Journal article
Aspirin and healthy lifespan in older people: main outcome of the ASPREE-XT observational study
The Lancet. Healthy longevity, Vol.6(9), 100764
09/2025
DOI: 10.1016/j.lanhl.2025.100764
PMCID: PMC12551462
PMID: 41043446
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).
Details
- Title: Subtitle
- Aspirin and healthy lifespan in older people: main outcome of the ASPREE-XT observational study
- Creators
- Raj C Shah - Rush University Medical CenterJoanne Ryan - Monash UniversityKatherine L Webb - Monash UniversityRory Wolfe - Monash UniversityAndrew Chan - Harvard Medical SchoolTrevor T-J Chong - Monash UniversityMichael E Ernst - University of IowaSara E Espinoza - Cedars-Sinai Medical CenterOlivia Flynn - Concord Repatriation General HospitalSong Yuin Lee - Prince of Wales HospitalJohn McNeil - Monash UniversityMark R Nelson - University of TasmaniaSuzanne G Orchard - Monash UniversityChristopher M Reid - Monash UniversityKerry Sheets - Hennepin Healthcare Research InstituteNigel P Stocks - The University of AdelaideNilakshi S Weerasinghe - Bankstown Lidcombe HospitalMichelle E Wilson - Monash UniversityRobyn L Woods - Monash UniversityAnne M Murray - Hennepin Healthcare Research Institute
- Resource Type
- Journal article
- Publication Details
- The Lancet. Healthy longevity, Vol.6(9), 100764
- DOI
- 10.1016/j.lanhl.2025.100764
- PMID
- 41043446
- PMCID
- PMC12551462
- NLM abbreviation
- Lancet Healthy Longev
- ISSN
- 2666-7568
- eISSN
- 2666-7568
- Publisher
- Elsevier
- Grant note
- National Institute on AgingNational Cancer Institute: U01AG029824, U19AG062682 National Health and Medical Research Council (Australia): 2016438, 334047, 1127060 National Institutes of Health
Data collection and management for the ASPREE trial and ASPREE-XT were funded by the National Institute on Aging and the National Cancer Institute (USA; U01AG029824 and U19AG062682). The National Health and Medical Research Council (Australia) also funded the ASPREE randomised clinical trial phase (334047 and 1127060). Bayer provided aspirin and the matching placebo for ASPREE. JR is funded by a National Health and Medical Research Council Leadership 1 Investigator Grant (2016438). AC reports receiving grants from the National Institutes of Health to his institution in support of this manuscript. RLW reports receiving salary support from the National Institute on Aging and National Health and Medical Research Council in support of this manuscript. We thank the dedicated and skilled staff in Australia and the USA for conducting the trial and the post-trial research study phases. We also thank the ASPREE participants, who willingly volunteered for this study, and the general practitioners and medical clinics who supported participants in the ASPREE and ASPREE-XT studies.
- Language
- English
- Electronic publication date
- 08/27/2026
- Date published
- 09/2025
- Academic Unit
- Family and Community Medicine; Pharmacy Practice and Science
- Record Identifier
- 9984969104702771
Metrics
21 Record Views