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STRATUS-US Trial. Smoking Cessation in Smokers Motivated to Quit . Presented at American College of Cardiology Scientific Sessions 2004 Presented by Dr. Robert Anthenelli . STRATUS-US Trial. 787 patients who smoked ≥10 cigarettes/day for at least 2 months and were motivated to stop smoking
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STRATUS-US Trial Smoking Cessation in SmokersMotivated to Quit Presented at American College of Cardiology Scientific Sessions 2004 Presented by Dr. Robert Anthenelli
STRATUS-US Trial 787 patients who smoked ≥10 cigarettes/day for at least 2 months and were motivated to stop smoking Randomized, double-blind, multicenter • Rimonabant • A selective cannabinoid type 1 receptor antagonist • 20 mg • n=261 • Rimonabant • A selective cannabinoid type 1 receptor antagonist • 5 mg • n=262 • Placebo • n=261 Treatment for 1 Year • Endpoints (1 year): • Smoking abstinence • Change in body weight in patients who stopped smoking Presented at ACC Scientific Sessions 2004
STRATUS-US Trial Smoking abstinence at 7-10 weeks p < 0.001 for high-dose vs placebo p = NS for low-dose vs placebo Smoking abstinence at end of study p < 0.001 for high-dose vs placebo p = NS for low-dose vs placebo Presented at ACC Scientific Sessions 2004
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) kg Presented at ACC Scientific Sessions 2004
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