Chest
Volume 139, Issue 3, March 2011, Pages 591-599
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Original Research
Tobacco Cessation & Prevention
Effects of Varenicline on Smoking Cessation in Patients With Mild to Moderate COPD: A Randomized Controlled Trial

https://doi.org/10.1378/chest.10-0865Get rights and content

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.

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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  • Cited by (0)

    Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (http://www.chestpubs.org/site/misc/reprints.xhtml).

    Funding/Support: This study was funded by Pfizer Inc.

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