STAREE trial - atorvastatin, cardiovascular events, and disability-free survival in older adults

Study design:

• double-blind, randomized, placebo-controlled trial at general medical practices across Australia
  • community-dwelling adults at least 70 years of age with no history of cardiovascular disease, diabetes, or dementia were randomly assigned in a 1:1 ratio to receive atorvastatin at a dose of 40 mg once daily or identical placebo
• two primary end points were a composite of death from cardiovascular causes, nonfatal myocardial infarction or stroke, or coronary revascularization (to assess effects on major cardiovascular events) and a composite of death from any cause, dementia, or persistent physical disability (to assess effects on disability-free survival)

Study results:

• total of 9971 participants were enrolled:
  • 4984 were assigned to receive atorvastatin and 4987 to receive placebo
  • mean (±SD) age of the participants was 74.7±4.5 years, and 51.9% were women
• after a median of 5.9 years
  • a primary cardiovascular event had occurred in 297 participants (10.9 events per 1000 person-years) in the atorvastatin group and in 412 participants (15.5 events per 1000 person-years) in the placebo group (hazard ratio, 0.70; 95% confidence interval [CI], 0.61 to 0.82; P<0.001)
  • death from any cause, dementia, or persistent physical disability occurred in 637 participants (21.6 events per 1000 person-years) in the atorvastatin group and in 676 participants (23.0 events per 1000 person-years) in the placebo group (hazard ratio, 0.94; 95% CI, 0.84 to 1.05; P=0.25)
  • serious adverse events occurred in 131 participants (2.7%) in the atorvastatin group and in 129 (2.7%) in the placebo group, with musculoskeletal, hepatobiliary, and diabetes-related adverse events occurring more commonly in the atorvastatin group

Study authors concluded:

“..Treatment with atorvastatin led to a lower risk of major cardiovascular events than placebo at a median of 5.9 years but did not result in longer disability-free survival among community-dwelling older adults without clinical cardiovascular disease..”

Reference:

1. Zoungas S et al; or the STAREE Investigators.Atorvastatin, Cardiovascular Events, and Disability-free Survival in Older Adults. NEJM August 28, 2026.