Protocol
Aspirin (low-dose, primary prevention in healthy older adults)
Tested in 19,114 healthy adults aged 70 and over (ASPREE).
Grade D, tested: in a human randomized trial, the treated group did worse on the endpoint The outcome a trial measures to decide whether the treatment worked, such as heart attacks, blood pressure or a symptom score. graded. How to read a grade →
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How this letter has changedLatest: October 2026 · Corrected.
The record cited only the ASPREE mortality report, McNeil 2018 (PMID PubMed ID: the permanent number the US National Library of Medicine gives a published paper. Each one links to that paper's record on PubMed. 30221595), and attributed the disability-free survival and bleeding results to it. Those come from the companion papers by the same group, now cited: McNeil 2018 (PMID 30221596), the primary endpoint The one outcome a trial names in advance as its main test. Results on other outcomes carry less weight. report, and McNeil 2018 (PMID 30221597), the cardiovascular and bleeding report. The mortality finding is stated as the paper states it: higher all-cause death, mostly cancer, called unexpected by the authors, and not confirmed over the decade of follow-up in Wolfe 2025 (PMID 40796244) and Shah 2025 (PMID 41043446), which found no long-term benefit, a higher event rate after stopping, and persisting bleeding. ASCEND, Bowman 2018 (PMID 30146931), and ARRIVE, Gaziano 2018 (PMID 30158069), are now cited and described as the different populations they are. Letter unchanged.PMID 30221595 PMID 30221596 PMID 30221597 PMID 40796244 PMID 41043446 PMID 30146931 PMID 30158069
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This is a daily low-dose aspirin taken by healthy adults over 70 to prevent illness. A large study of over 19,000 people found that aspirin did not help them live longer without disability. It did not meaningfully lower heart attacks or strokes. It did raise serious bleeding. This finding is about healthy older people, not people who already had a heart attack.
Tested in 19,114 healthy adults aged 70 and over (ASPREE). Did not prolong disability-free survival, did not reduce cardiovascular events, increased major hemorrhage, and all-cause death was higher on aspirin during the trial, mostly from cancer, a finding the authors called unexpected; a decade of follow-up found no lasting death excess and no long-term benefit. Secondary prevention after an event is a different question entirely.
Why this gradeGrade D, tested, harm found. The reasoning, and what the grade does not cover.
Grade D on Route 2 Human randomized trials have been run and did not show benefit on the stated outcome. One of the two routes to the lowest letter on EBL's scale.: tested, harm found. ASPREE randomized 19,114 healthy adults aged 70 and over to 100 mg aspirin daily or placebo An inactive substitute made to look like the real treatment, so participants cannot tell which one they received. for a median of 4.7 years. Disability-free survival, the primary endpoint, was not improved, cardiovascular events were not meaningfully reduced, and major hemorrhage increased. In adjacent populations, ASCEND (diabetes) found fewer vascular events but more bleeding, and ARRIVE (moderate risk) was null with doubled gastrointestinal bleeding; neither enrolled healthy older adults. During ASPREE, all-cause death was higher on aspirin, mostly from cancer, which the investigators called unexpected; a decade of follow-up found no lasting death excess, no long-term benefit, and a persisting excess of major bleeding. The finding is not that aspirin does nothing, it is that in people who have not had an event, the bleeding it causes outweighs the events it prevents.
WHAT THIS GRADE DOES NOT COVERthis letter grades starting low-dose aspirin for PRIMARY prevention in healthy older adults. It does not grade aspirin taken after a heart attack, a stent, a stroke or a transient ischemic attack. That is secondary prevention, a different question with different trials and a different answer, and stopping it abruptly raises the risk of a further event. Nothing on this page is a basis for changing a prescribed medication, and that decision sits with the prescribing physician.
A grade describes the human evidence for a named use. It is not advice, and it is not a judgment on any individual prescription. How the letters are decided →
The bleeding is the finding. ASPREE randomized healthy older adults to low-dose aspirin and found no cardiovascular benefit and more major hemorrhage. This record is a Route 2 D: tested, harm found. Secondary prevention after an established cardiovascular event is a different question and is not what this letter covers.
The evidence, in fullSeven papers, each linked to its PubMed record.
ASPREE, three companion reports: McNeil et al. (N Engl J Med, 2018; PMID 30221596), the primary endpoint, disability-free survival, not improved (21.5 versus 21.2 events per 1,000 person-years, hazard ratio How often an event happened in the treated group compared with the control group over the same period. A ratio of 0.80 means 20 percent fewer events. 1.01), with major hemorrhage higher; McNeil et al. (N Engl J Med, 2018; PMID 30221597), cardiovascular disease not reduced (hazard ratio 0.95, 95% CI 0.83 to 1.08) and major hemorrhage up 38 percent (8.6 versus 6.2 per 1,000 person-years); McNeil et al. (N Engl J Med, 2018; PMID 30221595), all-cause mortality higher on aspirin (hazard ratio 1.14, 95% CI 1.01 to 1.29), mostly cancer deaths, which the authors call unexpected and to be interpreted with caution. Extended follow-up: Wolfe et al. (Eur Heart J, 2025; PMID 40796244), no long-term benefit on major cardiovascular events over the trial and 4.3 post-trial years (hazard ratio 1.04), a higher event rate in the post-trial period after stopping (1.17), and a persisting excess of major hemorrhage (1.24); Shah et al. (Lancet Healthy Longev, 2025; PMID 41043446), no effect on disability-free survival over almost a decade and no lasting death excess. Adjacent populations, neither healthy older adults: ASCEND (Bowman et al., N Engl J Med, 2018; PMID 30146931), 15,480 adults with diabetes, serious vascular events down 12 percent, major bleeding up 29 percent; ARRIVE (Gaziano et al., Lancet, 2018; PMID 30158069), 12,546 adults at moderate risk, null on its primary endpoint with gastrointestinal bleeding doubled, funded by Bayer. ASPREE was funded by the National Institute on Aging. D Route 2: tested, harm found.
DO NOT STOP SECONDARY-PREVENTION ASPIRIN ON THE STRENGTH OF THIS PAGE. This record grades low-dose aspirin for PRIMARY prevention in healthy older adults only. If you have had a heart attack, a stent, a stroke or a TIA, you are on it for secondary prevention, a different question with different evidence, and stopping it abruptly raises the risk of a further event. That decision belongs with your physician. Current RCT Randomized controlled trial: people are assigned to the treatment or a comparison by chance, so the groups differ only in what they received. It is the design that can show cause and effect. evidence (ARRIVE, ASPREE, ASCEND) does not support low-dose aspirin for primary prevention in healthy older adults: bleeding risk exceeds benefit. If taking for secondary prevention under physician direction, track occult GI bleeding with annual FIT test. GI symptoms and any bleeding events.
Evidence notes: randomized trial
Endpoint graded: Disability-free survival in healthy adults aged 70 and over (hard)
Last reviewed: July 2026
Educational use only · Not medical advice · EBL grades published human evidence and does not recommend treatment. Stopping a prescription is a decision for your physician.
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