The Australian STAREE trial has delivered long-awaited evidence for primary prevention in older people but found no improvement in disability-free survival.
Starting atorvastatin after the age of 70 can cut the risk of a first major cardiovascular event by 30%, according to a landmark Australian trial that could reshape preventive prescribing in older patients.
The Statins in Reducing Events in the Elderly (STAREE) trial found that adults aged 70 years and older who took atorvastatin 40mg daily had significantly fewer major cardiovascular events than those given placebo over a median 5.9 years.
The landmark, 10-year double-blind randomised trial was conducted at general practices across Australia and analysed the cardiovascular outcomes of almost 10,000 participants while they took either a statin or placebo.
Participants had no history of cardiovascular disease, diabetes, or dementia.
This made it one of the largest trials to specifically test statins for primary prevention in this age group, the researchers said.
They reported 297 primary cardiovascular events in the atorvastatin group, compared with 412 in the placebo group – equivalent to 10.9 versus 15.5 events per 1000 person-years.
That translated to a 30% relative reduction in the primary cardiovascular endpoint, a composite of cardiovascular death, non-fatal myocardial infarction or stroke, and coronary revascularisation (HR 0.70; 95% CI 0.61-0.82).
The number needed to treat to prevent one major cardiovascular event over the median 5.9 years was 37.
The findings, published in the New England Journal of Medicine and presented at the European Society of Cardiology Congress 2026, addressed a longstanding evidence gap around starting statins in otherwise healthy older people, the researchers said.
Lead researcher Adjunct Professor Sophia Zoungas, from the Monash School of Public Health and Preventive Medicine, said the findings would change the way clinicians managed cardiovascular risk in older people.
“What we hope to see, now that we have provided such strong evidence, are updated treatment guidelines to help clinicians make use of this new finding,” Professor Zoungas said.
“The risk of heart attack and stroke is a major concern for older people. Knowing there is a safe and effective measure for lowering that risk will be a huge reassurance to older people and their families.
“Anyone who has seen a loved one impacted by cardiovascular disease will know just how important prevention is.”
Previous evidence has established the benefits of statins in people with established cardiovascular disease or diabetes, but evidence for primary prevention after 70 – and particularly after 75 – has been sparse. Guidelines have consequently lacked strong recommendations for this group.
Importantly, the benefit was seen in a population whose average LDL cholesterol was not especially high. Mean LDL cholesterol at baseline was 3.27mmol/L, falling by an average 1.23mmol/L in the atorvastatin group compared with 0.42mmol/L in the placebo group.
Related
The cardiovascular benefit also appeared similar among participants aged 70-74 and those aged 75 and older and was consistent across subgroups defined by baseline LDL cholesterol, blood pressure, BMI, and kidney function.
The reduction in individual cardiovascular outcomes was most pronounced for myocardial infarction and revascularisation. Fatal or non-fatal MI occurred at 2.9 events per 1000 person-years with atorvastatin compared with 5.0 with placebo (HR 0.57; 95% CI 0.43-0.75), while coronary revascularisation occurred at rates of 4.0 and 7.0 respectively (HR 0.57; 95% CI 0.45-0.72).
Stroke results were less definitive. Fatal or non-fatal stroke occurred at 4.4 events per 1000 person-years in the atorvastatin group and 5.1 with placebo (HR 0.87; 95% CI 0.68-1.11). Cardiovascular mortality was identical at 2.4 events per 1000 person-years in both groups.
But the trial did not meet its other primary endpoint: extending disability-free survival.
Death from any cause, dementia, or persistent physical disability occurred in 637 atorvastatin recipients and 676 placebo recipients, with no significant difference between groups (HR 0.94; 95% CI 0.84-1.05).
Nor was there evidence of a difference in dementia, with 290 cases in the atorvastatin group and 280 in the placebo group (HR 1.03; 95% CI 0.87-1.21). All-cause mortality and hospitalisation were also similar.
The researchers said the failure of fewer cardiovascular events to translate into longer disability-free survival may partly reflect the fact that 80% of deaths during the trial were from non-cardiovascular causes.
Safety findings were broadly reassuring, although atorvastatin was not entirely benign. Serious adverse events occurred in 2.7% of participants in each group, but medically important musculoskeletal, hepatobiliary, and diabetes-related adverse events were more common among people taking atorvastatin.
Co-author Professor Mark Nelson, a GP and adjunct professor at Monash University and research fellow at the University of Tasmania’s Menzies Institute for Medical Research, said the results were particularly relevant to general practice.
“This was a particularly important trial because it was conducted in the community, with more than 3400 GPs taking part across Australia,” Professor Nelson said.
“In light of this new evidence, older patients should have a conversation with their GP about whether statins are an appropriate treatment for their cardiovascular health to help them remain fit and healthy.”
The trial recruited participants through general practices across metropolitan, regional, and rural Australia, although the published paper reports that eligible patients were identified through clinical databases at 1013 practices. Participants had a mean age of 74.7 years, 52% were women, and more than 40% were aged over 75.
Professor Zoungas said the findings had implications beyond Australia as populations continued to age.
“With the world’s population ageing at an unprecedented rate, answering fundamental questions about healthy longevity has become a universal imperative,” she said.
“STAREE stands as a benchmark for international clinical trials that can directly inform preventive care worldwide.”
Professor Derek Chew, chief scientific and medical officer at the National Heart Foundation of Australia, which contributed funding to the trial, welcomed the results.
“For several decades now, statins have played a major role in reducing cardiovascular events,” Professor Chew said.
“This study shows that they can do so even when started much later in life.
“The Heart Foundation is proud to have supported Professor Sophia Zoungas and her team on this remarkable, long-term study and we congratulate all involved on its important findings.”
