Zoungas S, Curtis A, Spark S, Wolfe R, McNeil JJ, Beilin L, Chong TT, Cloud G, Hopper I, Kost A, Nelson M, Nicholls SJ, Reid CM, Ryan J, Tonkin A, Ward SA, and Wierzbicki A
Introduction: The world is undergoing a demographic transition to an older population. Preventive healthcare has reduced the burden of chronic illness at younger ages but there is limited evidence that these advances can improve health at older ages. Statins are one class of drug with the potential to prevent or delay the onset of several causes of incapacity in older age, particularly major cardiovascular disease (CVD). This paper presents the protocol for the STAtins in Reducing Events in the Elderly (STAREE) trial, a randomised double-blind placebo-controlled trial examining the effects of statins in community dwelling older people without CVD, diabetes or dementia., Methods and Analysis: We will conduct a double-blind, randomised placebo-controlled trial among people aged 70 years and over, recruited through Australian general practice and with no history of clinical CVD, diabetes or dementia. Participants will be randomly assigned to oral atorvastatin (40 mg daily) or matching placebo (1:1 ratio). The co-primary endpoints are disability-free survival defined as survival-free of dementia and persistent physical disability, and major cardiovascular events (cardiovascular death or non-fatal myocardial infarction or stroke). Secondary endpoints are all-cause death, dementia and other cognitive decline, persistent physical disability, fatal and non-fatal myocardial infarction, fatal and non-fatal stroke, heart failure, atrial fibrillation, fatal and non-fatal cancer, all-cause hospitalisation, need for permanent residential care and quality of life. Comparisons between assigned treatment arms will be on an intention-to-treat basis with each of the co-primary endpoints analysed separately in time-to-first-event analyses using Cox proportional hazards regression models., Ethics and Dissemination: STAREE will address uncertainties about the preventive effects of statins on a range of clinical outcomes important to older people. Institutional ethics approval has been obtained. All research outputs will be disseminated to general practitioner co-investigators and participants, published in peer-reviewed journals and presented at national and international conferences., Trial Registration Number: NCT02099123., Competing Interests: Competing interests: SZ has received NHMRC and Australian Heart Foundation research funding as the principal investigator of the STAREE trial; and payment to the institution (Monash University) from Amgen Australia, AstraZeneca, Boehringer-Ingelheim, Eli Lilly Australia, Merck Sharp & Dohme Australia, Novo Nordisk, Sanofi and Servier for consultancy work outside the submitted work. IH has received research funding from NHMRC and Royal Australasian College of Physicians and honoraria for lectures or advisory board participation from Boehringer Ingelheim, Vifor and Eli Lilly. JJM is supported by an NHMRC Leadership Fellowship (IG1173690). MN has served on a Novartis advisory board on lipid management in 2020. CMR is supported through an NHMRC Principal Research Fellowship (APP 1136372). SJN has received research support from AstraZeneca, New Amsterdam Pharma, Amgen, Anthera, Eli Lilly, Esperion, Novartis, Cerenis, The Medicines Company, Resverlogix, InfraReDx, Roche, Sanofi-Regeneron and LipoScience and is a consultant for AstraZeneca, Amarin, Akcea, Eli Lilly, Anthera, Omthera, Merck, Takeda, Resverlogix, Sanofi-Regeneron, CSL Behring, Esperion, Boehringer Ingelheim and Vaxxinity. TT-JC has received honoraria for lectures from Roche. AW has been a clinical trial investigator for Akcea, Amgen, Regeneron and Silence Therapeutics. He has served as a guideline chair and done consultancy work for the National Institute of Health and Care Excellence in the UK. AT has received research support or honoraria for lectures, advisory board or data monitoring committee participation from Amgen, The Medicines Group, Merck, Novartis and Pfizer. SAW has received payment to attend an advisory meeting on dementia for Roche., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)