Baseline Characteristics of Participants in STAREE: A Randomized Trial for Primary Prevention of Cardiovascular Disease Events and Prolongation of Disability‐Free Survival in Older People

Background The risk–benefit balance of statin use in healthy older people is uncertain. We describe the baseline characteristics of the STAREE (Statins in Reducing Events in the Elderly) trial, which is a randomized, double‐blind, placebo‐controlled trial among community‐dwelling older people; the t...

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Main Authors: Sophia Zoungas, Chris Moran, Andrea J. Curtis, Simone Spark, Zachary Flanagan, Lawrence Beilin, Trevor T.‐J. Chong, Geoffrey C. Cloud, Ingrid Hopper, Alissia Kost, John J. McNeil, Stephen J. Nicholls, Christopher M. Reid, Joanne Ryan, Andrew M. Tonkin, Stephanie Ward, Anthony S. Wierzbicki, Rory Wolfe, Zhen Zhou, Mark R. Nelson
Format: Article
Language:English
Published: Wiley 2024-11-01
Series:Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease
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Online Access:https://www.ahajournals.org/doi/10.1161/JAHA.124.036357
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author Sophia Zoungas
Chris Moran
Andrea J. Curtis
Simone Spark
Zachary Flanagan
Lawrence Beilin
Trevor T.‐J. Chong
Geoffrey C. Cloud
Ingrid Hopper
Alissia Kost
John J. McNeil
Stephen J. Nicholls
Christopher M. Reid
Joanne Ryan
Andrew M. Tonkin
Stephanie Ward
Anthony S. Wierzbicki
Rory Wolfe
Zhen Zhou
Mark R. Nelson
author_facet Sophia Zoungas
Chris Moran
Andrea J. Curtis
Simone Spark
Zachary Flanagan
Lawrence Beilin
Trevor T.‐J. Chong
Geoffrey C. Cloud
Ingrid Hopper
Alissia Kost
John J. McNeil
Stephen J. Nicholls
Christopher M. Reid
Joanne Ryan
Andrew M. Tonkin
Stephanie Ward
Anthony S. Wierzbicki
Rory Wolfe
Zhen Zhou
Mark R. Nelson
author_sort Sophia Zoungas
collection DOAJ
description Background The risk–benefit balance of statin use in healthy older people is uncertain. We describe the baseline characteristics of the STAREE (Statins in Reducing Events in the Elderly) trial, which is a randomized, double‐blind, placebo‐controlled trial among community‐dwelling older people; the trial evaluated the effect of atorvastatin 40 mg for the prevention of major cardiovascular events (cardiovascular death, nonfatal myocardial infarction or stroke), and on disability‐free survival (survival free of both dementia and persistent physical disability). Methods and Results STAREE enrolled people aged ≥70 years from 1583 general practices across Australia with no history of clinical cardiovascular disease, diabetes, or dementia. Baseline data collected included demographic, clinical, cognitive (Modified Mini‐Mental State Examination), psychological (Center for Epidemiologic Studies Short Depression Scale), lifestyle, medical, physical, blood and urine measures, and quality of life. Demographic and clinical characteristics of study participants were then compared with publicly available landmark statin trials. A total of 9971 participants were recruited (mean±SD age 74.7±4.5 years, 4023 (40%) ≥75 years, 52% women) between July 2015 and March 2023. The mean low‐density lipoprotein cholesterol was 3.27 mmol/L (SD=0.72; 126 mg/dL). Hypertension was reported by 43% of participants and the mean blood pressure was 136/80 mm Hg. Compared with previous landmark statin trials that included primary prevention cohorts, STAREE is unique in including such a large number of older (≥75 years) independent‐living people. Conclusions STAREE is the largest primary prevention trial of statins powered to address the important clinical outcomes of major cardiovascular events, disability‐free survival, and cognition in older people. Registration https://www.clinicaltrials.gov; Unique identifier: NCT02099123.
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spelling doaj-art-0f943baeac03416d90ac362724f0bb842024-11-19T12:31:39ZengWileyJournal of the American Heart Association: Cardiovascular and Cerebrovascular Disease2047-99802024-11-01132210.1161/JAHA.124.036357Baseline Characteristics of Participants in STAREE: A Randomized Trial for Primary Prevention of Cardiovascular Disease Events and Prolongation of Disability‐Free Survival in Older PeopleSophia Zoungas0Chris Moran1Andrea J. Curtis2Simone Spark3Zachary Flanagan4Lawrence Beilin5Trevor T.‐J. Chong6Geoffrey C. Cloud7Ingrid Hopper8Alissia Kost9John J. McNeil10Stephen J. Nicholls11Christopher M. Reid12Joanne Ryan13Andrew M. Tonkin14Stephanie Ward15Anthony S. Wierzbicki16Rory Wolfe17Zhen Zhou18Mark R. Nelson19School of Public Health and Preventive Medicine Monash University Melbourne Victoria AustraliaSchool of Public Health and Preventive Medicine Monash University Melbourne Victoria AustraliaSchool of Public Health and Preventive Medicine Monash University Melbourne Victoria AustraliaSchool of Public Health and Preventive Medicine Monash University Melbourne Victoria AustraliaSchool of Public Health and Preventive Medicine Monash University Melbourne Victoria AustraliaSchool of Medicine Royal Perth Hospital, University of Western Australia Perth Western Australia AustraliaTurner Institute for Brain and Mental Health, School of Psychological Sciences Monash University Melbourne Victoria AustraliaDepartment of Neurology Alfred Health Melbourne Victoria AustraliaSchool of Public Health and Preventive Medicine Monash University Melbourne Victoria AustraliaSchool of Public Health and Preventive Medicine Monash University Melbourne Victoria AustraliaSchool of Public Health and Preventive Medicine Monash University Melbourne Victoria AustraliaSchool of Public Health and Preventive Medicine Monash University Melbourne Victoria AustraliaSchool of Public Health and Preventive Medicine Monash University Melbourne Victoria AustraliaSchool of Public Health and Preventive Medicine Monash University Melbourne Victoria AustraliaSchool of Public Health and Preventive Medicine Monash University Melbourne Victoria AustraliaSchool of Public Health and Preventive Medicine Monash University Melbourne Victoria AustraliaDepartment of Metabolic Medicine/Chemical Pathology Guy’s & St Thomas’ Hospitals London United KingdomSchool of Public Health and Preventive Medicine Monash University Melbourne Victoria AustraliaSchool of Public Health and Preventive Medicine Monash University Melbourne Victoria AustraliaSchool of Public Health and Preventive Medicine Monash University Melbourne Victoria AustraliaBackground The risk–benefit balance of statin use in healthy older people is uncertain. We describe the baseline characteristics of the STAREE (Statins in Reducing Events in the Elderly) trial, which is a randomized, double‐blind, placebo‐controlled trial among community‐dwelling older people; the trial evaluated the effect of atorvastatin 40 mg for the prevention of major cardiovascular events (cardiovascular death, nonfatal myocardial infarction or stroke), and on disability‐free survival (survival free of both dementia and persistent physical disability). Methods and Results STAREE enrolled people aged ≥70 years from 1583 general practices across Australia with no history of clinical cardiovascular disease, diabetes, or dementia. Baseline data collected included demographic, clinical, cognitive (Modified Mini‐Mental State Examination), psychological (Center for Epidemiologic Studies Short Depression Scale), lifestyle, medical, physical, blood and urine measures, and quality of life. Demographic and clinical characteristics of study participants were then compared with publicly available landmark statin trials. A total of 9971 participants were recruited (mean±SD age 74.7±4.5 years, 4023 (40%) ≥75 years, 52% women) between July 2015 and March 2023. The mean low‐density lipoprotein cholesterol was 3.27 mmol/L (SD=0.72; 126 mg/dL). Hypertension was reported by 43% of participants and the mean blood pressure was 136/80 mm Hg. Compared with previous landmark statin trials that included primary prevention cohorts, STAREE is unique in including such a large number of older (≥75 years) independent‐living people. Conclusions STAREE is the largest primary prevention trial of statins powered to address the important clinical outcomes of major cardiovascular events, disability‐free survival, and cognition in older people. Registration https://www.clinicaltrials.gov; Unique identifier: NCT02099123.https://www.ahajournals.org/doi/10.1161/JAHA.124.036357primary preventionrandomized clinical trialstatins
spellingShingle Sophia Zoungas
Chris Moran
Andrea J. Curtis
Simone Spark
Zachary Flanagan
Lawrence Beilin
Trevor T.‐J. Chong
Geoffrey C. Cloud
Ingrid Hopper
Alissia Kost
John J. McNeil
Stephen J. Nicholls
Christopher M. Reid
Joanne Ryan
Andrew M. Tonkin
Stephanie Ward
Anthony S. Wierzbicki
Rory Wolfe
Zhen Zhou
Mark R. Nelson
Baseline Characteristics of Participants in STAREE: A Randomized Trial for Primary Prevention of Cardiovascular Disease Events and Prolongation of Disability‐Free Survival in Older People
Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease
primary prevention
randomized clinical trial
statins
title Baseline Characteristics of Participants in STAREE: A Randomized Trial for Primary Prevention of Cardiovascular Disease Events and Prolongation of Disability‐Free Survival in Older People
title_full Baseline Characteristics of Participants in STAREE: A Randomized Trial for Primary Prevention of Cardiovascular Disease Events and Prolongation of Disability‐Free Survival in Older People
title_fullStr Baseline Characteristics of Participants in STAREE: A Randomized Trial for Primary Prevention of Cardiovascular Disease Events and Prolongation of Disability‐Free Survival in Older People
title_full_unstemmed Baseline Characteristics of Participants in STAREE: A Randomized Trial for Primary Prevention of Cardiovascular Disease Events and Prolongation of Disability‐Free Survival in Older People
title_short Baseline Characteristics of Participants in STAREE: A Randomized Trial for Primary Prevention of Cardiovascular Disease Events and Prolongation of Disability‐Free Survival in Older People
title_sort baseline characteristics of participants in staree a randomized trial for primary prevention of cardiovascular disease events and prolongation of disability free survival in older people
topic primary prevention
randomized clinical trial
statins
url https://www.ahajournals.org/doi/10.1161/JAHA.124.036357
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