Johnson & Johnson (NYSE:JNJ) said today that 5-year results from the Ethicon-funded Stampede trial exploring the benefits of bariatric surgery and intensive medical therapy for diabetes patients were published in the New England Journal of Medicine.
The trial aimed to explore the use of bariatric surgery and medical therapy for obese Type II diabetes patients with a BMI of greater than or equal to 27, according to Johnson & Johnson.
At 5 years, patients who underwent bariatric surgery reported sustained gylcemic control improvements and less diabetes medications, according to the study.
“The landmark Stampede study, along with other studies supported by Ethicon, provide the high level evidence that inform and influence treatment options. The American Diabetes Association’s 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,” J&J therapeutic area lead for metabolics Dr. Elliott Fegelman said in a prepared statement.
J&J’s Ethicon said it will continue to explore the effectiveness of bariatric and metabolic surgery with the ARMMS study, which when combined with the Stampede and 3 other trials will provide data on the impact of such surgeries for up to 10 years.
“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. 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,” Dr. Francesco Rubino of King’s College London said in a press release.
J&J’s Ethicon subsidiary said last month it won FDA 510(k) clearance for its Echelon Flex 45mm endocutter with proprietary gripping surface technology.
The clearance follows an earlier pass by the federal agency for Ethicon’s Echelon Flex 60mm powered plus stapler. With the new clearance, Echelon’s Flex GST system offers both 45mm and 60mm endocutters with exclusive reloads.