Department of Pharmacy Practice and Science, College of Pharmacy, The University of Iowa, Iowa City, IA, United States of America; Department of Family Medicine, Carver College of Medicine, The University of Iowa, Iowa City, IA, United States of America.
School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.
Contemp Clin Trials. 2023 Jul;130:107231. doi: 10.1016/j.cct.2023.107231. Epub 2023 May 15.
Aspirin as a primary preventative in healthy older adults did not prolong disability-free survival in the ASPREE randomized trial. Observational studies following randomized trials allow assessment of benefits and harms which may not appear during the trial. We describe health characteristics, physical function, and aspirin use in the ASPREE-eXTension (ASPREE-XT) observational study cohort.
Descriptive statistics compared health characteristics of those consented to ASPREE-XT at their first post-trial baseline (XT01) to corresponding ASPREE baseline values, and to those not consented. Likelihood of an indication for aspirin was assessed in participants reporting aspirin use at XT01.
16,317 (93%) of the remaining and eligible 17,546 ASPREE participants were consented into ASPREE-XT; 14,894 completed XT01. Mean participant age had increased from 74.9 to 80.6 years. Overall health and physical function declined from the original ASPREE baseline; more participants were living alone, there was higher prevalence of chronic kidney disease, diabetes, and frailty, grip strength was lower and gait speed slower. Those not consented into ASPREE-XT were slightly older, and had lower cognitive scores and higher prevalence of age-related conditions than those who continued. 1015/11,717 (8.7%) participants without an apparent indication for aspirin reported using aspirin at XT01.
The ASPREE-XT cohort was slightly less healthy at the XT01 visit than at ASPREE trial initiation, and rates of aspirin use without indication were similar to ASPREE baseline. Participants will be followed long-term to investigate aspirin's potential legacy towards dementia and cancer prevention and explore determinants of healthy aging.
在 ASPREE 随机试验中,阿司匹林对健康老年人的一级预防并未延长无残疾生存时间。随机试验后的观察性研究可评估试验期间可能未出现的益处和危害。我们描述了 ASPREE-XT(ASPREE-XT)观察性研究队列中的健康特征、身体功能和阿司匹林使用情况。
描述性统计比较了首次试验后基线(XT01)时同意纳入 ASPREE-XT 的研究对象与 ASPREE 基线的健康特征,并与未同意纳入的研究对象进行比较。评估了在 XT01 报告使用阿司匹林的参与者中阿司匹林使用的适应症可能性。
17546 名符合条件的 ASPREE 参与者中,有 16317 名(93%)同意纳入 ASPREE-XT;其中 14894 名完成了 XT01。参与者的平均年龄从 74.9 岁增加到 80.6 岁。总体健康状况和身体功能从原始 ASPREE 基线下降;独居的参与者比例更高,慢性肾脏病、糖尿病和衰弱的患病率更高,握力较低,步速较慢。未同意纳入 ASPREE-XT 的参与者年龄稍大,认知评分较低,与继续参与的参与者相比,年龄相关疾病的患病率更高。1015/11717(8.7%)名无明显阿司匹林适应症的参与者报告在 XT01 时使用了阿司匹林。
与 ASPREE 试验开始时相比,XT01 就诊时的 ASPREE-XT 队列健康状况略差,且无适应症使用阿司匹林的比例与 ASPREE 基线相似。参与者将被长期随访,以研究阿司匹林对预防痴呆和癌症的潜在作用,并探讨健康老龄化的决定因素。