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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

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Smoking and tobacco
Original research
Neuropsychiatric safety of varenicline in the general and COPD population with and without psychiatric disorders: a retrospective cohort study in a real-world setting
  1. Yuanyuan Wang1,
  2. Jens H. Bos1,
  3. Catharina C.M. Schuiling-Veninga1,
  4. H. Marike Boezen2,3,
  5. Job F. M. van Boven3,4,
  6. Bob Wilffert1,4,
  7. Eelko Hak1,2
  1. 1Department of PharmacoTherapy, -Epidemiology & -Economics, Groningen Research Institutte of Pharmacy, University of Groningen, Groningen, The Netherlands
  2. 2Department of Epidemiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands
  3. 3Groningen Research Institute for Asthma and COPD (GRIAC), University Medical Center Groningen, University of Groningen, Groningen, The Netherlands
  4. 4Department of Clinical Pharmacy & Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands
  1. Correspondence to Dr Yuanyuan Wang; yuanyuanwang.research{at}gmail.com

Abstract

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.

  • depression & mood disorders
  • anxiety disorders
  • epidemiology

Data availability statement

Data are available on reasonable request. The data analysed in this study were obtained from the IADB.nl database. Researchers interested in these data could send email to info@iadb.nl.

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/.

https://doi.org/10.1136/bmjopen-2020-042417

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    Data availability statement

    Data are available on reasonable request. The data analysed in this study were obtained from the IADB.nl database. Researchers interested in these data could send email to info@iadb.nl.

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    Footnotes

    • Contributors YW and EH are involved in designing the study; JHB contributed the data collection, YW analysed the data and drafted the article; CCM-SV, HMB, JFMvB, BW and EH contributed to the interpretation of results and revision of the manuscript. All authors read and approved the final manuscript.

    • Funding This study was supported by internal funding. YW got the funding from China Scholarship Council (file no: 201506010259) for her PhD study.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.