NEJM Editors Call for Removal of Sibutramine from U.S. Market

September 1st, 2010

NEJM Editors Call for Removal of Sibutramine from U.S. Market

Larry Husten, PHD

Earlier this year, following the discovery of signals of potential danger in a large clinical trial, the weight loss drug sibutramine (Meridia) was withdrawn from the market in Europe while the FDA added a strongly worded contraindication to its use in people with cardiovascular disease. Now, 2 weeks before an FDA advisory panel will vote on whether the drug should remain on the market in the U.S., the results of the clinical trial that sparked the concerns have been published in the New England Journal of Medicine.

The Sibutramine Cardiovascular Outcomes (SCOUT) trial randomized 9804 overweight or obese subjects with preexisting cardiovascular disease and/or diabetes to either sibutramine or placebo. After 3.4 years of treatment, the combined rate of nonfatal MI, nonfatal stroke, resuscitation after cardiac arrest, or cardiovascular death was 11.4% with sibutramine versus 10.0% with placebo (HR, 1.16; 95% CI, 1.03-1.31; P=0.02). The differences in nonfatal MI (4.1% vs. 3.2%) and nonfatal stroke (2.6% vs. 1.9%) were significant themselves.

In an accompanying editorial, three NEJM editors — Gregory Curfman, Stephen Morrissey, and Jeffrey Drazen — take issue with the SCOUT investigators, who concluded that sibutramine should remain available, albeit limited to people without cardiovascular disease. They write:

We surely need safe and effective medications to help overweight and obese patients lose weight and improve their long-term health. But given that sibutramine has minimal efficacy for weight loss, no apparent benefit for clinical outcomes, a worrisome cardiovascular risk profile, and a plausible mechanism to explain the cardiovascular risk, it is difficult to discern a credible rationale for keeping this medication on the market.

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September 1st, 2010