The Results Are In:
Bariatric Surgery Beats Medical Therapy for Diabetes… AGAIN

Published in February Issue             

The 5-year results of the Surgical Treatment and Medications Potentially Eradicate Diabetes Efficiency (STAMPEDE) study are in and the news is good for patients with obesity and uncontrolled diabetes who had bariatric surgery. They did significantly better than those treated with intensive medical therapy alone. The randomized, controlled trial was published in the February 16 issue of the New England Journal of Medicine.

Bariatric surgery was superior to intensive medical therapy in terms of glycemic control, weight loss, medication reduction, improvement in lipid levels, and quality of life. The authors concluded, “The results of surgery are striking in this population with long-standing, uncontrolled diabetes.”

In the study, 29 percent of gastric bypass patients and 23 percent of sleeve gastrectomy patients reached an HbA1C of less than 6 percent, which is considered in the normal range for people without diabetes. Only 5 percent of medical therapy patients could get there. Researchers noted that a duration of diabetes of less than 8 years was the main predictor of achieving a glycated hemoglobin level of 6.0% or less; a finding that “underscores the importance of early surgical intervention for maximal glycemic benefit.”

Nearly 90 percent of patients who had surgery achieved glycemic control that was considered to be “very good to acceptable” (average glycated hemoglobin level of 7 percent), without the use of insulin. Little more than 60 percent of patients in the medical therapy group were not taking insulin at five years with an average glycated hemoglobin level
of 8.5 percent.

Overall, gastric bypass patients who required insulin dropped from 47 percent to 12 percent, from 45 percent to 11 percent in the sleeve gastrectomy group, and 52 percent to 40 percent in the medical therapy group.

Philip Schauer, MD

“The amount of benefit you get from this surgery, in terms of improving diabetes, improving other cardiovascular risk factors, improving quality of life and losing weight is pretty remarkable, and it’s durable,” said
Philip R. Schauer, MD, from Cleveland Clinic, Ohio who led the study.

Patients who had bariatric surgery also lost significantly more weight. The mean BMI dropped from 37.0 to 28.9 in the gastric bypass group and from 36.0 to 29.3 in the sleeve gastrectomy group. The medical group BMI went from 36.4 to 34.0.

The study included patients with BMIs from 27 to 43. The authors pointed out that nearly all financial coverage policies for bariatric surgery worldwide (public and private) exclude patients with a BMI of less than 35.

Stacy Brethauer, MD

“Our study showed that the benefits of bariatric surgery on glycemic control are durable, even among patients with mild obesity (BMI of 27 to 34), and lead to a sustained reduction in the use of diabetes and cardiovascular medications,” said Stacy Brethauer, MD, study co-author from Cleveland Clinic, OH and ASMBS president. “Coverage policies throughout the world should be looked at to reflect what the data is telling us.”

The study was supported by grants from Ethicon, LifeScan, the Cleveland Clinic, and the National Institutes of Health (NIH).

Earlier this year, the American Diabetes Association issued
new standards that bolstered the use of metabolic or bariatric surgery in diabetes treatment. In addition to recommending surgery to treat type 2 diabetes in higher BMI patients with diabetes, the ADA said metabolic surgery should be considered for adults with type 2 diabetes and BMI 30.0–34.9 (27.5–32.4 in Asian Americans) if hyperglycemia is inadequately controlled despite optimal medical control by either oral or injectable medications (including insulin).