Smoking Cessation in Smokers Motivated to Quit Presented at American College of Cardiology Scientific Sessions 2004 Presented by Dr. Robert Anthenelli STRATUS-US Trial

www. Clinical trial results.org Rimonabant A selective cannabinoid type 1 receptor antagonist  5 mg  n=262 Rimonabant A selective cannabinoid type 1 receptor antagonist  5 mg  n=262 Endpoints (1 year):  Smoking abstinence  Change in body weight in patients who stopped smoking Endpoints (1 year):  Smoking abstinence  Change in body weight in patients who stopped smoking STRATUS-US Trial Presented at ACC Scientific Sessions patients who smoked ≥10 cigarettes/day for at least 2 months and were motivated to stop smoking Randomized, double-blind, multicenter 787 patients who smoked ≥10 cigarettes/day for at least 2 months and were motivated to stop smoking Randomized, double-blind, multicenter Placebo  n=261 Placebo  n=261 Rimonabant A selective cannabinoid type 1 receptor antagonist  20 mg  n=261 Rimonabant A selective cannabinoid type 1 receptor antagonist  20 mg  n=261 Treatment for 1 Year

www. Clinical trial results.org STRATUS-US Trial Smoking abstinence at 7-10 weeks p < for high-dose vs placebo p = NS for low-dose vs placebo Presented at ACC Scientific Sessions 2004 Smoking abstinence at end of study p < for high-dose vs placebo p = NS for low-dose vs placebo

www. Clinical trial results.org STRATUS-US Trial Change in weight from baseline among patients with a prolonged abstinence from smoking p<0.001 for rimonabant 20 mg vs placebo Among patients with a prolonged abstinence from smoking, change in weight from baseline was significantly  in high-dose group compared with placebo (Figure) In subgroup of patients who were overweight initially, BMI was significantly  in high-dose group versus placebo (-0.1 vs. 1.7, p<0.001) Presented at ACC Scientific Sessions 2004 kg

www. Clinical trial results.org STRATUS-US Trial Among patients smoking ≥10 cigarettes per day and motivated to stop smoking, use of the selective cannabinoid type 1 receptor antagonist rimonabant in a 20 mg dose was associated with an increase in prolonged smoking abstinence compared with placebo, but there was no difference between the 5 mg dose of rimonabant and placebo Additionally, weight gain, which can be a negative side effect of smoking cessation, was lower in patients who received rimonabant 20 mg, with benefit seen even in obese patients Further evaluation warranted Among patients smoking ≥10 cigarettes per day and motivated to stop smoking, use of the selective cannabinoid type 1 receptor antagonist rimonabant in a 20 mg dose was associated with an increase in prolonged smoking abstinence compared with placebo, but there was no difference between the 5 mg dose of rimonabant and placebo Additionally, weight gain, which can be a negative side effect of smoking cessation, was lower in patients who received rimonabant 20 mg, with benefit seen even in obese patients Further evaluation warranted