Risk of Neuropsychiatric Adverse Events Associated with Varenicline Treatment for Smoking Cessation among Dutch Population

Autor: Yuanyuan Wang, Jens H. J. Bos, Catharina C. M. Schuiling-Veninga, Eelko Hak, H. Marike Boezen, Bob Wilffert, Job F M van Boven
Přispěvatelé: PharmacoTherapy, -Epidemiology and -Economics, Groningen Research Institute for Asthma and COPD (GRIAC), Real World Studies in PharmacoEpidemiology, -Genetics, -Economics and -Therapy (PEGET), Value, Affordability and Sustainability (VALUE), Life Course Epidemiology (LCE), Reproductive Origins of Adult Health and Disease (ROAHD), Microbes in Health and Disease (MHD)
Jazyk: angličtina
Rok vydání: 2022
Předmět:
Zdroj: Pharmacoepidemiology and Drug Safety, 31(2), 158-166. Wiley
ISSN: 1053-8569
DOI: 10.1002/pds.5351
Popis: Purpose Varenicline is an effective treatment for smoking cessation. While clinical trials did not confirm a causal role, case reports suggested a possible link of varenicline with neuropsychiatric adverse drug events (NPAEs). This study aims to investigate the risk of NPAEs associated with varenicline initiation among the general population in a real-world setting. Methods We conducted a sequence symmetry analysis (SSA) based on the University of Groningen IADB.nl prescription database. We selected incident users of both varenicline and marker drugs for NPAEs, including depression, anxiety and sleep disorder within different time-intervals. Adjusted sequence ratios (aSR) were calculated for each time-interval. Results Within 365-days' time-interval 1,066 patients were incident users of both varenicline and NPAE marker drugs. In total, 505 patients were prescribed varenicline before NPAE marker drugs and 561 vice versa (crude sequence ratio (cSR) 0.90, 95% CI: 0.80-1.02). After adjustments for trends in prescriptions, overall a null association was found (aSR 1.00, 95% CI: 0.89-1.13). Regarding specific NPAEs, no increased risks were found for depression nor anxiety within any time-interval. A small transient increased risk was found for sleep disorders, particularly in earlier time-intervals 3 and 6 months (aSRs 1.52, 95% CI: 1.10-2.11 and 1.45, 95% CI: 1.15-1.83, respectively). Subgroup and sensitivity analyses showed similar findings. Conclusions Varenicline initiation was unlikely to be associated with an increased risk of taking anti-depressants nor anti-anxiety drugs. Yet a small, but statistically significant, transient association with drugs for sleep disorders was noticed, possibly associated with withdrawal symptoms caused by smoking cessation. This article is protected by copyright. All rights reserved.
Databáze: OpenAIRE
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