Rimonabant, a Promising Anti-Obesity Drug, Appears to Increse depression

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Summary and Comment

Rimonabant, a Promising Anti-Obesity Drug, Appears to Increase Risk for Depression

The FDA has withheld approval of this drug, which is used in several European countries.

Rimonabant, a cannabinoid type 1 receptor blocker, is available in several European countries for treatment of obesity. In four related manufacturer-sponsored trials, patients who took rimonabant (20 mg daily) for 6 to 12 months had 4 kg to 6 kg greater weight loss than patients who received placebo. Each trial showed a nonsignificant trend toward increased treatment discontinuation because of depressive symptoms with rimonabant. Investigators now report the results of a meta-analysis of these trials with particular attention to psychiatric adverse effects.

A total of 4105 obese patients were followed for 1 year. Significantly more rimonabant recipients than placebo recipients discontinued treatment because of depressed mood disorders (3.0% vs. 1.4%) and anxiety (1.0% vs. 0.3%). In addition, the rimonabant group had a significantly greater increase in anxiety scores than the placebo group on a standardized screening test; a greater increase in depression scores in the rimonabant group did not reach statistical significance.

Comment: In June 2007, the FDA published its own meta-analysis, which included patient-level data from these same four trials and several unpublished trials of rimonabant. The FDA found significantly more psychiatric adverse events in patients taking rimonabant than in those taking placebo (26% vs. 14%); rimonabant recipients also were more likely to have depressive symptoms and to receive prescribed anxiolytics and antidepressants. These findings are particularly important because patients with a history of severe depression — common among patients with obesity — were excluded. The FDA withheld approval of rimonabant pending further safety data.

— Bruce Soloway, MD

Published in Journal Watch General Medicine November 27, 2007

Citation(s):

Christensen R et al. Efficacy and safety of the weight-loss drug rimonabant: A meta-analysis of randomised trials. Lancet 2007 Nov 17; 370:1706.

Medline abstract (Free)

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