Abstract
BackgroundSome smokers may benefit from a therapy that combines different nicotine replacement therapies (NRT) or drugs with different mechanisms of action.The aim of this study was to determine the efficacy of the combined therapy of varenicline and nicotine patches versus varenicline monotherapy.MethodsThree hundred forty-one smokers who smoked 20 or more cigarettes per day were recruited from a smoking cessation clinic between February 2012 and June 2013. The participants were randomized to receive a varenicline plus nicotine patch of 21 mg every 24 hours (170) or varenicline plus a placebo patch (171). All of the smokers received a standard 12-week course of varenicline and an 11-week course of either the placebo patch or the active patch after the target quit day. Both groups received behavioral support. The primary outcome was continuous abstinence for weeks 2 through 12 confirmed by exhaled levels of carbon monoxide. Post hoc subgroup analyses were performed to evaluate the treatment effects for a specific endpoint in subgroups of smokers.ResultsThe combination of the nicotine patch with varenicline was not associated with higher rates of continuous abstinence at 12 weeks (39.1% versus 31.8%; odds ratio (OR) 1.24; 95% confidence interval (CI) 0.8 to 2.6) and 24 weeks (32.8% versus 28.2%; OR 1.17; 95% CI 0.4 to 1.9). When participants were analyzed by subgroups according to cigarette consumption, the abstinence rates among smokers who smoked more than 29 cigarettes per day at 12 weeks (OR 1.39; 95% CI 1.2 to 2.5) and 24 weeks (OR 1.46; 95% CI 1.2 to 2.8) were significantly higher in the combination group. Other post hoc analyses based on level of dependence and previous quit attempts did not show subgroup differences. No differences between the groups for the reported adverse events were observed (χ2 value 0.07; P 0.79).ConclusionsThe combination of varenicline with the nicotine patch does not improve abstinence rates at 12 and 24 weeks compared with varenicline used as monotherapy when all smokers were analyzed as a whole, independent of consumption level.Trial registrationThis study is registered at clinicaltrial.gov (NCT01538394).
Highlights
Some smokers may benefit from a therapy that combines different nicotine replacement therapies (NRT) or drugs with different mechanisms of action
Seven first-line pharmacotherapies that are currently available are recommended in clinical practice guidelines to treat tobacco dependence; all of these therapies have been tested to be effective for increasing tobacco abstinence rates when used as monotherapies in comparison with a placebo [1]
In a recent meta-analysis conducted by Mills et al [2], treatment with NRT did not show a superior effect compared with the standard treatment of either nicotine patches or varenicline used as monotherapies
Summary
Some smokers may benefit from a therapy that combines different nicotine replacement therapies (NRT) or drugs with different mechanisms of action. None of the available first-line pharmacological therapies to treat tobacco dependence have been labelled in Spain for use in combination with other therapies. Some smokers may benefit from a combination therapy featuring the simultaneous use of different nicotine replacement therapies (NRT) or drugs with different mechanisms of action (for example, NRT and bupropion). In the meta-analysis by Cahill et al [3], varenicline was shown to be superior to both NRT (odds ratio (OR) 1.57; 95% confidence interval (CI) 1.29 to 1.91) and bupropion (OR 1.59; 95% CI 1.29 to 1.96) but not to an NRT combination (OR 1.06; 95% CI 0.75 to 1.48)
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