ACC.14: STAMPEDE gallops forward with promising results at 3 years

Combining bariatric surgery with medical therapy for three years was more effective at glycemic control than medical therapy alone among obese patients with type 2 diabetes, according to research presented March 31 at the American College of Cardiology (ACC) scientific session in Washington, D.C.

In the Surgical Treatment and Medications Potentially Eradicate Diabetes Efficiently (STAMPEDE) trial, Philip R. Schauer, MD, of the Cleveland Clinic, and co-investigators evaluated outcomes three years after randomizing 150 obese patients with uncontrolled type 2 diabetes to treatment with either intensive medical therapy alone or intensive medical therapy along with either a Roux-en-Y gastric bypass or a sleeve gastrectomy.

The primary endpoint was a glycated hemoglobin level of 6 percent of less without the use of diabetes medications.

Three years after randomization, 13 patients either withdrew or were lost to follow-up. At baseline, average glycated hemoglobin level was 9.3 percent and average baseline body mass index (BMI) was 36. The attainment of the primary outcome was significantly better among the bariatric surgery group (38 percent in the bypass group and 24 percent in the sleeve gastrectomy group vs. 5 percent in the medical therapy only group). Fewer of the bariatric surgery patients used diabetes medications as well.

Surgery patients had greater average percentage reductions in weight (24.5 percent among the bypass patients and 21.1percent among the sleeve-gastrectomy group vs. 4.2 percent in the medical therapy group). Quality of life measures were also significantly better among the surgery patients.

The investigators acknowledged their sample size was small and their follow-up period was shorter than the five years specified by protocol, but they argued that “bariatric surgery represents a potentially useful strategy for the management of type 2 diabetes, allowing many patients to reach and maintain therapeutic targets of glycemic control that otherwise would not be achievable with intensive medical therapy alone.”

The study was simultaneously published in the New England Journal of Medicine.