Atorvastatin reduced major cardiovascular events by 30% relative to placebo in adults aged 70 years and older without known cardiovascular disease, diabetes, or dementia, but did not significantly improve disability-free survival, according to results from the STAREE trial presented in a Hot Line session at the European Society of Cardiology (ESC) Congress 2026 in Munich, Germany.¹
The findings were published simultaneously in the New England Journal of Medicine. STAREE is the first large randomized controlled trial to test statin therapy for primary prevention specifically in older adults.¹
Statin trials underlying current primary prevention guidance largely enrolled adults up to age 75, leaving the risk-benefit balance of initiating a statin in older, healthier adults uncertain.² Existing guidelines, including the ACC/AHA and USPSTF recommendations, remain equivocal on statin initiation for primary prevention beyond age 75 due to this evidence gap.²
“The STAREE trial is the first large randomised controlled trial to examine whether statins can be used for primary prevention in older patients to help them live longer in good health,” Sophia Zoungas, PhD, Monash University School of Public Health and Preventive Medicine, said in a statement.
Atorvastatin Efficacy and STAREE Trial Design in Older Adults
STAREE was a double-blind, placebo-controlled trial conducted among adults aged 70 years and older with no history of clinical cardiovascular disease, diabetes, or dementia, recruited from Australian general practice.¹ Investigators randomly assigned 9971 participants (1:1) to oral atorvastatin 40 mg daily or placebo.¹ The study population had a mean age of 74.7 years and 52% were female, an enrollment profile the investigators note has historically been underrepresented in pivotal statin trials.¹
The trial specified 2 primary endpoints: major cardiovascular events, defined as cardiovascular death, nonfatal myocardial infarction, stroke, or coronary revascularization, and disability-free survival, defined as survival free of dementia and physical disability.¹ Over a median follow-up of 5.9 years, the risk of major cardiovascular events was reduced by 30% with atorvastatin compared with placebo (6.0% vs 8.3%; hazard ratio [HR], 0.70; 95% CI, 0.61-0.82; P <.001).¹
Atorvastatin Safety and Disability-Free Survival in STAREE
The risk of death, dementia, or persistent physical disability, the composite disability-free survival endpoint, did not differ substantively between groups (12.8% with atorvastatin vs 13.6% with placebo; HR, 0.94; 95% CI, 0.84-1.05; P = .25).¹ Muscle, liver, and diabetes-related adverse events were more frequent in the atorvastatin group than with placebo.¹ According to the investigators, serious adverse events overall were uncommon and occurred at a similar rate in both groups, 2.7% with atorvastatin and 2.7% with placebo.¹
STAREE arrives alongside PREVENTABLE, an ongoing NIA/NHLBI-funded pragmatic trial enrolling up to 20,000 US adults aged 75 and older, designed to evaluate statin effects on dementia, disability, and cardiovascular outcomes in a similarly underrepresented population.³
Zoungas framed the findings as evidence to guide an aging population: "With the world's population ageing at an unprecedented rate, answering fundamental questions about healthy longevity has become a universal imperative. 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.”
References
European Society of Cardiology. Cholesterol-lowering medication reduces major cardiovascular events by 30 per cent in older people without known cardiovascular disease. Published August 29, 2026. Accessed August 29, 2026.
Nanna MG, Abdullah A, Mortensen MB, Navar AM. Primary prevention statin therapy in older adults. Curr Opin Cardiol. 2023;38(1):11-20. doi:10.1097/HCO.0000000000001003
Joseph J, Pajewski NM, Dolor RJ, et al. Pragmatic evaluation of events and benefits of lipid lowering in older adults (PREVENTABLE): Trial design and rationale. J Am Geriatr Soc. 2023;71(6):1701-1713. doi:10.1111/jgs.18312
