Pfizer reports positive results from smoking cessation study
Pfizer has reported positive results from a smoking cessation study which showed that 42.3% of smokers with mild-to-moderate chronic obstructive pulmonary disease, or COPD, who took Chantix/Champix were able to quit smoking and remain abstinent during the last four weeks of treatment compared with 8.8% of those given placebo.
The multicenter, double-blind, placebo-controlled trial included 499 adults who had smoked an average of 10 cigarettes or more per day in the year before enrollment. Study participants had mild-to-moderate COPD and smoked for an average of 41 years. Participants had a high level of nicotine dependence as indicated by the average Fagerstrom test for nicotine dependence score of 6.1 (on a 10-point scale).
Study participants were randomized to 12 weeks of treatment with either varenicline (n=248) or placebo (n=251) and were followed to week 52 in a blinded post-treatment phase. All participants received smoking cessation counseling throughout the study.
The primary efficacy objective was to compare 12 weeks of treatment with varenicline (1mg twice daily) to placebo for smoking cessation in smokers with mild-to-moderate COPD, and to evaluate abstinence from smoking for the 40 weeks after the treatment period. The safety objective was to gather safety data for 12 weeks of treatment with varenicline or placebo in smokers with mild-to-moderate COPD.
During the last four weeks of treatment (weeks 9-12), 42.3% of study participants with mild-to-moderate COPD who were randomized to take varenicline remained abstinent compared with 8.8% of those given placebo (p<0.0001). At the end of 52 weeks, 18.6% of participants who took varenicline remained abstinent, compared with 5.6% of participants randomized to take placebo (p<0.0001). Varenicline was generally well-tolerated in the study.
Briggs Morrison, senior vice president of the primary care medicines development group at Pfizer, said: "We at Pfizer want to help people quit smoking. We sponsored this trial to offer healthcare providers additional information on smokers who are at risk for or diagnosed with COPD, who might especially benefit from quitting. This is just one of several planned and ongoing studies of varenicline that we hope will enhance the medical community's understanding of this important medicine."
