Living evidence page · Drugs & supplements
Low-dose aspirin
Released coverage keeps the secondary healthspan composite, disability-free survival, cardiovascular outcomes, cancer follow-up and major bleeding separate.
Safety and regulatory context: Released coverage reports major hemorrhage separately from the secondary healthspan composite, disability-free survival, cardiovascular outcomes and cancer follow-up. This page does not provide personal prevention advice.
Compare coverage
Three different evidence questions
Counts and order describe what More Years has released. They do not indicate evidence strength, efficacy, safety, importance, popularity or recommendation.
Released reporting
What the covered evidence says
Large randomized trial · Human clinical events · secondary composite analysis of a large randomized trial
ASPREE’s broader healthspan composite stayed near the null
- Population
- 19,114 generally healthy community-dwelling older adults in Australia and the United States
- Measured
- time to first cardiovascular disease, diabetes, dementia, cancer or death event
Aspirin and placebo rates were 82.1 and 82.7 events per 1,000 person-years; HR 0.98, 95% CI 0.92–1.05.
Does not establish: The analysis did not prove zero effect, component-specific effects, a universal healthspan measure or advice for an individual.
Published 2026-10-13 · verified 2026-10-13
Large randomized trial · Human function and safety · large randomized trial
ASPREE found no gain in disability-free survival—and more major bleeding
- Population
- 19,114 community-dwelling older adults without cardiovascular disease, dementia or independence-limiting disability at enrollment
- Measured
- disability-free survival · major bleeding
In 19,114 selected older adults, daily low-dose aspirin did not improve the trial’s composite of death, dementia or persistent physical disability over a median 4.7 years. Major hemorrhage was higher.
Does not establish: The result does not prove aspirin has zero effect in every group, erase individual components, or apply to people with established cardiovascular disease. Disability-free survival is not a direct lifespan measure.
Published 2026-08-03 · verified 2026-08-03
Large randomized trial · Human cardiovascular and safety outcomes · large randomized trial
ASPREE did not lower cardiovascular events—and increased major bleeding
- Population
- 19,114 community-dwelling older adults without cardiovascular disease at enrollment
- Measured
- cardiovascular events · major bleeding
In selected older adults without cardiovascular disease, low-dose aspirin did not significantly reduce the trial’s cardiovascular composite. Major hemorrhage occurred more often.
Does not establish: A confidence interval crossing 1 is not proof of zero possible cardiovascular effect. Nor can ASPREE be generalized to people with prior heart attack, stroke or established vascular disease, who were outside its prevention setting.
Published 2026-08-03 · verified 2026-08-03
Randomized trial · Human mortality and cancer outcomes · randomized trial plus observational extension
ASPREE’s cancer signal changed across longer follow-up
- Population
- 19,114 original ASPREE participants; 14,907 cancer-free survivors in the post-trial analysis
- Measured
- cancer mortality · long-term follow-up
The randomized trial found an unexpected cancer-mortality imbalance. Longer follow-up found no difference in overall cancer incidence and no post-trial mortality legacy effect.
Does not establish: The studies do not establish that aspirin broadly causes cancer, prevents cancer, or changes lifespan for every older adult. Cancer incidence is not cancer mortality, and a post-trial null legacy association does not erase the randomized-period signal.
Published 2026-08-03 · verified 2026-08-03
Primary publications and governing syntheses
7 covered studies
These records preserve identifiers, populations, outcomes and interpretation boundaries from the released evidence library.
Randomized trial · peer-reviewed
Effect of aspirin on healthspan in community-dwelling older adults: the ASPirin in reducing events in the elderly study
DOI: 10.1093/ageing/afag218
- Population
- 19,114 generally healthy community-dwelling older adults in Australia and the United States
- Measured
- time to first cardiovascular disease, diabetes, dementia, cancer or death event
- Result in released coverage
- 82.1 versus 82.7 events per 1,000 person-years; HR 0.98, 95% CI 0.92–1.05.
- Evidence maturity
- peer-reviewed secondary composite analysis of a large randomized primary-prevention trial
- Funding / conflicts
- NIH/NIA/NCI, NHMRC, Monash University and Victorian Cancer Agency support; authors declared no competing interests. Bayer supplied trial tablets in kind and was reported to have no other trial role.
- Limitations
- Loss of healthspan was not an ASPREE main outcome and combines unlike first events. · Prevalent diabetes counted at time zero and dominated the reported component mix. · The selected older primary-prevention population limits generalization.
The estimate does not prove zero effect, isolate effects on the five components, measure years lived in good health or establish treatment advice.
Verified 2026-10-11 · correction state: none
Randomized trial · peer-reviewed
Aspree Xt Cancer
DOI: 10.1001/jamaoncol.2025.6196
- Population
- 19,114 community-dwelling older adults in Australia and the United States, generally age 70 or older (65 or older for Black and Hispanic US participants), without cardiovascular disease, dementia or independence-limiting physical disability at enrollment
- Measured
- Cancer incidence and mortality across combined and post-trial follow-up
- Result in released coverage
- ASPREE-XT was an observational extension after assigned aspirin or placebo stopped; post-trial legacy analyses are not continued randomized-treatment evidence. · Across median 8.6 years combined follow-up, original aspirin assignment was not associated with overall cancer incidence; HR 0.98, 95% CI 0.92 to 1.05. · Across combined follow-up, cancer-related mortality was higher by original aspirin assignment; HR 1.15, 95% CI 1.03 to 1.29. · In the post-trial legacy analysis, original aspirin assignment was not associated with cancer incidence; HR 0.91, 95% CI 0.82 to 1.01. · In the post-trial legacy analysis, original aspirin assignment was not associated with cancer mortality; HR 1.02, 95% CI 0.83 to 1.25.
- Evidence maturity
- randomized-period secondary mortality evidence plus trial-derived observational extension follow-up
- Funding / conflicts
- ASPREE was supported by US and Australian public/institutional funders; Bayer supplied aspirin and matching placebo in kind and was reported to have no other trial role. The 2026 follow-up discloses author grants and several outside pharmaceutical relationships.
- Limitations
- Combined follow-up includes years after randomized study drug stopped; post-trial estimates compare original assignment but do not represent continued randomized exposure.
The measured result does not establish a general longevity benefit beyond the population, design and outcomes reported.
Verified 2026-08-03 · correction state: none
Randomized trial · peer-reviewed
Aspree Primary
DOI: 10.1056/NEJMoa1800722
- Population
- 19,114 community-dwelling older adults in Australia and the United States, generally age 70 or older (65 or older for Black and Hispanic US participants), without cardiovascular disease, dementia or independence-limiting physical disability at enrollment
- Measured
- Disability-free survival composite and components over median 4.7 years
- Result in released coverage
- ASPREE randomized 19,114 selected community-dwelling older adults without cardiovascular disease, dementia or independence-limiting disability to 100 mg daily enteric-coated aspirin or placebo. · The disability-free-survival composite occurred at 21.5 events per 1,000 person-years with aspirin and 21.2 with placebo; HR 1.01, 95% CI 0.92 to 1.11. · Disability-free survival combined death, dementia and persistent physical disability and is not equivalent to lifespan or any one component. · Assigned-treatment adherence in the final trial year was 62.1% with aspirin and 64.1% with placebo. · Major hemorrhage occurred in 3.8% with aspirin and 2.8% with placebo; HR 1.38, 95% CI 1.18 to 1.62.
- Evidence maturity
- large human randomized primary-prevention evidence over median 4.7 years
- Funding / conflicts
- ASPREE was supported by US and Australian public/institutional funders; Bayer supplied aspirin and matching placebo in kind and was reported to have no other trial role. The 2026 follow-up discloses author grants and several outside pharmaceutical relationships.
- Limitations
- Applies to ASPREE's selected primary-prevention population, 100 mg daily enteric-coated aspirin versus placebo, median 4.7 years randomized follow-up and incomplete late adherence; it does not determine secondary-prevention benefit or an individual medication decision.
The measured result does not establish a general longevity benefit beyond the population, design and outcomes reported.
Verified 2026-08-03 · correction state: none
Randomized trial · peer-reviewed
Aspree Mortality
DOI: 10.1056/NEJMoa1803955
- Population
- 19,114 community-dwelling older adults in Australia and the United States, generally age 70 or older (65 or older for Black and Hispanic US participants), without cardiovascular disease, dementia or independence-limiting physical disability at enrollment
- Measured
- All-cause and cause-specific mortality over median 4.7 years
- Result in released coverage
- All-cause mortality was 12.7 per 1,000 person-years with aspirin and 11.1 with placebo; HR 1.14, 95% CI 1.01 to 1.29. · Cancer-related death in the randomized period occurred in 3.1% with aspirin and 2.3% with placebo; HR 1.31, 95% CI 1.10 to 1.56. · The randomized-period mortality and cancer signal was a secondary, unexpected finding that the investigators said should be interpreted cautiously.
- Evidence maturity
- randomized-period secondary mortality evidence plus trial-derived observational extension follow-up
- Funding / conflicts
- ASPREE was supported by US and Australian public/institutional funders; Bayer supplied aspirin and matching placebo in kind and was reported to have no other trial role. The 2026 follow-up discloses author grants and several outside pharmaceutical relationships.
- Limitations
- Applies to ASPREE's selected primary-prevention population, 100 mg daily enteric-coated aspirin versus placebo, median 4.7 years randomized follow-up and incomplete late adherence; it does not determine secondary-prevention benefit or an individual medication decision.
The measured result does not establish a general longevity benefit beyond the population, design and outcomes reported.
Verified 2026-08-03 · correction state: none
Randomized trial · peer-reviewed
Aspree Cardiovascular
DOI: 10.1056/NEJMoa1805819
- Population
- 19,114 community-dwelling older adults in Australia and the United States, generally age 70 or older (65 or older for Black and Hispanic US participants), without cardiovascular disease, dementia or independence-limiting physical disability at enrollment
- Measured
- Cardiovascular composite and major hemorrhage over median 4.7 years
- Result in released coverage
- The cardiovascular composite rate was 10.7 per 1,000 person-years with aspirin and 11.3 with placebo; HR 0.95, 95% CI 0.83 to 1.08. · The cardiovascular composite included fatal coronary heart disease, nonfatal myocardial infarction, fatal or nonfatal stroke, or hospitalization for heart failure. · Major hemorrhage occurred at 8.6 per 1,000 person-years with aspirin and 6.2 with placebo; HR 1.38, 95% CI 1.18 to 1.62. · Major hemorrhage included hemorrhagic stroke, symptomatic intracranial bleeding, or qualifying extracranial bleeding requiring major care or causing death. · ASPREE studied primary prevention; its findings do not erase aspirin's established uses for selected people with cardiovascular disease or prior events.
- Evidence maturity
- large human randomized evidence for prespecified cardiovascular and bleeding outcomes
- Funding / conflicts
- ASPREE was supported by US and Australian public/institutional funders; Bayer supplied aspirin and matching placebo in kind and was reported to have no other trial role. The 2026 follow-up discloses author grants and several outside pharmaceutical relationships.
- Limitations
- Applies to ASPREE's selected primary-prevention population, 100 mg daily enteric-coated aspirin versus placebo, median 4.7 years randomized follow-up and incomplete late adherence; it does not determine secondary-prevention benefit or an individual medication decision.
The measured result does not establish a general longevity benefit beyond the population, design and outcomes reported.
Verified 2026-08-03 · correction state: none
Other human evidence · publication record
Fda Aspirin Safety
Source: fda-aspirin-facts-2026
- Population
- Consumers considering aspirin for preventive use
- Measured
- Bleeding, interaction and clinician-guidance context
- Result in released coverage
- ASPREE studied primary prevention; its findings do not erase aspirin's established uses for selected people with cardiovascular disease or prior events. · FDA says daily preventive aspirin is not right for everyone, can cause serious bleeding, and should be considered with a health professional rather than self-directed.
- Evidence maturity
- large human randomized primary-prevention evidence over median 4.7 years · large human randomized evidence for prespecified cardiovascular and bleeding outcomes · randomized-period secondary mortality evidence plus trial-derived observational extension follow-up
- Funding / conflicts
- ASPREE was supported by US and Australian public/institutional funders; Bayer supplied aspirin and matching placebo in kind and was reported to have no other trial role. The 2026 follow-up discloses author grants and several outside pharmaceutical relationships.
- Limitations
- Applies to ASPREE's selected primary-prevention population, 100 mg daily enteric-coated aspirin versus placebo, median 4.7 years randomized follow-up and incomplete late adherence; it does not determine secondary-prevention benefit or an individual medication decision. · FDA safety information is general regulatory guidance; it does not individualize indication, dose, bleeding risk, drug interactions, secondary-prevention needs, or whether a particular person should start, continue, or stop aspirin.
ASPREE found no gain in disability-free survival—and more major bleeding · ASPREE did not lower cardiovascular events—and increased major bleeding · ASPREE’s cancer signal changed across longer follow-up
Verified 2026-08-03 · correction state: not-applicable
Other human evidence · publication record
Uspstf Aspirin Guidance
Source: uspstf-aspirin-2022
- Population
- Adults without known cardiovascular disease considered for primary prevention
- Measured
- Dated initiation recommendation by age
- Result in released coverage
- The April 26, 2022 USPSTF recommendation advises against initiating low-dose aspirin for primary CVD prevention in adults 60 or older.
- Evidence maturity
- large human randomized primary-prevention evidence over median 4.7 years · large human randomized evidence for prespecified cardiovascular and bleeding outcomes
- Funding / conflicts
- ASPREE was supported by US and Australian public/institutional funders; Bayer supplied aspirin and matching placebo in kind and was reported to have no other trial role. The 2026 follow-up discloses author grants and several outside pharmaceutical relationships.
- Limitations
- Applies to ASPREE's selected primary-prevention population, 100 mg daily enteric-coated aspirin versus placebo, median 4.7 years randomized follow-up and incomplete late adherence; it does not determine secondary-prevention benefit or an individual medication decision.
ASPREE found no gain in disability-free survival—and more major bleeding · ASPREE did not lower cardiovascular events—and increased major bleeding
Verified 2026-08-03 · correction state: not-applicable
Registry records
1 connected clinical trial
Status and results availability are kept separate from evidence conclusions.
Unknown · No registry results posted
low-dose aspirin — NCT01038583
- Population
- 19,114 community-dwelling older adults without cardiovascular disease at enrollment
- Intervention / comparator
- 100 mg aspirin daily versus matching placebo
- Primary outcome
- disability-free survival (death, dementia or persistent physical disability)
- Sponsor / funding context
- ASPREE was supported by US and Australian public/institutional funders; Bayer supplied aspirin and matching placebo in kind and was reported to have no other trial role. The 2026 follow-up discloses author grants and several outside pharmaceutical relationships.
Registry status is operational information, not evidence of benefit.
Status checked 2026-10-13 · registry link checked 2026-10-13
Coverage timeline
When this reporting was released
- ASPREE found no gain in disability-free survival—and more major bleedingHuman function and safety · large randomized trial
- ASPREE did not lower cardiovascular events—and increased major bleedingHuman cardiovascular and safety outcomes · large randomized trial
- ASPREE’s cancer signal changed across longer follow-upHuman mortality and cancer outcomes · randomized trial plus observational extension
- ASPREE’s broader healthspan composite stayed near the nullHuman clinical events · secondary composite analysis of a large randomized trial