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Journal editors criticise Abbott drug

Editors of the New England Journal of Medicine have suggested that the US Food and Drug Administration pull Abbott's Meridia due to health risks

The editors of the prestigious New England Journal of Medicine (NEJM) have strongly suggested that the US Food and Drug Administration (FDA) should pull Abbott's appetite-suppressant drug Meridia (sibutramine) from the market due to what they believe are unacceptable cardiovascular risks given the drug's limited efficacy.

The opinion piece appears in the journal alongside a large-scale study of the drug that was funded by Abbott. The study authors concluded that no changes are necessary in the clinical use of Meridia, which is already limited to patients who do not have pre-existing cardiovascular disease.

The study enrolled 10,744 overweight or obese subjects, 55 years of age or older, with pre-existing cardiovascular disease, type 2 diabetes, or both to assess the cardiovascular safety of the drug in high-risk patients. It found that long-term sibutramine treatment in the group increased the risk of non-fatal myocardial infarction and non-fatal stroke but not of cardiovascular death or death from any other cause.

The journal editors maintained that the drug's efficacy profile does not justify the increased risk of non-fatal events. "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," they wrote.

"At 12 months, the weight loss with sibutramine was 4.5 per cent of initial body weight — less than the 5 per cent figure stipulated by the FDA as one of the key efficacy benchmarks for approval of a weight-loss drug," the editors pointed out. "Thus, in exchange for an average weight loss of less than 4kg, a subject had a one in 70 chance (or a one in 52 chance for those with known cardiovascular disease) of having a myocardial infarction or stroke — an unattractive benefit-to-risk ratio."

The study and editorial were published in advance of a September 15 advisory committee meeting at which a panel of experts will make recommendations to the federal agency regarding the safety of the drug, which was approved by the FDA in 1997.

The two articles are available online to subscribers of the NEJM:
Sibutramine — Another Flawed Diet Pill
Effect of Sibutramine on Cardiovascular Outcomes in Overweight and Obese Subjects

3rd September 2010

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