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

• Published in: European journal of clinical pharmacology Vol. 77; no. 6; pp. 841 - 847
• Main Authors: Zhou, Zhen, Jose, Kim, Curtis, Andrea J., Kost, Alissia, Breslin, Monique, Zoungas, Sophia, Nelson, Mark R.
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Springer Berlin Heidelberg 01.06.2021; Springer Nature B.V
• Subjects: Adverse events; Biomedical and Life Sciences; Biomedicine; Clinical Trial; Clinical trials; Patient compliance; Pharmacology/Toxicology; Qualitative research; Quality of life; Statins; Medication adherence; Qualitative research; Clinical trial; Aged
• ISSN: 0031-6970; 1432-1041
• DOI: 10.1007/s00228-020-03073-x

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.