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| |  Obese Patients Taking Rimonabant Experience Greatest Risk for Trial Discontinuation Due to Adverse Events: Presented at ECO By Timothy A. O'Leary GENEVA -- May 23, 2008 -- Patients who took the anti-obesity drug rimonabant had a greater risk of clinical-trial discontinuation because of adverse effects than did patients who took orlistat and sibutramine. Researchers reported the finding here on May 17 at the 16th European Congress on Obesity (ECO). Researchers conducted a meta-analysis of trial discontinuations from all causes and from adverse effects in randomised, placebo-controlled trials of the 3 anti-obesity drugs. The trials all lasted at least 1 year and used doses within the European Medicines Evaluations Agency indications. "There is a concern regarding both compliance and adverse effects of weight-loss compounds," said Kari Johansson, MD, Nutritionist, Obesity Department, Karolinska Institute for Medicine, and Professor of Medicine, Karolinska University Hospital - Huddinge, Stockholm, Sweden. "Drop[ping] out from any cause can be interpreted as a composite measure for safety and compliance, and drop[ping] out due to adverse effects as a general indicator of safety," she said. Fifteen of the 26 trials that met the inclusion criteria were focused on orlistat, 7 were focused on sibutramine, and 4 were focused on rimonabant. All of the trials reported all causes of discontinuation; however, 4 trials -- 1 of sibutramine and 3 of orlistat -- did not report discontinuations due to adverse effects. The pooled risk ratios for trial discontinuation due to adverse effects were significantly elevated for both orlistat 1.62 (confidence interval [CI], 1.21-2.18) and rimonabant 1.92 (CI, 1.55-2.38), but not for sibutramine 1.00 (0.74-1.35). Overall discontinuations were similar for sibutramine compared to placebo (34% vs 37%) and rimonabant (41% vs 42%), but were lower for orlistat (29% vs 38%). The risk differences compared to placebo for discontinuation due to adverse events were largest for rimonabant (14% vs 7%), followed by orlistat (8% vs 5%), while no difference was seen for sibutramine (9% vs 10%). "Orlistat was associated with the best compliance, while the greatest risk (absolute and relative) for drop out due to adverse events was seen for rimonabant," Dr. Johansson concluded in her poster presentation. Dr. Johansson and colleagues added that head-to-head trials comparing all 3 drugs would be of interest to compare the validity of this conclusion.
[Presentation title: Meta-Analysis of Drop Out From All Causes and Adverse Events in RCTs of Orlistat, Sibutramine and Rimonabant. Abstract T2:PS.33]
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