STAREE was a double-blind, placebo-controlled trial in Australian general practices. It enrolled 9,971 community-dwelling adults aged at least 70 — mean age 74.7, 51.9% women — with no history of cardiovascular disease, diabetes or dementia, and randomised them to atorvastatin 40 mg daily or placebo. Two co-primary endpoints were tested in a hierarchical plan: major cardiovascular events, and a composite of death, dementia or persistent physical disability.
The cardiovascular result is clear. Over a median 5.9 years, a primary cardiovascular event occurred in 297 participants on atorvastatin (10.9 per 1000 person-years) versus 412 on placebo (15.5 per 1000 person-years), hazard ratio 0.70 (95% CI 0.61 to 0.82, p<0.001). That is a 30% relative reduction, and it settles a genuine uncertainty: statin trials have systematically under-recruited the over-70s, and clinicians have been extrapolating.
The second endpoint did not move. Death from any cause, dementia or persistent physical disability occurred at 21.6 versus 23.0 per 1000 person-years, hazard ratio 0.94 (95% CI 0.84 to 1.05, p=0.25). Serious adverse events were identical at 2.7% in both arms, though musculoskeletal, hepatobiliary and diabetes-related adverse events were more common on atorvastatin.
This is the honest version of a conversation clinicians have been having on intuition. For a 74-year-old with no vascular disease, a statin lowers the chance of a heart attack or stroke over about six years. It does not measurably lengthen the time they stay independent, and it carries a real if modest chance of muscle symptoms and new diabetes. Both facts belong in the consultation. A patient whose priority is avoiding a stroke will weigh this differently from one whose priority is avoiding tablets.
- Offer a statin for primary prevention in a fit patient over 70 on the strength of a 30% relative reduction in cardiovascular events
- Do not promise longer independent life or dementia protection — the disability-free survival endpoint was flat
- Warn about muscle symptoms, liver enzyme changes and new-onset diabetes, all of which were more common on atorvastatin
- Note the exclusions: no diabetes, no dementia, no established cardiovascular disease at entry, so this does not apply to secondary prevention or to frail patients
- Revisit the decision if the patient's priorities or frailty change — a six-year benefit horizon is long for someone in their late 80s
The statistics, in plain English
A hazard ratio of 0.70 with a confidence interval of 0.61 to 0.82 is a firm result: the whole interval sits below 1.0, so the direction is not in doubt. In absolute terms the difference is 4.6 events per 1000 person-years, meaning roughly 217 people treated for a year to prevent one event — reasonable for a cheap drug, unremarkable for an expensive one. The second endpoint's interval, 0.84 to 1.05, straddles 1.0 and is narrow, so this is a genuine null rather than an underpowered one: the trial can rule out anything better than a 16% reduction in death, dementia or disability. Note that the hierarchical testing plan means the two results are not equally weighted evidence.
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