RESUMO
BACKGROUND: We evaluated efficacy, predictors of quitting success and the safety profile of varenicline for smoking cessation in the Belgian participants in an observational, "real world" study. METHODS: In this post-hoc analysis of a prospective, observational, non-comparative study, participants were adult smokers who were motivated to quit and were prescribed varenicline in accordance with the recommendations of the European Summary of Product Characteristics. The 7-day point prevalence of abstinence at Weeks 12 and 24 was determined based on patient reporting, and these data were further analysed by time to first cigarette on waking and by the use of behavioural support. The safety profile of varenicline was also assessed. RESULTS: Overall, 61.1% of participants (n= 226) successfully quit smoking by the end of Week 12. There was a significant association between abstinence and time to first cigarette on waking (Week 12: OR, 0.69 [95% CI, 0.50-0.94], p = 0.02; Week 24: OR, 0.70 [95% CI, 0.52-0.94], p=0.02) and the use of behavioural support (Week 12: OR, 6.18 [95% CI, 3.41-11.2], p<0.01; Week 24: OR, 5.37 [95% CI, 2.89-9.98], p<0.01). The most frequent treatment-emergent adverse event was nausea (9.3%). CONCLUSIONS: In this post-hoc analysis, varenicline was an effective smoking cessation aid with an acceptable safety profile in real world clinical practice in Belgian smokers. Significant predictors of abstinence were time to first cigarette on waking and use of behavioural support.
