Varenicline versus transdermal nicotine patch for smoking cessation: results from a randomised open-label trial

Abstract

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.

Reward Anticipation Is Differentially Modulated by Varenicline and Nicotine in Smokers

“…The dissociation between the observed effects of nicotine and VAR may inform why VAR is a successful pharmacotherapy for smoking cessation when compared with nicotine replacement therapy (NRT; Aubin et al, 2008). In the acute nicotine deprivation model employed in the current study, nicotine reduces deactivations in the MCL circuitry of smokers, 'normalizing' their reward-related processing to that seen in non-smokers.…”

Association of Out-of-Pocket Pharmacy Costs with Adherence to Varenicline

“…3 Pharmacological treatment options include first-line treatment interventions such as nicotine replacement therapy (NRT), bupropion, and varenicline. 3 Clinical trial data suggest that varenicline, a nicotinic receptor partial agonist, may be associated with higher rates of smoking abstinence than other first-line pharmacological interventions [4][5][6][7] ; however, findings from clinical trials of varenicline also indicate that treatment success is strongly associated with treatment adherence thus amplifying the need to identify barriers to adherence. 8,9 Among Medicare beneficiaries, cost-related nonadherence is a significant issue with over one-quarter reporting nonadherence to treatment due to costs.…”

Success Rates of Pharmacological Therapies Used for Smoking Cessation and Factors that Affect Smoking Cessation Rates

“…But Jorenby et al (13) concluded that randomized controlled trials in general involve highly selected patients who may not be representative of patients in actual practice. Similarly, Aubin et al (22) pointed out that smoking cessation medications have no useful applications in "real-world" settings. Thus, our study may havea significance in showing real-world results.…”