Background: Varenicline, a new treatment for smoking cessation, has demonstrated significantly greater efficacy over placebo and sustained release bupropion (bupropion SR). A study was undertaken to 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, UK and USA, participants were randomly assigned (1:1) to receive varenicline uptitrated to 1 mg twice daily for 12 weeks or transdermal NRT (21 mg/day reducing to 7 mg/day) for 10 weeks. Non-treatment follow-up continued to week 52. The primary outcome was the biochemically confirmed (exhaled carbon monoxide ⩽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 treatment. 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: A total of 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%; OR 1.70, 95% 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) compared with NRT. The most frequent adverse event was nausea (varenicline, 37.2%; NRT, 9.7%).
Conclusions: The outcomes of this trial established that abstinence from smoking was greater and craving, withdrawal symptoms and smoking satisfaction were less at the end of treatment with varenicline than with transdermal NRT.
Trial registration number: NCT00143325.
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Funding: This study was funded by Pfizer Inc. Editorial support was provided by Brenda Smith PhD and Abegale Templar PhD of Envision Pharma and was funded by Pfizer Inc.
Competing interests: H-JA has received sponsorship to attend scientific meetings, speaker honorariums and consultancy fees from GlaxoSmithKline, Pierre-Fabre Sante, Sanofi-Aventis, Merck-Lipha and Pfizer Inc. AB has received sponsorship to attend scientific meetings, speaker honorariums and consultancy fees from Boehringer Ingelheim, GlaxoSmithKline, Novartis and Pfizer Inc. In the past 5 years JRB has received consultancy fees from Xenova and Novartis and his employing institution has received consultancy fees and honoraria on his behalf from Pfizer Inc. CO has received honoraria and consulting fees from Pfizer, nicotine and placebo products for research studies at no cost from GlaxoSmithKline and honoraria from Pri-Med and CME outfitters. CBB, JG, KEW and KRR are employees of Pfizer Inc.
Ethics approval: Ethical approval was gained from Independent Review Boards for each centre.
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