Background: Varenicline, a new treatment for smoking cessation, has demonstrated significantly greater efficacy over placebo and sustained release bupropion (bupropion SR). Here we compare a 12-week standard regimen of varenicline with a 10-week standard regimen of transdermal nicotine replacement therapy (NRT) for smoking cessation.
Methods: In this 52-week, open-label, randomised, multicentre, phase 3 trial conducted in Belgium, France, the Netherlands, United Kingdom and United States, participants were randomly assigned (1:1) to receive varenicline up-titrated to 1 mg twice daily for 12 weeks or transdermal nicotine (21 mg/day reducing to 7 mg/day) for 10 weeks. Non-treatment follow-up continued to Week 52. The primary outcome was biochemically confirmed (exhaled carbon monoxide of ≤10 ppm) self-reported continuous abstinence rate (CAR) for the last 4 weeks of the treatment period in participants who had taken at least one dose of therapy. Secondary outcomes included CAR from the last 4 weeks of treatment through Weeks 24 and 52, and measures of craving, withdrawal and smoking satisfaction.
Results: In total, 376 and 370 participants assigned to varenicline and NRT respectively were eligible for analysis. The CAR for the last 4 weeks of treatment was significantly greater for varenicline (55.9%) than NRT (43.2%; odds ratio [OR] 1.70, 95% confidence interval [CI] 1.26 to 2.28, p<0.001). The Week 52 CAR (NRT,Weeks 8-52; varenicline,Weeks 9-52) was 26.1% for varenicline and 20.3% for NRT (OR 1.40, 95% CI, 0.99 to 1.99, p=0.056). Varenicline significantly reduced craving (p<0.001), withdrawal symptoms (p<0.001) and smoking satisfaction (p<0.001) versus NRT. The most frequent adverse event was nausea (varenicline, 37.2%, NRT, 9.7%).
Conclusions: The outcomes of this registered clinical trial (Clinical Trials Identification Number: NCT00143325) established that abstinence from smoking was greater, and craving, withdrawal symptoms and smoking satisfaction less, at the end of treatment with varenicline than with transdermal nicotine.
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