Risk of cardiovascular events associated with sibutramine

January 01, 0001

Risk of cardiovascular events associated with sibutramine

These investigators from multiple countries enrolled 10,744 overweight or obese subjects, 55 years of age or older, with preexisting cardiovascular disease, type 2 diabetes mellitus, or both to assess the cardiovascular consequences of weight management with and without sibutramine in subjects at high risk for cardiovascular events. All the subjects received sibutramine in addition to participating in a weight-management program during a 6-week, single-blind, lead-in period, after which 9804 subjects underwent random assignment in a double-blind fashion to sibutramine (4906 subjects) or placebo (4898 subjects). The primary end point was the time from randomization to the first occurrence of a primary outcome event (nonfatal myocardial infarction, nonfatal stroke, resuscitation after cardiac arrest, or cardiovascular death).

They found: "The mean duration of treatment was 3.4 years. The mean weight loss during the lead-in period was 2.6 kg; after randomization, the subjects in the sibutramine group achieved and maintained further weight reduction (mean, 1.7 kg). The mean blood pressure decreased in both groups, with greater reductions in the placebo group than in the sibutramine group (mean difference, 1.2/1.4 mm Hg). The risk of a primary outcome event was 11.4% in the sibutramine group as compared with 10.0% in the placebo group (hazard ratio, 1.16; significant). The rates of nonfatal myocardial infarction and nonfatal stroke were 4.1% and 2.6% in the sibutramine group and 3.2% and 1.9% in the placebo group, respectively (hazard ratio for nonfatal myocardial infarction, 1.28; hazard ratio for nonfatal stroke, 1.36; both significant). The rates of cardiovascular death and death from any cause were not increased."

The authors concluded: "Subjects with preexisting cardiovascular conditions who were receiving long-term sibutramine treatment had an increased risk of nonfatal myocardial infarction and nonfatal stroke but not of cardiovascular death or death from any cause."

The risk does not appear to be worth the potential benefit of the modest mean weight loss achieved.

For the full abstract, click here.

N Engl J Med 363:905-917, 2 September 2010
© 2010 to the Massachusetts Medical Society
Effect of Sibutramine on Cardiovascular Outcomes in Overweight and Obese Subjects. W. Philip T. James, Ian D. Caterson, Walmir Coutinho, et al. Correspondence to Dr. James: jeanhjames@aol.com

Category: K. Circulatory, T. Endocrine/Metabolic/Nutritional. Keywords: obesity, sibutramine, cardiovascular disease, myocardial infarction, stroke, randomized controlled trial, journal watch.
Synopsis edited by Dr Linda French, Toledo, Ohio. Posted on Global Family Doctor 14 September 2010

Pearls are an independent product of the Cochrane primary care group and are meant for educational use and not to guide clinical care.