Abstract
AimsTo assess (1) how far the efficacies of front‐line smoking cessation pharmacotherapies vary as a function of smoker characteristics and (2) associations between these characteristics and success of smoking cessation attempts.DesignProspective correlational study in the context of a double‐blind randomized trial. The outcome was regressed individually onto each covariate after adjusting for treatment, and then a forward stepwise model constructed. Treatment moderator effects of covariates were tested by treatment × covariate interactions.SettingHealth service facilities in multiple countries.ParticipantsData came from 8120 smokers willing to make a quit attempt, randomized to varenicline, bupropion, nicotine replacement therapy (NRT) or placebo in Evaluating Adverse Events in a Global Smoking Cessation Study (EAGLES) between 30 November 2011 and 13 January 2015.MeasurementsSmoker characteristics measured at baseline were country, psychiatric history, sex, age, body mass index (BMI), ethnic group, life‐time suicidal ideation/behaviour, anxiety, depression, aggression, psychotropic medication, history of alcohol/substance use disorder, age of starting smoking, cigarette dependence [Fagerström Test for Cigarette Dependence (FTCD)] and prior use of study medicines. Outcome was biochemically confirmed continuous abstinence at weeks 9–24 from start of treatment.FindingsNo statistically significant treatment × covariate interactions were found. Odds of success were associated independently positively with age [odds ratio (OR) = 1.01; 95% confidence interval (CI) = 1.00, 1.01], BMI (1.01; 95% CI = 1.00, 1.02) and age of starting smoking (1.03; 95% CI = 1.02, 1.04). Odds were associated independently negatively with US (versus non‐US) study site (0.53; 95% CI = 0.46, 0.61), black (versus white) ethnic group (0.57; 95% CI = 0.45, 0.72), mood disorder (0.85; 95% CI = 0.73, 0.99), anxiety disorder (0.71; 95% CI = 0.55, 0.90) and psychotic disorder (0.73; 95% CI = 0.50, 1.07), taking psychotropic medication (0.81; 95% CI = 0.68, 0.95), FTCD (0.89; 95% CI = 0.87, 0.92) and previous use of NRT (0.78; 95% CI = 0.67, 0.91).ConclusionsWhile a range of smoker characteristics—including psychiatric history, cigarette dependence and prior use of nicotine replacement therapy (NRT)—are associated with lower cessation rates, they do not substantially influence the efficacy of varenicline, bupropion or NRT.
Highlights
Evaluating Adverse Events in a Global Smoking Cessation Study (EAGLES; NCT01456936) was a large, multicentre, randomized, placebo-controlled trial that examined the safety and efficacy of varenicline, bupropion and transdermal nicotine patch [a form of nicotine replacement therapy (NRT)] for smoking cessation [1].The size of the trial, randomizing smokers in a tripledummy fashion into three active treatments and placebo, including smokers from multiple countries with varying psychiatric histories, and gathering data on a wide range of smoker characteristics provided an unparalleled opportunity to assess how smoker characteristics predict smoking cessation outcomes and how they may influence treatment efficacy
The odds ratio (OR) for continuous abstinence weeks 9–24 for active treatment versus placebo based on the stepwise model were 2.84 [95% confidence interval (CI) = 2.35, 3.42] for varenicline, 1.96 for bupropion and 1.86 for NRT
Results indicate that ORs for treatment versus placebo comparisons were consistent across different values of covariates, with larger deviations limited to strata with small sample sizes
Summary
Evaluating Adverse Events in a Global Smoking Cessation Study (EAGLES; NCT01456936) was a large, multicentre, randomized, placebo-controlled trial that examined the safety and efficacy of varenicline, bupropion and transdermal nicotine patch [a form of nicotine replacement therapy (NRT)] for smoking cessation [1].The size of the trial, randomizing smokers in a tripledummy fashion into three active treatments and placebo, including smokers from multiple countries with varying psychiatric histories, and gathering data on a wide range of smoker characteristics provided an unparalleled opportunity to assess how smoker characteristics predict smoking cessation outcomes and how they may influence treatment efficacy. There is less consistent, conflicting or negative evidence on the effects of age of smoking onset [2,3], substance use disorder [8], psychiatric disorder [6,9], gender [4,6,10], geographical location [11,12], body mass index (BMI) [2,3,10,13,14] and prior use of smoking cessation treatments [15] These covariates were assessed in the EAGLES trial. With such a large and diverse sample receiving a variety of treatments and a substantial number receiving placebo, the EAGLES trial can add significantly to our knowledge to help build models of cigarette addiction and assist clinicians in treating this disorder
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