Glycemic control, weight loss endure out to five years
The beneficial effects of bariatric surgery on glycemic control in obese patients with type 2 diabetes are durable out to at least five years, with the advantage over intensive medical therapy appearing to widen over time.
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That’s the key takeaway of the final, five-year follow-up report from the pivotal STAMPEDE trial, which was presented April 4 by Cleveland Clinic bariatric surgeon Philip Schauer, MD, as a late-breaking trial at ACC.16, the American College of Cardiology’s 65th Annual Scientific Session.
“Our findings show continued durability of glycemic control after metabolic surgery as well as persistent weight loss and reductions in diabetes and cardiovascular medications at five years,” says Dr. Schauer.
STAMPEDE is a three-arm controlled trial conducted at Cleveland Clinic that randomized 150 obese patients with type 2 diabetes to intensive medical therapy alone or in combination with plus Roux-en-Y gastric bypass or sleeve gastrectomy. Findings from the new prespecified five-year follow-up confirm those from the one-year and three-year reports and include the following:
The five-year analysis also yielded several new insights, including the following:
“Some advantages of gastric bypass over sleeve gastrectomy have emerged during follow-up,” Dr. Schauer adds. “At five years, gastric bypass maintained greater weight loss than sleeve gastrectomy while requiring fewer medications.”
The single-center study was coordinated by the Cleveland Clinic Coordinating Center for Clinical Research (C5Research).
He also notes that the final STAMPEDE results might help expand the population of patients in whom bariatric surgery may be considered for improving glycemic control. “Most clinical guidelines and insurance policies for bariatric surgery limit access to patients with a BMI of 35 or above,” Dr. Schauer says. “But our five-year results demonstrate that glycemic improvement in patients with a BMI of 27 to 34 is durable at least out to five years.”
Despite these confirmatory final results, the STAMPEDE trial should be considered in context by clinicians, points out STAMPEDE co-investigator Sangeeta Kashyap, MD, a Cleveland Clinic endocrinologist. “The superior benefits of surgery to attain diabetes treatment goals must be carefully balanced with the long-term risks associated with surgery for individual patients,” she says.
Dr. Schauer adds that STAMPEDE was not large enough or long enough to detect differences in cardiovascular complications: “The potential benefits of bariatric surgery on clinical end points can be assessed only through large multicenter trials.”
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