Chantix/Champix meets endpoints in Smoking Cessation trial - Pfizer

Pfizer Inc. has announced that a new smoking-cessation clinical study assessing the efficacy and safety of varenicline (Chantix/Champix) met its primary and secondary endpoints. This is the first study of varenicline using the approach of reducing smoking prior to quitting. Smokers in this study were unwilling or unable to abruptly quit smoking within four weeks, but were willing to reduce smoking over a period of 12 weeks, with the goal of quitting by the end of that period. Smokers in the study were treated for a 12-week reduction phase followed by a 12-week abstinence phase (for a total of 24 weeks of treatment).

In the study of smokers (N=1,510) who were willing to gradually reduce smoking with a goal of quitting within 12 weeks, patients were randomized to either varenicline (Chantix/Champix) 1mg BID or placebo for 24 weeks of treatment, followed by a 28-week non-treatment phase. All patients received brief smoking-cessation counselling throughout the study. Preliminary results demonstrated that continuous abstinence rates (CAR) at weeks 15 through 24, the primary endpoint, were significantly higher in patients treated with Chantix/Champix than in patients treated with placebo (32.1 percent vs. 6.9 percent, Odds Ratio [OR]=8.74, p=<0.0001).>