- Design
- Randomised, double-blind, placebo-controlled (STAREE)
- Population
- 9,971 adults aged 70 or over without cardiovascular disease, diabetes or dementia, Australia
- Primary outcome
- Major cardiovascular events; death, dementia or persistent disability
- Effect
- Cardiovascular events HR 0.70 (95% CI 0.61 to 0.82); disability-free survival HR 0.94 (0.84 to 1.05)
STAREE, published in August in the New England Journal of Medicine, randomised 9,971 community-dwelling Australians aged 70 or over (mean 74.7) without cardiovascular disease, diabetes or dementia to atorvastatin 40 mg daily or placebo, through general practices.
After a median 5.9 years, major cardiovascular events occurred at 10.9 per 1,000 person-years on atorvastatin and 15.5 on placebo (HR 0.70, 95% CI 0.61 to 0.82). The co-primary endpoint, death, dementia or persistent physical disability, did not differ (HR 0.94, 0.84 to 1.05). Serious adverse events were similar (2.7% in each group), though musculoskeletal, hepatobiliary and diabetes-related events were more frequent with atorvastatin.
This is the placebo-controlled trial that older-adult primary prevention lacked. It shows statins prevent heart attacks and strokes after 70, about 4.6 fewer events per 1,000 people treated per year. It does not show they keep people alive and independent for longer. The conversation with an older patient can now be specific: fewer cardiovascular events, no clear gain in disability-free life, and a small rise in muscle and glucose side effects.
- Offer a statin for primary prevention to adults over 70 who value avoiding heart attack and stroke.
- Explain that the trial showed fewer cardiovascular events but no longer disability-free survival.
- Check HbA1c periodically after starting, given the excess of diabetes-related events.
- Ask about muscle symptoms at follow-up, and review liver tests if symptoms suggest it.
Why it matters
It turns statin discussions after 70 from extrapolation into a direct trade-off patients can weigh.
Don't overread it
People with diabetes or dementia were excluded, so the results do not extend to them.
The statistics, in plain English
A hazard ratio of 0.70 means about a 30% relative reduction; in absolute terms, about 4.6 fewer cardiovascular events per 1,000 people per year. The disability-free survival interval (0.84 to 1.05) crosses 1, so the trial cannot rule out no effect, and a large benefit is unlikely.
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