Pfizer Inc. announced that a new smoking-cessation clinical study assessing the efficacy and safety of varenicline (Chantix/Champix) has met its primary and secondary endpoints. This is the first study of varenicline using the approach of reducing smoking prior to quitting.
Smokers in this study were unwilling or unable to abruptly quit smoking within four weeks, but were willing to reduce smoking over a period of 12 weeks, with the goal of quitting by the end of that period. Smokers in the study were treated for a 12-week reduction phase followed by a 12-week abstinence phase (for a total of 24 weeks of treatment).
“Setting a fixed quit date can be daunting to smokers, which is why reducing the number of cigarettes smoked is a commonly-used approach to quitting,” said Steven J Romano, MD, senior vice president and medicines development group head, Global Innovative Pharmaceuticals, Pfizer Inc. “This study was designed with this quitting approach in mind.”
In the study of smokers (N=1,510) who were willing to gradually reduce smoking with a goal of quitting within 12 weeks, patients were randomized to either varenicline (Chantix/Champix) 1mg BID or placebo for 24 weeks of treatment, followed by a 28-week non-treatment phase. All patients received brief smoking-cessation counselling throughout the study. Preliminary results demonstrated that continuous abstinence rates (CAR) at weeks 15 through 24, the primary endpoint, were significantly higher in patients treated with Chantix/Champix than in patients treated with placebo (32.1 per cent vs. 6.9 per cent, Odds Ratio [OR]=8.74, p=<0.0001).
The safety and tolerability of varenicline in this study were generally consistent with findings seen in previous clinical studies. The most common treatment-emergent all-causality adverse events reported in over 10 per cent of patients in either the varenicline or placebo treatment group were (varenicline versus placebo): nausea (27.8 per cent vs. 9.0 per cent), nasopharyngitis (13.0 per cent vs. 12.0 per cent), abnormal dreams (11.5 per cent vs. 5.8 per cent) and insomnia (10.7 per cent vs. 6.9 per cent).
This study was a 52-week, randomized, double-blind, placebo-controlled, multinational, parallel group study evaluating the efficacy and safety of varenicline 1 mg BID for smoking cessation using the reduce-to-quit approach. Patients included in this study were adult smokers (N=1,510) who were unwilling or unable to quit within four weeks, but were willing to reduce their smoking with the ultimate goal of quitting within 12 weeks.
Participants were treated with varenicline (n=760) or placebo (n=750) for 24 weeks and targeted at least a 50 per cent reduction in the number of cigarettes smoked by the end of the first four weeks of treatment, and a further 50 per cent reduction after the following eight weeks of treatment, with the goal of complete abstinence by 12 weeks. Smokers who had not made a quit attempt in the 12-week reduction phase of the study were encouraged to do so in the next 12 weeks of treatment.
The study inclusion criteria allowed for enrollment of smokers with certain psychiatric diagnoses, with appropriate monitoring throughout the study.
These are preliminary data and are subject to additional analyses. Results from this study will be submitted for publication in a peer-reviewed journal.
CHANTIX was approved by the US FDA in May 2006 as an aid to smoking- cessation treatment in adults 18 and older. CHANTIX has been shown to increase the likelihood of abstinence from smoking for as long as one year compared to treatment with placebo. Adults who smoke may benefit from smoking-cessation support programs and/or counselling during their quit attempt. It’s possible that patients might slip up and smoke while taking CHANTIX. If patients slip up, they can stay on CHANTIX and keep trying to quit.
Pfizer strives to set the standard for quality, safety and value in the discovery, development and manufacture of health care products and works across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time.
Nessun commento:
Posta un commento