McNeil John J, Woods Robyn L, Nelson Mark R, Murray Anne M, Reid Christopher M, Kirpach Brenda, Storey Elsdon, Shah Raj C, Wolfe Rory S, Tonkin Andrew M, Newman Anne B, Williamson Jeff D, Lockery Jessica E, Margolis Karen L, Ernst Michael E, Abhayaratna Walter P, Stocks Nigel, Fitzgerald Sharyn M, Trevaks Ruth E, Orchard Suzanne G, Beilin Lawrence J, Donnan Geoffrey A, Gibbs Peter, Johnston Colin I, Grimm Richard H
Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
Menzies Institute for Medical Research, University of Tasmania, Hobart, Australia.
J Gerontol A Biol Sci Med Sci. 2017 Oct 12;72(11):1586-1593. doi: 10.1093/gerona/glw342.
There are no primary prevention trials of aspirin with relevant geriatric outcomes in elderly people. ASPirin in Reducing Events in the Elderly (ASPREE) is a placebo-controlled trial of low-dose aspirin that will determine whether 5 years of daily 100-mg enteric-coated aspirin extends disability-free and dementia-free life in a healthy elderly population and whether these benefits outweigh the risks.
Set in primary care, this randomized double-blind placebo-controlled trial has a composite primary endpoint of death, incident dementia or persistent physical disability. Participants aged 70+ years (non-minorities) or 65+ years (U.S. minorities) were free of cardiovascular disease, dementia, or physical disability and without a contraindication to, or indication for, aspirin. Baseline data include physical and lifestyle, personal and family medical history, hemoglobin, fasting glucose, creatinine, lipid panel, urinary albumin:creatinine ratio, cognition (3MS, HVLT-R, COWAT, SDMT), mood (CES-D-10), physical function (gait speed, grip strength), Katz activities of daily living and quality of life (SF-12).
Recruitment ended in December 2014 with 16,703 Australian and 2,411 U.S. participants, a median age of 74 (range 65-98) years and 56% women. Approximately 55% of the U.S. cohort were from minority groups; 9% of the total cohort. Proportions with hypertension, overweight, and chronic kidney disease were similar to age-matched populations from both countries although lower percentages had diabetes, dyslipidemia, and osteoarthritis.
Findings from ASPREE will be generalizable to a healthier older population in both countries and will assess whether the broad benefits of daily low-dose aspirin in prolonging independent life outweigh the risks.
尚无针对老年人相关老年结局的阿司匹林一级预防试验。老年人阿司匹林减少事件（ASPREE）是一项低剂量阿司匹林的安慰剂对照试验，将确定每日服用100毫克肠溶阿司匹林5年是否能延长健康老年人群无残疾和无痴呆的寿命，以及这些益处是否大于风险。
该随机双盲安慰剂对照试验在初级保健机构开展，复合主要终点为死亡、新发痴呆或持续性身体残疾。年龄在70岁及以上（非少数族裔）或65岁及以上（美国少数族裔）的参与者无心血管疾病、痴呆或身体残疾，且无阿司匹林使用禁忌证或适应证。基线数据包括身体状况和生活方式、个人及家族病史、血红蛋白、空腹血糖、肌酐、血脂谱、尿白蛋白：肌酐比值、认知功能（3MS、HVLT-R、COWAT、SDMT）、情绪（CES-D-10）、身体功能（步速、握力）、Katz日常生活活动能力和生活质量（SF-12）。
招募工作于2014年12月结束，共有16703名澳大利亚参与者和2411名美国参与者，中位年龄为74岁（范围65 - 98岁），女性占56%。美国队列中约55%为少数族裔；占总队列的9%。高血压、超重和慢性肾病的比例与两国年龄匹配人群相似，不过糖尿病、血脂异常和骨关节炎的比例较低。
ASPREE的研究结果将适用于两国更健康的老年人群，并将评估每日低剂量阿司匹林在延长独立生活方面的广泛益处是否大于风险。
