A statin cut heart attacks in healthy over-70s. Independent years did not follow.

Whether to start a statin in a healthy 75-year-old has been one of the more honest admissions of uncertainty in preventive medicine. Landmark statin trials largely did not enrol people that old without existing disease, and the risk–benefit balance in healthy older people has remained uncertain [s2]. STAREE was designed to answer it, and the answer published in the New England Journal of Medicine is split cleanly down the middle [s1].

The trial

STAREE was a double-blind, randomised, placebo-controlled trial conducted at general medical practices across Australia [s1]. It enrolled community-dwelling adults aged at least 70 with no history of cardiovascular disease, diabetes or dementia, randomly assigned 1:1 to atorvastatin 40 mg once daily or identical placebo [s1].

There were two primary endpoints, and the trial used a hierarchical testing plan [s1]. The first was a composite of death from cardiovascular causes, non-fatal myocardial infarction or stroke, or coronary revascularisation. The second was a composite of death from any cause, dementia, or persistent physical disability — the disability-free survival endpoint [s1].

That second endpoint is the reason the trial was built. Recruitment ran from July 2015 to March 2023 across 1,583 general practices, and the design paper describes STAREE as the largest primary prevention statin trial powered to address major cardiovascular events, disability-free survival and cognition in older people [s2].

What it found

A total of 9,971 participants were enrolled — 4,984 to atorvastatin, 4,987 to placebo — with a mean age of 74.7 years (SD 4.5) and 51.9% women [s1].

After a median of 5.9 years, a primary cardiovascular event had occurred in 297 participants in the atorvastatin group (10.9 events per 1,000 person-years) and 412 in the placebo group (15.5 per 1,000 person-years): hazard ratio 0.70 (95% CI, 0.61–0.82; P < 0.001) [s1].

Death from any cause, dementia or persistent physical disability occurred in 637 participants on atorvastatin (21.6 per 1,000 person-years) and 676 on placebo (23.0 per 1,000 person-years): hazard ratio 0.94 (95% CI, 0.84–1.05; P = 0.25) [s1].

Serious adverse events were equally common — 131 participants (2.7%) on atorvastatin and 129 (2.7%) on placebo — with musculoskeletal, hepatobiliary and diabetes-related adverse events occurring more commonly in the atorvastatin group [s1].

Two true things at once

A 30% relative reduction in major cardiovascular events in a primary-prevention population this old is a substantial result, and the absolute difference — 4.6 fewer events per 1,000 person-years [s1] — is not trivial over six years.

The disability-free survival null is equally substantial, and it is the finding that speaks to what many people in their seventies actually want to know. The composite bundles death, dementia and persistent physical disability, and the trial found no significant effect on it [s1]. Fewer heart attacks did not translate into more years of independent life over the follow-up period.

There are structural reasons that can happen without either result being wrong. Cardiovascular events are a minority of the pathways into disability and dementia at this age; a trial can prevent them and still leave the composite unmoved because falls, cancer, frailty and neurological disease dominate the remainder. A median of 5.9 years may also be short relative to how long dementia takes to accrue.

The safety profile deserves the same plainness. Serious adverse events were identical in rate, but musculoskeletal, hepatobiliary and diabetes-related events were more common on atorvastatin [s1]. The diabetes signal is notable given the trial excluded people with diabetes at baseline [s1], and in a group starting a drug specifically to preserve function, muscle symptoms are not a cosmetic complaint.

Where this leaves the question

STAREE gives clinicians and older adults something the field did not previously have: a randomised estimate of both benefits, in the same population, over the same period. What it does not do is resolve the trade-off, because the trade-off is a values question. A person who wants fewer heart attacks has an answer. A person who wants to stay independent longer has an answer too, and it is not the same one.

The trial was funded by the National Health and Medical Research Council and others, and is registered as NCT02099123 [s1]. Its baseline paper reported a mean LDL cholesterol of 3.27 mmol/L (SD 0.72; 126 mg/dL), hypertension in 43% of participants and mean blood pressure of 136/80 mm Hg [s2] — a cohort that was, by design, healthier than those in the statin trials that came before.

Sources

• [s1] "Atorvastatin, Cardiovascular Events, and Disability-free Survival in Older Adults," New England Journal of Medicine, 29 August 2026. https://doi.org/10.1056/NEJMoa2607314
• [s2] "Baseline Characteristics of Participants in STAREE: A Randomized Trial for Primary Prevention of Cardiovascular Disease Events and Prolongation of Disability-Free Survival in Older People," Journal of the American Heart Association, 15 November 2024. https://doi.org/10.1161/JAHA.124.036357