- Design
- Phase 3, randomised, double-blind, placebo-controlled (STAREE)
- Population
- 9,971 community-dwelling adults aged ≥70 without CVD, diabetes or dementia, Australia
- Primary outcome
- Major cardiovascular events; and death, dementia or persistent disability (co-primary)
- Effect
- MACE HR 0.70 (95% CI 0.61–0.82); disability-free survival HR 0.94 (0.84–1.05)
STAREE was a double-blind, placebo-controlled trial run through Australian general practices. It enrolled 9,971 community-dwelling adults aged 70 or over (mean 74.7, 52% women) with no cardiovascular disease, diabetes or dementia, and randomised them to atorvastatin 40 mg or placebo. It had two primary endpoints tested hierarchically.
Over a median 5.9 years, major cardiovascular events (cardiovascular death, MI, stroke or coronary revascularisation) occurred at 10.9 versus 15.5 per 1,000 person-years (HR 0.70, 95% CI 0.61–0.82). The second primary endpoint — death, dementia or persistent physical disability — was 21.6 versus 23.0 per 1,000 person-years (HR 0.94, 0.84–1.05), not significantly different. Serious adverse events were 2.7% in both groups; musculoskeletal, hepatobiliary and diabetes-related events were more common with atorvastatin.
This settles the question that observational data could not: statins do prevent cardiovascular events in healthy people over 70, with a relative effect similar to younger adults. What they did not do, over six years, was keep people alive and independent for longer. That makes the decision in older patients a matter of what the patient values — fewer heart attacks and strokes, versus a daily tablet that will not obviously extend healthy life.
It is a reason to offer, and to discuss honestly, rather than to prescribe by default.
- Offer atorvastatin for primary prevention to adults over 70; about 4.6 fewer cardiovascular events per 1,000 people per year of treatment.
- Tell patients plainly that it reduced heart attacks and strokes but did not extend life free of dementia or disability.
- Watch for new-onset diabetes, muscle symptoms and liver enzyme rises, which were more common on atorvastatin.
- Do not deprescribe a well-tolerated statin in a fit older adult on the argument that the evidence is missing — it now exists.
- Results apply to people without diabetes, dementia or established cardiovascular disease.
Why it matters
It replaces the 'no evidence after 70' argument with trial data, and shifts the conversation from whether statins work to what the patient wants from them.
Don't overread it
The null disability-free survival result means no benefit was shown over six years, not that statins make older people frailer.
The statistics, in plain English
An HR of 0.70 is a 30% relative reduction. In absolute terms, 15.5 minus 10.9 is about 4.6 events per 1,000 people per year, so roughly 220 people treated for a year prevents one event, or about 37 over six years. The disability-free survival interval (0.84–1.05) includes no effect and cannot rule out a small benefit.
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