at 24 months.” Children with ASD may experience concurrent symptoms of anxiety, ADD (attention deficit disorder), ADHD (attention deficit hyperactivity disorder), aggression, epilepsy, or gastrointestinal disorders. Sometimes it is these conditions that prompt an initial visit to a physician and a subsequent diagnosis of ASD. If you suspect your child may have ASD, see your physician. There are cognitive assessment tests that can be given to even very young children.
Autism spectrum disorder to page 19
Not all forms of ASD are severe.
Contributing factors ASD is often genetic. Siblings of children with autism have ten times the risk of being diagnosed with ASD compared to siblings of children without the condition. Research continues to identify genes associated with the disorder, but this research has not yet led to personalized clinical treatment or prevention. Environmental factors can also lead to autism. These include advanced ages of the parents, prenatal infections, fetal cerebral hypoxemia (a shortage of oxygen during pregnancy), prematurity, or exposure to toxins. Despite some publicity to the contrary, immunizations and vaccines have not been found to contribute to ASD. Diagnosing ASD Most children with ASD are diagnosed at age two or older, when they start exhibiting symptoms, including a failure to make eye APRIL 2017 MINNESOTA HEALTH CARE NEWS
CALENDAR IRRITABLE BOWEL SYNDROME AWARENESS MONTH Irritable bowel syndrome (IBS) affects more than 30 million people in the U.S. However, even more people remain undiagnosed and unaware that their symptoms indicate a disorder. In April, the International Foundation for Functional Gastrointestinal Disorders works to spread the word about IBS diagnosis, treatment, and quality of life issues. IBS is caused by abnormalities in intestinal functioning. Symptoms include constipation, diarrhea, increased gas, stool urgency, and abdominal bloating, cramping, and pain, typically over months or years. These symptoms tend to go through periods of remission and exacerbation, which often reflect factors such as stress/anxiety or a known irritant such as wheat. IBS can cause a great deal of discomfort and distress, and severely affect a person’s quality of life. If your daily schedule is often affected by intestinal discomfort, talk to your doctor to get tested for IBS. While there is no cure, there are ways to manage symptoms, such as following a healthy diet and practicing good stress management techniques. For those with moderate to severe IBS, there are therapeutic options that can be considered as well.
Beyond Medicine for Children with Special Needs
PACER hosts this free workshop for parents of children with mental health, emotional, or behavioral needs. Come find out how to optimize your children’s frequent doctor visits and learn what role medications play in treatment and how to apply that information to have better outcomes at school, home, and in the community. Call (952) 838-9000 to register. Tuesday, April 18, 6:30–8:30 p.m., PACER Center, 8161 Normandale Blvd., Minneapolis
Bladder Cancer Support Group
Thursday, April 20, 6–8 p.m., Richard M. Schulze Family American Cancer Society Hope Lodge, 2500 University Ave. SE, Minneapolis
Allina Health offers this free weekly support group for people with aphasia to practice communicating. Led by Courage Kenny Rehabilitation Institute speech therapists. No registration required; call Elise at (612) 775-2676 for more information. Friday, April 21, 10–11 a.m., Courage Kenny Rehabilitation Institute, 3915 Golden Valley Rd., Golden Valley
Rett Syndrome Education Day
Gillette Children’s Specialty Healthcare and the Midwest Rett Syndrome Foundation present this free day of learning and connection for families and caregivers of people living with Rett Syndrome. Come learn about drug and research updates, communication issues, and parenting tips. Call Kelly at at (651) 310-1810 to register. Saturday, April 22, 8 a.m.–4 p.m., 10 River Park Plaza, St. Paul
Wednesday, May 3, 6–7:30 p.m., Walker Library, 2880 Hennepin Ave., Minneapolis
Cancer Survivorship Conference
The University of Minnesota hosts this free annual educational conference that focuses on questions and issues survivors and their families often face after cancer treatment or following stem-cell transplantation. Registration required. To sign up, call (612) 624-2620. Saturday, May 6, 8 a.m.–1 p.m., University of Minnesota, McNamara Alumni Center, 200 SE Oak St. SE, Minneapolis
Aphasia Communication Group
Health Care Directives
Hennepin County Library and Fairview Health Services offer this class for anyone wanting to learn more about advance care planning. Come learn how to complete or review your own health care directive. Registration not required; other dates and locations available. To learn more, call (612) 543-5669.
Fairview Health Services offers this free support group for bladder cancer survivors and their caregivers, friends, and family. Come be part of the conversation with others affected by bladder cancer to support and educate each other. Call (612) 379-6352 for more information
Look Good, Feel Better
HealthEast offers this free program in collaboration with the American Cancer Society. Join a licensed cosmetologist who teaches people with cancer ways to enhance their appearance and self-image during chemotherapy and radiation treatments. Registration required. Call (800) 227-2345 to sign up or for more information. Wednesday, May 10, 10 a.m.–12 p.m., St. John’s Hospital, Nygaard Rm., 1575 Beam Ave., St. Paul
Park Nicollet offers this monthly class for people who are at risk of developing lymphedema from surgical procedures or radiation therapy. Come learn the causes, signs, and symptoms of lymphedema and discuss practices to decrease the risk of developing it. Call (952) 993-5700 to register. Wednesday, May 10, 12:30–1:30 p.m., Park Nicollet Frauenshuh Cancer Center, Curtis and Alrene Carlson Family Community Rm., 3931 Louisiana Ave. S., St. Louis Park
America’s leading source of health information online 18
MINNESOTA HEALTH CARE NEWS APRIL 2017
Autism spectrum disorder from page 17
and promised treatments. Sadly, there are a number of unproven treatments advertised that probably do more harm than good.
Stressing early intervention Evidence shows that early, intensive behavioral intervention can improve cognitive ability, adaptive skills, and language in those with ASD, underscoring the importance of early identification. There is now evidence to support the use of a screening tool at 18- and 24-month well child visits for those children suspected of having the disorder.
Parents who are interested in trying new medications for their children may be eligible for a clinical trial. Ask your physician about studies in your area, or visit www.nih.gov/health/clinicaltrials or www.clinicaltrials.gov for more information.
While there is no cure, physicians have long known that early intervention leads to better outcomes for children with ASD who are treated with cognitive and communication training. Treatment for ASD targets the behaviors. Therapists use highly structured interventions and skill-oriented training to help children with their social skills, language development, and reversal of negative behaviors. No medication has yet been approved to treat the underlying symptoms of ASD, but there are drugs that can ease individual symptoms, including anxiety, depression, and obsessive-compulsive disorder. Physicians may prescribe antipsychotic medications to treat severe behavioral problems, anticonvulsant drugs to treat seizures, and medications such as Ritalin and Adderall to treat those with attention deficit disorder. Parents almost always want to do something to help their children. As a result, they often are misled by unreliable sources of information
Looking forward If you suspect your child may have ASD, reach out for help early. Schools can help guide you to available resources. It can be difficult to grow comfortable with the uncertainty of your childâ&#x20AC;&#x2122;s future, but support groups and autism day treatment programs can link you with others for advice and encouragement. Remember to focus on the positive. Praise your child for his or her good behaviors. Stay consistent in your daily planning for activities. Routines are good. Learn all you can about ASD so you can make good choices for your child. Your physician will partner with you as you travel this journey with your child, offering medical advice and psychological support. You are not alone.
Stuart Steichen, DO, is a board-certified family medicine physician at the Apple Valley Medical Center.
APRIL 2017 MINNESOTA HEALTH CARE NEWS
Sciatica A symptom, not a diagnosis
By Tacjana K.E. Friday, MD
ciatica causes pain, tingling, or numbness along the path of the sciatic nerve, which originates in the lumbar (lower) spine and extends down the leg. Sciatica refers to the symptoms of an underlying condition—most often involving the lumbar spine— and is not a specific diagnosis. Bones and nerves Your spine consists of mobile bones, or vertebrae, separated by
discs that act as shock absorbers and as flexible connectors. At each level and on both sides of the spine, nerve roots, or radicular nerves, exit through holes in the bone (foramen) and lead to different parts of the body. The lumbar spine’s lowest two segments, the L4-L5 and L5-S1 vertebrae, bear the most weight, and are most prone to degradation and injury. The sacrum—a triangular bone formed by fused vertebrae just above the tailbone—meets the flexible lumbar spine at the lumbosacral joint (L5-S1). This joint allows rotation, so the pelvis and hips can swing when walking and running. The lumbar spine is designed to be incredibly strong, protecting the spinal cord, which ends at the upper lumbar area, and the spinal nerve roots, which are at each level. At the same time, it is highly flexible and provides mobility of the lower back, including flexion, extension, side bending, and rotation. This lower spine region also marks the starting point of the largest nerve in your body: the sciatic nerve. About as big around as a man’s thumb at its largest point, the sciatic nerve originates from nerve roots on each side of the lower spine, extends through an opening in the pelvis, and travels down the buttock area below the piriformis muscle, which starts at the lower spine and connects to the upper surface of the thighbone (femur). The sciatic nerve sends nerve endings down the legs as far as the foot. It supplies sensation and strength to the leg, as well as the reflexes of the leg. Injury to the sciatic nerve can lead to muscle weakness and/or numbness and tingling in the leg, ankle, foot, and/or toes. A condition of pain Sciatica is a symptom of an underlying condition and is not a diagnosis in itself. It is typically felt on only one side of the body. Sciatica symptoms refer to pain, tingling, or numbness along the sciatic nerve, all of which can also lead to weakness of the leg or foot. Sciatic pain is described as searing or sharp, burning or
MINNESOTA HEALTH CARE NEWS APRIL 2017
tingling. The pain can vary from intermittent and irritating, to constant and incapacitating. Pain is typically worse when sitting or standing, and improved with lying down and/or walking. Symptoms may be aggravated with sneezing or coughing, or when changing positions, such as standing up after being seated. Storing objects in your back pockets—a phone or wallet, for example—may aggravate the condition. Symptoms may be felt in different areas of the leg and foot, depending on where the sciatic nerve roots are compressed. The vast majority of sciatica symptoms result from lower back disorders between the L4 and S1 levels that put pressure on or cause irritation to a lumbar nerve root. Multiple causes Seven factors can cause sciatica: A herniated disc, the most common cause, occurs when the soft inner material of the disc leaks out, or “herniates,” and presses against a nerve root. Disc degeneration (degenerative disc disease), can cause discs to herniate. Disc degeneration may occur due to normal age-related changes, or it may result from underlying ligament tears that
Trauma to the lumbar or sacral spinal nerve roots may lead to direct nerve compression and symptoms of sciatica. Examples of trauma include motor vehicle accidents, falls, and sports injuries. The impact may injure the nerves, or fragments of broken bone may compress the nerves. Spinal tumors can compress nerves and cause sciatica, although tumors are a rare cause of the condition. Risk factors Risk factors for sciatica include age, obesity, certain occupations, prolonged sitting, and diabetes. Age-related changes of the spine, such as herniated discs and bone spurs, are the most common causes of sciatica, but the condition can occur at any age. Excess body weight increases the stress on the spine, and can contribute to the spinal changes that trigger sciatica. Occupations that require repetitive twisting of the back, carrying heavy loads, or driving for long periods might also play a role. In addition, people who sit for prolonged periods or have a sedentary lifestyle are more likely to develop sciatica. People with certain medical conditions, including diabetes, have a higher risk of nerve damage.
weaken the spine. Sciatica to page 25
The condition can occur at any age.
Spinal stenosis, a narrowing of the open spaces within the spine, can produce pressure on the nerves extending through the spine to the legs. Spinal stenosis is commonly caused by wear-andtear changes in the spine, and is common in adults older than 60. Bone spurs created by arthritic changes of the spine are a common cause of spinal stenosis. Spondylolisthesis—in which vertebrae slip forward and out of place—may also cause sciatica. Spondylolisthesis is categorized as “developmental” (found at birth or developed during childhood), or as “acquirable” from spinal degeneration, trauma, or physical stress, such as lifting weights. Piriformis syndrome results from the sciatic nerve getting irritated or pinched as it runs under the piriformis muscle, located deep in the buttock. This muscle helps to rotate the hip, allowing turning of the leg and foot outward. Pain may occur when walking upstairs or on inclines, and may worsen after prolonged sitting.
APRIL 2017 MINNESOTA HEALTH CARE NEWS
Prosthetics and orthotics Improving the “new normal”
By Charles W. Kuffel, MSM, CPO, FAAOP
hroughout history, we have crafted artificial devices to replace lost limbs, and strapped on splints or braces to boost mobility after an injury. Today’s professional prosthetists and orthotists have advanced that art far beyond the primitive wooden limbs and leather bindings of years past, employing new materials and custom designs that can restore and, in some cases, even enhance mobility.
Definitions Prosthetics and orthotics (P&O) is a health care and rehabilitative profession that focuses primarily on the needs of individuals living with limb impairment or loss. A certified prosthetist/orthotist (CPO) is a member of the health care team who works closely with orthopedic, vascular, and general physicians, as well as physical and occupational therapists, to fill written orders for orthotic and prosthetic devices. Breaking down the disciplines: Certified orthotists focus on managing those patients requiring either custom, off-the-shelf, or pre-fabricated orthopedic bracing. An orthotist may assist one patient following spinal surgery by evaluating, fabricating, and fitting a spinal orthosis (back brace), or may assist another patient with osteoarthritic changes of the knee by evaluating, fabricating, and fitting a knee orthosis (knee brace). Other examples of orthopedic bracing include post-stroke orthoses, pediatric cranial remolding orthoses, orthoses to address pediatric development, and foot orthotics. Certified prosthetists work closely with the managing physician prior to and following an amputation surgery. The certified prosthetist, along with others in the health care team, helps to establish rehabilitative protocols before the amputation and to manage the patient’s prosthetic needs and rehabilitation after the amputation. The certified prosthetist’s responsibilities include evaluation, fabrication, fitting, and follow-up care for those requiring artificial limbs. Prosthetists are specifically trained to manage upper limb, lower limb, finger, and toe amputations. Certified orthotists/prosthetists are individuals specifically trained in both the orthotic and prosthetic disciplines. Recent advancements History documents the early use of prosthetics, beginning with rudimentary artificial toes and legs made from leather and wicker. Those initial prostheses were designed to manage the loss of a limb by filling the void, rather than focusing on the biomechanics of the missing limb.
MINNESOTA HEALTH CARE NEWS APRIL 2017
Modern prosthetists focus not only on filling the void, but also managing the biomechanics of the missing limb. The field has seen revolutionary changes during the past 20 years, primarily driven by the U.S. Department of Defense. Utilizing new materials developed specifically for prosthetics, as well as materials specific to other applications, clinical prosthetists manage the needs of amputees and assist their return to their “new normal.” Prosthetists often use microprocessor controlled components, myoelectric interfaces, carbon fiber, titanium, elastomers, and other materials to fabricate prosthetic limbs that are unique to each amputee, allowing them to return to their new normal. The discipline of orthotics has also seen significant changes throughout history. Current trends in orthotic management include the use of microprocessors, carbon fiber, thermoplastics, and elastomers to allow individuals to return to near normal function. Historically, materials such as metal, leather, and rubber were commonplace in orthotic use. These provided incredible strength, but were very heavy in design. As the profession has evolved, so have the materials being used to build orthotics. New materials offer improved function through dynamic loading while minimizing weight, allowing users to function for longer periods of time while using less energy. Carbon fiber, like the material used in prosthetic running feet, capitalizes on the energy-storing principles of the material. Carbon fiber is being used in various orthoses, including foot orthotics, foot drop orthotics, and knee orthotics.
but the primary factors are vascular disease (54 percent), trauma (45 percent), and cancer (less than 2 percent). Vascular disease complications—the largest single cause of limb loss in the U.S.— include those related to diabetes and peripheral vascular disease.
Between 2 and 3 million Americans live with some level of limb loss. Statistics on orthotics are more difficult to discern, given the wide range of orthotics. Foot orthotics, back bracing, finger splints, and orthopedic shoes are all categorized as “orthotics,” for example. Off-the-shelf or pre-fit orthotics, often sold in pharmacies and stores, add to the difficulty of crunching the numbers. Although those involved in the prosthetics and orthotics profession fit off-the-shelf and pre-fit orthotics, the profession’s primary focus is managing those individuals who require custom long-term intervention. The worldwide need of those requiring prosthetic and orthotic intervention far exceeds the needs within this country. It has been reported that prosthetic and orthotic use in the U.S. represents only 5 percent of the global need. Prosthetics and orthotics to page 24
Certified prosthetists/orthotists (CPOs) spend many years in formalized university-based education, followed by clinical residencies and rotations. Course offerings from Concordia University, in collaboration with Century College, illustrate the range of positions and responsibilities. Century College’s White Bear Lake campus offers programs for prosthetic and orthotic technicians (who build custom prosthetics and orthotics), assistants (who assist the certified prosthetist/orthotist), fitters (who are trained to work with pre-fit and off-the-shelf prosthetics and orthotics), and pedorthists (who are specifically trained to work with foot and ankle orthoses). Concordia University’s St. Paul campus offers a Master of Science degree in Orthotics and Prosthetics (MSOP) that combines on-campus and online instruction. Following the completion of the formalized program, the board-eligible prosthetist/orthotist must complete a combined 18-month residency or two individual 12-month disciplinespecific residencies. Following the successful completion of the university-based education and residency experience, the boardeligible clinician must sit for six exams to demonstrate knowledge and proficiency. Once the exams are successfully completed, the prosthetist/orthotist is certified under either the American Board for Certification (ABC) or Board of Certification (BOC). By the numbers Between 2 and 3 million Americans live with some level of limb loss, according to the Amputee Coalition, and approximately 185,000 new amputations are performed each year. The causes of limb loss vary, APRIL 2017 MINNESOTA HEALTH CARE NEWS
Prosthetics and orthotics from page 23
On the horizon Current research and development focuses primarily on prosthetic knees, feet, and hands, as well as suspension (how the prosthesis is attached to the body). Many prosthetic knees and feet are now controlled by microprocessors that allow prosthetic users to walk and move about with less effort—and to increase their ability to do so safely. The use of carbon fiber, titanium, and other proprietary materials within prosthetic feet allows users to walk further distances with less noticeable impairment and increased safety. Prosthetic hands and elbows employ individual microprocessorcontrolled sensors and motors to closely mimic the control of the anatomical hand and elbow. Individual finger servos, controlled by microprocessors, allow for a more normal appearance, while allowing the user to closely mimic normal hand function. The methods used to suspend, or maintain the fit of the prosthesis, have also changed. Long gone are the days of waist straps and belts to hold a prosthesis onto the amputee’s limb. Current trends use elevated vacuum (a technology developed in Minnesota), suction, and integrated locking mechanisms. Newer suspension methods under development include osseointegration, which attaches an above-the-knee prosthesis directly to the bone, similar to dental implants.
MINNESOTA HEALTH CARE NEWS APRIL 2017
Technology also promises to improve the way in which we make prosthetics. Evolving fabrication techniques include threedimensional scanning of limbs, coupled with fabrication via 3-D printing. This scanning and 3-D printing remains in the infancy stage, but is a promising advancement. Summing up The field of prosthetics and orthotics has matured and evolved throughout history, with the pace of change increasing over the past 20 years. As awareness of amputation and orthopedic complications has increased, so has the number of advancements. Amputation is no longer the end of an individual’s normal activity, but rather the beginning of their “new normal.” Orthotic intervention helps in the proper orthopedic development of the pediatric population and helps athletes to function at higher levels while minimizing risk of injury. Increased awareness through the print and televised media has increased exposure to those with limb loss and limb impairment. The prosthetics and orthotics profession has evolved through enhanced education, improved materials, and increased understanding of those requiring artificial limbs and orthopedic bracing. Charles W. Kuffel, MSM, CPO, FAAOP, is a founding owner, president, and clinical director of Arise Orthotics & Prosthetics, Inc., in Blaine. He currently serves as chairman of the National Commission on Orthotic and Prosthetic Education (NCOPE).
Sciatica from page 21
Other important factors to help improve sciatic pain and prevent further injury include: lifestyle changes, such as weight
Diagnosis and treatment Sciatica is diagnosed with a medical history and physical exam that may include X-rays, MRI (magnetic resonance imaging), or CT (computed tomography). An X-ray can reveal a bony growth causing compression of the nerve. An MRI provides detailed images of the bone and soft tissues, which can identify herniated discs, disc degeneration, spondylolisthesis, and/or structural abnormalities such as tumors. A CT can help to evaluate certain structural
loss and smoking cessation; regular low-impact aerobic exercise, such as walking and pool therapy; adequate control of diabetes; maintaining proper posture; and incorporating ergonomics into everyday life. Take action Sciatic symptoms warranting immediate medical attention include: onset after trauma, continued worsening, leg weakness
abnormalities or changes in bone that could compress nerves and
as well as numbness, and/or involvement of both legs. Cauda
contribute to sciatica. A CT would be used if there is metal in
equina syndrome, caused by the compression of several nerve
the body, such as a pacemaker. Electromyography (EMG), which
roots, can lead to paralysis, and should be addressed on an
measures muscle responses or electrical activity in response to a
emergency basis. This syndrome may be marked by changes in
nerveâ&#x20AC;&#x2122;s stimulation of the muscle, can confirm nerve compression
bowel or bladder function, as well as sensory changes in the
caused by herniated disks or spinal stenosis.
genital area. If you are experiencing symptoms of sciatica, seek evaluation by a medical provider to avoid the risk of potential further injury
Sciatica symptoms often improve over time.
Sciatica symptoms often improve over time, with most episodes
and chronic symptoms.
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.
of pain subsiding within three months. Treatment for sciatica includes both nonsurgical and surgical options. Nonsurgical treatments include exercise or physical therapy, ice and/or heat, and/or over-the-counter anti-inflammatory medications, such as ibuprofen or naproxen. Oral steroids can reduce the inflammation causing pain. Muscle relaxants or narcotic medications may also be prescribed on a short-term basis to alleviate pain. Regular exercise can help relieve the pain most people experience. Common forms of alternative care include chiropractic manipulation, acupuncture, cognitive behavior therapy, and massage therapy. For severe pain or ongoing flare-ups of sciatic nerve pain, epidural steroid injections may be applied. Unlike oral medications, these injections go directly into the painful area around the sciatic nerve to address the pain-inducing inflammation. Although the effects of an epidural steroid injection are temporary, it can be quite effective for relieving acute sciatic pain. It does not work for everyone, however. The goal of the injection is to provide sufficient pain relief to allow individuals to actively engage in exercise, preferably with the guidance of rehabilitation programs such as physical therapy. In some instances, surgery targeting the herniated discs, bones, or other sources of nerve injury may be the best option for pain relief and to prevent or minimize future symptoms.
APRIL 2017 MINNESOTA HEALTH CARE NEWS
Understanding gout Diagnosis and treatment By Umbreen Hasan, MD, MBA
out is a painful arthritis caused by deposits of uric acid crystals in the joints. Formed naturally as waste products are broken down, uric acid is normally filtered out of your blood and excreted, but if your kidneys filter too little—or if your body produces too much—it can accumulate in your system. Many patients with high levels of uric acid (hyperuricemia) never develop gout, but 30 percent do. In those patients, sharp, needlelike crystals of uric acid settle in one or more joints, triggering
the hallmarks of a gout attack: inflammation, swelling, and pain. Gout often strikes the big toe first, but it can appear in other joints as well. In addition to joint pain, gout can decrease kidney function or cause kidney stones. Prevalence and risk factors Gout strikes 4 percent of all Americans, but is rarely seen in children. Among patients under the age of 65, gout is more prevalent in men, perhaps because of higher levels of uric acid in their blood. Men also acquire the disease at a younger average age (30–45 years), while women are more likely to experience gout after they turn 55. In patients older than 65, gout strikes both men and women with the same frequency. Certain lifestyle choices and medical conditions can increase your risk of gout. These include: • Chronic kidney disease that results in decreased filtration of uric acid • Obesity • High blood pressure • High consumption of liver, red meat, seafood, or non-diet sodas containing high-fructose corn syrup • Excessive amounts of alcohol, especially beer, gin, whiskey, vodka, or rum • Certain medications, including diuretics • Family history of gout Symptoms and disease course Gout produces flare-ups of joint pain, redness, and inflammation. These are generally confined to a single joint, but some people experience inflammation in multiple joints. Most attacks occur in the early morning hours, when the body’s fluid state is contracted. Flare-ups can last for a few days, or may continue for weeks.
MINNESOTA HEALTH CARE NEWS APRIL 2017
Flare-ups occur when white blood cells, sent to the joint by your immune system, perceive the uric acid crystals as a foreign body to be fought off. This immune system response is what causes the inflammation and pain.
Gout produces flare-ups of joint pain, redness, and inflammation. Gout generally follows three phases: 1. Acute gouty arthritis refers to individual flare-ups in one or more joints, commonly the big toe or knees. People with degenerative arthritis in their hands may suffer frequent attacks. 2. Intercritical gout is the time in between attacks. Generally a repeat flare-up occurs within two years of the initial attack. If the disease remains untreated, the duration between flare-ups decreases, and patients have more frequent and severe attacks. 3. Chronic tophaceous gout is a more persistent, long-term form of the arthritis in which deposits of uric acid crystals form in soft tissues and under the skin. These deposits, or tophi, can erode into the bones and cause a deforming arthritis. Patients may be predisposed to this condition if they are taking certain chemotherapy medications, have kidney disease, and have had untreated gout for several years.
effects can include nausea, vomiting, abdominal cramps and pain, and diarrhea. Corticosteroids, another class of anti-inflammatories, can rapidly decrease inflammation in the joints. Your doctor might prescribe prednisone or another oral corticosteroid at a high initial dose, or burst, followed by tapered doses. If your gout affects just a single joint, your rheumatologist might inject that joint with corticosteroids. Long-term therapy To control gout and prevent disability, your physician may recommend both lifestyle modifications and certain long-term medications. These urate-lowering therapies are intended to decrease uric acid to less than 6 mg/dl. Patients with uric acid levels higher than 10 mg/dl or experiencing more than three flare-ups per year may receive life-long treatment. Urate-lowering medications fall into several categories: â&#x20AC;˘ Uricosuric medications such as probenecid increase your kidneyâ&#x20AC;&#x2122;s ability to filter uric acid from the blood. Increased water intake is required with this medicine, to aid in flushing
Understanding gout to page 31
Complications associated with gout can include kidney stone formation and deforming arthritis. Diagnosis and treatment If you believe you have gout, seek diagnosis and treatment early to prevent complications. Although your primary care doctor can start the investigation, it is important to follow up with a rheumatologist, who is an expert in treating arthritis. Your rheumatologist will take a thorough medical history, perform a physical examination, and order relevant laboratory tests, including assessments of kidney function and levels of uric acid in your blood. X-rays will look for any joint destruction. In some cases, your rheumatologist might use a needle to extract fluid from your joint and examine it for uric acid crystals. Depending on your age and medical condition, your physician might recommend one of these common medications: Nonsteroidal anti-inflammatory medications (NSAIDs) such as ibuprofen, indomethacin, and naproxen can decrease pain and inflammation during the early part of the attack, but should not be taken by people with a history of kidney disease, stomach ulcers, or allergy to any medication in this class. Colchicine, a strong anti-inflammatory prescription drug, prevents white cells from entering the joint and causing inflammation. To be effective, it should be taken at the first sign of an attack or within 48 hours. It is not used in people with kidney failure. Side APRIL 2017 MINNESOTA HEALTH CARE NEWS
HEALTH INSUR ANCE
Understanding your health care coverage Ways to minimize out-of-pocket costs By Alison Renneke
f you’ve ever received a medical bill that was higher than you expected, you’re not alone. Every health insurance plan— even those offered by the same company—will cover different doctors, clinics, prescriptions, and services. These factors, along with differences in deductibles and copays, could affect the final amount you pay. If you have Original Medicare or are enrolled in a supplemental Medicare plan, your hospitalization status may also affect your coverage in a skilled nursing facility.
Knowing what your plan covers is the first step to understanding how much you’ll have to pay for your care. Some basic terms apply to all plans, whether you purchase insurance on your own, are covered by an employer’s plan, or are enrolled in Medicare. Coverage and networks If a service is covered, your health plan will pay some or all of the cost. The exact amount depends on the type of care and where you receive it. For some covered services, you won’t pay anything. These include annual physical exams, which are considered preventive care and will be paid for by your plan.
The amount you pay will depend on the type of plan you have. For many other covered services, your plan will pay part of the cost, and you will also pay some. Examples include a trip to the doctor for a lingering sinus infection, or filling a prescription for covered antibiotics. The amount you pay will depend on the type of plan you have and whether you have paid all of your deductible— the amount that you pay up front before your plan starts helping you. Deductibles vary widely among different plans. The most likely culprit for unexpected bills? Seeing a doctor that isn’t in your network, the list of specific doctors, specialists, and clinics that honor your individual insurance plan. To avoid unexpected bills, do your homework before scheduling an appointment: • Visit your health plan’s website to find an updated list of doctors, pharmacies, and clinics in your network. • If you have Original Medicare, visit www.medicare.gov and search for your doctor or health care professional, as well as
MINNESOTA HEALTH CARE NEWS APRIL 2017
the clinic or hospital you want to use. (When you make the appointment, reconfirm that they accept Medicare.) • Call your health plan’s member services department. They’ll help you understand your specific plan details and point you to a doctor, clinic, or pharmacy that’s in-network. Your member services phone number is typically listed on your insurance card. Always check with your insurance company if you have questions. Don’t rely solely on your doctor’s office. Your doctor’s office may say they “accept” your insurance, but that doesn’t mean they accept your specific plan, which may have a very specific network.
Do your homework before scheduling an appointment. Types of services From doctor visits and physical therapy sessions to blood tests, X-rays, ambulance rides, and hospital stays, all plans cover health care services differently. Two common questions about services involve preventive care and the distinction between inpatient and outpatient services.
The terms can be confusing. You might stay overnight in a regular hospital bed, but still be considered by Medicare or by your health plan to be an outpatient. Your hospital admission status is based on your doctor’s judgment and your need for medically necessary hospital care. You can’t control your admission status, but you should be aware of the distinction. Some general guidelines: • Inpatient status means that you are formally admitted to the hospital with a doctor’s order. • Outpatient status means that you are getting emergency department services, observation services, outpatient surgery, lab tests, X-rays, or any other hospital services, but that the doctor has not written an order to admit you to a hospital as an inpatient. In these cases, you’re an outpatient even if you spend the night in the hospital. Medicare offers a chart listing common hospital situations and a description of Medicare coverage at http://tinyurl.com/HCNMedicare-Chart. Review this information for a general sense of how physician orders could affect your hospitalization status and ultimate bill, and be prepared to discuss your specific circumstances with plan representatives. You may also wish to designate someone else to act on your behalf.
Understanding your health care coverage to page 30
Preventive care. Routine preventive care describes the steps you take before you’re sick to remain healthy. You get a flu shot to help avoid the flu. You have your cholesterol checked to identify potential risks. You get a colonoscopy so if anything looks abnormal, you can address it before it gets worse. In some instances, the same service might be covered in full as preventive care, or billed to the patient. For example, your coverage for a blood pressure check would depend on your health situation. If your provider checks your blood pressure during a regular checkup to see if it’s in the normal range, the service would be considered preventive. On the other hand, if you visit the doctor with undiagnosed symptoms and the doctor checks your blood pressure to help determine the cause, the test is not considered preventive. If you’re not sure what preventive care you’re due for or whether your appointment is preventive or not, log onto your health plan’s online account for reminders. Or call your insurance company to find out what preventive care is covered. Inpatient vs. outpatient status. In most cases, you’ll be able to determine whether the care you want is covered—and the amount you’ll have to pay—before you schedule an appointment. But what about an unplanned visit to the hospital? Your hospital status—whether you’re an inpatient or an outpatient—affects how much you pay for hospital services. For those with Medicare, your status can also affect whether Medicare will cover care you get in a skilled nursing facility following a hospital stay.
APRIL 2017 MINNESOTA HEALTH CARE NEWS
Understanding your health care coverage from page 29
• Network search tools. Log into your online account to review your plan’s network, provider, and physicians. Check that the
EOBs and bills After a trip to the doctor, your health plan mails you an Explanation of Benefits (EOB). The form looks like a bill—it even says “amount you owe” at the bottom. But an Explanation of Benefits is not a bill, so you shouldn’t pay anything yet. It’s a report of what your insurance plan is going to cover, based on what the doctor has charged and what type of plan you have. Save your Explanation of Benefits forms until you get the final bill from your doctor or health care provider. Compare the amount you owe on the EOB to the amount on the bill. If they match, that’s the amount you’ll need to pay.
doctor you want to see is covered. • Drug formularies and prices. Log into your online account and search for your plan’s formulary (drug list). All plans have a list of the prescriptions they cover. Search the list to make sure the prescriptions you need are included, and note that formularies may change over time. A prescription that was in formulary last year may be non-formulary this year. Consult with your health care provider before making any changes in prescriptions, and check to see if a generic equivalent is available. Some plans also offer a calculator tool to help you find the lowest prices on prescriptions from specific pharmacies. Call your insurance company with questions about what your
Other resources A few more resources to help determine what’s covered: • Evidence of Coverage (EOC). Sent to you when you enrolled and available online, this standard document lists services covered by the plan and how much you can expect to pay. If you have Original Medicare, you can also use the Medicare. gov website to look up coverage information and to log into your account.
MINNESOTA HEALTH CARE NEWS APRIL 2017
plan covers. There’s no such thing as a silly question. Member services representatives can tell you whether a doctor, prescription, or service is covered and how much your insurance will pay. They may even tell you something you didn’t think to ask about. Alison Renneke, senior manager of member services at HealthPartners, heads a team providing answers, information, and support for Medicare and Medicaid members and providers.
Understanding gout from page 27
out the uric acid and to prevent it from precipitating into crystals in the kidneys. You may also be given a separate medication to control the pH level of your urine. Patients with kidney stones should not take probenecid. • Losartan, a blood pressure medication, may be prescribed in conjunction with gout medications to provide better control of uric acid levels. • Allopurinol and febuxostat, the main medications used to manage gout, prevent the formation of uric acid. In rare cases, allopurinol can cause rash, decreased white cell count, diarrhea, and fever. A small percentage of patients may experience a hypersensitivity reaction. Febuxostat requires no dose adjustment for people with kidney disease. • If patients taking allopurinol or febuxostat still have high levels of uric acid, lesinurad may be added. This medication is not used on its own. • Patients with advanced, treatment-resistant gout may be given pegloticase, an intravenous medication that breaks down uric acid into allantoin, which is easily excreted by the kidneys. This drug is expensive, can decrease the immune system, and provides long-term benefits for just 50 percent
of patients, so it is only used in cases involving advanced, resistant gout. Take control A healthy lifestyle can reduce the risk of gout and decrease flare-ups in those who have already developed this painful arthritis. Obesity is one key risk factor, so work with your health care provider to manage your weight. Increase your intake of low-fat dairy products, as well as foods with complex carbohydrates, such as beans, brown rice, and oats. Vitamin C (500 mg per day) and cherries are thought to increase excretion of uric acid and reduce gout flare-ups.
Complications associated with gout can include kidney stone formation. Avoid seafood, especially shellfish; liver and other organ-rich foods; high levels of alcohol, including beer; high-fructose corn syrup; and red meat. Weight loss and dietary changes alone cannot control gout, but are used in conjunction with medications prescribed by your doctor. Umbreen Hasan, MD, MBA, is a rheumatologist located in the Twin Cities.
APRIL 2017 MINNESOTA HEALTH CARE NEWS
Alzheimer’s disease and dementia from page 15
4 Misplacing things and losing the ability to retrace steps 4 Decreased or poor judgment
Finally, it’s never too late to give your brain a workout. If additional schooling is impractical, challenge yourself with reading, crossword puzzles, chess, or other mental exercises. Spotting the signs People with possible signs of Alzheimer’s and other dementias may find it hard to recognize they have a problem, even when the warning signs are obvious to family members or friends. Too many patients and their families either ignore or downplay warning signs out of fear or lack of awareness. Tragically, diagnosis is frequently triggered by a health crisis that might have been avoided with earlier diagnosis.
10 warning signs that may mean a person is developing Alzheimer’s:
4 Memory loss that disrupts daily life 4 Challenges in planning or solving problems 4 Difficulty completing familiar tasks at home, work, or leisure 4 Confusion with time or place 4 Trouble understanding visual images and spatial relationships 4 New problems with words in speaking or writing
4 Withdrawal from work or social activities 4 Changes in mood and personality Individuals may experience one or more of these signs in different degrees. If you notice any of them, seek professional help immediately, or call the Alzheimer’s Association Minnesota-North Dakota 24/7 Helpline at 800-272-3900. Join the fight Get in touch with national and local associations working to reduce the impact of Alzheimer’s and other forms of dementia on patients and families. Search online for opportunities to support local offices and groups, attend events or educational programs, or sign on to efforts to bolster research funding or promote legislation. Your individual physician or health care provider can provide a wealth of additional information. For those already affected by dementia or concerned about its impact, many health care providers and community groups schedule both formal and informal support groups. Debbie Richman is vice president of education and outreach for the Alzheimer’s Association Minnesota-North Dakota chapter.
FEBRUARY 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 understand what is meant by the term genetic counseling.
2. I believe genetic testing is an important diagnostic tool. 50
40 30 20 10 0
4. I believe genetic data should be part of a patient’s medical record.
20 10 Strongly Agree
Percentage of respondents
Percentage of respondents
5. If genetic testing revealed a risk for developing a specific illness, I feel it is important to share this information with one’s genetic family.
35 25 20 15 10 5 0
35 Percentage of respondents
Percentage of respondents
Percentage of respondents
3. I believe genetic testing and genetic counseling should be fully covered by health insurance.
MINNESOTA HEALTH CARE NEWS APRIL 2017
40 30 20 10 0
30 25 20 15 10 5 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 APRIL 2017 MINNESOTA HEALTH CARE NEWS
Genetic counseling and testing from page 13
What is the process for genetic testing? Once these questions have been addressed and the patient chooses testing, he or she signs consent forms and has a blood sample drawn. The blood draw is usually quite small, only one or two vials. In some cases, saliva samples can be used instead of blood samples. Cardiac genetic testing usually involves sequencing the DNA of several different genes, essentially running a spell check of the four-letter DNA “alphabet” (A, C, T, and G) that “writes” your individual genes. Each of these test panels has a different detection rate for finding genetic variants. Therefore, some tests have a high likelihood for finding the genetic cause for disease, while others have a very low yield for finding genetic variants. For some known conditions, such as hypertrophic cardiomyopathy, genetic testing focuses on genes specific to that disease. These tests are unlikely to discover information about other conditions or risks. While this article focuses on cardiology conditions, genetic testing is also used for hundreds of other conditions, including cancer, connective tissue disorders, prenatal conditions, genetic syndromes, and neurological conditions.
MINNESOTA HEALTH CARE NEWS APRIL 2017
Summary Genetic counseling and testing can identify people who are at risk for heart disease and can potentially save lives. Ideally, we want to diagnose cardiac conditions as early as possible to slow down the progression of the disease or limit the risk of sudden death. If a diagnosis occurs later in the course of the disease, treatment options are fewer and previous damage to the heart cannot be undone. In cardiovascular genetics, testing must be performed first in an affected person before testing can occur in at-risk family members. Therefore, the first person to be tested may provide family members with an important opportunity to recognize their true risk. Ask your cardiologist for a referral to a genetic counselor to discuss risk and testing options in more detail.
S. Kimara March, MD, FACC, FSCAI, is a cardiologist specializing in congenital heart disease, women’s heart care, and interventional cardiology. She treats patients at University of Minnesota Health Heart Care clinics, including locations in Minneapolis, Edina, and Wyoming, Minn. Sarah Kreykes, CGC, is a certified genetic counselor specializing in genetic counseling for people with or at risk for genetic heart disease. She is the only dedicated cardiac genetic counselor in the Twin Cities metro area. She sees patients at University of Minnesota Health Heart Care clinics in Burnsville, Edina, and Minneapolis.
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