Acomplia rimonabant: Phase III data

In the double-blind, international Phase III Crescendo trial in 18,695 patients with previously manifest or increased risk of vascular disease, 20 mg Acomplia missed the composite primary endpoint of significantly reducing the incidence of CV death, MI or stroke vs. placebo (3.9% vs. 4%, p=0.68). Acomplia also significantly increased gastrointestinal (33% vs. 22%), neuropsychiatric (32% vs. 21%) and serious psychiatric side effects (2.5% vs. 1.3%) vs. placebo. Additionally, 4 patients treated with Acomplia and 1 patient treated with placebo committed suicide. Data were published in The Lancet. The trial was stopped after a mean follow-up of 13.8 months due to concerns by regulatory authorities about suicide in patients receiving Acomplia (see BioCentury, Nov. 10, 2008). ...