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STAMPEDE: Glycemic benefits of bariatric surgery sustained up to 5 years
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CHICAGO — Patients with mild to moderate obesity and type 2 diabetes who underwent bariatric surgery had better glycemic control than patients who were assigned an intensive medical therapy approach, according to the 5-year follow-up of the STAMPEDE trial presented at the American College of Cardiology Scientific Session.
“Of the approximately 25 million Americans with type 2 diabetes, only about 50% of them are actually at good glycemic control with current medication strategies,” Philip Schauer, MD, an endocrinologist at Cleveland Clinic’s Endocrinology & Metabolism Institute, said in a presentation. “Our findings show continued durability of glycemic control after metabolic surgery, as well as persistent weight loss, reduction in diabetes and CV medications at 5 years.”
Philip Schauer
Initial study
In the initial three-arm randomized controlled, single-center trial, 150 patients with BMI of 27 kg/m2 to 43 kg/m2 and an HbA1c level of more than 7% were randomly assigned intensive medical therapy, intensive medical therapy with Roux-en-Y gastric bypass surgery or intensive medical therapy with sleeve gastrectomy. The primary endpoint was an HbA1c level of 6% or less, with or without the use of diabetes medications. The 3-year results showed that only 5% of patients in the medical therapy group achieved target HbA1c level of 6% vs. 38% of patients in the gastric bypass group (P < .001) and 24% in the sleeve gastrectomy group (P = .01).
5-year data
The 5-year data presented here show that the glycemic benefits of bariatric surgery are sustained over time. At 5 years, more than 88% of patients in both surgery groups had maintained healthy HbA1c levels without the use of insulin. In addition, 29% of patients in the gastric bypass group and 23% in the sleeve gastrectomy group had achieved and maintained healthy HbA1c levels vs. the 5% in the medical therapy group.
“Of note, a significant amount of patients in the gastric bypass and sleeve gastrectomy groups are on no medications and relatively few are on insulin at the 5-year mark compared to the patients in the medical therapy group,” Schauer said.
Weight loss also was significantly greater in the surgery groups than in the medical therapy group. Twenty percent of the patients in the medical therapy group had a weight gain of 5% or greater, according to Schauer.
“Patients with a BMI less than 35 [kg/m2] compared to those with more severe obesity tended to have as good a benefit, and this is important because most guidelines and insurance companies do not cover bariatric surgery for BMI less than 35 [kg/m2] for any reason,” he said. “These data suggest that those with a BMI between 27 kg/m2 and 34 kg/m2 fare just as well in terms of glycemic benefit as the most severe patients.”
Schauer said there were some limitations of the study, and future multicenter studies with a larger sample size would be helpful in the generalizability of these results. – by Tracey Romero
Reference:
Schauer P, et. al. Featured Clinical Research II. Presented at: American College of Cardiology Scientific Session; April 2-4, 2016; Chicago.
Disclosure: The STAMPEDE trial was funded by Ethicon, part of the Johnson & Johnson family of companies, through its Metabolic Applied Research Strategy (MARS) program. Schauer reports receiving consulting fees from Ethicon.