Atorvastatin reduces major cardiovascular events but misses disability-free survival goal

Atorvastatin reduced major cardiovascular events by 30% in older people without known cardiovascular disease, diabetes or dementia, but did not significantly improve disability-free survival, according to results presented in a Hot Line session today at ESC Congress 2026 and published simultaneously in the New England Journal of Medicine.

Statins are commonly prescribed to manage high cholesterol in people up to 75 years of age due to their proven benefits in reducing the risk of heart attack and stroke. However, until now, the risk−benefit of statins to prevent cardiovascular events in older adults without known cardiovascular disease, diabetes or dementia was uncertain due to underrepresentation in major statin trials.

An estimated 21,000 older Australians suffer from major cardiovascular events, like heart attack and stroke, each year. The STAREE trial is the first large randomized controlled trial to examine whether statins can be used for primary prevention in older patients to help them live longer in good health."

Professor Sophia Zoungas, Lead Researcher, Monash University School of Public Health and Preventive Medicine, Melbourne, Australia

STAREE was a double-blind trial conducted among people aged 70 years and over with no history of clinical cardiovascular disease, diabetes or dementia recruited from Australian general practice. In total, 9,971 participants were randomised (1:1) to oral atorvastatin 40 mg daily or placebo. The study population had a mean age of 74.7 years and 52% were women. The two primary endpoints were major cardiovascular events, defined as cardiovascular death, nonfatal myocardial infarction, stroke or coronary revascularisation, and disability-free survival, defined as survival free of dementia and physical disability.

Over a median follow-up of 5.9 years, the researchers demonstrated that the risk of major cardiovascular events was reduced by 30% in the atorvastatin group compared with the placebo group (6.0% vs. 8.3%; hazard ratio [HR] 0.70; 95% confidence interval [CI] 0.61 to 0.82; p<0.001).

However, the risk of death, dementia or persistent physical disability did not substantively differ between the two groups (12.8% vs. 13.6%; HR 0.94; 95% CI 0.84 to 1.05; p=0.25). Muscle, liver and diabetes-related adverse events were more frequent in the atorvastatin group; however, all serious adverse events were uncommon, occurring in 2.7% of participants in both the atorvastatin and placebo groups.

"With the world's population aging at an unprecedented rate, answering fundamental questions about healthy longevity has become a universal imperative," explained Professor Zoungas. "The risk of heart attack and stroke is a concern for older people and knowing there is an effective measure for lowering that risk will be a huge reassurance to older people and their families. We hope to see updated guidelines to help clinicians make use of these new findings," she concluded.