A Cochrane review included 3 phase three trials involving a total of 1 567 smokers and 1 661 quitters. At one year, the pooled odds ratio (OR) for quitting with rimonabant 20 mg was 1.61 (95% CI 1.12 to 2.30). Rimonabant at 5 mg dosage was not beneficial. In the relapse prevention trial, smokers who had quit on the 20 mg regimen were 1½ times more likely to remain abstinent on rimonabant than on placebo (for the 20mg group OR 1.49, 95% CI 1.09 to 2.04, and for the 5 mg group OR 1.51, 95% CI 1.11 to 2.07). There appeared to be no significant benefit of maintenance treatment for the 5 mg quitters. Adverse events included nausea and upper respiratory tract infections. Weight gain was reported to be lower among the 20 mg quitters than in the 5 mg or placebo quitters. During treatment, overweight or obese smokers tended to lose weight, while normal weight smokers did not.
Comment: The quality of evidence is downgraded by study quality and by publication bias (incompletely reported and unpublished data of the pharmaceutical company sponsored trials). There is concern over a possible association with depression and with suicidal thoughts especially in patients with a past history of psychiatric illness.
Note: Rimonabant was withdrawn from the market in 2008 because of association with depression and suicidality.