Statins for extension of disability-free survival and primary prevention of cardiovascular events among older people: protocol for a randomised controlled trial in primary care (STAREE trial)

Simple item page
dc.contributor.authorZoungas, S.
dc.contributor.authorCurtis, A.
dc.contributor.authorSpark, S.
dc.contributor.authorWolfe, R.
dc.contributor.authorMcNeil, J.J.
dc.contributor.authorBeilin, L.
dc.contributor.authorChong, T.T.J.
dc.contributor.authorCloud, G.
dc.contributor.authorHopper, I.
dc.contributor.authorKost, A.
dc.contributor.authorNelson, M.
dc.contributor.authorNicholls, S.J.
dc.contributor.authorReid, C.M.
dc.contributor.authorRyan, J.
dc.contributor.authorTonkin, A.
dc.contributor.authorWard, S.A.
dc.contributor.authorWierzbicki, A.
dc.date.issued2023
dc.description.abstractIntroduction: 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.
dc.description.statementofresponsibilitySophia Zoungas, Andrea Curtis, Simone Spark, Rory Wolfe, John J McNeil, Lawrence Beilin, Trevor T-J Chong, Geoffrey Cloud, Ingrid Hopper, Alissia Kost, Mark Nelson, Stephen J Nicholls, Christopher M Reid, Joanne Ryan, Andrew Tonkin, Stephanie A Ward, Anthony Wierzbicki, On behalf of STAREE investigator group
dc.identifier.citationBMJ Open, 2023; 13(4):e069915-1-e069915-9
dc.identifier.doi10.1136/bmjopen-2022-069915
dc.identifier.issn2044-6055
dc.identifier.issn2044-6055
dc.identifier.orcidNicholls, S.J. [0000-0002-9668-4368]
dc.identifier.urihttps://hdl.handle.net/2440/138789
dc.language.isoen
dc.publisherBMJ Journals
dc.relation.granthttp://purl.org/au-research/grants/nhmrc/1068146
dc.relation.granthttp://purl.org/au-research/grants/nhmrc/1161503
dc.relation.granthttp://purl.org/au-research/grants/nhmrc/2006611
dc.relation.granthttp://purl.org/au-research/grants/nhmrc/1165440
dc.rights© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/ licenses/by/4.0/.
dc.source.urihttps://doi.org/10.1136/bmjopen-2022-069915
dc.subjectSTAREE investigator group
dc.subject.meshHumans
dc.subject.meshDementia
dc.subject.meshCardiovascular Diseases
dc.subject.meshMyocardial Infarction
dc.subject.meshHydroxymethylglutaryl-CoA Reductase Inhibitors
dc.subject.meshPrimary Prevention
dc.subject.meshQuality of Life
dc.subject.meshAged
dc.subject.meshAged, 80 and over
dc.subject.meshPrimary Health Care
dc.subject.meshAustralia
dc.subject.meshRandomized Controlled Trials as Topic
dc.subject.meshStroke
dc.titleStatins for extension of disability-free survival and primary prevention of cardiovascular events among older people: protocol for a randomised controlled trial in primary care (STAREE trial)
dc.typeJournal article
pubs.publication-statusPublished

Files

Original bundle
Now showing 1 - 1 of 1
No Thumbnail Available
Name:
hdl_138789.pdf
Size:
385.12 KB
Format:
Adobe Portable Document Format
Description:
Published version
Download

Collections

Medicine publications