Assessment of Safety of Use of Antismoking Drug Cytisine in a Hospital Setting

• Published in: Drug safety Vol. 45; no. 10; pp. 1272 - 1273
• Main Authors: Toldo, S, Campagnari, S, Torazzi, A, Arzenton, E, Marini, P, Lugoboni, F, Chiamulera, C
• Format: Journal Article
• Language: English
• Published: Auckland Springer Nature B.V 01.10.2022
• Subjects: Acetylcholine receptors (nicotinic); Cardiology; Comorbidity; Data analysis; Effectiveness; Health services; Informed consent; Insomnia; Nausea; Observational studies; Patients; Rheumatology; Safety; Side effects; Sleep disorders; Smoking; Tobacco; Withdrawal
• ISSN: 0114-5916; 1179-1942

Introduction: Tobacco is one of the worlds largest preventable causes of premature death, which provoked more than 8 million deaths each year [1]. To effectively stop smoking, an integrated approach that includes psychological and intervention is required. Cytisine, selective partial agonist at nicotinic acetylcholine receptors, has been shown to reduce smoking withdrawal symptoms and tobacco use satisfaction [2]. Objective: To assess safety profile of cytisine treatment on a hospital setting; the efficacy and compliance have been also assessed. Methods: A monocentric, observational, prospective study in smoking patients hospitalized in the medical school hospital of Verona (AOUI) treated with cytisine. For each patient, eligibility for treatment with cytisine and subsequently eligibility for the observational study is assessed. The smoker is asked to sign the informed consent form and the therapeutic plan is defined by the physician. The galenic cytisine preparation is prepared by AOUI Verona pharmacy. The primary endpoint is the number of adverse events and adverse drug reactions (ADRs) in the 12-month time period following start of treatment (quit day). ADRs are characterized by type of reaction, day of onset, severity and outcome. Results: In total, 300 subjects will be enrolled. In the first six months of recruitment, 94 smoking patients with relevant comorbidities hospitalized in different departments of AOUI Verona (including cardiology, rheumatology, nephrology) were enrolled. From preliminary data analysis, the safety profile of cytisine is consistent with literature data. The most common ADR is nausea, followed by initial insomnia and sleep disorder. Most cases occurred within 3 days from the quit day. No serious ADRs have been reported. Conclusion: To our knowledge, this is the first observational study with cytisine in a hospital setting. Findings from this study support the safety profile of cytisine, and preliminary data confirm the efficacy of the cytisine in this treatment context.