STAREE: atorvastatin after 70 cut events by 30% but not disability

Design

Phase 3, randomised, double-blind, placebo-controlled

Population

9,971 adults aged 70 or older without cardiovascular disease, diabetes or dementia

Primary outcome

Major cardiovascular events; disability-free survival

Effect

MACE HR 0.70 (0.61–0.82); disability-free survival HR 0.94 (0.84–1.05)

STAREE, published on 29 August, was a double-blind placebo-controlled trial in Australian general practices. It randomised 9,971 community-dwelling adults aged 70 or older, mean age 75, with no cardiovascular disease, diabetes or dementia, to atorvastatin 40 mg daily or placebo.

After a median of 5.9 years, major cardiovascular events (cardiovascular death, myocardial infarction, stroke or revascularisation) occurred at 10.9 against 15.5 per 1,000 person-years (HR 0.70, 95% CI 0.61–0.82). The second primary end point, death, dementia or persistent physical disability, did not differ (HR 0.94, 0.84–1.05). Serious adverse events were 2.7% in each arm, but musculoskeletal, hepatobiliary and diabetes-related events were more common on atorvastatin.

This fills the largest gap in statin evidence. For a fit older adult who wants fewer heart attacks and strokes, the case for a statin is now trial-based. It does not support telling patients a statin will keep them independent or free of dementia.

• Offer atorvastatin to fit adults over 70 without cardiovascular disease who want fewer cardiovascular events.
• Explain that the trial showed no gain in survival free of dementia or disability.
• Expect about 4.6 fewer major cardiovascular events per 1,000 people treated each year.
• Monitor for muscle symptoms, liver tests where indicated and new diabetes.
• Make the decision jointly, especially with frailty or limited life expectancy.

Why it matters

Statin decisions after 70 have rested on extrapolation from younger trials until now.

Don't overread it

The trial excluded people with diabetes and dementia, so it does not speak to them.

The statistics, in plain English

HR 0.70 means a 30% lower rate of major events, and the interval excludes no effect. For disability-free survival the interval 0.84–1.05 crosses 1.0, so the trial cannot show any benefit there.

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