Neuropsychiatric safety of varenicline in the general and COPD population with and without psychiatric disorders: a retrospective cohort study in a real-world setting.

Autor:	Wang Y; Department of PharmacoTherapy, -Epidemiology & -Economics, Groningen Research Institutte of Pharmacy, University of Groningen, Groningen, The Netherlands yuanyuanwang.research@gmail.com., Bos JH; Department of PharmacoTherapy, -Epidemiology & -Economics, Groningen Research Institutte of Pharmacy, University of Groningen, Groningen, The Netherlands., Schuiling-Veninga CCM; Department of PharmacoTherapy, -Epidemiology & -Economics, Groningen Research Institutte of Pharmacy, University of Groningen, Groningen, The Netherlands., Boezen HM; Department of Epidemiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.; Groningen Research Institute for Asthma and COPD (GRIAC), University Medical Center Groningen, University of Groningen, Groningen, The Netherlands., van Boven JFM; Groningen Research Institute for Asthma and COPD (GRIAC), University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.; Department of Clinical Pharmacy & Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands., Wilffert B; Department of PharmacoTherapy, -Epidemiology & -Economics, Groningen Research Institutte of Pharmacy, University of Groningen, Groningen, The Netherlands.; Department of Clinical Pharmacy & Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands., Hak E; Department of PharmacoTherapy, -Epidemiology & -Economics, Groningen Research Institutte of Pharmacy, University of Groningen, Groningen, The Netherlands.; Department of Epidemiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2021 May 25; Vol. 11 (5), pp. e042417. Date of Electronic Publication: 2021 May 25.
DOI:	10.1136/bmjopen-2020-042417
Abstrakt:	Objectives: To evaluate the real-world association between varenicline and neuropsychiatric adverse events (NPAEs) in general and chronic obstructive pulmonary disease (COPD) population with and without psychiatric disorders compared with nicotine replacement therapy (NRT) to strengthen the knowledge of varenicline safety. Design: A retrospective cohort study. Setting: Prescription database IADB.nl, the Netherlands. Participants: New users of varenicline or NRT among general (≥18 years) and COPD (≥40 years) population. Psychiatric subcohort was defined as people prescribed psychotropic medications (≥2) within 6 months before the index date. Outcome Measures: The incidence of NPAEs including depression, anxiety and insomnia, defined by new or naive prescriptions of related medications in IADB.nl within 24 weeks after the first treatment initiation of varenicline or NRT. Results: For the general population in non-psychiatric cohort, the incidence of total NPAEs in varenicline (4480) and NRT (1970) groups was 10.5% and 12.6%, respectively (adjusted OR (aOR) 0.85, 95% CI 0.72 to 1.00). For the general population in psychiatric cohort, the incidence of total NPAEs was much higher, 75.3% and 78.5% for varenicline (1427) and NRT (1200) groups, respectively (aOR 0.82, 95% CI 0.68 to 0.99). For the COPD population (1598), there were no differences in the incidence of NPAEs between comparison groups in both the psychiatric cohort (aOR 0.97, 95% CI 0.66 to 1.44) and non-psychiatric cohort (aOR 0.81, 95% CI 0.54 to 1.20). Results from subgroup or sensitivity analyses also did not reveal increased risks of NPAEs but showed decreased risk of some subgroup NPAEs associated with varenicline. Conclusions: In contrast to the concerns of a possible increased risk of NPAEs among varenicline users, we found a relative decreased risk of total NPAEs in varenicline users of the general population in psychiatric or non-psychiatric cohorts compared with NRT and no difference for NPAEs between varenicline and NRT users in smaller population with COPD. Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)
Databáze:	MEDLINE
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