老年人的残障自由生存期延长和心血管事件初级预防:一项在初级保健中进行的随机对照试验(STAREE试验)的方案。
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).
发表日期:2023 Apr 03
作者:
Sophia 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,
来源:
DIABETES & METABOLISM
摘要:
世界正在经历老龄人口的人口转变。预防性医疗降低了年轻时慢性病的负担,但有限的证据表明这些进步对老年人的健康改善效果有限。他汀类药物是防止或延缓老年时多种能导致失能的病因的一类药物,尤其是主要心血管疾病(CVD)。本文介绍了《老年人STAtins减少事件(STAREE)》试验的方案,该试验是一项随机双盲安慰剂对照试验,研究他汀类药物在没有CVD、糖尿病或痴呆症的社区老年人中的效果。
我们将在70岁及以上的人群中,通过澳大利亚普通诊所招募没有临床CVD、糖尿病或痴呆症状的参与者进行双盲、随机安慰剂对照试验。参与者将随机分配到口服阿托伐他汀(每日40毫克)或配对安慰剂(1:1比例)。共同主要终点是无残疾生存,即没有痴呆和持久的身体残疾的生存率,以及主要心血管事件(心血管死亡或非致命性心肌梗死或中风)。次要终点包括全因死亡、痴呆和其他认知下降、持久的身体残疾、致命和非致命的心肌梗死、致命和非致命的中风、心力衰竭、房颤、致命和非致命的癌症、全因住院、需要永久住院护理和生活质量。分配治疗方案之间的比较将基于意向治疗,每个共同主要终点将通过使用Cox比例风险回归模型分别进行时间为首次事件的分析。
STAREE将解决有关他汀类药物预防老年人重要临床结果的不确定性。我们已获取了伦理批准。所有研究成果都将传达给诊所合作者和参与者,并发表于同行评审的期刊上,并在国内外会议上进行展示。
NCT02099123。©作者(或其雇主)2023年。CC BY下的重复使用。由BMJ出版。
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.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.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.NCT02099123.© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.