In the final, five-year follow-up report from the influential STAMPEDE trial, Cleveland Clinic research shows that bariatric surgery's beneficial effects on blood glucose control in mild and moderately obese patients with type 2 diabetes may persist for up to five years, with the advantage over diabetes medications-only approach widening over time.
The five-year follow-up also reported that:
"Our findings show continued durability of glycemic control after metabolic surgery, as well as persistent weight loss, reduction in diabetes and cardiovascular medications at five years," said Philip Schauer, M.D., lead author and Cleveland Clinic bariatric surgeon, who presented the results today at ACC.16, the American College of Cardiology's 65th Annual Scientific Session.
"The superior benefits of surgery to attain diabetes treatment goals must be carefully balanced with the long-term risks associated with surgery for individual patients," said Sangeeta Kashyap, M.D., co-investigator involved with the trial and an endocrinologist at Cleveland Clinic's Endocrinology & Metabolism Institute.
According to the CDC, 29 million people in the United States (9.3 percent) have diabetes. More than 70,000 persons die annually due to complications associated with diabetes, according to the American Diabetes Association. Approximately 50 percent of patients currently treated for type 2 diabetes with medications are not meeting standard targets of glycemic control and thus are at risk for developing complications of diabetes.
"Left unchecked, diabetes can lead to kidney failure, blindness, and limb amputation," said Dr. Kashyap. "At the five-year mark, bariatric surgery's metabolic effect persists and is more effective at treating type 2 diabetes in moderate and severely obese patients when compared to medical therapy."
The STAMPEDE (Surgical Therapy And Medications Potentially Eradicate Diabetes Efficiently) trial is the largest randomized trial with one of the longest follow-ups comparing medical therapy with bariatric surgery.
The trial initially involved 150 overweight patients with poorly controlled diabetes. The patients were divided into three groups: 1) Fifty patients received intensive medical therapy only, including counseling and medications; 2) Fifty patients underwent Roux-en-Y gastric bypass surgery and received medical therapy; 3) Fifty patients underwent sleeve gastrectomy and received medical therapy.
Effectiveness was gauged by the percentage of patients who achieved blood sugar control, defined in this study as hemoglobin HbA1c level of less than or equal to 6.0 percent -- a more aggressive target than the American Diabetes Association's guidelines. HbA1c is a standard laboratory test that reflects average blood sugar over three months.
Findings from the five-year follow-up confirm those from the one-year and three-year reports and include the following:
The five-year analysis also yielded several new insights, including the following:
"Some advantages of gastric bypass over sleeve gastrectomy have emerged during follow-up," Dr. Schauer said. "At five years, gastric bypass maintained greater weight loss than sleeve gastrecomy while requiring fewer medications."
He also notes that the final STAMPEDE results might help expand the population of patients in whom bariatric surgery may be considered for improving glycemic control.
"Most clinical guidelines and insurance policies for bariatric surgery limit access to patients with a BMI of 35 or above," Dr. Schauer added. "Our five-year results demonstrate that glycemic improvement in patients with a BMI of 27 to 34 is durable at least up to five years."
Materials provided by Cleveland Clinic. Note: Content may be edited for style and length.
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