A placebo-controlled, double-blind study of Zyban LP: An effective and well-tolerated aid to smoking cessation - preliminary results

OBJECTIVE: To demonstrate the efficacy and safety of Zyban LP in smokers. METHODS: 504 adults, motivated to quit and smoking at least 10 cigarettes/day were randomized (2:1) from 91 French centres and received bupropion SR 150mg bid or placebo for 7 weeks with twice monthly counselling. RESULTS: Baseline characteristics were similar between treatment groups. Zyban LP treated subjects had significantly greater abstinence compared to placebo (continuous abstinence weeks 4-7: 41% vs 21%, p=.0001, OR=2.5 and weeks 4-26: 25% vs 13%, p=.0001, OR=2.2 ; point prevalence abstinence week 7: 48% vs 24%, p=.0001, OR=3.0 and week 26: 31% vs 16%, p=.0004, OR=2.3). Among 4-week continuous abstinence failures, week 7 point prevalence abstinence was significantly higher with Zyban LP compared to placebo (12% vs 3%, p=.003). Among quitters, Zyban LP compared to placebo reduced weight gain (1.0kg vs 2.1kg; p=.006). Common adverse events for both groups were sleep disorders, headache and anxiety with a higher incidence of sleep disorders in Zyban LP group. No seizure occurrence was reported. CONCLUSION: This study confirms the very good benefit/risk ratio of Zyban LP as an aid to smoking cessation.