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| |  Varenicline Effective for Smoking Cessation in a Real-World Setting: Presented at SRNT By Liz Meszaros BALTIMORE, Md -- March 2, 2010 -- Varenicline is effective and well tolerated as an aid to smoking cessation, according to results from a study presented here on February 27 at the 2010 Society for Research on Nicotine and Tobacco (SRNT) Annual Meeting. “The aim of this study was to see whether the efficacy and safety of varenicline demonstrated in well-controlled clinical trials is seen also in real-life use of the medication, where behavioural support is not standardised and follow-up is not as frequent,” explained Hedwig Boudrez, PhD, Smoking Cessation Clinic, University Hospital Ghent, Heart Centre, Ghent, Belgium. “Patients at participating centres were eligible for inclusion in this study simply if they had been prescribed varenicline at the clinical discretion of the doctor and agreed to participate, so there were no strict inclusion and exclusion criteria,” continued Dr. Boudrez. The multicentre, multinational, 12-week, prospective, observational, noncomparative study, included 551 individuals (mean age, 45.5 y) who had an intent to quit smoking and were receiving varenicline. One-third of the individuals participated in an intensive behavioural support program for smoking cessation for the length of the study. Continuous abstinence was determined based on verbal reporting in the 7-day period between week 11 and week 12 of treatment. Most patients were white (97.1%) and male (53.5%), with a mean smoking history of 27.0 years and an average number of 25.3 cigarettes per day. Mean score on the Fagerström Test for Nicotine Dependence in these subjects was 6.1. The most common comorbidities relevant to smoking were elevated cholesterol (20.7%), hypertension (20.0%), and chronic obstructive pulmonary disease (18.2%). At the end of the 12-week treatment period, 64.6% of individuals had quit smoking. The most frequent adverse events were nausea (8.9%), insomnia (2.9%), and sleep disorder (2.2%). Seven patients had serious adverse events, and 1 mortality unrelated to the study drug occurred. In all, 3.4% of individuals (n = 19) discontinued because of adverse events related to treatment. “Varenicline is an effective and well-tolerated smoking cessation aid in daily practice,” concluded Dr. Boudrez. “Only a third of patients overall received any sort of formal behavioural support, although the level of support varied greatly between countries.” Dr. Boudrez added the following caveats to the study results: “The quit status of patients was not always biochemically verified [ie, with carbon monoxide or cotinine measurements]. Patient contact in real-life practice is much less frequent than in clinical trials, so adverse events were not solicited as frequently as in a clinical trial, contributing to lower rates observed in this study than in controlled clinical trials.” Funding for this study was provided by Pfizer Ltd. UK. [Presentation title: Effectiveness of Varenicline as an Aid to Smoking Cessation: Results of an Intereuropean Observational Study. Abstract POS5-82]
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