Bariatric surgery versus intensive medical therapy for diabetes–3-year outcomes

Schauer PR, Bhatt DL, Kirwan JP, et al; for the STAMPEDE Investigators. Bariatric surgery versus intensive medical therapy for diabetes–3-year outcomes. N Engl J Med. 2014. doi: 10.1056/NEJMoa1401329.

One-year findings from the STAMPEDE trial showed a significantly greater percentage of subjects who achieved A1C ≤6.0%, as well as reduction in CV risk factors and the need for antihyperglycemic medications, with bariatric surgery vs medical therapy.1 Newly published data demonstrated the 3-year durability of these initial findings.

STAMPEDE was a randomized, controlled trial comparing bariatric surgery vs intensive medical therapy for treatment of uncontrolled type 2 diabetes. Subjects (N=150) were obese (BMI 27-43 kg/m2) and had A1C ≥7.0%. Randomization was 1:1:1 to intensive medical therapy (n=40), intensive medical therapy + Roux-en-Y gastric bypass (n=48), or intensive medical therapy + sleeve gastrectomy (n=49), stratified by the use of insulin at baseline. Mean baseline A1C was 9.3%.

Primary endpoint
At 3 years, a significantly greater percentage of subjects who underwent bariatric surgery met the primary endpoint, A1C ≤6.0%: 38% who had gastric bypass (P<0.001) and 24% who had sleeve gastrectomy (P=0.01), vs 5% who received medical therapy only. This translated to an absolute decrease in A1C of 2.5 percentage points which was sustained over the 3-year study period. Both surgery groups were superior to medical therapy alone in achieving A1C 6.5% and 7.0%, regardless of whether antihyperglycemic medications were used (P<0.05 for all comparisons).

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STAMPEDE A1C Less Than or Equal To 6 Percent at 3 Yrs With Bariatric Surgery Vs Medical Therapy
STAMPEDE: A1C ≤6.0% at 3 Yrs With
Bariatric Surgery Vs Medical Therapy


Additional findings  

  • FPG levels were significantly lower among patients who underwent surgery vs medical therapy alone (P<0.01 for both comparisons)
  • There was a 24.5% weight reduction from baseline in the gastric bypass group and a 21.1% reduction in the sleeve-gastrectomy group, vs a 4.2% reduction in the medical therapy group (P<0.001 for both comparisons)
  • BMI, waist-to-hip ratio, and waist circumference showed greater reductions in the surgery groups compared with medical therapy
  • Use of antihyperglycemic medications, including insulin, and lipid-lowering medication was reduced at 3 years in the surgical groups

Clinical guidelines recommend bariatric surgery for patients with BMI ≥40 kg/m2 without coexisting medical problems and for patients with BMI ≥35 kg/m2 and 1 or more severe obesity-related comorbidities.2,3 The guidelines further note that evidence for recommending bariatric surgery in patients with BMI <35 kg/m2 is limited.2,3 Subjects in STAMPEDE had BMI ranging from 27-43 kg/m2 (mean BMI 36 kg/m2).

BMI=body mass index; BP=blood pressure; STAMPEDE=Surgical Treatment and Medications Potentially Eradicate Diabetes Efficiently; TG=triglycerides

1. Schauer PR, Kashyap SR, Wolski K, et al. Bariatric surgery versus intensive medical therapy in obese patients with diabetes. N Engl J Med. 2012;366(17):1567-1576.
2. Mechanick JI, Youdim A, Jones DB, et al. Clinical practice guidelines for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric surgery patient—2013 update: cosponsored by American Association of Clinical Endocrinologists, The Obesity Society, and American Society for Metabolic & Bariatric Surgery. Endocr Pract. 2013;19(2):337-72.
3. Jensen MD, Ryan DH, Apovian CM, et al. 2013 ACC/AHA/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. J Am Coll Cardiol. 2013. doi:10.1016/j.jacc.2013.11.004. 

 

   

April 2014 

This overview was created by KnowledgePoint360 Group, LLC, and was not associated with funding via an educational grant or a promotional/commercial interest.  

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