- Design
- Phase 3, randomised, double-blind, placebo-controlled trial
- Population
- 9,971 community-dwelling adults aged ≥70 without CVD, diabetes or dementia
- Primary outcome
- Major cardiovascular events; death, dementia or persistent disability
- Effect
- CV events HR 0.70 (95% CI 0.61 to 0.82); disability-free survival HR 0.94 (0.84 to 1.05)
STAREE was a double-blind trial in Australian general practices. It randomised 9,971 community-dwelling adults aged 70 or over (mean 74.7) with no cardiovascular disease, diabetes or dementia to atorvastatin 40 mg or placebo, with two primary endpoints tested in order.
After a median 5.9 years, cardiovascular death, non-fatal MI or stroke, or revascularisation occurred at 10.9 against 15.5 events per 1,000 person-years (HR 0.70). The second endpoint, death, dementia or persistent physical disability, did not differ (21.6 against 23.0 per 1,000 person-years; HR 0.94, 0.84 to 1.05). Serious adverse events were equal, but musculoskeletal, liver and diabetes-related events were more common with atorvastatin.
This is the first large placebo-controlled answer for primary prevention in older adults, a group earlier trials barely enrolled. It supports offering a statin to fit older people for cardiovascular protection. It does not support promising that a statin will keep them independent for longer, and that distinction belongs in the conversation.
- Offer a statin to fit over-70s for primary prevention when cardiovascular risk is the goal
- Frame the benefit honestly: fewer heart attacks and strokes, not longer independent life
- Ask about muscle symptoms and check glucose after starting
- Weigh frailty, life expectancy and pill burden before prescribing
Why it matters
It settles whether statins work at this age, and separates that from the outcome older patients often care most about.
Don't overread it
A neutral disability-free survival result does not show harm, and it does not cancel the cardiovascular benefit.
The statistics, in plain English
The cardiovascular hazard ratio of 0.70 is a 30% relative reduction. In absolute terms, 4.6 fewer events per 1,000 people per year, about 27 events avoided per 1,000 treated over the trial. The disability-free survival interval (0.84 to 1.05) allows a 16% benefit or a 5% harm, so the trial cannot exclude a small effect either way. Because the endpoints were tested in order, the first result is robust and the second is simply not shown.
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