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A study was conducted to determine the efficiency and safety of varenicline for smoking cessation compared with placebo or sustained release bupropion (bupropion SR). Varenicline was found to be efficacious, safe and well-tolerated cessation pharmacotherapy and its short-term and long-term efficacy exceeded that of both placebo and bupropion SR.

A stronger-dose nicotine patch and intensive counseling do not appear to improve the rates of smoking cessation. Researchers assigned 252 smokers to wear a 22-milligram (mg) nicotine patch and 252 to wear a 44-mg patch for 8 weeks. In each group, one-third received a pamphlet on smoking cessation, one-third received the pamphlet plus encouragement from their physician and a follow-up letter and one-third received all of that plus group counseling. All participants returned weekly to report their success in quitting and have their urine tested for nicotine metabolites. By the 8th week, smoking cessation rates were similar in both the low-dose and high-dose group. Those in the high-dose group reported more side effects from the patch. Different counseling techniques also had little effect on smoking cessation rates. At the end of 26 weeks, only one-fourth to one-third of the smokers had successfully quit smoking., Objective. - To compare the efficacy and safety of 22-mg and 44-mg doses of transdermal nicotine therapy when it is paired with minimal, individual, or group counseling to improve smoking cessation rates. Design. - An 8-week clinical that (4 weeks double-blind followed by 4 weeks open label) using random assignment of participants to both dose (22 or 44 mg) and counseling (minimal, individual, or group) conditions. Participants. - Daily cigarette smokers ([greater than or equal to] 15 cigarettes per day for at least 1 year) who volunteered to participate in a study of smoking cessation treatment. A total of 504 participants were enrolled at two sites. Intervention. - Four weeks of 22- or 44-mg transdermal nicotine therapy followed by 4 weeks of dosage reduction (2 weeks of 22 mg followed by 2 weeks of 11 mg). Counseling consisted, of a self-help pamphlet (minimal); a self-help pamphlet, a brief physician motivational message, and three brief (

Importance: Combining pharmacotherapies for tobacco-dependence treatment may increase smoking abstinence.Objective: To determine efficacy and safety of varenicline and bupropion sustained-release (SR; combination therapy) compared with varenicline (monotherapy) in cigarette smokers.Design, Setting, and Participants: Randomized, blinded, placebo-controlled multicenter clinical trial with a 12-week treatment period and follow-up through week 52 conducted between October 2009 and April 2013 at 3 midwestern clinical research sites. Five hundred six adult (≥18 years) cigarette smokers were randomly assigned and 315 (62%) completed the study.Interventions: Twelve weeks of varenicline and bupropion SR or varenicline and placebo.Main Outcomes and Measures: 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.Results: 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; 95% CI, 1.05-2.12; P = .03 and OR, 1.36; 95% CI, 0.95-1.93; P = .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; 95% CI, 1.04-2.22; P = .03 and OR, 1.32; 95% CI, 0.91-1.91; P = .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; 95% CI, 0.93-2.07; P = .11 and OR, 1.40; 95% CI, 0.96-2.05; P = .08, respectively). Participants receiving combination therapy reported more anxiety (7.2% vs 3.1%; P = .04) and depressive symptoms (3.6% vs 0.8%; P = .03).Conclusions and Relevance: 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.Trial Registration: clinicaltrials.gov Identifier: http://clinicaltrials.gov/show/NCT00935818. [ABSTRACT FROM AUTHOR]

The article presents a study comparing the safety and effectiveness of varenicline with sustained-release bupropion (bupropion SR) and placebo for smoking cessation. Varenicline is an α2β2 nicotinic acetylcholine receptor partial agonist. Varenicline decreases nicotine withdrawal symptoms and lowers the rewarding properties of nicotine. The study found that varenicline is a safe smoking cessation pharmacotherapy and was more effective than the placebo and bupropion SR for smoking cessation.