Sibutramine (諾美婷) Increases Risk for MI and Stroke

[熊哥]

The weight-loss drug sibutramine (Meridia) — up for review by FDA advisers on Sept. 15 — poses increased risk for cardiovascular events among adults with cardiovascular disease (CVD), according to a New England Journal of Medicine study.
Industry-supported researchers randomized nearly 10,000 overweight or obese adults with cardiovascular disease and/or diabetes to receive sibutramine or placebo. During 3.4 years' treatment, sibutramine recipients were at greater risk for nonfatal MI (4.1% vs. 3.2%) and stroke (2.6% vs. 1.9%), although not cardiovascular mortality. In subgroup analyses, the increased risks were seen among subjects with CVD and CVD plus diabetes, but not among those with diabetes alone.
The authors conclude that sibutramine "should continue to be excluded from use in patients with preexisting cardiovascular disease." Editorialists, however, take a stronger stance: "Given that sibutramine has minimal efficacy for weight loss, no apparent benefit for clinical outcomes, [and] a worrisome cardiovascular risk profile, ... it is difficult to discern a credible rationale for keeping this medication on the market."

http://www.nejm.org/doi/full/10.1056/NEJMoa1003114

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