Atorvastatin reduced major cardiovascular events by 30 percent in older adults without known cardiovascular disease, diabetes, or dementia, according to findings presented at the ESC Congress 2026 and published in the New England Journal of Medicine. Led by researchers at Monash University, the STAREE trial evaluated 9,971 participants aged 70 and older over a median follow-up of 5.9 years to test statins for primary prevention.
Understanding the STAREE Trial Results on Atorvastatin
Statins are frequently prescribed to manage high cholesterol in patients up to 75 years old due to proven benefits against heart attacks and strokes. Yet, the risk-benefit balance for older adults without existing conditions remained unclear because clinical trials historically underrepresented this demographic. An estimated 21,000 older Australians experience major cardiovascular events annually, making primary prevention a critical public health priority, according to Monash University School of Public Health and Preventive Medicine lead researcher Professor Sophia Zoungas.
The STAREE trial used a double-blind design to track participants recruited through Australian general practices. Researchers randomized 9,971 individuals aged 70 or older—with a mean age of 74.7 years, where 52 percent were women—to receive either 40 mg of oral atorvastatin daily or a placebo. The study tracked two primary endpoints: major cardiovascular events, which included cardiovascular death, nonfatal myocardial infarction, stroke, or coronary revascularisation, and disability-free survival, defined as survival free of dementia and physical disability.
Cardiovascular Risk Reduction Versus Disability-Free Survival
Over the 5.9-year median follow-up period, participants taking atorvastatin experienced a 30 percent reduction in major cardiovascular events compared to the placebo group. Specifically, 6.0 percent of participants in the atorvastatin group suffered an event, compared to 8.3 percent in the control group, yielding a hazard ratio of 0.70.
Key Trial Metrics at a Glance
- Cardiovascular Event Risk: Reduced by 30% with atorvastatin (6.0% vs. 8.3%).
- Disability-Free Survival: No significant difference between atorvastatin (12.8%) and placebo (13.6%).
- Serious Adverse Events: Uncommon and equal across both groups at 2.7%.
Despite the clear reduction in heart attacks and strokes, the trial found that atorvastatin did not significantly improve disability-free survival. The combined risk of death, dementia, or persistent physical disability showed no substantive difference between the two study arms, registering at 12.8 percent for the atorvastatin group and 13.6 percent for the placebo group.
Managing Side Effects and Safety Profiles in Older Adults
While cardiovascular benefits were clear, the trial documented specific side effects associated with statin therapy. Muscle, liver, and diabetes-related adverse events occurred more frequently among participants taking atorvastatin. However, serious adverse events overall remained uncommon, affecting just 2.7 percent of participants in both the treatment and placebo cohorts.
“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,” stated Professor Zoungas regarding the clinical implications. Researchers hope the data will prompt updated medical guidelines to assist clinicians in applying these findings to everyday practice.
Did You Know?
The STAREE trial is the first large randomized controlled trial designed specifically to investigate whether statins can effectively serve as a primary prevention tool for older patients to help them maintain health in later life.
Frequently Asked Questions
Who participated in the STAREE trial?
The trial included 9,971 participants aged 70 and older with no prior history of clinical cardiovascular disease, diabetes, or dementia, recruited from Australian general practices.
What was the main benefit of atorvastatin in the study?
Atorvastatin lowered the risk of major cardiovascular events—such as heart attacks and strokes—by 30 percent compared to a placebo over a median follow-up of 5.9 years, according to trial data published in the New England Journal of Medicine.
Did atorvastatin prevent physical disability or dementia?
No. The trial found no significant difference in overall disability-free survival, which measured survival free of dementia and physical disability between the treatment and placebo groups.
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