FINAL STAMPEDE RESULTS: GLYCEMIC BENEFITS OF BARIATRIC SURGERY PERSIST OVER TIME
Glycemic control, weight loss endure out to five years
CHICAGO, Illinois—In the final, five-year follow-up report from the influential STAMPEDE (Surgical Therapy And Medications Potentially Eradicate Diabetes Efficiently) trial, Cleveland Clinic research shows that bariatric surgery’s beneficial effects on blood glucose control in mild and moderately obese patients with type 2 diabetes may persist for up to five years, with the advantage over diabetes medications-only approach widening over time.
The five-year follow-up also reported that:
• Over 88 percent of gastric bypass and sleeve gastrectomy patients maintained healthy blood glucose levels without the use of insulin.
• 29 percent of gastric bypass patients and 23 percent of sleeve gastrectomy patients achieved and maintained normal blood glucose levels, compared to just 5 percent of those on medication alone.
• Weight loss was significantly greater with gastric bypass and sleeve gastrectomy than with medications and was the primary driver for glucose control.
• The effects of both surgical procedures to normalize glucose levels did however diminish overtime and some late complications were noted with surgery.
“Our findings show continued durability of glycemic control after metabolic surgery, as well as persistent weight loss, reduction in diabetes and cardiovascular medications at five years,” said Philip Schauer, MD, lead author and Cleveland Clinic bariatric surgeon, who presented the results at ACC.16, the American College of Cardiology’s 65th Annual Scientific Session.
“The superior benefits of surgery to attain diabetes treatment goals must be carefully balanced with the long-term risks associated with surgery for individual patients,” said Sangeeta Kashyap, MD, co-investigator involved with the trial and an endocrinologist at Cleveland Clinic’s Endocrinology & Metabolism Institute.
According to the CDC, 29 million people in the United States (9.3 percent) have diabetes. More than 70,000 persons die annually due to complications associated with diabetes, according to the American Diabetes Association. Approximately 50 percent of patients currently treated for type 2 diabetes with medications are not meeting standard targets of glycemic control and thus are at risk for developing complications of diabetes.
“Left unchecked, diabetes can lead to kidney failure, blindness, and limb amputation,” said Dr. Kashyap. “At the five-year mark, bariatric surgery’s metabolic effect persists and is more effective at treating type 2 diabetes in moderate and severely obese patients when compared to medical therapy.”
The STAMPEDE trial is the largest randomized trial with one of the longest follow-ups comparing medical therapy with bariatric surgery.
The trial initially involved 150 overweight patients with poorly controlled diabetes. The patients were divided into three groups: 1) Fifty patients received intensive medical therapy only, including counseling and medications; 2) Fifty patients underwent Roux-en-Y gastric bypass surgery and received medical therapy; 3) Fifty patients underwent sleeve gastrectomy and received medical therapy.
Effectiveness was gauged by the percentage of patients who achieved blood sugar control, defined in this study as hemoglobin HbA1c level of less than or equal to 6.0 percent—a more aggressive target than the American Diabetes Association’s guidelines. HbA1c is a standard laboratory test that reflects average blood sugar over three months.
Findings from the five-year follow-up confirm those from the one-year and three-year reports and include the following:
• Rates of achieving and maintaining an HbA1c level of 6.0 percent or less at five years were significantly higher with gastric bypass (29 percent) and sleeve gastrectomy (23 percent) than with intensive medical therapy alone (5 percent).
• Weight loss was significantly greater with gastric bypass and sleeve gastrectomy than with medical therapy.
• Use of cardiovascular and glucose-lowering medications, including insulin, at five years was significantly reduced from baseline in both surgical groups, and was significantly lower in the surgical groups than in the medical therapy group. Over 88 percent of surgically treated patients maintained glycemic control without use of insulin.
The five-year analysis also yielded several new insights, including the following:
• In the two surgical groups, achieving the primary end point of an HBA1c less than or equal to ≤ 6.0 percent was predicted both by a reduction in body mass index (BMI) and a duration of diabetes of less than eight years.
• There were no late major complications of surgery except for one reoperation (a successful laparoscopic conversion of sleeve gastrectomy to gastric bypass for recurrent gastric fistula) four years after randomization.
• Significant and durable improvements in bodily pain and general health were demonstrated using a validated quality-of-life instrument in both surgical groups relative to the medical group.
• Several biomarkers associated with heightened cardiovascular risk were reduced in the surgical arms, but there were no beneficial effects on retinopathy or nephropathy seen at 5 years.
“Some advantages of gastric bypass over sleeve gastrectomy have emerged during follow-up,” Dr. Schauer said. “At five years, gastric bypass maintained greater weight loss than sleeve gastrecomy while requiring fewer medications.”
He also notes that the final STAMPEDE results might help expand the population of patients in whom bariatric surgery may be considered for improving glycemic control.
“Most clinical guidelines and insurance policies for bariatric surgery limit access to patients with a BMI of 35 or above,” Dr. Schauer added. “Our five-year results demonstrate that glycemic improvement in patients with a BMI of 27 to 34 is durable at least up to five years.”
More information on the STAMPEDE clinical trial can be found at clevelandclinic.org/weightloss
Obesity Day to highlight growing obesity epidemic in Europe
Brussels, Belgium—The growing obesity epidemic, which is predicted to affect more than half of all European citizens by 2030, will be the focus of European Obesity Day to be held on May 21, 2016.
According to World Health Organization (WHO), obesity is one of the greatest public health challenges of the 21st century. Its prevalence has tripled in many countries of the WHO European Region since the 1980s, and the numbers of those affected continue to rise at an alarming rate.
European Obesity Day is organized by the European Association for the Study of Obesity (EASO) in conjunction with its 32 member associations in 32 countries. As well as events on the day itself, various initiatives will be taking place throughout Europe during the month beforehand.
Other European disease organizations, including those related to cancer, diabetes, cardiovascular, hypertension, diet, and liver disease will also be taking part to highlight the dangers of overweight and obesity.
Last year, EASO published the findings of a survey* among 14,000 members of the public in seven European countries, showing that the majority of people underestimate their own weight, misjudge the weight of others around them, and appear to have little knowledge of the consequences.
It also showed that the vast majority of people regard obesity as a problem purely of personal lifestyle, rather than recognizing that there are other underlying issues which society needs to address.
“Obesity is a complex and chronic disease with numerous causes, many of which are beyond an individual’s control,” says EASO President, Professor Hermann Toplak. “The causes can range from genetic and endocrine conditions to environmental factors, such as stress, diet and increasingly sedentary working patterns.
“A healthier lifestyle, including a healthy diet and regular physical activity can help maintain a normal weight. However, obesity is a chronic disease and should be recognized and treated as such. Accepting and supporting people with obesity will help them seek the help and treatment they need,” he said.
WHO says that both societies and governments need to act to curb the epidemic. “National policies should encourage and provide opportunities for greater physical activity, and improve the affordability, availability and accessibility of healthy foods. They should also encourage the involvement of different government sectors, civil society, the private sector and other stakeholders.”
Professor Toplak agrees that obesity has become a symptom of our rapidly changing society. “Individuals are vulnerable to changes in food production, processing and marketing and to changes in physical work and transportation. Many of these changes are linked to obesity so we should look out for and take action on changes in the wider society as well as for individuals,” he added.
In line with the theme for European Obesity Day 2016, Action for a Healthier Future, people across all EU member states are being encouraged to participate.
Further details of how to support European Obesity Day and where to find more information on obesity, and obesity prevention and treatment, are available on the European Obesity Day website: www.europeanobesityday.eu. Activities can also be followed on Twitter (@EOD2016 and #EOD2016) and on Facebook (EuropeanObesityDay).
*Obesity: An Underestimated Threat. http://easo.org/perception-survey/summary-of-all-countries/
Clinical Obesity Education for Health Care Professionals Now Accessible Online through Obesity Medicine Academy
DENVER, Colorado—Health care professionals seeking high-quality education about treating patients with obesity in a clinical setting need not look further than the new Obesity Medicine Academy, an online learning platform containing all of the Obesity Medicine Association’s top-rated obesity educational programming.
The Obesity Medicine Academy (www.OMAcademy.org) is an online library of video-based presentations about the diagnosis, treatment, reversal, and prevention of obesity and obesity-related conditions. Topics such as nutrition, physical activity, behavior, medication, patient evaluation, comorbidities, practice management, and more are included in the academy’s library of more than 250 presentations.
Accessing the Obesity Medicine Academy is easy. Anyone may visit www.OMAcademy.org and click through to find presentations of interest, or search by topic or speaker. All presentations housed within the academy are eligible for continuing medical education (CME) or continuing education credit, which can be earned by taking a short quiz after watching a presentation.
The academy’s education dashboard will keep track of each user’s presentations and credit earned. Users may also download audio or video files of the presentations to listen to or watch at their leisure.
“The Obesity Medicine Academy brings the learning experience so much closer to those interested in clinical obesity treatment,” said Dr. Bill McCarthy, CME program director the Obesity Medicine Association (OMA). “Health care professionals can easily access high-quality obesity education and immediately use what they learn to help their patients reverse obesity and gain better health.”
Further your obesity medicine education today at www.OMAcademy.org.
About the Obesity Medicine Association. The Obesity Medicine Association (OMA) is the largest organization of clinicians dedicated to preventing, treating, and reversing the disease of obesity. OMA members believe that sustained results—brought about by comprehensive, individualized treatment plans—improve overall health and provide hope for those affected by obesity. Learn more about OMA at www.obesitymedicine.org.
News from The Endocrine Society
About The Endocrine Society. The Endocrine Society is the world’s oldest and largest organization of scientists devoted to hormone research and physicians who care for people with hormone-related conditions.
Endocrine Society Calls for Integrative Approach to Improve Diabetes Care
Washington, DC—To provide integrated care for people who have diabetes and may be at risk of developing related medical complications, the United States health care system needs to continue building effective multidisciplinary care team models, according to new recommendations issued by the Endocrine Society.
The Endocrine Society’s analysis of the challenges and opportunities created by the Affordable Care Act’s (ACA) implementation was published online in the Journal of Clinical Endocrinology & Metabolism. The recommendations were published on the sixth anniversary of the ACA being signed into law.
The policy recommendations were developed by physician experts in diabetes as a result of the Society’s September 2014 policy summit on diabetes and ACA implementation. The endocrinology field includes medical doctors (MDs) who are highly specialized in diabetes management as well as scientists who research diabetes.
An estimated 29 million Americans have diabetes, according to the Society’s Endocrine Facts and Figures Report. The condition occurs when the body’s ability to process sugar is impaired. In 2012, treating diabetes cost the U.S. health care system $245 billion—a figure that is expected to more than double by 2021.
The number of people diagnosed with diabetes is likely to rise as more people gain health insurance coverage through the ACA. One study found a 23 percent increase in Medicaid patients diagnosed with diabetes in states that adopted the ACA Medicaid expansion, compared to a 0.4 percent increase in states that did not. About one in four Americans with diabetes is undiagnosed, so expanded access to care is likely to lead to earlier diagnosis and treatment.
People who have diabetes face an increased risk of developing other conditions, including eye problems, foot complications than can require amputation, diabetic nerve pain and kidney problems. As a result, they often need see a diverse group of medical specialists such as nephrologists, podiatrists or ophthalmologists who may become part of the patient’s “care team.”
“A fundamental challenge in diabetes care is how can we transform multidisciplinary care teams to provide optimal care,” said the white paper’s lead author, endocrinologist Alvin C. Powers, MD, of Vanderbilt University Medical Center in Nashville, TN. “Coordinated care is necessary to ensure the best possible outcomes for people with diabetes. An effective team-based approach must provide comprehensive, continuous and timely care without duplicating any tests or services.”
Without enough trained health care providers, it will be challenging to provide this level of care. The Endocrine Society’s 2014 workforce analysis found that the supply of endocrinologists who treat adults will outpace the growing demand for their services until at least 2024.
This will mean longer waits for appointments for people with diabetes and other endocrine conditions. The Society recommends training more endocrinologists and primary care providers to adequately treat patients and support integrated care teams for people with diabetes.
The Endocrine Society’s recommendations include the following:
• Prevention and management of diabetes and prediabetes should be better integrated into health systems as well as community and employer-based health programs.
• Reimbursement should be reformed to reward health care providers for providing integrated, comprehensive care that complies with industry guidelines for best practices.
• We need an increase in federal funding and other financial support for research to address gaps in knowledge about diabetes care and promote the development of next-generation treatment options.
• The U.S. Food and Drug Administration and Centers for Medicare and Medicaid Services must accelerate the approval process for new treatments that address unmet needs in diabetes care.
• Conduct ongoing research to monitor how ACA implementation affects diabetes outcomes and care models.
“Implementing these policies will improve care for people with diabetes and ensure Americans receive greater value for the hundreds of billions of dollars spent annually to treat and prevent the condition,” Powers said.
Other authors of the study include: Robert A. Vigersky, MD, of Medtronic Diabetes in Minneapolis, MN, and the Uniformed Services University of the Health Sciences in Bethesda, MD; Jason A. Wexler, MD, of MedStar Washington Hospital Center in Washington, DC; Robert W. Lash, MD, of the University of Michigan Health System in Ann Arbor, MI; and Meredith C. Dyer and Mila N. Becker, JD, of the Endocrine Society.
The white paper, “Affordable Care Act Implementation: Challenges and Opportunities to Impact Patients with Diabetes,” is available at http://press.endocrine.org/doi/10.1210/jc.2016-1047, ahead of print.
Endocrine Society Applauds Proposed Medicare Coverage of National Diabetes Prevention Program
Washington, DC—The Secretary of the Department Health and Human Services (HHS), Sylvia Burwell, announced that the Centers for Medicare and Medicaid Services (CMS) plans to provide coverage for the National Diabetes Prevention Program (NDPP). The Endocrine Society is pleased with HHS’ decision to provide coverage and looks forward to working with the agency and with coalition partners to ensure that this program has a measurable impact on the lives of people with prediabetes.
The NDPP is an evidence-based lifestyle intervention program that has been shown to reduce or delay the onset of diabetes by 71 percent in the Medicare population. NDPP promotes weight loss and encourages increased physical activity and healthier eating habits for people with prediabetes via a core 16-session lifestyle intervention: one hour a week, in a group setting, directed by a lifestyle coach. Studies show that Medicare saved $2,650 for each individual who was enrolled in a program, as individuals were able to substantially reduce their risk for future diabetes.
Over the past five years, the Endocrine Society has been a leading advocate calling for Medicare coverage of NDPP, meeting with both Congressional offices and federal agencies and working with other diabetes advocates.
The proposed expansion in Medicare coverage was made possible by provisions in the Affordable Care Act, which was signed into law six years ago.