A Cochrane review 1 (abstract , review [Abstract]) included four studies (the two RIO-studies described above plus two other RIO-arms) with a total of 6 625 subjects evaluating rimonabant 20 mg versus rimonabant 5 mg versus placebo in addition to a hypocaloric diet. Compared with placebo, rimonabant 20 mg produced a 4.9 kg greater reduction in body weight at one year (weighted mean difference [WMD] -4.9, 95% confidence interval [CI] -5.3 to -4.5). Reduction in waist circumference was 3.8 cm for the rimonabant 20 mg group when compared with placebo (WMD -3.8 cm, 95% CI -4.3 to -3.4). Improvements in high-density lipoprotein cholesterol, triglyceride levels and systolic and diastolic blood pressure were also seen. Weight reduction gained with rimonabant 5 mg was only 1.3 kg greater than with placebo. No clinically relevant effects on plasma lipids and blood pressure were found. Rimonabant 20 mg caused significantly more adverse effects, especially of nervous system, psychiatric or gastro-intestinal origin. Attrition rates were approximately 40% at the end of one year. Author's comment: The results have to be interpreted with caution due to high discontinuation rates of study participants and the overall low quality of the included studies.
A meta-analysis included 4 RCTs, all in the RIO programme, with a total of 4105 subjects analyzed on intention-to-treat basis. Depressive mood was in exclusion criterion in all trials. Treatment with rimonabant resulted in a 4.7 kg greater weight reduction than placebo after 1 year (95% CI 4.1 to 5.3 kg), NNT = 6. Patients given rimonabant were 2.5 times more likely to discontinue treatment because of depressive mood disorder (OR 2.5, 95% CI 1.2 to 5.1, NNH = 49), and 3 times more likely to discontinue treatment because of anxiety (OR 3.0, 95% CI 1.1 to 8.4, NNH = 166). The OR for all adverse reactions, the OR was 1.4, 95% CI 1.1 to 1.6, NNH = 25).
Note: Rimonabant has been from the market globally and it is no longer under development.
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