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

• Published in: Clinical therapeutics 2001-05, Vol.23 (5), p.744-752
• Main Authors: Jamerson, Brenda D., Nides, Mitchell, Jorenby, Douglas E., Donahue, Rafe, Garrett, Peter, Andrew Johnston, J., Fiore, Michael C., Rennard, Stephen I., Leischow, Scott J.
• Format: Article
• Language: English
• Subjects: Administration, Cutaneous; Adult; Biological and medical sciences; Bupropion - administration & dosage; Bupropion - adverse effects; bupropion SR; Delayed-Action Preparations; Double-Blind Method; Drug Therapy, Combination; Female; Follow-Up Studies; Humans; Male; Medical sciences; Miscellaneous; Nicotine - administration & dosage; Nicotine - adverse effects; nicotine patch; Pharmacology. Drug treatments; smoking; smoking cessation; Smoking Cessation - methods; Tobacco Use Disorder - drug therapy; Treatment Failure; Treatment Outcome
• ISSN: 0149-2918; 1879-114X
• DOI: 10.1016/S0149-2918(01)80023-0

Objective: The purpose of this study was to evaluate the efficacy of long-term use of bupropion sustained release (SR), the nicotine patch, and the combination of these 2 treatments in patients who initially failed treatment. Methods: This was a post hoc analysis of a multicenter, double-blind, randomized, placebo-controlled clinical trial in 893 smokers. Patients were randomly 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 smoking cessation after 14 or 21 days of therapy and long-term success was defined 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 patients were white, and 52% were female. The study subjects smoked an average of 27 cigarettes per day. Among the 467 patients who initially failed treatment in the first 3 weeks, treatment with bupropion SR alone and in combination 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% combination, 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 therapy with bupropion SR, either alone or in combination with the nicotine patch, resulted in significantly higher short- and long-term smoking cessation rates than treatment with the nicotine patch alone or placebo.