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Bariatric surgery provided long-term diabetes control out to 3 years
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WASHINGTON — Three-year data from the STAMPEDE trial demonstrate that significantly more obese patients with diabetes who underwent bariatric surgery maintained long-term glycemic control compared with patients who received intensive medical therapy alone.
In addition, bariatric surgery — either Roux-en-Y gastric bypass or sleeve gastrectomy — was associated with improved quality of life and less need for diabetes and CV medications.
The STAMPEDE trial involved 150 obese patients with poorly controlled diabetes for at least 8 years (mean age, 48 years; 68% women; mean BMI, 36). Patients were randomly assigned intensive medical therapy consisting of counseling, lifestyle changes and FDA-approved medications (n=50), Roux-en-Y gastric bypass plus medical therapy (n=50) or sleeve gastrectomy plus medical therapy (n=50).
The study’s primary endpoint was HbA1c ≤6%, which was achieved by 5% of the medical therapy group vs. 37.5% of the gastric bypass group (P<.001) and 24.5% of the sleeve gastrectomy group (P=.012) at 3 years, Sangeeta Kashyap, MD, from the department of endocrinology, diabetes and metabolism at Cleveland Clinic, said at a late-breaking clinical trials session.
At 3 years, mean BMI was 27.9 (baseline, 37.1) in the gastric bypass group, 29.2 (baseline, 36.1) in the sleeve gastrectomy group and 34.8 (baseline, 36.4) in the medical therapy group, according to results presented.
Sangeeta Kashyap
Mean HbA1c at 3 years was 6.7% in the gastric bypass group and 7% in the sleeve gastrectomy group vs. 8.4% in the medical therapy group. “Both surgical groups had a dramatic and very rapid reduction in HbA1c of 3% that was sustained up to 36 months. The medical therapy group had a modest reduction in HbA1c of 1.5% at 6 months that relapsed thereafter,” Kashyap said.
In addition, the researchers observed dramatic increases in HDL levels of about 35% among surgical patients vs. 5% with medical therapy. Triglycerides were lowered by about 45% in the gastric bypass group and 30% in the sleeve gastrectomy group vs. 20% in the medical therapy group. There were no changes across groups in LDL, systolic or diastolic BP, or change in carotid intima media thickness.
At the start of the trial, each patient was taking three or more antidiabetes medications and three or more CV medications. At 3 years, 6% to 8% of surgical patients were using insulin compared with 55% of patients in the medical therapy group. Average use of CV agents, including statins, beta-blockers and antihypertensive agents, also decreased in both surgical groups. Nearly two-thirds of patients in the gastric bypass group and 43% in the sleeve gastrectomy group required no CV agents at 3 years; in contrast, more than 50% of patients in the medical therapy group still required three or more CV agents, Kashyap said.
Quality of life data reveal significant improvements in five of eight mental and physical domains on the SF-36 questionnaire in the gastric bypass group and two of eight domains in the sleeve gastrectomy group. There was no improvement in the medical therapy group.
No major late surgical complications were reported out to 3 years. The most common issues reported with surgery at 1 year included short-term dehydration, bleeding and one leak. Four surgical patients required operative intervention to manage complications occurring within the first year.
“Multicenter studies are needed to determine if these results can be generalized and larger studies will need to determine the potential benefit [of bariatric surgery] on cardiovascular events and diabetes-related microvascular complications,” she said. – by Katie Kalvaitis
For more information:
Schauer PR. Joint American College of Cardiology/New England Journal of Medicine Late-Breaking Clinical Trials. Presented at: American College of Cardiology Scientific Sessions; March 29-31, 2014; Washington, D.C.
Schauer PR. N Engl J Med. 2014;doi:10.1056/NEJMoa1401329.
Perspective
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Darren K. McGuire, MD, MHSc
This is a randomized trial of patients with type 2 diabetes and obesity, who were randomized to medical therapy vs. two different strategies for bariatric surgery: gastric sleeve and Roux-en-Y gastric bypass surgery. We saw, previously published, the 1-year data, which were very interesting, with significant weight loss with each of the surgical interventions and marked improvements in multiple parameters of glycometabolic control. What we see in these 3-year data are sustained, long-term effects, where the surgical interventions had sustained weight loss, reduction in HbA1c, and in fact had many patients below HbA1c and off of diabetes medicines. The Roux-en-Y surgery was slightly better than the gastric sleeve.
This adds to the emerging data on the importance of mechanical interventions to reduce obesity and caloric resorption by the duodenum and improved glycometabolic parameters: HbA1c, triglycerides, HDL cholesterol. Unfortunately, this trial was too small to be powered to look at clinical outcomes, so micro- and macrovascular disease complications cannot be evaluated. But this adds to the accumulating evidence asking the question, long-term, what is going to be the clinical efficacy of bariatric interventions on macrovascular and microvascular disease complications?
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