A major new clinical trial shows that taking daily atorvastatin reduces the risk of heart attacks and strokes by 30% in adults aged 70 and older without known cardiovascular disease. However, researchers found the medication did not significantly improve overall disability-free survival over a median follow-up of 5.9 years.
The findings, presented in a Hot Line session at the ESC Congress 2026 and published simultaneously in the New England Journal of Medicine, address a long-standing question in preventative cardiology. While statins are widely prescribed to manage high cholesterol in patients up to 75 years of age, robust clinical trial data for primary prevention in older adults have historically been scarce. Older populations have often been underrepresented in major statin trials, leaving clinicians with uncertainty regarding the balance of risks and benefits for healthy older patients.
An estimated 21,000 older Australians suffer from major cardiovascular events like heart attacks and strokes each year. To close this evidence gap, researchers conducted the STAREE trial, a large randomized controlled trial examining whether statins can help older patients live longer in good health as a primary prevention measure.
Inside the STAREE Trial: Methodology and Core Findings
The double-blind study enrolled 9,971 participants aged 70 years and over with no prior history of clinical cardiovascular disease, diabetes, or dementia. Recruited from general practices across Australia, the study population had a mean age of 74.7 years, and 52% of the participants were women. Participants were randomized in a 1:1 ratio to receive either oral atorvastatin at 40 mg daily or a matching placebo.
Researchers tracked two primary endpoints: major cardiovascular events—comprising cardiovascular death, nonfatal myocardial infarction, stroke, or coronary revascularization—and disability-free survival, defined as survival free of dementia and physical disability. Over the course of the median 5.9-year follow-up, the data revealed a clear divergence between the two endpoints.
The risk of major cardiovascular events dropped by 30% in the atorvastatin group compared with the placebo group. Specifically, 6.0% of participants on atorvastatin experienced a major cardiovascular event, compared with 8.3% in the placebo group, yielding an absolute risk reduction of 2.3 percentage points.
However, the trial did not meet its secondary primary endpoint regarding disability-free survival. The combined risk of death, dementia, or persistent physical disability showed no substantive difference between the treatment and placebo groups, registering at 12.8% and 13.6% respectively.
“With the world’s population aging at an unprecedented rate, answering fundamental questions about healthy longevity has become a universal imperative.”
Professor Sophia Zoungas, Lead Researcher, Monash University School of Public Health and Preventive Medicine
Adverse events related to muscle, liver, and new-onset diabetes occurred more frequently among participants taking atorvastatin. Even so, serious adverse events remained uncommon, affecting 2.7% of participants in both the treatment and control arms.
Broader Context of Cholesterol Management and Statins
Statins operate by decreasing the production of cholesterol in the liver, which assists the body in removing excess low-density lipoprotein (LDL) cholesterol from the bloodstream. Beyond atorvastatin, commonly prescribed statins include rosuvastatin, simvastatin, and pravastatin, alongside various combination medications. While lifestyle modifications such as diet and exercise remain foundational first steps for managing cholesterol, medications are frequently introduced when lifestyle changes alone prove insufficient.
For patients who cannot tolerate statins due to side effects like muscle pain or weakness, alternative therapies exist, though each carries its own specific considerations. Bile acid sequestrants help the body dispose of LDL cholesterol by binding to bile during digestion, though they must be avoided by individuals with gallbladder issues or high triglycerides.
Clinical Implications and Potential Guideline Updates
The results provide long-sought evidence regarding primary prevention in a demographic that continues to expand globally.
“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.”
Professor Sophia Zoungas, Lead Researcher, Monash University School of Public Health and Preventive Medicine
