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。

IF 5 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Journal of the American Heart Association Pub Date : 2024-11-19 Epub Date: 2024-11-15 DOI:10.1161/JAHA.124.036357

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

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引用次数: 0

摘要

背景：健康老年人使用他汀类药物的风险-收益平衡尚不确定。我们描述了 STAREE（他汀类药物减少老年人心血管事件）试验的基线特征，该试验是在社区居住的老年人中进行的一项随机、双盲、安慰剂对照试验；该试验评估了阿托伐他汀 40 毫克对预防重大心血管事件（心血管死亡、非致命性心肌梗死或中风）和无残疾生存期（无痴呆和持续性肢体残疾生存期）的影响：STAREE 从澳大利亚的 1583 家全科诊所招募了年龄≥70 岁、无临床心血管疾病、糖尿病或痴呆症病史的患者。收集的基线数据包括人口统计学、临床、认知（改良小型精神状态检查）、心理（流行病学研究中心抑郁简表）、生活方式、医疗、物理、血液和尿液测量以及生活质量。然后将研究参与者的人口统计学和临床特征与公开的里程碑式他汀类药物试验进行比较。2015年7月至2023年3月期间，共招募了9971名参与者（平均年龄（±SD）为74.7±4.5岁，4023人（40%）≥75岁，52%为女性）。低密度脂蛋白胆固醇的平均值为 3.27 mmol/L（SD=0.72；126 mg/dL）。43%的参与者患有高血压，平均血压为136/80毫米汞柱。与以往包括一级预防队列的里程碑式他汀类药物试验相比，STAREE的独特之处在于纳入了如此多的独立生活的老年人（≥75岁）：STAREE是最大规模的他汀类药物一级预防试验，其研究对象包括老年人主要心血管事件、无残疾生存和认知能力等重要临床结果。注册：https://www.clinicaltrials.gov；唯一标识符：NCT02099123。

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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.

Registration: https://www.clinicaltrials.gov; Unique identifier: NCT02099123.

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来源期刊

Journal of the American Heart Association CARDIAC & CARDIOVASCULAR SYSTEMS-

CiteScore

9.40

自引率

1.90%

发文量

1749

审稿时长

12 weeks

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.