Aspirin and healthy lifespan in older people: main outcome of the ASPREE-XT observational study.

Abstract

In the Aspirin in Reducing Events in the Elderly (ASPREE) clinical trial, low-dose aspirin was not associated with survival free of dementia and persistent physical disability (a measure of a healthy lifespan); however, there was a small increased risk of death. Given the long pre-clinical phase of many ageing conditions, we aimed to examine the legacy effect (post-trial) and the longer-term effect of aspirin versus placebo through extended follow-up in the ASPREE-XT observational study. Between March 10, 2010, and Dec 24, 2014, 19 114 community-dwelling people in Australia and the USA, aged predominantly 70 years and older, were randomly assigned to low-dose aspirin or placebo for a median of 4·7 years as part of the ASPREE trial. Post-trial observational follow-up continued for a median of 4·3 years (IQR 4·1-4·6). All components of the primary endpoint (ie, incident dementia, persistent physical disability, and death) were adjudicated by masked expert panels. Analyses used Cox proportional hazards models with intention-to-treat. 15 633 participants (8836 [56·5%] were women, 6797 [43·5%] were men; 981 [6·3%] were not White) were eligible for and agreed to observational follow-up. There was no effect of randomisation to aspirin (34·37 events per 1000 person-years) versus placebo (33·68 per 1000 person-years) on the primary endpoint (hazard ratio [HR] 1·02; 95% CI 0·94-1·11; p=0·63) in the ASPREE-XT period. Similarly, over the period of both ASPREE and ASPREE-XT, no long-term effect of aspirin versus placebo was observed on the composite outcome of death, dementia, or persistent physical disability over almost a decade of follow-up (HR 1·01; 95% CI 0·95-1·08; p=0·65), including no long-term effect on deaths (1·06; 0·99-1·14; p=0·10). No effect of aspirin on incident major haemorrhagic events as compared with placebo was found in ASPREE-XT; however, aspirin was associated with an increased hazard for incident major haemorrhagic events across both ASPREE and ASPREE-XT (1·24; 1·10-1·39). Low-dose aspirin does not appear to be effective in promoting a healthy lifespan in initially healthy, community-dwelling older people. National Institute on Aging and the National Cancer Institute (USA).