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August 30, 2026New England Journal of Medicine1 citations
Atorvastatin, Cardiovascular Events, and Disability-free Survival in Older Adults
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Key Result
Atorvastatin reduced the risk of major cardiovascular events compared to placebo (HR 0.70; 95% CI 0.61-0.82; P<0.001) but did not result in longer disability-free survival in older adults.
Key Points
- To assess the efficacy and safety of daily atorvastatin for the primary prevention of cardiovascular events and extension of disability-free survival in community-dwelling older adults.
- Double-blind, randomized, placebo-controlled trial across general practices in Australia (STAREE; NCT02099123) enrolling 9,971 community-dwelling adults aged ≥70 years (mean age 74.7±4.5 years, 51.9% women) without cardiovascular disease, diabetes, or dementia.
- Participants were randomly assigned in a 1:1 ratio to receive atorvastatin 40 mg daily (N=4,984) or matching placebo (N=4,987) with a median follow-up of 5.9 years.
- Dual primary endpoints were major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction/stroke, or coronary revascularization) and disability-free survival (death from any cause, dementia, or persistent physical disability).
- Major cardiovascular events occurred in 297 participants (10.9 per 1000 person-years) in the atorvastatin group versus 412 participants (15.5 per 1000 person-years) in the placebo group (HR 0.70; 95% CI, 0.61 to 0.82; P<0.001).
- Disability-free survival events occurred in 637 participants (21.6 per 1000 person-years) receiving atorvastatin versus 676 participants (23.0 per 1000 person-years) receiving placebo (HR 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 129 (2.7%) in the placebo group, with higher rates of musculoskeletal, hepatobiliary, and diabetes-related adverse events in the atorvastatin arm.
Study Design
Type
RCT (n=9,971)
Blinding
Double-blind
Randomization
1:1
Multicenter
Yes
Structured PICO
Does atorvastatin 40 mg once daily reduce cardiovascular events and improve disability-free survival in community-dwelling adults ≥70 years without prior cardiovascular disease, diabetes, or dementia?
P
Population
9,971 community-dwelling adults aged ≥70 years without cardiovascular disease, diabetes, or dementia, followed for a median of 5.9 years.
I
Intervention
Atorvastatin 40 mg oral once daily
C
Comparator
Identical placebo
O
Outcome
Two primary end points: 1) composite of death from cardiovascular causes, nonfatal myocardial infarction or stroke, or coronary revascularization; 2) composite of death from any cause, dementia, or persistent physical disability, assessed at a median of 5.9 yearscomposite
In older adults without prior cardiovascular disease, atorvastatin 40 mg daily significantly reduced major cardiovascular events but did not extend disability-free survival.
Main Result
Hazard Ratio: 0.7 (95% CI 0.61–0.82)
Absolute Event Rate: 10.9% vs 15.5%
p-value: p=<0.001
Abstract
BackgroundThe effectiveness and safety of statins for the primary prevention of cardiovascular events and the extension of disability-free survival among older adults remain uncertain. MethodsWe conducted a 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. The 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). Analyses were performed according to a hierarchical testing plan. ResultsA total of 9971 participants were enrolled: 4984 were assigned to receive atorvastatin and 4987 to receive placebo. The 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. ConclusionsTreatment 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. (Funded by the National Health and Medical Research Council and others; STAREE ClinicalTrials.gov number, NCT02099123.)Atorvastatin and Cardiovascular Events in Older Adults
Expert Takes40 quotes
1/40
“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.”
ACC Journal ScanView source
Trending Research#1 this week
Presented at ESC 2026 Hot Line; simultaneous NEJM publication; covered by Guardian, MedPage, Healio, ACC, ESC press (dozens of articles); major guideline implications for primary prevention in elderly.
Social attention
95
Preprint velocity
0
News coverage
98
Conference
100
Expert commentary
90
Cite This Study
Zoungas et al. (2026) conducted an RCT in Primary prevention of cardiovascular events (n=9,971). Atorvastatin vs. Placebo was evaluated on composite of death from cardiovascular causes, nonfatal myocardial infarction or stroke, or coronary revascularization (HR 0.70, 95% CI 0.61 to 0.82, p=<0.001). Atorvastatin reduced the risk of major cardiovascular events compared to placebo (HR 0.70; 95% CI 0.61-0.82; P<0.001) but did not result in longer disability-free survival in older adults.