3 years ago

Pooled analysis of three randomized, double-blind, placebo controlled trials with rimonabant for smoking cessation

Pooled analysis of three randomized, double-blind, placebo controlled trials with rimonabant for smoking cessation
Maher Karam-Hage, Jason D. Robinson, Raymond Niaura, Paul M. Cinciripini, Lowell C. Dale, , Robert M. Anthenelli, Henri-Jean Aubin
Despite the withdrawal of CB1 antagonists, such as rimonabant, from the market and from active clinical development because of concerns about their side effect profiles, research suggests that the endocannabinoid system may play an important role in modulating nicotine's effects. We report the combined results, using a pooled analysis, of three previously unpublished trials assessing rimonabant as a smoking cessation pharmacotherapy conducted between 2002 and 2004. Smokers (n = 2097) motivated to quit were enrolled in three randomized, double-blind, placebo-controlled trials, STRATUS EU, US, and META, which consisted of a 10-week treatment period with either rimonabant 20 mg (n = 789), 5 mg (n = 518; used in only two of the three studies), or placebo (n = 790), in conjunction with brief counseling. The impact of drug on prolonged abstinence and adverse events was examined at 8 weeks (end-of-treatment) and at 48 weeks (available for STRATUS EU and US) after the targeted quit date. Rimonabant 20 mg resulted in significantly higher abstinence at end-of-treatment and at 48 weeks post-targeted quit date compared with placebo, while rimonabant 5 mg and placebo did not differ. Serious AEs did not differ by drug group. The 20 mg rimonabant dose, compared with placebo, produced increased nausea, diarrhea, anxiety symptoms, hyporexia, and vomiting, and decreased headache, constipation, and cough. These results support rimonabant 20 mg as a modestly effective aid for smoking cessation. Although work on CB1 antagonists such as rimonabant has mostly been stopped because of unacceptable adverse events, these results may inform and spur the development of other endocannabinoids for smoking cessation. We conducted pooled analysis of three previously unpublished trials (STRATUS EU, US, and META) assessing 10 weeks on the CB1 antagonist rimonabant 20 and 5 mg or placebo for smoking cessation. Rimonabant 20 mg resulted in significantly higher abstinence than the 5 mg or placebo dose but also produced increased nausea, diarrhea, anxiety symptoms, hyporexia, and vomiting, and decreased headache, constipation, and cough, compared with placebo. These results may inform and spur the development of other endocannabinoids for smoking cessation.

Publisher URL: http://onlinelibrary.wiley.com/resolve/doi

DOI: 10.1111/adb.12508

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