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Varenicline Is Effective for Smoking Cessation in Patients With Mild to Moderate COPD: Presented at CHEST 2009

By Betty S. Riggs

SAN DIEGO -- November 9, 2009 -- Compared with placebo, varenicline treatment resulted in a higher percentage of patients with chronic obstructive pulmonary disease (COPD) who were able to quit smoking and remain abstinent, according to a study presented here at CHEST 2009, the annual meeting of the American College of Chest Physicians.

Donald Tashkin, MD, University of California, Los Angeles, Los Angeles, California, reported the findings of a randomised, double-blind, multinational study on November 4.

The study included 499 smokers aged 48 years and older with a diagnosis of COPD, who were motivated to quit. Patients were randomised to receive varenicline 1 mg twice daily (n = 248) or a placebo (n = 251) for 12 weeks.

Titration to a full dose occurred over 7 days beginning at baseline and the target quit date coincided with the week 1 visit. All patients also received smoking cessation counselling throughout the study.

After the randomised treatment period, all patients were then followed for 40 additional weeks in a blinded, post-treatment study phase. Randomised patients who took at least 1 dose of study drug were included in the efficacy and safety analyses.

The primary endpoint was the continuous abstinence rate (CAR) for weeks 9 to 12 confirmed by exhaled carbon monoxide <=10 parts per million. A secondary endpoint was CAR during weeks 9 to 52, also verified by carbon monoxide testing.

For weeks 9 to 12, the CAR was significantly better in the varenicline-treated group (42.3%) compared with the placebo-treated group (8.8%; P = .0001). The greater efficacy observed with varenicline was also maintained long term.

During the post-randomised treatment period (weeks 9 to 52), the CAR was 18.6% in the varenicline group compared with 5.6% in the placebo group (P < .0001).

The incidence of adverse events (AEs) was similar between groups (73.8% in the varenicline group vs 65.3% in the placebo group). The most common AEs were nausea, abnormal dreams, upper respiratory tract infection, and insomnia.

Reports of depression, depressed mood, and depressive symptoms were similar for both treatment groups. There was 1 adverse event of suicidal ideation reported in the placebo group, but none in the varenicline group.

Serious AEs occurred in 2.8% of the varenicline-treated group and in 4.4% of the placebo-treated group. Two varenicline-treated patients and 1 placebo-treated patient died during the study.

"Quitting smoking is of paramount importance for all smokers, particularly those with a smoking-related illness, such as COPD," said Dr. Tashkin. "This study shows that varenicline is an effective means of smoking cessation for a highly nicotine-dependent, difficult-to-treat group of patients. The safety profile of varenicline in this study was consistent with its preapproval clinical trials."

Funding for this study was provided by Pfizer Inc.

[Presentation title: Efficacy and Safety of Varenicline for Smoking Cessation in Patients With Mild to Moderate COPD]

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