Combination Treatment With Varenicline and Bupropion in an Adaptive Smoking Cessation Paradigm

• Published in: The American journal of psychiatry 2014-11, Vol.171 (11), p.1199-1205
• Main Authors: Rose, Jed E., Behm, Frédérique M.
• Format: Article
• Language: English
• Subjects: Adult; Aged; Benzazepines - administration & dosage; Benzazepines - adverse effects; Benzazepines - therapeutic use; Bupropion - administration & dosage; Bupropion - adverse effects; Bupropion - therapeutic use; Clinical outcomes; Clinical trials; Double-Blind Method; Drug therapy; Drug Therapy, Combination; Female; Humans; Male; Medication Adherence; Middle Aged; Nicotine; Nicotinic Agonists - administration & dosage; Nicotinic Agonists - adverse effects; Nicotinic Agonists - therapeutic use; Odds Ratio; Quinoxalines - administration & dosage; Quinoxalines - adverse effects; Quinoxalines - therapeutic use; Smoking - adverse effects; Smoking - epidemiology; Smoking cessation; Smoking Cessation - methods; Tobacco Use Cessation Products; Tobacco Use Disorder - drug therapy; Treatment Outcome; United States - epidemiology; Varenicline
• ISSN: 0002-953X; 1535-7228
• DOI: 10.1176/appi.ajp.2014.13050595

Objective:The authors assessed the efficacy and safety of combination treatment with varenicline and sustained-release bupropion for smokers who, based on an assessment of initial smoking reduction prior to the quit date, were deemed unlikely to achieve abstinence using nicotine patch treatment.Method:In a randomized, double-blind, parallel-group adaptive treatment trial, the authors identified 222 cigarette smokers who failed to show a reduction of more than 50% in smoking after 1 week of nicotine patch treatment. Smokers were randomly assigned to receive 12 weeks of varenicline plus bupropion or varenicline plus placebo. The primary outcome measure was continuous smoking abstinence at weeks 8–11 after the target quit date.Results:Both treatments were well tolerated. Participants who received the combination treatment had a significantly higher abstinence rate than those who received varenicline plus placebo (39.8% compared with 25.9%; odds ratio=1.89; 95% CI=1.07, 3.35). Combination treatment had a significantly greater effect on abstinence rate in male smokers (odds ratio=4.26; 95% CI=1.73, 10.49) than in female smokers (odds ratio=0.94; 95% CI=0.43, 2.05). It also had a significantly greater effect in highly nicotine-dependent smokers (odds ratio=3.51, 95% CI=1.64, 7.51) than in smokers with lower levels of dependence (odds ratio=0.71, 95% CI=0.28, 1.80).Conclusions:Among smokers who did not show a sufficient initial response to prequit nicotine patch treatment, combination treatment with varenicline and bupropion proved more efficacious than varenicline alone for male smokers and for smokers with a high degree of nicotine dependence.