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.
- Nicotine replacement therapy
- Smoking cessation
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.