The STAREE randomised trial found that daily atorvastatin 40 mg produced a 30% relative reduction in major cardiovascular events among older adults without known cardiovascular disease, diabetes or dementia, the European Society of Cardiology reported.
Large, randomised evidence for primary prevention in older adults
STAREE enrolled 9,971 participants from Australian general practice settings in a double‑blind, 1:1 randomised comparison of atorvastatin 40 mg daily versus placebo. The population had a mean age of 74.7 years and was 52% female. After a median follow‑up of 5.9 years, major cardiovascular events occurred in 6.0% of those assigned atorvastatin compared with 8.3% of those given placebo.
Major cardiovascular events were defined to include cardiovascular death, non‑fatal myocardial infarction, stroke or coronary revascularisation. The difference between groups equated to a statistically significant 30% relative risk reduction for the atorvastatin arm.
Benefit on cardiovascular events but not on disability‑free survival
Despite the reduction in cardiovascular events, STAREE did not demonstrate an improvement in the trial’s co‑primary outcome of disability‑free survival. The combined outcome of death, dementia or persistent physical disability occurred in 12.8% of participants receiving atorvastatin and 13.6% receiving placebo — a difference that was not statistically significant.
- Population: adults aged 70 years and older without clinical cardiovascular disease, diabetes or dementia
- Intervention: atorvastatin 40 mg daily versus placebo
- Follow‑up: median 5.9 years
- Main result: 6.0% (atorvastatin) vs 8.3% (placebo) for major cardiovascular events — 30% relative risk reduction
- No benefit on: disability‑free survival (death, dementia, persistent physical disability)
| Outcome | Atorvastatin (40 mg) | Placebo |
|---|---|---|
| Major cardiovascular events | 6.0% | 8.3% |
| Death, dementia or persistent physical disability | 12.8% | 13.6% |
Interpretation and limits
STAREE addresses a long‑standing evidence gap: older adults have been underrepresented in earlier primary prevention statin trials. Its size, randomised double‑blind design and nearly six years’ median follow‑up strengthen the likelihood that the observed reduction in cardiovascular events is causally related to atorvastatin therapy in this selected population.
However, important caveats remain. The trial recruited participants without prior cardiovascular disease, diabetes or dementia, so results do not apply to those with those conditions. Participants were drawn from Australian general practice, and baseline risk profiles and healthcare context may differ from other countries. The summary available does not present detailed subgroup analyses, absolute risk reductions or numbers needed to treat across different ages and risk strata in full, nor does it include a full breakdown of adverse events in the material provided here.
The report notes that muscle‑related and liver‑related adverse effects were evaluated, but the brief summary does not give the detailed safety figures. Clinicians and guideline committees will need the complete safety dataset, plus prespecified subgroup and absolute effect estimates, to weigh benefits against harms for individual patients.
For policy and practice, the trial adds substantial weight to considering statin therapy for primary prevention in well‑selected older adults, but it does not prove a net benefit for outcomes that matter most to older people, such as maintaining independence and avoiding dementia. Shared decision‑making that takes account of patient values, baseline cardiovascular risk and potential side‑effects will remain essential.
Further peer‑reviewed publication of the full STAREE dataset, including prespecified subgroup analyses and comprehensive safety data, will be needed before national guideline bodies can confidently update recommendations for routine primary prevention statin use in this age group.
