STAREE: atorvastatin cut vascular events in healthy over-70s but did not extend disability-free survival

Design

Double-blind, randomised, placebo-controlled trial in Australian general practices

Population

9,971 adults aged 70 or over without cardiovascular disease, diabetes or dementia; median follow-up 5.9 years

Primary outcome

Major cardiovascular events; and death, dementia or persistent physical disability

Effect

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, randomised, placebo-controlled trial in general practices across Australia. It enrolled 9,971 community-dwelling adults aged 70 or over, mean age 74.7 and 51.9% women, with no history of cardiovascular disease, diabetes or dementia. They received atorvastatin 40 mg daily or placebo.

After a median of 5.9 years, the first primary end point (cardiovascular death, non-fatal myocardial infarction or stroke, or coronary revascularisation) occurred in 297 participants on atorvastatin (10.9 per 1000 person-years) and 412 on placebo (15.5), a hazard ratio of 0.70 (95% CI 0.61 to 0.82). The second primary end point, death, dementia or persistent physical disability, occurred in 637 (21.6 per 1000 person-years) and 676 (23.0), a hazard ratio of 0.94 (0.84 to 1.05).

Serious adverse events were equal at 2.7% in each arm, with musculoskeletal, hepatobiliary and diabetes-related events more common on atorvastatin.

This is a choice about what is valued. The vascular benefit is real in this population, and the independence benefit was not shown. Current guidelines have not changed on the strength of this single trial.

• For healthy adults aged 70 or over without vascular disease, discuss statin therapy as a choice rather than a default.
• Explain benefit in absolute terms: about 4.6 fewer cardiovascular events per 1000 person-years over about 6 years.
• Tell patients that disability-free survival was not improved.
• Monitor for muscle symptoms, liver abnormalities and glycaemia if a statin is started.

Why it matters

It answers a long-standing gap in statin evidence for older adults and separates preventing events from preserving independence.

Don't overread it

Participants were healthy and community-dwelling; the result does not apply to older adults with diabetes, frailty or existing vascular disease.

The statistics, in plain English

A hazard ratio of 0.70 with an interval of 0.61 to 0.82 is a precise estimate of lower vascular risk. The second end point's interval of 0.84 to 1.05 includes 1.0, so the trial found no detectable effect on disability-free survival; it cannot rule out a small one either way.

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