1. Varenicline and nicotine patches were more effective than varenicline alone at achieving 4 week abstinence from nicotine products in smokers.
2. The combination therapy appeared to be well tolerated, but this study was not powered to comment on safety endpoints.
Evidence Rating Level: 2 (Good)
Study Rundown: Smoking cessation is currently one of the most important public health initiatives. There are multiple strategies for smoking cessation, including pharmacologic agents (eg. varenicline) and nicotine replacement therapy. This trial included 446 participants who were randomized to receive varenicline and a nicotine patch or varenicline and a placebo patch to determine whether combining varenicline and nicotine replacement is more effective than varenicline alone in achieving smoking cessation. All participants took varenicline for 13 weeks and used a patch (either nicotine or placebo) for 16 hours per day. The primary endpoint was abstinence for 4 continuous weeks at the end of treatment (weeks 9-12), as confirmed by expiratory carbon monoxide measurements. 55.4% of those receiving both varenicline and active nicotine replacement therapy achieved 4 week abstinence at week 12, whereas only 40.9% of those on varenicline and placebo achieved 4 week abstinence at week 12, a significant difference. At week 12, the difference in continued abstinence was 14.5% between the two groups. Strengths of this study include the double-blinded randomized placebo-controlled methodology and the large number of participants included. Another strength is the use of self-reported nicotine use and expiratory carbon monoxide were both used to understand the practices of participants. One weakness of this study is the fact that only 62.3% of participants completed the protocol. The study also included a fairly homogenous population of individuals. Ultimately, this trial suggests that a combination of varenicline and nicotine replacement therapy may be better than varenicline alone in achieving smoking cessation, but a study with a more diverse population and longer follow up time should be done before the standard of care changes.
In-Depth [randomized controlled trial]: This study randomized 446 individuals between 18 and 75 years of age interested in tobacco cessation assistance to receive varenicline and nicotine replacement with a patch or varenicline and placebo patch. All participants received varenicline treatment for 13 weeks, and patches were worn for 16 hours every day. At week 12, 55.4% of individuals in the nicotine patch group had achieved 4 week abstinence and 40.9% of those in the placebo patch group had achieved 4 week abstinence (p=0.007). At 24 week, 49.0% of those in the active nicotine patch group and 32.6% of those in the placebo patch group achieved continuous abstinence (p=0.004). The difference in observed abstinence was 14.5% (95% CI, 5.2%-23.8%) at 12 weeks. At 24 weeks, the difference was 16.4% (95% CI, 7.2%-25.5%). The number needed to treat to achieve one additional successful smoking cessation was 7 (95% CI, 5-20) at week 12 and 7 (95% CI, 4-14) at week 24. Combination therapy appeared to be well tolerated, but the study was not powered to measure safety endpoints.
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