Long-term use appears to increase risk of nonfatal MI and nonfatal stroke in overweight subjects
WEDNESDAY, Sept. 1 (HealthDay News) -- In overweight or obese subjects with cardiovascular disease (CVD) and diabetes, long-term use of sibutramine is associated with an increased risk of nonfatal myocardial infarction (MI) and nonfatal stroke but not cardiovascular death or any-cause death, according to a study in the Sept. 2 issue of the New England Journal of Medicine.
W. Philip T. James, M.D., of the London School of Hygiene and Tropical Medicine, and colleagues assembled a cohort of 10,744 overweight/obese subjects, age 55 or older, with CVD, type 2 diabetes mellitus, or both. The researchers treated the subjects with sibutramine and enrolled them in an initial six-week weight-management program, after which, they randomized 9,804 subjects to either sibutramine or placebo. The study end points included nonfatal MI, nonfatal stroke, resuscitation after cardiac arrest, and cardiovascular death.
In a mean 3.4 years of treatment, the researchers found that the overall risk of a primary outcome event was significantly higher in the sibutramine group compared to the placebo group (hazard ratio, 1.16). Nonfatal MI and nonfatal stroke rates were significantly higher in the sibutramine group compared to the placebo group (hazard ratios, 1.28 and 1.36, respectively), but no significant difference was seen for cardiovascular death or death from any cause.
"On the basis of these results, sibutramine should continue to be excluded from use in patients with preexisting CVD," the authors write.
The research was funded by Abbott. Study authors disclosed financial relationships with Abbott and other medical device and/or pharmaceutical companies.
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