title: Late-term smoking cessation despite initial failure: an evaluation of bupropion sustained release, nicotine patch, combination therapy, and placebo.
abstract: 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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Clinical Development Depression/Dependence, Medical Affairs, GlaxoSmithKline, Research Triangle Park, North Carolina 27709-3398, USA. bdj7585@gsk.com
authors.forename: B D
authors.initials: BD
authors.lastname: Jamerson
authors.forename: M
authors.initials: M
authors.lastname: Nides
authors.forename: D E
authors.initials: DE
authors.lastname: Jorenby
authors.forename: R
authors.initials: R
authors.lastname: Donahue
authors.forename: P
authors.initials: P
authors.lastname: Garrett
authors.forename: J A
authors.initials: JA
authors.lastname: Johnston
authors.forename: M C
authors.initials: MC
authors.lastname: Fiore
authors.forename: S I
authors.initials: SI
authors.lastname: Rennard
authors.forename: S J
authors.initials: SJ
authors.lastname: Leischow
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D016642:Bupropion / Q000008:administration & dosage* / Q000009:adverse effects; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D009538:Nicotine / Q000008:administration & dosage* / Q000009:adverse effects; D016540:Smoking Cessation / Q000379:methods*; D014029:Tobacco Use Disorder / Q000188:drug therapy*; D017211:Treatment Failure; D016896:Treatment Outcome
chemical_list: D003692:Delayed-Action Preparations; D016642:Bupropion; D009538:Nicotine