Chest
Original ResearchTobacco Cessation & PreventionEffects of Varenicline on Smoking Cessation in Patients With Mild to Moderate COPD: A Randomized Controlled Trial
Section snippets
Study Design
A multicenter, double-blind, placebo-controlled trial for smoking cessation in patients with mild to moderate COPD was conducted in 27 centers in four countries: the United States (17 sites), Spain (three sites), France (four sites), and Italy (three sites). Participants were randomized to receive varenicline or placebo for 12 weeks, with a 40-week follow-up period. The study, conducted from May 2, 2006, to April 30, 2009, complied with the ethical principles of the Declaration of Helsinki. All
Results
Of 1,010 participants screened, 504 were randomly allocated to receive varenicline (n = 250) or placebo (n = 254). The disposition of participants in the trial is shown in Figure 1. Most screen failures were due to failed pulmonary function entry criteria. Two participants allocated to varenicline and three to placebo did not receive study medication; the remaining 248 and 251 participants, respectively, were included in the efficacy and safety analyses. A larger proportion of participants
Discussion
In, to our knowledge, this first randomized, placebo-controlled trial of varenicline in participants with mild to moderate COPD, varenicline has comparable efficacy (CO-confirmed CAR > 40% for weeks 9–12, > 25% for weeks 9–24, and > 18% for weeks 9–52) with that of previously reported findings in two pivotal trials involving the general smoking population15, 16 (Table 4). In comparing these studies, it is noteworthy that certain baseline characteristics of the smokers with COPD differed
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Funding/Support: This study was funded by Pfizer Inc.