Meta-analysis suggests Acomplia increases risk of psychiatric adverse events

A meta-analysis published in the current issue of The Lancet suggests that sanofi-aventis' obesity drug, Acomplia (rimonabant) increases the risk of psychiatric adverse events such as anxiety and depression, compared with placebo.

The study researchers collected data from four randomised controlled studies involving a total of 4105 patients that compared Acomplia with placebo. While the findings showed that patients administered Acomplia experienced a 4.7 kilogram greater weight reduction after one year compared with those who received placebo, those who took sanofi-aventis' drug were 2.5 times more likely to discontinue treatment as a result of depressive mood disorders. Additionally, patients who received Acomplia were three times as likely to discontinue treatment with Acomplia due to anxiety, compared with those in the placebo group.

The researchers concluded that the findings suggest the risk of psychiatric adverse events with Acomplia increases despite "depressed mood being an exclusion criterion in these trials." Lead researcher Arne Astrup commented that "taken together with the recent US FDA finding of increased risk of suicide during treatment with rimonabant, we recommend increased alertness by physicians to these potentially severe psychiatric adverse reactions." In June, an FDA panel recommended against approving the obesity drug over concerns that it increases suicidal thoughts and behaviour.

In response to the news, sanofi-aventis spokesperson, Salah Mahyaoui stated that the results do not "reveal any new data beyond what is known by the treating clinicians or health authorities." Mahyaoui added that EU regulators confirmed that Acomplia's benefits outweighed its risks in patients who aren't depressed following a review of available data.

In related news, a different meta-analysis published in the BMJ suggested that Acomplia and two other obesity drugs, orlistat and sibutramine, offer limited weight loss benefits over the long-term. The findings showed that each of the drugs reduced weight by less than 5 kilograms, or less than 5 percent of total body weight.

In the analysis, researchers examined 30 trials that lasted between one and four years. Compared with placebo, the findings showed that orlistat reduced weight by 2.9 kilograms, sibutramine by 4.2 kilograms and Acomplia by 4.7 kilograms. The results also demonstrated that patients who took one of the three drugs were significantly more likely to achieve weight loss of between 5 percent and 10 percent, compared to those who took a placebo. All three drugs were also associated with certain adverse events, according to the findings.

Roche sells orlistat as Xenical, while Abbott markets sibutramine as Meridia.

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