STAREE Trial Finds Atorvastatin Cuts Major Cardiovascular Events 30% in Adults 70+

An Australian trial of nearly 10,000 adults aged 70 and older found that daily atorvastatin reduced major cardiovascular events by 30% relative to placebo over almost six years, providing randomized evidence for statin use in an age group that has been underrepresented in earlier prevention studies. The benefit did not extend to the trial’s other co-primary outcome, disability-free survival.

STAREE, short for STAtins in Reducing Events in the Elderly, randomized 9,971 community-dwelling adults without known cardiovascular disease, diabetes or dementia to atorvastatin 40 mg daily or placebo. Participants had a mean age of 74.7 years, and 52% were women. The results were presented on Aug. 29 at ESC Congress 2026 in Munich and published simultaneously in the New England Journal of Medicine.

Over a median 5.9 years of follow-up, major cardiovascular events occurred in 6.0% of participants assigned atorvastatin and 8.3% assigned placebo. The hazard ratio was 0.70, with a 95% confidence interval of 0.61 to 0.82 and a p value below 0.001, according to the European Society of Cardiology’s official report. The cardiovascular endpoint included cardiovascular death, nonfatal myocardial infarction, stroke or coronary revascularization.

Cardiovascular benefit did not extend to disability-free survival

STAREE was designed around two co-primary outcomes rather than cardiovascular events alone. Its second primary measure was disability-free survival, defined as remaining alive without dementia or persistent physical disability. On that measure, the difference between the atorvastatin and placebo groups was not statistically significant.

The composite of death, dementia or persistent physical disability occurred in 12.8% of participants assigned atorvastatin and 13.6% of those assigned placebo. The hazard ratio was 0.94, with a 95% confidence interval of 0.84 to 1.05 and a p value of 0.25. The trial therefore produced a split result: fewer major cardiovascular events with atorvastatin, but no demonstrated improvement in the broader outcome intended to capture longer life without dementia or persistent disability.

The split result is central to interpreting the study. Preventing a first heart attack, stroke or revascularization procedure is a clinically important outcome, but STAREE was also built to test whether treatment would translate into a wider healthy-aging benefit. The cardiovascular result was clear within the trial’s population, while the disability-free survival hypothesis was not confirmed.

Safety findings also require a balanced reading. Muscle, liver and diabetes-related adverse events were more frequent in the atorvastatin group, according to the ESC report, although serious adverse events overall were uncommon and occurred in 2.7% of participants in each group. The release did not provide category-specific rates for each of those more frequent adverse-event types, so the overall result does not support treating the safety profile as identical in every respect.

STAREE targeted a long-standing evidence gap in people over 70

Older adults, particularly those over 75, have historically made up a relatively small share of major statin primary-prevention trials. Existing evidence has been much stronger for people with established cardiovascular disease and for younger adults at elevated risk than for independently living older adults who have not yet had a cardiovascular event.

Monash University’s STAREE program describes the study as a double-blind, randomized, placebo-controlled trial created to test atorvastatin in adults aged 70 and older living independently in the community. The trial specifically excluded people with a history of clinical cardiovascular disease, diabetes or dementia, which made it a primary-prevention study rather than a test of statins in patients who already had established cardiovascular disease.

Baseline work published before the main results showed that 40% of the 9,971 participants were at least 75 years old and that 52% were women. Mean low-density lipoprotein cholesterol was about 126 mg/dL, while 43% of participants reported hypertension. Recruitment ran from July 2015 through March 2023 and involved general practices across Australia, giving the trial a population drawn from routine community care rather than a single specialist center.

Funding also separates STAREE from many large drug trials. Monash University’s STAREE site says the project was supported by public health research grants and did not accept pharmaceutical-company funding. The European Society of Cardiology identified the National Health and Medical Research Council and the Heart Foundation of Australia as funders, while Monash University is listed as the trial sponsor in the federal ClinicalTrials.gov registry.

Because eligibility was deliberately narrow, the result has a defined scope. STAREE offers direct randomized evidence about atorvastatin for primary prevention in independently living adults aged 70 and above who entered the study without the major conditions excluded by the protocol. It does not directly answer the same question for people with established cardiovascular disease, diabetes, dementia, substantial disability or serious illnesses that would have made them ineligible for enrollment.

The 30% reduction is relative, not a 30-point drop in event rates

The headline 30% figure is a relative reduction. The observed event proportions were 8.3% with placebo and 6.0% with atorvastatin, an absolute difference of 2.3 percentage points over the trial’s median 5.9 years of follow-up. Put another way, the trial did not find that 30 percentage points of participants avoided an event; it found that the hazard of the composite cardiovascular endpoint was about 30% lower in the atorvastatin group than in the placebo group.

Clinical decisions still depend on an individual’s baseline cardiovascular risk, life expectancy, other medications, treatment tolerance and personal preferences. STAREE supplies evidence that had been missing from this age group, but it does not turn age 70 alone into a universal instruction to start atorvastatin.

Guideline writers now have direct randomized primary-prevention data in a population that had been difficult to study. Lead investigator Sophia Zoungas said the research team hopes the findings will be reflected in updated treatment guidance. Any guideline change would still need to weigh the reduction in major cardiovascular events against the absence of a significant disability-free survival benefit and the higher frequency of some muscle, liver and diabetes-related adverse events.

The Aug. 29 publication and ESC presentation establish the main cardiovascular and disability-free survival findings. Registered STAREE ancillary studies are also examining brain health and cardiac aging, leaving additional questions about the broader effects of statin therapy in older adults to be addressed separately from the cardiovascular result reported here.