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

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 knowledg...

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Autores principales: Wang, Yuanyuan, Bos, Jens H., Schuiling-Veninga, Catharina C.M., Boezen, H. Marike, van Boven, Job F. M., Wilffert, Bob, Hak, Eelko
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8154988/
https://www.ncbi.nlm.nih.gov/pubmed/34035088
http://dx.doi.org/10.1136/bmjopen-2020-042417
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author Wang, Yuanyuan
Bos, Jens H.
Schuiling-Veninga, Catharina C.M.
Boezen, H. Marike
van Boven, Job F. M.
Wilffert, Bob
Hak, Eelko
author_facet Wang, Yuanyuan
Bos, Jens H.
Schuiling-Veninga, Catharina C.M.
Boezen, H. Marike
van Boven, Job F. M.
Wilffert, Bob
Hak, Eelko
author_sort Wang, Yuanyuan
collection PubMed
description 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.
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spelling pubmed-81549882021-06-10 Neuropsychiatric safety of varenicline in the general and COPD population with and without psychiatric disorders: a retrospective cohort study in a real-world setting Wang, Yuanyuan Bos, Jens H. Schuiling-Veninga, Catharina C.M. Boezen, H. Marike van Boven, Job F. M. Wilffert, Bob Hak, Eelko BMJ Open Smoking and Tobacco 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. BMJ Publishing Group 2021-05-25 /pmc/articles/PMC8154988/ /pubmed/34035088 http://dx.doi.org/10.1136/bmjopen-2020-042417 Text en © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
spellingShingle Smoking and Tobacco
Wang, Yuanyuan
Bos, Jens H.
Schuiling-Veninga, Catharina C.M.
Boezen, H. Marike
van Boven, Job F. M.
Wilffert, Bob
Hak, Eelko
Neuropsychiatric safety of varenicline in the general and COPD population with and without psychiatric disorders: a retrospective cohort study in a real-world setting
title Neuropsychiatric safety of varenicline in the general and COPD population with and without psychiatric disorders: a retrospective cohort study in a real-world setting
title_full Neuropsychiatric safety of varenicline in the general and COPD population with and without psychiatric disorders: a retrospective cohort study in a real-world setting
title_fullStr Neuropsychiatric safety of varenicline in the general and COPD population with and without psychiatric disorders: a retrospective cohort study in a real-world setting
title_full_unstemmed Neuropsychiatric safety of varenicline in the general and COPD population with and without psychiatric disorders: a retrospective cohort study in a real-world setting
title_short Neuropsychiatric safety of varenicline in the general and COPD population with and without psychiatric disorders: a retrospective cohort study in a real-world setting
title_sort neuropsychiatric safety of varenicline in the general and copd population with and without psychiatric disorders: a retrospective cohort study in a real-world setting
topic Smoking and Tobacco
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8154988/
https://www.ncbi.nlm.nih.gov/pubmed/34035088
http://dx.doi.org/10.1136/bmjopen-2020-042417
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