Effectiveness of Cytisinicline Treatment in Hospital Smoking Units

[EN] This article synthesizes and analyzes the findings from 14 observational studies (disaggregated to 15 for analysis), presented at the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR) Congresses, regarding the real-world effectiveness of cytisinicline for smoking cessation. Cytisinicline, a drug recently funded in Spain, was administered as part of a comprehensive intervention to 1136 patients across these studies. The findings showed high weighted mean abstinence rates: 78.3% at 1 month, 49.7% at 3 months, 38.2% at 6 months, and 27% at 12 months. These rates were generally higher than those reported in previous controlled clinical trials. The analysis found no significant difference in abstinence between prospective and retrospective studies, or between self-reported and biochemically verified abstinence. While cytisinicline showed comparable effectiveness to bupropion, higher abstinence rates were observed when it was used in combination with nicotine replacement therapy (NRT) or in a sequential regimen starting with cytisinicline followed by NRT. Adverse events were mostly mild (gastrointestinal symptoms, headache, insomnia, weight gain), with a weighted mean incidence of 16.2%. The authors conclude that these observational results provide valuable real-world evidence of cytisinicline's high effectiveness