Combining pharmacotherapies for tobacco-dependence treatment may increase smoking abstinence. A study has determined efficacy and safety of Varenicline and Bupropion sustained-release ( SR; combination therapy ) compared with Varenicline ( monotherapy; Champix, Chantix ) in cigarette smokers.
Randomized, blinded, placebo-controlled multicenter clinical trial with a 12-week treatment period and follow-up through week 52 was conducted in the period 2009-2013 at 3 midwestern clinical research sites.
Five hundred six adult ( 18 years or more ) cigarette smokers were randomly assigned and 315 ( 62% ) completed the study.
Primary outcome was abstinence rates at week 12, defined as prolonged ( no smoking from 2 weeks after the target quit date ) abstinence and 7-day point-prevalence ( no smoking past 7 days ) abstinence.
Secondary outcomes were prolonged and point-prevalence smoking abstinence rates at weeks 26 and 52.
Outcomes were biochemically confirmed.
At 12 weeks, 53.0% of the combination therapy group achieved prolonged smoking abstinence and 56.2% achieved 7-day point-prevalence smoking abstinence compared with 43.2% and 48.6% in Varenicline monotherapy ( odds ratio, OR=1.49; P =0 .03 and OR=1.36; P = 0.09, respectively ).
At 26 weeks, 36.6% of the combination therapy group achieved prolonged and 38.2% achieved 7-day point-prevalence smoking abstinence compared with 27.6% and 31.9% in Varenicline monotherapy ( OR=1.52; P = 0.03 and OR=1.32; P =0 .14, respectively ).
At 52 weeks, 30.9% of the combination therapy group achieved prolonged and 36.6% achieved 7-day point-prevalence smoking abstinence compared with 24.5% and 29.2% in Varenicline monotherapy ( OR=1.39; P = 0.11 and OR=1.40; P = 0.08, respectively ).
Participants receiving combination therapy reported more anxiety ( 7.2% vs 3.1%; P = 0.04 ) and depressive symptoms ( 3.6% vs 0.8%; P = 0.03 ).
Among cigarette smokers, combined use of Varenicline and Bupropion, compared with Varenicline alone, increased prolonged abstinence but not 7-day point prevalence at 12 and 26 weeks. Neither outcome was significantly different at 52 weeks.
Further research is required to determine the role of combination therapy in smoking cessation. ( Xagena )
Ebbert JO et al, JAMA 2014;311:155-163