ACC 2014 Report: Bariatric surgery vs. intensive medical therapy for uncontrolled diabetes: STAMPEDE Trial

by Bruce Sylvester – For managing uncontrolled type 2 diabetes in obese patients, gastric bypass and sleeve gastrectomy are each more effective than intensive medical therapy alone.

Researchers from the 3-year STAMPEDE trial reported findings on March 31, 2014 at American College of Cardiology/ACC 2014. The findings were also published on that date in the New England Journal of Medicine.

“Both surgical options maintain their supremacy over standard intensive medical therapy at the three-year mark,” said Philip Schauer, MD, professor of surgery, director of the Bariatric and Metabolic Institute, Cleveland Clinic, and lead investigator of the study.

The investigators randomized 150 patients into three cohorts, intensive medical therapy only, intensive medical therapy plus Roux-en-Y gastric bypass, or intensive medical therapy plus sleeve gastrectomy.

The medical therapy-only group received counseling and a combination of insulin sensitizers, GLP-1 agonists, sulfonylureas and multiple insulin injections. They also enacted lifestyle changes.

At baseline, the subjects had a mean baseline glycated hemoglobin level (HbA1c) of 9.3 percent, were diagnosed with uncontrolled diabetes for eight years or longer, and were taking three or more anti-diabetic drugs and three or more cardiovascular drugs.

They ranged in age from 41 to 57 years. They were mildly to moderately obese at baseline. And 68 percent were female.

The primary endpoint of the study was achievement of an HbA1c ≤6 percent .

At three years, only 5 percent of subjects in the medical therapy group achieved the primary endpoint, compared with 37.5 percent in the gastric bypass group (P<0.001) and 24.5 percent of sleeve gastrectomy group (P=0.01).

Compared to medical therapy subjects, those in a surgical group achieved greater improvement in measures of the metabolic syndrome, including BMI, waist circumference, triglycerides and HDL cholesterol. Surgical groups also achieved significant reduction in the use of antihypertensive and lipid-lowering drugs.

At endpoint, 5-10 percent of the surgical subjects were using insulin, compared to 55 percent in the medical therapy group.

As a secondary endpoint, the investigators measured kidney function as determined by urinary albumin changes. They reported improvement in albuminuria in the surgical groups, despite a reduction in the use of renin-angiotensin system blockers. This suggests, they said, that bariatric surgery could have a role in preventing renal parenchymal damage.