5 Years Later: Surgery Still Beats Conventional Treatment for Type 2 DiabetesFriday, February 17, 2017
Readers will recall previous posts on the STAMPEDE trial, an ongoing trial of 150 patients who had type 2 diabetes and a BMI of 27 to 43 who were randomly assigned to receive intensive medical therapy alone or intensive medical therapy plus Roux-en-Y gastric bypass or sleeve gastrectomy.
Now the 5 year results of this trial have been published in the New England Journal of Medicine.
Of the 150 patients who underwent randomization, 1 patient in the medical-therapy group died during the 5-year follow-up period (from myocardial infarction during year 4) and 1 patient in the sleeve-gastrectomy group had a stroke; 134 of the remaining 149 patients (90%) completed 5 years of follow-up. One patient in the medical-therapy group, underwent gastric bypass during year 3, owing to failure of the medical treatment. One patient in the sleeve-gastrectomy group underwent gastric bypass during year 4 for the treatment of a gastric fistula.
At 5 years, the criterion for the primary end point (Hba1c <6% without the use of anti-diabetic mediations) was met by 2 of 38 patients (5%) who received medical therapy alone, as compared with 14 of 49 patients (29%) who underwent gastric bypass and 11 of 47 patients (23%) who underwent sleeve gastrectomy.
At 5 years, changes from baseline observed in the gastric-bypass and sleeve-gastrectomy groups were superior to the changes seen in the medical-therapy group with respect to body weight (−23%, −19%, and −5% in the gastric-bypass, sleeve-gastrectomy, and medical-therapy groups, respectively), triglyceride level (−40%, −29%, and −8%), high-density lipoprotein cholesterol level (32%, 30%, and 7%), use of insulin (−35%, −34%, and −13%), and quality-of-life measures.
Excessive weight gain was observed in 19% of the patients in the medical-therapy group and in no patients in either surgical group.
No major late surgical complications were reported except for the one reoperation mentioned above.
From these findings the author conclude that,
“…bariatric surgery was superior to intensive medical therapy in terms of glycemic control, weight reduction, medication reduction, improvement in lipid levels, and quality of life. Patients who underwent gastric bypass or sleeve gastrectomy were significantly more likely to achieve and maintain a glycated hemoglobin level of 6.0% or less, with or without medications, than were those who received intensive medical therapy alone…The surgically treated patients had superior glycemic control throughout the 5-year period while also using fewer diabetes medications, including insulin. More than 88% of the surgical patients had glycemic control that was considered to be very good to acceptable (average glycated hemoglobin level of 7.0%), without the use of insulin. A majority of the surgical patients who achieved a glycated hemoglobin level of 6.0% or less reached that target without the use of diabetes medications, whereas none of the patients in the medical-therapy group reached that target without the use of diabetes medications.”
No doubt this study supports the notion of long-term benefits of bariatric surgery (even in people with BMI in the 27-34 range) compared to intensive medical treatment alone. Clearly, this should be a treatment that may be considered for patients with type 2 diabetes, who struggle with glycemic control.