A peer-reviewed, evidence-based journal that promotes clinical development and metabolic insights in total bariatric patient care for the healthcare professional
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24 News and Trends Bariatric Times • July 2016 NEWS FROM THE AMERICAN DIABETES ASSOCIATION'S (ADA) 76 TH SCIENTIFIC SESSION BARIATRIC SURGERY FOUND TO BE A MORE EFFECTIVE WAY TO CONTROL DIABETES IN OBESE ASIAN INDIAN PATIENTS COSMID Trial indicates that bariatric surgery is more effective than medical and lifestyle management in controlling type 2 diabetes in population that gets sicker sooner CINCINNATI, Ohio—During the American Diabetes Association's (ADA) 76th Scientific Session in June 2016, data from an Ethicon- funded study was presented that demonstrates bariatric surgery may be a better treatment option than medical therapy and lifestyle management alone for obese Asian Indian patients with inadequately controlled type 2 diabetes. The COSMID (Comparison of Surgery vs. Medicine for Indian Diabetes) Trial is the first randomized controlled study that specifically addresses the Asian Indian population, which develops type 2 diabetes at an earlier age and a lower BMI than Caucasians. "There are more than 300 million people suffering from obesity in India and type 2 diabetes is growing at an alarming rate there," said Dr. Elliott Fegelman, Therapeutic Area Expert, Metabolics, Johnson & Johnson Innovations. "When compared to Caucasians, the Asian Indian population tends to get sick from diabetes at a lower BMI, but it was unclear if bariatric surgery would be as effective in this less obese population. The COSMID Trial filled that knowledge gap and the results prove that bariatric surgery is more effective at managing and controlling type 2 diabetes than medical and lifestyle management alone for this group." India's population is the third most obese in the world1 and obesity is the number one cause of type 2 diabetes in India; over 80 percent of adult diabetics in India are clinically overweight. Asian Indians have a strong ethnic and g enetic predisposition for developing diabetes at a younger age and at lower body mass index than the Caucasian population. At the same weight as a Caucasian, an Asian I ndian is at greater risk for obesity- related conditions such as heart disease and diabetes. "Current medical and lifestyle treatments for Asian Indians who suffer from obesity and type 2 diabetes are often inadequate to control morbidities and mortalities associated with these conditions. COSMID provides evidence that gastric bypass is a superior treatment to medical management alone, and should be an option for patients who qualify," said Dr. Shashank Shah, one of the principal investigators for the study, who will be presenting the findings at the ADA Scientific Session. Dr. Shah is also this year's recipient of the ADA's prestigious Vivian Fonseca Scholar Award recognizing diabetes research focused on the South Asian, Asian American, Native Hawaiian, and Pacific Islander populations and/or research by a scientist from these areas of the world. The results of the COSMID study are of importance not only to India, but also globally for Asian Indian populations wherever they reside - the Middle East, UK, Italy and Netherlands, as well as in North America have high concentrations of Asian Indians. Additionally, the results also could apply to other populations that tend to develop type 2 diabetes and other obesity related conditions at lower BMI's than Caucasians. Ethicon is committed to the fight against obesity around the world, and continues to lead global initiatives, including clinical research like COSMID, to demonstrate that surgery, along with medical therapy if needed, can be a long-term effective solution for weight loss and obesity-related health conditions. In addition to research and evidence, Ethicon is committed to developing best-in-class devices and solutions designed to increase awareness and a ccess to bariatric surgery for improved patient outcomes and quality of life. The COSMID trial two year results, along with the recent five-year results of the STAMPEDE s tudy, build on the existing body of evidence, demonstrating that surgery is a highly effective treatment for obesity-related diabetes for certain patients. About the COSMID trial. COSMID is a prospective, randomized, parallel-group, single center clinical trial to compare the impact of Roux-en Y gastric bypass (plus medical therapy as needed) vs. optimal medical and lifestyle management among Asian Indian adults with type 2 diabetes and a BMI between 25 and 40 kg/m2. The study results are from a 5-year international scientific collaboration among Dr. Shah, David Cummings, MD from the University of Washington, and Keith Kim, MD, Celebration Health, Florida. The two-year study, following 80 subjects, found gastric bypass to be superior to medical management alone in treating patients with type 2 diabetes. COSMID is the first study to specifically address the Asian Indian population which has a different pathogenesis of type 2 diabetes than Caucasians. About Ethicon. From creating the first sutures, to revolutionizing surgery with minimally invasive procedures, Ethicon has made significant contributions to surgery for nearly 60 years. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues, and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. Learn more at www.ethicon.com/obesity, and follow us on Twitter @Ethicon. VICTOZA ® SIGNIFICANTLY REDUCED THE RISK OF MAJOR CARDIOVASCULAR EVENTS AND DEATH IN ADULTS WITH TYPE 2 DIABETES IN THE LEADER TRIAL NEW ORLEANS, Louisiana—Novo N ordisk announced that Victoza ® (liraglutide) significantly reduced the risk of the composite primary endpoint of cardiovascular (CV) death, non-fatal myocardial infarction (heart attack) or non-fatal stroke by 13% vs placebo (95% confidence interval [CI]: 0.78; 0.97, p=0.01), when added to standard of care in 9,340 adults with type 2 diabetes at high CV risk. The main results of the LEADER trial were presented at the American Diabetes Association's 76th Scientific Sessions (ADA 2016) and also published in the New England Journal of Medicine.[1],[2] Victoza ® is the only approved GLP-1 receptor agonist to demonstrate a superior reduction of major CV events vs placebo, both on top of standard of care, in a cardiovascular outcomes trial. There was a significant 22% reduction in cardiovascular death with Victoza ® treatment vs placebo (95% CI: 0.66; 0.93, p=0.007) and reductions in non-fatal myocardial infarction (HR=0.88, 95% CI: 0.75; 1.03, p=0.11) and non-fatal stroke (HR=0.89, 95% CI: 0.72; 1.11, p=0.30).[1],[2] "These findings are exciting, as it demonstrates that Victoza ® can improve outcomes beyond glucose reduction and weight loss by helping to avoid cardiovascular complications and death in people with type 2 diabetes," said Dr John Buse, chairman of the LEADER Steering Committee and chief of Endocrinology and director of the Diabetes Care Centre at the University of North Carolina School of Medicine. "Type 2 diabetes treatments that can also reduce cardiovascular risk are important since cardiovascular disease is the leading cause of death worldwide in this patient population." All-cause death was significantly reduced by 15% with Victoza ® News and Trends JULY 2016