Atorvastatin reduced cardiovascular events but not disability in STAREE trial

What happened

A large randomized trial has found that atorvastatin reduced major cardiovascular events among community-dwelling adults aged 70 or older who began the study without cardiovascular disease, diabetes or dementia. The treatment did not, however, significantly improve disability-free survival—the trial’s broader measure of healthy longevity.

Results from STAREE, or Statins in Reducing Events in the Elderly, were presented August 29 at the European Society of Cardiology Congress and published simultaneously in the *New England Journal of Medicine*. The distinction between its two principal findings matters: preventing heart attacks, strokes and coronary procedures did not translate into a measurable reduction in the combined risk of death, dementia or persistent physical disability during the trial.

How the trial was designed

STAREE enrolled 9,971 adults living independently in Australia. Participants were randomly assigned under double-blind conditions to receive atorvastatin at a target dose of 40 milligrams daily or matching placebo. Median follow-up was approximately 5.9 years.

The population was deliberately selected to address primary prevention in later life. Participants had no established cardiovascular disease, diabetes or dementia at enrollment. Important exclusions included serious illness likely to cause death within five years, moderate or severe kidney or liver disease, very high cholesterol and existing lipid-lowering treatment that could not be stopped.

One primary endpoint was a composite of cardiovascular death, nonfatal myocardial infarction, stroke or coronary revascularization. The other measured disability-free survival, defined as survival without dementia or persistent physical disability.

Cardiovascular events fell by 30% relatively

A major cardiovascular event occurred in 297 participants assigned to atorvastatin and 412 assigned to placebo. The hazard ratio was 0.70, with a 95% confidence interval from 0.61 to 0.82, representing a 30% relative reduction during follow-up.

The investigators reported that the difference was driven primarily by fewer nonfatal events, particularly myocardial infarctions and coronary revascularizations. Cardiovascular deaths were uncommon. The result provides direct randomized evidence that statin therapy can prevent cardiovascular events in selected adults over 70, a population underrepresented in many earlier primary-prevention trials.

Relative risk does not convey the entire clinical effect. Based on the reported event counts and nearly equal treatment groups, roughly 6% of atorvastatin participants and 8% of placebo participants experienced the cardiovascular composite. Individual benefit would still depend on baseline cardiovascular risk, competing health risks and treatment tolerability.

No significant gain in disability-free survival

The disability-free survival endpoint occurred in 637 atorvastatin participants and 676 placebo participants, corresponding to 12.8% and 13.6%, respectively. The hazard ratio was 0.94, with a 95% confidence interval from 0.84 to 1.05 and a p-value of 0.25. The result was not statistically significant.

This means the trial did not establish that atorvastatin prolonged life without dementia or persistent physical disability. It also does not prove that statins have no effect on any component of that endpoint; the composite result indicates that STAREE did not detect an overall benefit of the specified magnitude during its follow-up period.

One possible explanation is competing risk. The investigators noted that about 80% of deaths were from noncardiovascular causes. Preventing predominantly nonfatal cardiovascular events may therefore have been insufficient to shift a broader endpoint influenced by dementia, disability and numerous other causes of death.

Safety and practical meaning

Overall serious adverse events were reported at similar rates in the two groups. Muscle-related, liver-related and diabetes-related adverse events were more frequent with atorvastatin, according to the congress report. Detailed definitions and absolute frequencies are important when weighing those signals.

STAREE is strong human evidence because it was large, randomized, placebo-controlled and followed participants for nearly six years using clinically meaningful endpoints. Its applicability is narrower than its size might suggest: participants were relatively healthy, lived independently and were recruited in Australia. Results may not extend unchanged to frail adults, nursing-home residents, people with diabetes or established cardiovascular disease, or those with substantial kidney, liver or competing illness.

The central conclusion is therefore two-part. Atorvastatin prevented major cardiovascular events in this selected older population, but it did not demonstrate an extension of disability-free survival. The findings strengthen the evidence base for cardiovascular prevention after age 70 without establishing a general longevity effect.