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

Zhou, Z ORCID: 0000-0002-0835-8686, Jose, K ORCID: 0000-0002-9346-6429, Curtis, AJ, Kost, A, Breslin, M ORCID: 0000-0002-8135-3136, Zoungas, S and Nelson, MR ORCID: 0000-0001-9941-7161 2021 , 'Older participant perspectives on permanent study drug discontinuation in an ongoing primary prevention trial of statins' , European Journal of Clinical Pharmacology , doi: 10.1007/s00228-020-03073-x.

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Abstract

Purpose: Study drug discontinuation is commonplace in clinical trials of older populations. Little is known about why older participantsdiscontinue the study drug. This qualitative study aimed to understand factors contributing to permanent study drug discontinuationamong 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 purposivelysampled by age (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 asthe major factors leading to the participants permanently discontinuing their study drug, despite an ambiguity about the cause ofthe AE. For some, concurrent challenging life circumstances further lowered their tolerance to perceived AEs thus makingdiscontinuation 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 factorscontributing to the permanent study drug discontinuation. Addressing anticipated participant-reported AEs and their concernsabout drug-related side effects at trial entry, as well as offering timely medical assistance and support when AEs occur, may beuseful to reduce drug discontinuation rates.

Item Type: Article
Authors/Creators:Zhou, Z and Jose, K and Curtis, AJ and Kost, A and Breslin, M and Zoungas, S and Nelson, MR
Keywords: statins, medication adherence, clinical trials, ageing, study drug discontinuation
Journal or Publication Title: European Journal of Clinical Pharmacology
Publisher: Springer-Verlag
ISSN: 0031-6970
DOI / ID Number: 10.1007/s00228-020-03073-x
Copyright Information:

Copyright 2021 Springer

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