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Bariatric surgery bested medical therapy for managing obese patients with diabetes
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CHICAGO — Bariatric surgery was significantly more effective than intensive medical therapy alone in achieving glycemic control in obese patients with uncontrolled type 2 diabetes, according to results of the STAMPEDE trial.
The three-arm, randomized, controlled, single-center Surgical Therapy and Medications Potentially Eradicate Diabetes Efficiently (STAMPEDE) trial included 150 patients. All had HbA1c ≥7%, BMI of 27 to 43 and were aged 20 to 60 years. Patients were randomly assigned in a 1:1:1 ratio to one of three treatments regimens: optimal medical therapy, optimal medical therapy combined with Roux-en-Y gastric bypass or optimal medical therapy combined with laparoscopic sleeve gastrectomy. The final analysis included 41 patients assigned to medical therapy alone, 50 patients to gastric bypass and 49 patients to sleeve gastrectomy.
At 1 year, glycemic control improved in all three groups, with a mean HbA1c of 7.5% in the medical therapy alone group, 6.4% in the medical therapy/gastric bypass group and 6.6% in the sleeve gastectomy group. Twelve percent of patients in the medical therapy alone group achieved the glycemic goal of ≤6%, compared with 42% in the medical therapy/gastric bypass group and 36.7% in the sleeve gastrectomy group (P=.002 for gastric bypass vs. medical therapy; P=.008 for sleeve gastrectomy vs. medical therapy).
“There was quite a large difference between the surgical group and the medical group in terms of success rate,” Philip R. Schauer, MD, professor of surgery and director of the Bariatric and Metabolic Institute at Cleveland Clinic, said at a press conference. “And, it should be noted that the surgery group did so without any medications.”
There were no major differences in BP or cholesterol between the groups. In addition, patients in the surgical groups saw a significant improvement in glycemic control and were able to dramatically reduce the number of glucose-, cholesterol- and BP-lowering medications they were taking.
“We saw reductions in diabetes and CV medications, hypertensive agents, statins and beta-blockers,” Schauer said. Medication use generally increased for patients assigned to medical therapy alone, he noted.
Surgical patients lost approximately 60 lb, compared with 10 lb in the medical therapy alone group.
“A significant change in body weight with surgery was not surprising,” he said. “However, it is remarkable that medical patients lost weight given that some of the drugs [they were taking] are associated with weight gain.”
Although surgery may come with risks, no complications or deaths were reported in the surgery groups.
“The overall take-home message is that surgical patients enjoyed superior improvement and glycemic control, and did so with few medications,” Schauer said.
Of note, Schauer said the researchers aimed to drive HbA1c to <6%, “which is a bit more rigorous than the American Diabetes Association standard to drive it to 7% or less.”
For more information:
- Schauer PR. JAMA. 2012;doi:10.1056/NEJMoa1200225.
- Schauer PR. Late-breaking clinical trials IV. Presented at: the American College of Cardiology 61st Scientific Sessions & Expo; March 24-27, 2012; Chicago.
Disclosure: Dr. Schauer has received research support from Amarin, Allergan, the American Diabetes Association, AstraZeneca, Bard-Davol, Baxter, Bristol-Myers Squibb, Covidien, Eisai, Ethicon Endo-Surgery, Gore, Medtronic, Nestle, the NIH, Sanofi-Aventis, ScottCare, Stryker Endoscopy and The Medicines Company. He also reports consulting and honoraria from Barosense, Bard-Davol, Carefusion, Covidien, Ethicon Endo-Surgery, Gore, Orexigen, RemedyMD, Stryker Endoscopy, Surgiquest and Vivus. STAMPEDE was sponsored by Ethicon Endo-Surgery with support from LifeScan and NIH-NIDDK.
Perspective
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C. Noel Bairey Merz, MD
This is a well-conducted, intermediate outcome trial with very definitive results. Could it have been designed better? Sure. They could have had a sham operation, but that probably would have been considered unethical. This resulted in a high dropout rate in the intensive medical therapy group, presumably because patients in this group were disappointed that they didn’t get randomized to surgery. Clinical trials that have a 20% dropout rate are not considered good trials, and they were right on the cusp of that. That said, overall, I think it is a good trial.
We all will be very interested in the 2, 3 and 4 year follow-up. It is clear that some patients can learn how to eat after this surgery and they re-gain weight, so it will be interesting to see how that plays out. As for very long-term follow up, it will be interesting to see whether these patients remain persistently anemic or whether they end up being deficient in other aspects of micronutrients. Although they escaped the ravages of diabetes, they may die of something else 10 or 20 years down the line.
We need a big outcome trial, because at the end of the day it’s not whether your A1c is low or whether your blood pressure is high or low, it’s whether you’re dead or alive. That will help us decide whether these so-called life-saving procedures are good or not.
Perspective
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Caroline Apovian, MD
In evaluating patients with obesity and diabetes, practitioners should focus on several factors when considering the risks and benefits of bariatric surgery. Patient BMI and number of years of diabetes should be considered in addition to age. BMI is considered as the current NIH/NHLBI guidelines recommend that patients should be considered surgical candidates only if BMI is ≥ 40 or ≥35 with at least one serious comorbidity. Other studies, including these two in the NEJM, have reported that BMI is not a predictor of remission of diabetes, however.
The practitioner and the patient should discuss the risks and benefits of bariatric surgery for that particular patient. The longer a patient has had diabetes, the less likely it is that surgery is going to permit a remission. Remission is defined by the American Diabetes Association as blood glucose <101 mg/dL and a glycated hemoglobin of ≤6% off medication. Age is another factor to weigh when considering the risks and benefits of surgery.
Previous studies on diabetes remission following surgery have reported number of years of clinical diabetes to be a predictor of response with greater than 6 years being somewhat of a cut-off.
I think a surgical option for diabetes is a big deal for practitioners. This is really going to make bariatric surgery a major conversation point for doctors and their patients who have obesity and diabetes.
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