{"entity":{"id":"aspree","kind":"trial","name":"ASPREE (ASPirin in Reducing Events in the Elderly)","aka":[],"tldr":"In healthy older people, daily low-dose aspirin did not extend disability-free life and, unexpectedly, was linked with more cancer deaths. It changed guidelines against routine aspirin in the elderly.","summary":"19,114 participants followed for a median 4.7 years. Aspirin did not reduce disability-free survival (HR 1.01) or cardiovascular events, increased major haemorrhage (HR 1.38), and was associated with higher all-cause mortality (HR 1.14, 95% CI 1.01-1.29), driven by cancer deaths (HR 1.31, 95% CI 1.10-1.56), particularly from advanced or metastatic cancers. Extended follow-up did not show a later emergence of cancer prevention. The finding contradicts long-term follow-up of earlier aspirin trials in middle-aged adults and is unexplained; hypotheses include a different effect of aspirin on established late-life cancers. It was central to the US Preventive Services Task Force 2022 decision to withdraw the recommendation for aspirin to prevent colorectal cancer.","status":"negative","asOf":"2026-09-08","links":[{"label":"ClinicalTrials.gov NCT01038583","url":"https://clinicaltrials.gov/study/NCT01038583"},{"label":"Mortality results (NEJM 2018)","url":"https://doi.org/10.1056/NEJMoa1803955"}],"tags":[],"related":[],"cancers":[],"sections":["nutrition-lifestyle","prevention"],"technologies":["aspirin-cancer-prevention","chemoprevention"],"targets":[],"drugs":["aspirin"],"companies":[],"institutions":[],"pathways":[],"terms":["hazard-ratio"],"trials":[],"people":[],"bottlenecks":["b-negative-results","b-aging-comorbidity"],"keyPapers":["paper-mcneil-n-engl-j-med"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01038583","phase":"3","setting":"Community-dwelling adults aged 70+ (65+ for US Black and Hispanic participants) without cardiovascular disease, dementia or disability: aspirin 100 mg/day vs placebo","sponsor":"Monash University / NIH National Institute on Aging","result":"All-cause mortality HR 1.14; cancer mortality HR 1.31; no cancer prevention.","started":"2010-01","startedType":"actual","yearReported":2018,"enrolled":19114,"enrolledBasis":"registry","outcomes":[{"endpoint":"Death from cancer","unit":"events","arms":[{"name":"Aspirin","n":9525,"value":295},{"name":"Placebo","n":9589,"value":227}],"hr":1.31,"ci":[1.1,1.56],"source":"https://doi.org/10.1056/NEJMoa1803955"}],"replication":"Discordant with pooled long-term follow-up of cardiovascular aspirin trials in younger adults (reduced colorectal cancer mortality); age-dependence of the aspirin effect is now the working explanation."},"route":"/trials/aspree/","neighbours":{"section":[{"id":"nutrition-lifestyle","kind":"section","name":"Diet, Exercise & Lifestyle","route":"/fronts/nutrition-lifestyle/"},{"id":"prevention","kind":"section","name":"Prevention & Risk","route":"/fronts/prevention/"}],"technology":[{"id":"aspirin-cancer-prevention","kind":"technology","name":"Aspirin for cancer prevention and adjuvant therapy","route":"/technologies/aspirin-cancer-prevention/"},{"id":"chemoprevention","kind":"technology","name":"Chemoprevention & risk-reducing surgery","route":"/technologies/chemoprevention/"}],"drug":[{"id":"aspirin","kind":"drug","name":"Aspirin","route":"/drugs/aspirin/"}],"term":[{"id":"hazard-ratio","kind":"term","name":"Hazard ratio (HR)","route":"/terms/hazard-ratio/"}],"bottleneck":[{"id":"b-negative-results","kind":"bottleneck","name":"Failures are hidden","route":"/bottlenecks/b-negative-results/"},{"id":"b-aging-comorbidity","kind":"bottleneck","name":"Older and multimorbid patients are excluded and undertreated","route":"/bottlenecks/b-aging-comorbidity/"}],"paper":[{"id":"paper-mcneil-n-engl-j-med","kind":"paper","name":"Effect of Aspirin on All-Cause Mortality in the Healthy Elderly","route":"/key-papers/paper-mcneil-n-engl-j-med/"}],"roadmap":[{"id":"prevention-roadmap","kind":"roadmap","name":"Cancer prevention roadmap: tobacco control and vaccines → biomarker-guided chemoprevention → interception in carriers","route":"/roadmaps/prevention-roadmap/"}]}}