CHICAGO — Bariatric surgery was significantly more effective than intensive medical therapy alone in achieving glycemic control in obese patients with uncontrolled type 2 diabetes, according to results of the STAMPEDE trial.
The three-arm, randomized, controlled, single-center Surgical Therapy and Medications Potentially Eradicate Diabetes Efficiently (STAMPEDE) trial included 150 patients. All had HbA1c ≥7%, BMI of 27 to 43 and were aged 20 to 60 years. Patients were randomly assigned in a 1:1:1 ratio to one of three treatments regimens: optimal medical therapy, optimal medical therapy combined with Roux-en-Y gastric bypass or optimal medical therapy combined with laparoscopic sleeve gastrectomy. The final analysis included 41 patients assigned to medical therapy alone, 50 patients to gastric bypass and 49 patients to sleeve gastrectomy.
At 1 year, glycemic control improved in all three groups, with a mean HbA1c of 7.5% in the medical therapy alone group, 6.4% in the medical therapy/gastric bypass group and 6.6% in the sleeve gastectomy group. Twelve percent of patients in the medical therapy alone group achieved the glycemic goal of ≤6%, compared with 42% in the medical therapy/gastric bypass group and 36.7% in the sleeve gastrectomy group (P=.002 for gastric bypass vs. medical therapy; P=.008 for sleeve gastrectomy vs. medical therapy).
“There was quite a large difference between the surgical group and the medical group in terms of success rate,” Philip R. Schauer, MD, professor of surgery and director of the Bariatric and Metabolic Institute at Cleveland Clinic, said at a press conference. “And, it should be noted that the surgery group did so without any medications.”
There were no major differences in BP or cholesterol between the groups. In addition, patients in the surgical groups saw a significant improvement in glycemic control and were able to dramatically reduce the number of glucose-, cholesterol- and BP-lowering medications they were taking.
“We saw reductions in diabetes and CV medications, hypertensive agents, statins and beta-blockers,” Schauer said. Medication use generally increased for patients assigned to medical therapy alone, he noted.
Surgical patients lost approximately 60 lb, compared with 10 lb in the medical therapy alone group.
“A significant change in body weight with surgery was not surprising,” he said. “However, it is remarkable that medical patients lost weight given that some of the drugs [they were taking] are associated with weight gain.”
Although surgery may come with risks, no complications or deaths were reported in the surgery groups.
“The overall take-home message is that surgical patients enjoyed superior improvement and glycemic control, and did so with few medications,” Schauer said.
Of note, Schauer said the researchers aimed to drive HbA1c to <6%, “which is a bit more rigorous than the American Diabetes Association standard to drive it to 7% or less.”
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Disclosure: Dr. Schauer has received research support from Amarin, Allergan, the American Diabetes Association, AstraZeneca, Bard-Davol, Baxter, Bristol-Myers Squibb, Covidien, Eisai, Ethicon Endo-Surgery, Gore, Medtronic, Nestle, the NIH, Sanofi-Aventis, ScottCare, Stryker Endoscopy and The Medicines Company. He also reports consulting and honoraria from Barosense, Bard-Davol, Carefusion, Covidien, Ethicon Endo-Surgery, Gore, Orexigen, RemedyMD, Stryker Endoscopy, Surgiquest and Vivus. STAMPEDE was sponsored by Ethicon Endo-Surgery with support from LifeScan and NIH-NIDDK.