The final 5-year results of the Surgical Treatment and Medications Potentially Eradicate Diabetes Efficiently trial of obese patients with uncontrolled type 2 diabetes showed that bariatric surgery plus intensive medical therapy was more effective than intensive medical therapy alone in decreasing or in some cases resolving hyperglycemia.
A previously reported, preliminary 5-year results were presented at the American College of Cardiology (ACC) 2016 Scientific Sessions in April. The final trial results, by Philip R Schauer, MD, from Cleveland Clinic, Ohio, and colleagues, were published in the February 15 issue of the New England Journal of Medicine.
“We’re certainly not saying in this study that medications and lifestyle are not useful, but for some patients [with type 2 diabetes] who are refractory to lifestyle [changes] and medication and not controlled even with insulin, surgery is a very good option and has durable results out to 5 years,” senior author Sangeeta R Kashyap, MD, Cleveland Clinic, told Medscape Medical News.
About one in four patients who had undergone Roux-en-Y gastric bypass or sleeve gastrectomy but only one in 20 patients who had received only intensive medical therapy attained the primary end point of HbA1c <6% at 5 years.
Moreover, the “beneficial effects of bariatric surgery on glycemic control were durable, even among patients with mild obesity (body mass index [BMI] of 27–34), which led to a sustained reduction in the use of diabetes and cardiovascular medications,” Dr Schauer and colleagues report.
However, this was a small study, and a longer, larger multi-center study — which the group is planning to do — will be needed to confirm these findings and see whether the improved control of diabetes is tied to reduced risk of diabetes-related cardiovascular, renal, or ophthalmic disease.
Bariatric Surgery vs Medications Alone
STAMPEDE randomized 150 patients with uncontrolled type 2 diabetes (a mean HbA1c of 9.2%) and a BMI of 27 to 43 to receive intensive medical therapy alone, Roux-en-Y gastric bypass, or sleeve gastrectomy.
All patients met with clinicians every 3 months for 2 years and every 6 months for 3 years to receive adjustments in their intensive medical therapies with the goal of an HbA1c of 6% without unacceptable side effects.
A total of 134 patients (89%) completed the 5-year trial. On average, when they entered the study, the patients (66% women) had been 49 years old and had had diabetes for 8.4 years, and 44% required insulin.
A total of 49 patients (37%) had mild obesity (BMI <35) at study entry. “Much of diabetes occurs at a BMI of about 30,” and these mildly obese patients tend to have greater visceral obesity, Dr Kashyap note
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