TY - JOUR
T1 - Statins for extension of disability-free survival and primary prevention of cardiovascular events among older people
T2 - Protocol for a randomised controlled trial in primary care (STAREE trial)
AU - Zoungas, Sophia
AU - Curtis, Andrea
AU - Spark, Simone
AU - Wolfe, Rory
AU - McNeil, John J.
AU - Beilin, Lawrence
AU - Chong, Trevor T.J.
AU - Cloud, Geoffrey
AU - Hopper, Ingrid
AU - Kost, Alissia
AU - Nelson, Mark
AU - Nicholls, Stephen J.
AU - Reid, Christopher M.
AU - Ryan, Joanne
AU - Tonkin, Andrew
AU - Ward, Stephanie A.
AU - Wierzbicki, Anthony
N1 - Funding Information:
STAREE is sponsored by Monash University and has received funding from the National Health and Medical Research Council (NHMRC APP1068146 and APP1161503) and the Heart Foundation of Australia (HF Stroke Prevention grant). STAREE MIND and STAREE HEART have been awarded NHMRC grant funding (#2006611 and #1165440). The funders have had no role in the study design, collection, management, analysis and interpretation of data or in writing or submission of reports or publications.
Funding Information:
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.
Publisher Copyright:
© Authors 2023
PY - 2023/4/3
Y1 - 2023/4/3
N2 - 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.
AB - 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.
KW - dementia
KW - ischaemic heart disease
KW - preventive medicine
UR - http://www.scopus.com/inward/record.url?scp=85151634891&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2022-069915
DO - 10.1136/bmjopen-2022-069915
M3 - Article
C2 - 37012015
AN - SCOPUS:85151634891
SN - 2044-6055
VL - 13
JO - BMJ Open
JF - BMJ Open
IS - 4
M1 - e069915
ER -