Effects of varenicline on smoking cessation in patients with mild to moderate COPD: a randomized controlled trial

Chest. 2011 Mar;139(3):591-599. doi: 10.1378/chest.10-0865. Epub 2010 Sep 23.


Background: Smoking is the most important risk factor for COPD and accelerates its progression. Despite the health implications, a large proportion of patients with COPD continue to smoke, so finding effective smoking cessation interventions for this population is paramount. To our knowledge, this is the first randomized clinical trial to compare the efficacy and safety of varenicline tartrate vs placebo in smokers with mild to moderate COPD.

Methods: In a 27-center, double-blind, multinational study, 504 patients with mild to moderate COPD (postbronchodilator FEV1/FVC, <70%; FEV1 percent predicted normal value, ≥50%) and without known psychiatric disturbances were randomized to receive varenicline (n=250) or placebo (n=254) for 12 weeks, with a 40-week nontreatment follow-up. The primary end point was carbon monoxide-confirmed continuous abstinence rate (CAR) for weeks 9 to 12. A secondary end point was CAR for weeks 9 to 52.

Results: CAR for weeks 9 to 12 was significantly higher for patients in the varenicline group (42.3%) than for those in the placebo group (8.8%) (OR, 8.40; 95% CI, 4.99-14.14; P<.0001). CAR in the patients treated with varenicline remained significantly higher than in those treated with placebo through weeks 9 to 52 (18.6% vs 5.6%) (OR, 4.04; 95% CI, 2.13-7.67; P<.0001). Nausea, abnormal dreams, upper-respiratory tract infection, and insomnia were the most commonly reported adverse events (AEs) for patients in the varenicline group. Serious AEs were infrequent in both treatment groups. Two patients in the varenicline group and one patient in the placebo group died during the study. Reports of psychiatric AEs were similar for both treatment groups.

Conclusions: Varenicline was more efficacious than placebo for smoking cessation in patients with mild to moderate COPD and demonstrated a safety profile consistent with that observed in previous trials.

Trial registry: ClinicalTrials.gov; No.: NCT00285012; URL: www.clinicaltrials.gov.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Benzazepines / adverse effects
  • Benzazepines / therapeutic use*
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • France
  • Humans
  • Italy
  • Male
  • Middle Aged
  • Nicotinic Agonists / adverse effects
  • Nicotinic Agonists / therapeutic use*
  • Pulmonary Disease, Chronic Obstructive / etiology*
  • Pulmonary Disease, Chronic Obstructive / physiopathology*
  • Quinoxalines / adverse effects
  • Quinoxalines / therapeutic use*
  • Respiratory Function Tests
  • Severity of Illness Index
  • Smoking / adverse effects*
  • Smoking Cessation / methods*
  • Spain
  • Spirometry
  • Treatment Outcome
  • United States
  • Varenicline


  • Benzazepines
  • Nicotinic Agonists
  • Quinoxalines
  • Varenicline

Associated data

  • ClinicalTrials.gov/NCT00285012