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Gathering evidence

Ethicon supports initiatives to expand access to surgery

‘Project Game Changer’ to close evidence gaps, reduce clinical and economic barriers and expand patient access to the surgical treatment of obesity and related diseases

Ethicon has announced major progress in its multi-year, multi-million dollar global initiative called, ‘Project Game Changer’, to close evidence gaps, reduce clinical and economic barriers and expand patient access to the surgical treatment of obesity and related diseases and conditions including type 2 diabetes, hypertension and orthopaedic issues.

"Ground-breaking clinical and economic studies, major treatment guidelines and real world evidence have contributed to the transformation of bariatric surgery from what was once considered by some to be either cosmetic or high risk to an effective lifesaving operation whose benefits go far beyond weight loss," said Michael del Prado, Company Group Chairman, Ethicon.

The worldwide prevalence of obesity more than doubled between 1980 and 2014. According to the World Health Organization (WHO), more than 1.9 billion adults were overweight in 2014. Of this group, more than 600 million have obesity. In the United States, more than two in three adults are overweight or have obesity, and about one in 13 are considered to have extreme obesity.

For the Game Changer Initiative, Ethicon is focusing its research and evidence generation efforts on the safety# and effectiveness of bariatric surgery on reducing obesity, and obesity-related diseases such as type 2 diabetes, heart disease and orthopaedic conditions, as well as the treatment's impact on healthcare costs. Several studies have already been published in peer reviewed journals and many more are underway.

"A wide range of evidence guides innovation, adoption of procedures and everyday treatment decisions. We are committed to working with the bariatric community to advance the specialty and expand access for the benefit of patients everywhere. Significant progress has been made, but much work is left to do," said Dr Elliott Fegelman, Therapeutic Area Lead for Metabolics at Johnson & Johnson Innovation.

For Ethicon, the focus on obesity and type 2 diabetes is not new. Through the years, the company has been a sponsor of randomized clinical trials including the landmark STAMPEDE study (Bariatric Surgery versus Intensive Medical Therapy for Diabetes — 5-Year Outcomes), whose five-year outcomes were published in The New England Journal of Medicine (NEJM). The study showed bariatric surgery with intensive medical therapy is a better long-term treatment than intensive medical therapy alone for obese patients with uncontrolled type 2 diabetes.

The three-year outcomes from STAMPEDE, also published in NEJM in 2012, were cited in global clinical guidelines from international diabetes organizations, that for the first time, included bariatric and metabolic surgery as a standard treatment option for people with diabetes, including those who are mildly obese and fail to respond to conventional treatment. Ethicon provided support for the Second Diabetes Surgery Summit (DSS-II), the international consensus conference that developed the guidelines that were endorsed and adopted by 45 medical professional societies including the European Association for the Study of Diabetes (EASD), International Diabetes Federation (IDF), American Diabetes Association (ADA), International Federation of Surgery of Obesity (IFSO), and the American Society for Metabolic and Bariatric Surgery (ASMBS).

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 ten years. This ongoing research increases awareness and access to bariatric surgery for improved patient outcomes and quality of life. Studies are also underway on metabolic surgery in Asian Indian populations, on the mechanism of action of bariatric surgery, and on the impact of bariatric surgery on diabetic nephropathy.

Ethicon collects and analyses real world evidence from actual clinical practice to better understand the impact and value for specific markets and populations.  Studies conducted in several regions throughout the world have shown bariatric surgery results in a reduction of healthcare costs and hospitalization and less reliance on medications for diabetes, dyslipidaemia, and hypertension, because of weight loss that leads to disease improvement or remission.

Ethicon is actively investigating the impact of bariatric surgery on other obesity-related diseases through studies such as SWIFT, an Ethicon-funded, multi-centre, case-matched control study, which seeks to understand if weight loss as a result of bariatric surgery can delay the need for a total knee replacement or improve function after total knee replacement. The company is also conducting a randomized controlled clinical trial of gastric bypass in patients with obesity and poorly controlled hypertension and in obese patients with diabetic nephropathy.

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