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Title: Study Shows Weight-Loss Drug Rimonabant Associated With Severe Adverse Psychiatric Events

"Study Shows Weight-Loss Drug Rimonabant Associated With Severe Adverse Psychiatric Events"

LONDON, UK -- November 15, 2007 -- Patients given the weight-loss drug rimonabant are at increased risk of severe psychiatric events, conclude authors of an Article published in this week's edition of [The Lancet.

The prevalence of obesity continues to increase worldwide, and there is a demand for effective and safe anti-obesity agents that can produce and maintain weight loss and thereby reduce prevalence of conditions associated with being overweight.

Professor Arne Astrup, Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen, Denmark, and colleagues did a meta-analysis of four double-blind randomised controlled trials featuring 4105 patients, which compared treatment with 20 mg per day rimonabant with placebo.

The researchers found that patients given rimonabant had a 4.7kg greater weight reduction after one year than did those given placebo. However, patients given rimonabant were at 40% higher risk of having adverse events or serious adverse events. Patients given rimonabant were 2.5 times more likely to discontinue treatment because of depressive disorders than were those given placebo, and three times more likely to discontinue treatment due to anxiety.

The authors point out that there were no follow-ups after discontinuation of active treatment with rimonabant, thus any weight regain could not be assessed. They say: "As with other weight-loss drugs, relapse is expected to occur after treatment has ended, and to achieve weight maintenance and maintain the improvement of the cardiovascular and diabetes risk factors the drug needs to be taken for life."

They conclude: "Our findings suggest that 20mg per day of rimonabant increases the risk of psychiatric events -- ie, depressed mood disorders and anxiety -- despite depressed mood being an exclusion criterion in these trials. Taken together with the recent US Food and Drug Administration finding of increased risk of suicide during treatment with rimonabant, we recommend increased alertness by physicians to these potentially severe psychiatric adverse reactions."

SOURCE: The Lancet

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