A study designed to compare bariatric surgery with lifestyle interventions found that Type II diabetics treated with gastric bypass or banding procedures fared better than patients who watched their diets and exercised. The question is, how much does it cost?
Results from “Bariatric Surgery versus Intensive Medical Therapy for Diabetes – 3-Year Outcomes,” which was funded by Johnson & Johnson (NYSE:JNJ) subsidiaries Ethicon and LifeScan, the Cleveland Clinic and the National Institutes of Health, were published online yesterday in the Journal of the American Medical Assn.
The 3-year, 61-patient study randomized obese subjects 1 of 3 arms: Roux-en-Y gastric bypass; laparoscopic adjustable gastric banding; or 1 year of intensive lifestyle intervention. After a year all 3 arms were subject to 2 years of low-level lifestyle intervention, according to the study. The primary endpoints were partial and complete Type II diabetes remission, with secondary endpoints of diabetes medications and weight change.
Forty percent of the gastric bypass arm and 29% of the gastric banding cohort achieved partial or complete remission, compared with no remission for the lifestyle intervention arm, according to the study. No diabetes meds were needed after 3 years for 65% for the bypass group and 33% for the banding group, compared with no change in medication for the lifestyle group.
The study was limited by its small size and short duration, which weren’t adequate to detect differences in complications such as myocardial infarction, stroke, or death, theUniversity of Pittsburgh School of Medicine researchers wrote. The trial’s protocol calls for another round of follow-ups at 5 years, “which should allow additional assessment of even longer-term efficacy and safety,” they wrote.
“Despite these limitations, we conclude that bariatric surgery represents a potentially useful strategy for the management of Type II diabetes, allowing many patients to reach and maintain therapeutic targets of glycemic control that otherwise would not be achievable with intensive medical therapy alone,” they wrote. “Some patients in our study had complete diabetes remission, whereas others had a marked reduction in the need for pharmacologic treatment. The reduction in cardiovascular risk factors was sustained, allowing for reductions in lipid-lowering and antihypertensive therapies. Other benefits of surgery included a significant improvement in the quality of life. 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.”
“I do think it adds strongly to the growing body of data that [surgery] should be considered” in treating obesity and diabetes, lead author Dr. Anita Courcoulas told the Wall Street Journal.
The results from Courcoulas and colleagues echo those from an earlier trial comparing intensive medical therapy alone versus medical therapy plus Roux-en-Y gastric bypass or sleeve gastrectomy in 150 obese patients with uncontrolled Type II diabetes.
“We should consider the use of bariatric (metabolic) surgery in all severely obese patients with [Type II diabetes] and start a mass treatment, similar to what was done with coronary artery bypass graft more than 50 years ago,” Dr. Michel Gagner, of Florida International University, wrote in an editorial accompanying the JAMA report.
“I don’t know how many studies we need to do to keep comparing the best medical treatment to surgery, but it’s clear to me that surgery is the only thing that offers resolution to diabetes,” Gagner told the Journal.