A large clinical trial has found that a daily statin pill cut the risk of major cardiovascular events by nearly a third in healthy adults over 70 who had no history of heart disease, offering the first solid trial evidence on a question doctors have long debated: whether to start cholesterol-lowering drugs in older patients purely as a preventive measure.
The STAREE trial, published August 29 in the New England Journal of Medicine and presented at the European Society of Cardiology's Congress in Munich, randomly assigned 9,971 Australian adults aged 70 and older, none of whom had known cardiovascular disease, diabetes or dementia at enrollment, to take either 40 milligrams of atorvastatin or a placebo daily. Participants had a mean age of about 75, and just over half were women. Over a median follow-up of 5.9 years, major cardiovascular events — a composite of cardiovascular death, non-fatal heart attack, stroke and coronary revascularization — occurred in 6.0% of the statin group versus 8.3% of the placebo group, a 30% relative risk reduction (hazard ratio 0.70; p<0.001).
A More Complicated Picture on Independence
The trial's second primary measure, disability-free survival — meaning survival without dementia or persistent physical disability — showed no significant difference between the two groups (12.8% versus 13.6%; hazard ratio 0.94). In other words, the drug reduced heart attacks and strokes without measurably extending the number of years participants lived independently, a distinction researchers say matters for how the results should be used in practice. Side effects were also more common with atorvastatin: musculoskeletal complaints affected 32.0% of the statin group versus 29.4% on placebo, liver-related adverse events occurred in 3.3% versus 0.9%, and new diabetes diagnoses were more frequent as well, at 4.0% versus 2.7%. Serious adverse events overall were uncommon and similar between groups.
"The STAREE trial is the first large randomised controlled trial to examine whether statins can be used for primary prevention in older patients," said Monash University's Sophia Zoungas, one of the trial's investigators, according to the European Society of Cardiology. Independent commentators at the congress said the results should shift how doctors approach the question. Cardiologist François Mach of Geneva University Hospital argued that age alone should no longer be treated as a reason to withhold statin therapy, saying guidelines "have to be adapted accordingly," while cautioning that decisions should still weigh a patient's life expectancy, other health conditions and personal priorities.
Other physicians commenting on the trial, including Abdulla Damluji of the Cleveland Clinic, drew a sharper line between the two findings: statins prescribed to older, independently living patients reduced cardiovascular events, he noted, but did not preserve independence — underscoring that a conversation about goals of care, not a blanket prescribing mandate, is the appropriate response to the data, as specialist outlets covering the presentation reported.
Because STAREE enrolled only community-dwelling adults in Australia who were healthy enough to be recruited through general practices, questions remain about how the results generalize to frailer or more diverse older populations. A separate, larger trial called PREVENTABLE, testing the same atorvastatin dose in roughly 20,000 participants, is already underway and may offer additional data on whether statins affect dementia and disability risk specifically. For now, researchers say the STAREE results give doctors and patients over 70 a clearer, if not simple, basis for weighing statin therapy against its modest additional risks.
