Observations on Cytisine as a Smoking Cessation Aid: Initial Findings with an Adapted Therapeutic Approach in a Clinical Setting.

<bold>Introduction:</bold> Treatment guidelines recommend adopting an integrated pharmacological andbehavioral intervention model. Cytisine, a partial agonist of nicotinic receptors, has shown promising efficacy in aiding smoking cessation based on trials conducted so far. The conventional cytisine treatment spans 25 days. However, a 40-day regimen with escalating doses and a prolonged treatment duration has been used in Italy, yet reports on its efficacy remain scarce. <bold>Methods:</bold> A retrospective, real-life observational study was conducted spanning from January 2016 to September 2022 in a University Hospital. Three hundred patients who received at least one dose of the study medication were included. The Wilcoxon-Mann-Whitney test was employed to compare continuous variables. Univariate and multivariate logistic regression models were utilized to assess self-reported seven-day point prevalence for abstinence at three, six, and 12 months. <bold>Results:</bold> The median age of the patients was 59 years, with 57% being women. The median smoking exposure was 33.8 pack-years. Self-reported smoking abstinence rates at three, six, and 12 months were 68.7%, 56.3%, and 47.3%, respectively. Eighty-four percent of patients completed the cytisine treatment, with 31.3% reporting adverse events, leading to treatment discontinuation in 8.3% of cases. <bold>Conclusion:</bold> Cytisine, administered within a novel therapeutic regimen in the real-life setting of a specialized anti-smoking center, significantly facilitates smoking abstinence. However, further randomized-controlled studies are suggested in ordet to evaluate the tolerability and efficacy of this new treatment approach.