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)
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 t...
| Main Authors: | , , , , , , , , , , , , , , , , |
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| Format: | Journal Article |
| Language: | English |
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2023
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| Online Access: | http://purl.org/au-research/grants/nhmrc/1068146 http://hdl.handle.net/20.500.11937/93106 |
| _version_ | 1848765699506307072 |
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| author | Zoungas, S. Curtis, A. Spark, S. Wolfe, R. McNeil, J.J. Beilin, L. Chong, T.T.J. Cloud, G. Hopper, I. Kost, A. Nelson, M. Nicholls, S.J. Reid, Christopher Ryan, J. Tonkin, A. Ward, S.A. Wierzbicki, A. |
| author_facet | Zoungas, S. Curtis, A. Spark, S. Wolfe, R. McNeil, J.J. Beilin, L. Chong, T.T.J. Cloud, G. Hopper, I. Kost, A. Nelson, M. Nicholls, S.J. Reid, Christopher Ryan, J. Tonkin, A. Ward, S.A. Wierzbicki, A. |
| author_sort | Zoungas, S. |
| building | Curtin Institutional Repository |
| collection | Online Access |
| description | 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. |
| first_indexed | 2025-11-14T11:39:24Z |
| format | Journal Article |
| id | curtin-20.500.11937-93106 |
| institution | Curtin University Malaysia |
| institution_category | Local University |
| language | eng |
| last_indexed | 2025-11-14T11:39:24Z |
| publishDate | 2023 |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | curtin-20.500.11937-931062023-09-19T01:12:48Z 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) Zoungas, S. Curtis, A. Spark, S. Wolfe, R. McNeil, J.J. Beilin, L. Chong, T.T.J. Cloud, G. Hopper, I. Kost, A. Nelson, M. Nicholls, S.J. Reid, Christopher Ryan, J. Tonkin, A. Ward, S.A. Wierzbicki, A. dementia ischaemic heart disease preventive medicine Aged Humans Aged, 80 and over Hydroxymethylglutaryl-CoA Reductase Inhibitors Quality of Life Australia Cardiovascular Diseases Myocardial Infarction Stroke Dementia Primary Prevention Primary Health Care Randomized Controlled Trials as Topic STAREE investigator group Humans Dementia Cardiovascular Diseases Myocardial Infarction Hydroxymethylglutaryl-CoA Reductase Inhibitors Primary Prevention Quality of Life Aged Aged, 80 and over Primary Health Care Australia Randomized Controlled Trials as Topic Stroke 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. 2023 Journal Article http://hdl.handle.net/20.500.11937/93106 10.1136/bmjopen-2022-069915 eng http://purl.org/au-research/grants/nhmrc/1068146 http://purl.org/au-research/grants/nhmrc/1161503 http://purl.org/au-research/grants/nhmrc/2006611 http://purl.org/au-research/grants/nhmrc/1165440 http://creativecommons.org/licenses/by/4.0/ fulltext |
| spellingShingle | dementia ischaemic heart disease preventive medicine Aged Humans Aged, 80 and over Hydroxymethylglutaryl-CoA Reductase Inhibitors Quality of Life Australia Cardiovascular Diseases Myocardial Infarction Stroke Dementia Primary Prevention Primary Health Care Randomized Controlled Trials as Topic STAREE investigator group Humans Dementia Cardiovascular Diseases Myocardial Infarction Hydroxymethylglutaryl-CoA Reductase Inhibitors Primary Prevention Quality of Life Aged Aged, 80 and over Primary Health Care Australia Randomized Controlled Trials as Topic Stroke Zoungas, S. Curtis, A. Spark, S. Wolfe, R. McNeil, J.J. Beilin, L. Chong, T.T.J. Cloud, G. Hopper, I. Kost, A. Nelson, M. Nicholls, S.J. Reid, Christopher Ryan, J. Tonkin, A. Ward, S.A. Wierzbicki, A. 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) |
| title | 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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) |
| topic | dementia ischaemic heart disease preventive medicine Aged Humans Aged, 80 and over Hydroxymethylglutaryl-CoA Reductase Inhibitors Quality of Life Australia Cardiovascular Diseases Myocardial Infarction Stroke Dementia Primary Prevention Primary Health Care Randomized Controlled Trials as Topic STAREE investigator group Humans Dementia Cardiovascular Diseases Myocardial Infarction Hydroxymethylglutaryl-CoA Reductase Inhibitors Primary Prevention Quality of Life Aged Aged, 80 and over Primary Health Care Australia Randomized Controlled Trials as Topic Stroke |
| url | http://purl.org/au-research/grants/nhmrc/1068146 http://purl.org/au-research/grants/nhmrc/1068146 http://purl.org/au-research/grants/nhmrc/1068146 http://purl.org/au-research/grants/nhmrc/1068146 http://hdl.handle.net/20.500.11937/93106 |