Late-term smoking cessation despite initial failure: An evaluation of bupropion sustained release, nicotine patch, combination therapy, and placebo

Objective: The purpose of this study was to evaluate the efficacy of long-t erm use of bupropion sustained release (SR), the nicotine patch, and the co mbination of these 2 treatments in patients who initially failed treatment. Methods: This was a post hoc analysis of a multicenter, double-blind, rando mized, placebo-controlled clinical trial in 893 smokers. patients were rand omly assigned to 9 weeks of treatment with placebo (n = 160), bupropion SR (n = 244), nicotine patch (n = 244), or a combination of nicotine patch and bupropion SR (n = 245). The study was originally designed with a follow-up period of 52 weeks. In this analysis, short-term success was defined as sm oking cessation after 14 or 21 days of therapy and long-term success was de fined as smoking cessation after > 21 days of therapy. Patients who did not achieve short-term success were evaluated for long-term success at week 9 (end of treatment), 6 months, and 1 year after the start of the study. Results: The mean age of the smokers was 44 years. The majority (93%) of pa tients were white, and 52% were female. The study subjects smoked an averag e of 27 cigarettes per day. Among the 467 patients who initially railed tre atment in the first 3 weeks, treatment with bupropion SR alone and in combi nation with the nicotine patch produced significant increases in successful smoking cessation rates from weeks 4 to 9 (19% bupropion SR or combination , 7% nicotine patch, 7% placebo), at month 6 (11% bupropion SR, 13% combina tion, 2% nicotine patch, 3% placebo), and at month 12 (10% bupropion SR, 7% combination, 2% nicotine patch, 1% placebo) (P < 0.05 for bupropion SR and combination vs nicotine patch or placebo). Conclusion: Among patients who initially failed treatment, continued therap y with bupropion SR, either alone or in combination with the nicotine patch , resulted in significantly higher short- and long-term smoking cessation r ates than treatment with the nicotine patch alone or placebo.