CINCINNATI, Feb. 16, 2017 /PRNewswire/ -- Ethicon* announced today the New England Journal of Medicine (NEJM) publication of the final five-year data from the Ethicon-funded STAMPEDE (Surgical Treatment And Medications Potentially Eradicate Diabetes Efficiently) study that demonstrates bariatric surgery with intensive medical therapy is a better long-term treatment option than intensive medical therapy alone for obese patients, BMI >27, with uncontrolled type 2 diabetes.
Patients who underwent bariatric surgery experienced sustained improvement in glycemic control with less diabetes medications, the five-year follow-up, randomized data concluded. The STAMPEDE trial, conducted by the Cleveland Clinic was led by Philip Schauer, M.D., director of the Bariatric and Metabolic Institute at the Cleveland Clinic and a paid consultant for Ethicon.1
"The landmark STAMPEDE study, along with other studies supported by Ethicon, provide the high level evidence that inform and influence treatment options," said Elliott Fegelman, M.D., Therapeutic Area Lead for Metabolics at Johnson & Johnson Innovation. "The American Diabetes Association's (ADA) newly updated Standards of Care in Diabetes is the most recent example of how research matters, and how studies like STAMPEDE are impacting the standard of care."
The STAMPEDE study is foundational to the mounting research and evidence that supports bariatric surgery as treatment for those suffering with severe obesity and related diseases. "STAMPEDE was recently recognized by the American College of Cardiology as one of the top 10 cardiovascular studies of 2016. In addition to STAMPEDE, Ethicon recently supported the Diabetes Surgery Summit (DSS), a consensus conference that involved representatives of diabetes, obesity and surgery societies from around the world. On the back of available evidence including STAMPEDE, the DSS global clinical guidelines for surgical treatment of diabetes promoted the new ADA guidelines.
"With the new guidelines from ADA and other major diabetes organizations, type 2 diabetes officially becomes an operable disease and bariatric/metabolic surgery a standard-of-care treatment. This is truly a historic development," said Francesco Rubino, M.D., Chair Metabolic and Bariatric Surgery, King's College London and one of the organizers of the DSS. "It is crucial that primary care physicians, policy makers and the public at large be made aware of the new guidelines so that appropriate surgical candidates can have access to a clinically proven and cost-effective form of diabetes treatment."
This critical new evidence continues to evolve and comes at a time when global obesity rates, and obesity-related health conditions, such as type 2 diabetes, are rising presenting a significant health and economic burden.2,3 Nearly 30 percent of the world's population – 2.1 billion people – are obese, with an annual economic impact of approximately two trillion dollars.4 In the United States alone, 29.1 million obese Americans have type 2 diabetes, resulting in $245 billion in medical costs and lost work and wages.5 Patients with multiple obesity-related conditions may reduce the number of medications they take, and improve both their health and quality of life through a single surgical intervention.6
Ethicon is committed to the fight against obesity and metabolic disease around the world and continues to support global initiatives, including clinical research like STAMPEDE and the DSS guidelines, to demonstrate that bariatric and metabolic surgery can be a long-term effective treatment for weight loss and obesity-related health conditions. The work of STAMPEDE will continue in ARMMS (Alliance of Randomized trials of Medicine versus Metabolic Surgery in type 2 diabetes), a study that combines STAMPEDE and three other trials to assess the impact of surgery for up to 10 years. This ongoing research increases awareness and access to bariatric surgery for improved patient outcomes and quality of life.
From creating the first sutures, to revolutionizing surgery with minimally invasive procedures, Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 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, and follow us on Twitter @Ethicon.
Dr. Schauer is a paid consultant for Ethicon.
The STAMPEDE study was funded by Ethicon.
* Ethicon represents the products and services of Ethicon, Inc., Ethicon Endo-Surgery, LLC and certain of their affiliates.
1 Schauer PR, Bhatt DL, Kirwan JP, et al. Bariatric Surgery versus Intensive Medical Therapy for Diabetes – 3-Year Outcomes. NEJM. 2014;370: 2002-2013. http://www.nejm.org/doi/full/10.1056/NEJMoa1401329. Accessed May 22, 2014.
2 Graziano da Silva, J. (2015, March 18). Reversing the Global Obesity Pandemic. Retrieved November 4, 2015.
3 Zhang P, Zhang X, Brown JB et al. Economic Impact of Diabetes. IDF Diabetes Atlas Fourth Edition.
4 Dobbs R, Sawer C, Thompson F, et al. Overcoming obesity: An initial economic analysis. McKinsey Global Institute. http://www.mckinsey.com/industries/healthcare-systems-and-services/our-insights/how-the-world-could-better-fight-obesity. 7 March 2012.
5 Economic Costs of Diabetes in the US in 2012; American Diabetes Association; 2013.
6 National Institute for Health and Care Excellence. Obesity: Identification, assessment and management of overweight and obesity in children, young people and adults. Partial update of CG43. November 2014.
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