Five Year Data From Ethicon-Funded Study Demonstrates Long-Term Benefit Of Bariatric Surgery For Control Of Diabetes

CINCINNATI, April 5, 2016 /PRNewswire-USNewswire/ -- Ethicon* announced new data presented this week at the American College of Cardiology meeting that demonstrates bariatric surgery with intensive medical therapy is a better long-term treatment option than intensive medical therapy alone for obese patients, BMI >=30, with uncontrolled type 2 diabetes. Patients who underwent bariatric surgery experienced sustained improvement in glycemic control and reduction in diabetes medications over time. The 5-year follow-up data concluded the STAMPEDE (Surgical Therapy And Medications Potentially Eradicate Diabetes Efficiently) trial, conducted by the Cleveland Clinic (Cleveland, Ohio, USA) and led by Philip Schauer, MD, director of the Bariatric and Metabolic Institute at the Cleveland Clinic.[1] The study was funded primarily by Ethicon.

"STAMPEDE's five year results definitively demonstrate the long-term benefit of bariatric surgery with intensive medical therapy over medical management alone in treating obese patients with type 2 diabetes," said Dr. Elliott Fegelman, Therapeutic Area Expert, Metabolics, Johnson & Johnson Innovations." We can now say with certainty that bariatric surgery is a more effective treatment for these patients, completely eliminating the need for diabetes medications in some patients and a marked reduction in need for drug treatment in others. Based on the study results we can move forward identifying the right procedure for each patient, based on that patient's unique factors."

The evidence comes at a time when global obesity rates, and obesity-related health conditions such as type 2 diabetes, are rising and present 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] As obesity rates have increased, so have those for type 2 diabetes, and over 30 percent of the obese population has type 2 diabetes.[5] In the U.S. alone, 29.1 million obese Americans have type 2 diabetes, resulting in $245 billion in medical costs and lost work and wages.[6]  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.[7]

Ethicon is committed to the fight against obesity around the world, and continues to lead global initiatives, including clinical research like STAMPEDE, to demonstrate that surgery can be a long-term effective solution for weight loss and obesity-related health conditions, and to increase awareness and access to bariatric surgery for improved patient outcomes and quality of life.

Key STAMPEDE findings at five year follow-up:

The results of this five year follow-up from the randomized STAMPEDE trial demonstrates bariatric surgery's superior ability to control type 2 diabetes over time compared with intensive medical therapy alone, resulting in superior glycemic control and weight reduction for obese patients with uncontrolled type 2 diabetes, concurrent with reductions in the need for hypertension and hyperlipidemia medications.  In addition, some advantages of gastric bypass over sleeve gastrectomy emerged during follow up. At five years, patients with gastric bypass maintained greater weight loss and higher rate of type 2 diabetes remission than sleeve gastrectomy patients while requiring fewer medications. 

STAMPEDE is one of four trials being combined into the ARRMS (Alliance of Randomized trials of Medicine vs. Metabolic Surgery in type 2 diabetes) study, partially funded by Ethicon, expanding data on bariatric surgery's long-term effectiveness for obese patients with type 2 diabetes and other obesity-related health conditions. With four study centers across the U.S., the ARRMS trial will significantly increase the number of patients with this chronic disease to be studied over an extended time.  Ethicon will continue to collaborate with key stakeholders to develop scientific evidence to support the effectiveness of bariatric surgery in an effort to extend coverage and benefits for bariatric surgery   

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.

Cautions Concerning Forward-Looking Statements: This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding the potential acquisition of NeuWave Medical, Inc. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Ethicon, Inc., Ethicon Endo-Surgery, Inc. and Johnson & Johnson. Risks and uncertainties include, but are not limited to: the satisfaction of closing conditions for the acquisition, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act; the possibility that the transaction will not be completed or, if completed, not completed in the expected timeframe; the potential that the expected benefits and opportunities may not be realized or may take longer to realize than expected; competition, including technological advances, new products and patents attained by competitors; challenges to patents; uncertainty of commercial success for new products; the ability of the company to successfully execute strategic plans; impact of business combinations and divestitures; challenges inherent in new product development, including obtaining regulatory approvals; economic conditions, including currency exchange and interest rate fluctuations; changes to applicable laws and regulations, including tax laws and global health care reforms; adverse litigation or government action; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; and trends toward health care cost containment. In addition, if and when the transaction is consummated, there will be risks and uncertainties related to the ability of the Johnson & Johnson family of companies to successfully integrate the products, employees and operations of NeuWave Medical, Inc., as well as the ability to ensure continued performance or market growth of NeuWave Medical, Inc.'s products. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 3, 2016, including in Exhibit 99 thereto, and the company's subsequent filings. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Ethicon, Ethicon Endo-Surgery, Inc. and Johnson & Johnson do not undertake to update any forward-looking statement as a result of new information or future events or developments.

Dr. Schauer is a paid consultant for Ethicon.

The STAMPEDE study was funded by Ethicon, part of the Johnson & Johnson family of companies.  

* 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] Bays HE, Chapman RH, Grandy S. The relationship of body mass index to diabetes mellitus, hypertension and dyslipidaemia: comparison of data from two national surveys.  Int J Clin Pract, May 2007, 61, 5, 737747.
[6] Economic Costs of Diabetes in the US in 2012; American Diabetes Association; 2013.
[7] 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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SOURCE Ethicon