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
{"title":"STAREE：老年人心血管疾病事件一级预防和延长无残疾生存期的随机试验》参与者的基线特征。","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","doi":"10.1161/JAHA.124.036357","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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).</p><p><strong>Methods and results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p><p><strong>Registration: </strong>https://www.clinicaltrials.gov; Unique identifier: NCT02099123.</p>","PeriodicalId":54370,"journal":{"name":"Journal of the American Heart Association","volume":" ","pages":"e036357"},"PeriodicalIF":5.0000,"publicationDate":"2024-11-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"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.\",\"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\",\"doi\":\"10.1161/JAHA.124.036357\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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).</p><p><strong>Methods and results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p><p><strong>Registration: </strong>https://www.clinicaltrials.gov; Unique identifier: NCT02099123.</p>\",\"PeriodicalId\":54370,\"journal\":{\"name\":\"Journal of the American Heart Association\",\"volume\":\" \",\"pages\":\"e036357\"},\"PeriodicalIF\":5.0000,\"publicationDate\":\"2024-11-19\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of the American Heart Association\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1161/JAHA.124.036357\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/11/15 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of the American Heart Association","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1161/JAHA.124.036357","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/11/15 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
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 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.
期刊介绍：
As an Open Access journal, JAHA - Journal of the American Heart Association is rapidly and freely available, accelerating the translation of strong science into effective practice.
JAHA is an authoritative, peer-reviewed Open Access journal focusing on cardiovascular and cerebrovascular disease. JAHA provides a global forum for basic and clinical research and timely reviews on cardiovascular disease and stroke. As an Open Access journal, its content is free on publication to read, download, and share, accelerating the translation of strong science into effective practice.
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