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STAMPEDE

STAMPEDE: Five-year data shows benefits of surgery

STAMPEDE study results support the long-term benefits of bariatric and metabolic surgery as treatment option for control of diabetes in patients with obesity

Bariatric and metabolic surgery with intensive medical therapy is a better long-term treatment option than intensive medical therapy alone, for patients with obesity (BMI≥27) and uncontrolled type 2 diabetes, according to the five-year outcomes from the STAMPEDE (Surgical Treatment And Medications Potentially Eradicate Diabetes Efficiently) study. The outcomes are outlined in the paper, ‘Bariatric Surgery versus Intensive Medical Therapy for Diabetes — 5-Year Outcomes’, published in the New England Journal of Medicine (NEJM).

The STAMPEDE trial, conducted by the Cleveland Clinic and funded by Ethicon, was led by Dr Philip Schauer, director of the Bariatric and Metabolic Institute at the Cleveland Clinic. The trial is one of the largest randomised trials with one of the longest follow-ups comparing medical therapy with bariatric surgery.

Philip Schauer

The trial initially involved 150 overweight patients with poorly controlled diabetes. The patients were divided into three groups: 1) 50 patients received intensive medical therapy only, including counselling and medications; 2) 50 patients underwent Roux-en-Y gastric bypass surgery and received medical therapy; 3) 50 patients underwent sleeve gastrectomy and received medical therapy. The primary outcome was a glycated hemoglobin level of 6.0% or less with or without the use of diabetes medications.

Outcomes

Of the 150 patients who underwent randomisation, one patient died during the five-year follow-up period; 134 of the remaining 149 patients (90%) completed five years of follow-up. At baseline, the mean (±SD) age of the 134 patients was 49±8 years, 66% were women, the mean glycated hemoglobin level was 9.2±1.5%, and the mean BMI was 37±3.5.

At five years, the criterion for the primary end point was met by 2 of 38 patients (5%) who received medical therapy alone, as compared with 14 of 49 patients (29%) who underwent gastric bypass (unadjusted p=0.01, adjusted p=0.03, p=0.08 in the intention-to-treat analysis) and 11 of 47 patients (23%) who underwent sleeve gastrectomy (unadjusted p=0.03, adjusted p=0.07, p=0.17 in the intention-to-treat analysis).

Patients who underwent surgical procedures had a greater mean percentage reduction from baseline in glycated haemoglobin level than did patients who received medical therapy alone (2.1% vs. 0.3%, p=0.003). At five years, changes from baseline observed in the gastric-bypass and sleeve-gastrectomy groups were superior to the changes seen in the medical-therapy group with respect to:

  • body weight (−23%, −19%, and −5% in the gastric-bypass, sleeve-gastrectomy, and medical-therapy groups, respectively) 
  • triglyceride level (−40%, −29%, and −8%)
  • high-density lipoprotein cholesterol level (32%, 30%, and 7%)
  • use of insulin (−35%, −34%, and −13%) and;
  • quality-of-life measures (general health score increases of 17, 16, and 0.3; scores on the RAND 36-Item Health Survey ranged from 0 to 100, with higher scores indicating better health) (p<0.05 for all comparisons).

There were no major late surgical complications reported, except for one re-operation.

Francesco Rubino

Overall, the paper concluded that at five years the patients who underwent bariatric and metabolic surgery experienced sustained improvement in glycaemic control with fewer diabetes medications.

“With the new guidelines from the American Diabetes Association (ADA) and other major diabetes organizations, type 2 diabetes has officially become an operable disease, with bariatric and metabolic surgery a standard of care treatment; this is truly a historic development,” said Professor Francesco Rubino, Chair of Metabolic and Bariatric Surgery, King’s College London. “It is crucial that primary care physicians, policy makers and the public at large be made aware of the new guidelines so that eligible patients have access to a clinically proven and cost-effective form of diabetes treatment.”

Obesity epidemic

This critical new evidence comes at a time when global obesity rates, and obesity-related health conditions, such as type 2 diabetes, are rising and presenting a significant health and economic burden, Nearly 30 percent of the world’s population – 2.1 billion people – and approximately 20 percent of the adult population in Europe are obese.

This continues to have significant economic implications in the EU, with nearly €33 billion annual health care costs attributed to obesity. Some of these patients suffering from multiple obesity-related conditions may reduce the number of medications they take, and improve both their health and quality of life through a single surgical intervention.

“Despite the growing evidence of its effectiveness, many diabetes care providers and patients are still inadequately informed about the indications and potential benefits of surgical treatment for obesity and type 2 diabetes,” said Silvia De Dominicis, Ethicon Franchise Vice President for EMEA. “At Ethicon, we believe patients suffering at the hands of these diseases should be made aware of, and have access to, effective treatment, including bariatric and metabolic surgery. We welcome both the STAMPEDE data and the ADA’s latest guidelines.”

The work of STAMPEDE will continue in ARMMS (Alliance of Randomized trials of Medicine versus Metabolic Surgery in type 2 diabetes), a study that combines STAMPEDE and three other trials to assess the impact of surgery for up to ten years.

This ongoing research increases awareness and access to bariatric and metabolic surgery for improved patient outcomes and quality of life. 

To view or to download the infographic, please click here or on the image.

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