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STAMPEDE: 3 year results show surgical effectiveness

Surgery patients show diabetes control and report QoL improvements
Bypass betters sleeve, both better medical therapy alone

Three year outcomes from the Surgical Therapy And Medications Potentially Eradicate Diabetes Efficiently (STAMPEDE) trial has shown that bariatric surgery is a highly effective and durable treatment for type 2 diabetes in obese patients, enabling nearly all surgical patients to be free of insulin and many to be free of all diabetic medications three years after surgery.

The results, which were simultaneously published in The New England Journal of Medicine and presented at the Annual Scientific Session of the American College of Cardiology in Washington DC, also revealed that surgery patients experienced an improvement in quality of life and a reduction in the need for cardiovascular medications to control blood pressure and cholesterol, compared to those receiving medical therapy.

As a result, patients in the surgery groups used less cardiovascular and glucose-lowering medications, 5-10% were on insulin compared to 55% of the patients in the medical therapy group.

Sangeeta Kashyap

“We see patients whose lives are ravaged by diabetes. At the three-year mark, this study shows that bariatric surgery is more effective with persistent benefits noted up to three years for treating type 2 diabetes in moderate and severely obese patients when compared to medical therapy,” said Dr Sangeeta Kashyap, one of the lead investigators and an endocrinologist at Cleveland Clinic’s Endocrinology & Metabolism Institute. “More than 90% of the patients who underwent bariatric surgery were able to lose 25 percent of their body weight and control their diabetes without the use of insulin and multiple diabetes drugs.”

STAMPEDE study

To date, the STAMPEDE study 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) 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.

Effectiveness was gauged by the percentage of patients who achieved blood sugar control, defined in this study as haemoglobin HbA1c level of less than or equal to 6.0%, a more aggressive target than the American Diabetes Association’s guidelines.

The mean (±SD) age of the patients at baseline was 48±8 years, 68% were women, the mean baseline glycated haemoglobin level was 9.3±1.5%, mean baseline BMI was 36.0±3.5 and the average duration of diabetes was 8.3±5.1 years, with 43% of patients requiring insulin at baseline. There were no significant differences between the study groups at baseline A total of 91% of the patients completed 36 months of follow-up.

Outcomes

Four surgical interventions were required within the first 12 months after randomization, although there were no deaths or no life-threatening complications in any of the groups.

At 3 years, the target glycated haemoglobin level of 6.0% or less was achieved in 5% of the patients in the medical-therapy group, compared with 38% of those in the gastric-bypass group (p<0.001) and 24% of those in the sleeve-gastrectomy group (p=0.01). This correlates with a weight loss five to six times greater on average for patients who underwent bariatric surgery compared with those in the intensive medical therapy group. The researchers found that a reduction in the BMI was the only significant predictor of achieving the target glycated haemoglobin level of 6.0% or less (p<0.001).

The researchers reported excessive weight gain (>5% from baseline) in seven of 43 patients (16%) in the medical-therapy group and in no patients in the two surgical groups (p<0.05 for both). In addition, the surgical groups had reductions in body weight, BMI, waist circumference, and waist-to-hip ratio. The reduction in body weight was greater in the bypass group compared with the sleeve (p=0.02).

Philip Schauer

“The three-year data confirm that bariatric surgery maintains its superiority over medical therapy for the treatment of type 2 diabetes in severely obese patients,” said lead investigator Dr Philip Schauer, Director of the Cleveland Clinic Bariatric and Metabolic Institute. “We looked at quality of life, because ultimately it is all about helping our patients live a healthier, happier life. When compared to sleeve gastrectomy and medical therapy, gastric bypass patients achieved greater weight loss, were on fewer medications, had a higher success rate in controlling their diabetes, and an improved quality of life.”

The impact of diabetes and obesity on the patients’ quality of life using a validated questionnaire (SF-36, Rand Corp.) showed significant improvements in five of eight mental and physical domains for patients in the gastric bypass group and two of eight domains for the patients in the sleeve gastrectomy group. There was no improvement in the medical therapy group.

“We conclude that bariatric surgery represents a potentially useful strategy for the management of type 2 diabetes, allowing many patients to reach and maintain therapeutic targets of glycaemic control that otherwise would not be achievable with intensive medical therapy alone,” the authors state. “The question as to whether the documented benefits will reduce microvascular and macrovascular morbidity and mortality, as shown in nonrandomized studies, can be adequately answered only through larger, multicenter clinical-outcome trials.”

The STAMPEDE study was funded by Ethicon, through its Metabolic Applied Research Strategy (MARS) programme.

For more information on the STAMPEDE clinical trial, please click here

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