Ten-Year Real-Life Experience With Varenicline in a Hospital-Based Smoking Cessation Program

To assess the real-life efficacy and safety of varenicline in a hospital-based smoking cessation program. We conducted a longitudinal prospective study including 310 smokers treated with varenicline at our hospital's Smoking Cessation Unit between 2011 and 2021. Abstinence rates at 3, 6, and 12 months were 51.3%, 40.0%, and 36.5%, respectively. Smoking the first cigarette within 5 min of waking was independently associated with treatment failure (OR: 2.516, <i>p</i> = 0.02). Adverse events occurred in 27% of patients, leading to treatment discontinuation in 11%. Varenicline demonstrated favorable efficacy and safety in real-world clinical practice, regardless of baseline motivation or comorbidities. Active follow-up is essential to optimize adherence and long-term success.