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Older participant perspectives on permanent study drug discontinuation in an ongoing primary prevention trial of statins

  • Clinical Trial
  • Published:
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Abstract

Purpose

Study drug discontinuation is commonplace in clinical trials of older populations. Little is known about why older participants discontinue the study drug. This qualitative study aimed to understand factors contributing to permanent study drug discontinuation among participants aged ≥ 70 years within an ongoing primary prevention trial of statins by exploring their experiences and perceptions.

Methods

Trial participants who had permanently discontinued the study drug within 2 years of randomisation were purposively sampled by age (< 75 and ≥ 75 years) and sex to participate in semi-structured phone interviews between March 2019 and February 2020. Interviews were audio-recorded, transcribed and analysed thematically.

Results

Thirty participants were interviewed (21 females; mean age, 77 years), and three themes were identified from the data. Perceived adverse events (AEs) and their effect on daily living (mobility, functional capacity, quality of life) were identified as the major factors leading to the participants permanently discontinuing their study drug, despite an ambiguity about the cause of the AE. For some, concurrent challenging life circumstances further lowered their tolerance to perceived AEs thus making discontinuation more likely. A few discontinuations were attributed to other factors (e.g. GP advice, unrelated illness).

Conclusion

Among healthy older participants enrolled in a statin trial, perceived AEs and their related impact were key factors contributing to the permanent study drug discontinuation. Addressing anticipated participant-reported AEs and their concerns about drug-related side effects at trial entry, as well as offering timely medical assistance and support when AEs occur, may be useful to reduce drug discontinuation rates.

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Data availability

All data generated or analysed during this study are included in this published article and its supplementary information files.

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Acknowledgements

The authors would like to thank the STAREE (Statins in Reducing Events in the Elderly) participants in this study who gave their precious time for interviews, and the STAREE Investigator Group for their support. Special thanks also go to Simona Markusevska and Naomi Szwarcbard who assisted in participant recruitment for this study.

Funding

STAREE has been awarded project grants from the NHMRC (Australia) (APP1068146 and APP1161503) and from a Stroke Prevention Grant from the Heart Foundation (#101663). There is no funding that specifically supports this qualitative research.

Author information

Authors and Affiliations

  1. Menzies Institute for Medical Research, University of Tasmania, 17 Liverpool Street, Hobart, TAS, 7000, Australia

    Zhen Zhou, Kim Jose, Monique Breslin & Mark R. Nelson

  2. Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia

    Andrea J. Curtis, Alissia Kost & Sophia Zoungas

Authors
  1. Zhen Zhou
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  2. Kim Jose
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  3. Andrea J. Curtis
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  4. Alissia Kost
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  6. Sophia Zoungas
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  7. Mark R. Nelson
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Consortia

on behalf of the STAREE Investigator Group

Contributions

Study concept and design: ZZ, KJ, AC, AK, SZ, MB, MN. Acquisition, analysis or interpretation of data: ZZ, KJ, AK. Drafting of the manuscript: ZZ. Critical revision of the manuscript for important intellectual content: ZZ, KJ, AC, AK, SZ, MB, MN. Administrative, technical or material support: AK, SZ. Study supervision: MN.

Corresponding author

Correspondence to Zhen Zhou.

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Conflict of interest

The authors declare that they have no conflict of interest.

Ethics approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. This study was approved by the Monash University Human Research Ethics Committee (15334) and Tasmanian Health and Medical Human Research Ethics Committee (H0017572).

Consent to participate

Verbal informed consent was obtained prior to the interview.

Consent to publish

Not applicable. No identifying information is included in this article.

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Key points

• Adverse events along with their impacts on daily living were identified as the major factors leading to older participants permanently discontinuing their study drug.

• Difficult life circumstances may increase the chance of study drug discontinuation among older trial participants.

• Proposed strategies may help prevent study drug discontinuation in older trial participants.

Supplementary information

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Zhou, Z., Jose, K., Curtis, A.J. et al. Older participant perspectives on permanent study drug discontinuation in an ongoing primary prevention trial of statins. Eur J Clin Pharmacol 77, 841–847 (2021). https://doi.org/10.1007/s00228-020-03073-x

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  • DOI: https://doi.org/10.1007/s00228-020-03073-x

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