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Varenicline (Chantix) Demonstrates Smoking-Cessation Efficacy
Subjects were unable or unwilling to quit (January 21)
A new smoking-cessation clinical study assessing the efficacy and safety of varenicline (Chantix, Pfizer) has 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 4 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 randomly assigned to receive either varenicline (1 mg twice daily) or placebo for 24 weeks, followed by a 28-week nontreatment phase. All patients received brief smoking-cessation counseling throughout the study.
Preliminary results demonstrated that continuous abstinence rates at weeks 15 through 24, the primary endpoint, were significantly higher in patients treated with varenicline than in patients given placebo (32.1% vs. 6.9%, respectively; odds ratio, 8.74, P < 0.0001).
Chantix (varenicline) was approved by the FDA in May 2006 as an aid to smoking-cessation treatment in adults 18 years old and older.
Source: Pfizer; January 21, 2014.