title: Retreatment with varenicline for smoking cessation in smokers who have previously taken varenicline: a randomized, placebo-controlled trial.
abstract: The efficacy and safety of retreatment with varenicline in smokers attempting to quit were evaluated in this randomized, double-blind, placebo-controlled, multicenter trial (Australia, Belgium, Canada, the Czech Republic, France, Germany, the United Kingdom, and the United States). Participants were generally healthy adult smokers (≥ 10 cigarettes/day) with ≥ 1 prior quit attempt (≥ 2 weeks) using varenicline and no quit attempts in ≤ 3 months; they were randomly assigned (1:1) to 12 weeks' varenicline (n = 251) or placebo (n = 247) treatment, with individual counseling, plus 40 weeks' nontreatment follow-up. The primary efficacy end point was the carbon monoxide-confirmed (≤ 10 ppm) continuous abstinence rate for weeks 9-12, which was 45.0% (varenicline; n = 249) vs. 11.8% (placebo; n = 245; odds ratio: 7.08; 95% confidence interval: 4.34, 11.55; P < 0.0001). Common varenicline group adverse events were nausea, abnormal dreams, and headache, with no reported suicidal behavior. Varenicline is efficacious and well tolerated in smokers who have previously taken it. Abstinence rates are comparable with rates reported for varenicline-naive smokers.
authors.affiliation: OHSU Smoking Cessation Center, Division of Pulmonary and Critical Care Medicine, Department of Medicine, Oregon Health & Science University, Portland, Oregon, USA.
authors.forename: D
authors.initials: D
authors.lastname: Gonzales
authors.affiliation: UK Centre for Tobacco and Alcohol Studies, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.
authors.forename: P
authors.initials: P
authors.lastname: Hajek
authors.affiliation: Department of Family Medicine, University of Toronto, Toronto, Canada.
authors.forename: L
authors.initials: L
authors.lastname: Pliamm
authors.affiliation: Respiratory Oncology Unit, Department of Pulmonology, University Hospital Gasthuisberg, Leuven, Belgium.
authors.forename: K
authors.initials: K
authors.lastname: Nackaerts
authors.affiliation: Pfizer, New York, New York, USA.
authors.forename: L-J
authors.initials: LJ
authors.lastname: Tseng
authors.affiliation: Pfizer, New York, New York, USA.
authors.forename: T D
authors.initials: TD
authors.lastname: McRae
authors.affiliation: Pfizer, New York, New York, USA.
authors.forename: J
authors.initials: J
authors.lastname: Treadow
mesh_terms: D000328:Adult; D000368:Aged; D001315:Australia; D001552:Benzazepines / Q000008:administration & dosage* / Q000009:adverse effects; D002170:Canada; D016009:Chi-Square Distribution; D003376:Counseling; D004311:Double-Blind Method; D005060:Europe; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018722:Nicotinic Agonists / Q000008:administration & dosage* / Q000009:adverse effects; D016017:Odds Ratio; D011810:Quinoxalines / Q000008:administration & dosage* / Q000009:adverse effects; D012008:Recurrence; D019233:Retreatment; D012907:Smoking / Q000009:adverse effects; D016540:Smoking Cessation / Q000379:methods*; D000074606:Smoking Prevention; D013997:Time Factors; D014029:Tobacco Use Disorder / Q000188:drug therapy*; D016896:Treatment Outcome; D014481:United States; D000068580:Varenicline; D055815:Young Adult
chemical_list: D001552:Benzazepines; D018722:Nicotinic Agonists; D011810:Quinoxalines; D000068580:Varenicline