Do statins still offer meaningful protection against cardiovascular disease as people grow older? A landmark Australian trial has provided some clarity.
The 10-year Statins in Reducing Events in the Elderly (STAREE) trial led by researchers from Monash University found that statin therapy can cut the risk of a first major cardiovascular event by almost a third in adults aged 70 and over without cardiovascular disease, diabetes and dementia.
Co-author Professor Mark Nelson – a GP and Adjunct Professor at the Monash School of Public Health and Preventive Medicine – spoke with AP about what the results mean in practice.
What does the evidence say?
STAREE randomised 9,971 participants aged 70 and over to atorvastatin 40 mg daily or placebo. After around 5.9 years, 6.0% of people taking atorvastatin experienced a major cardiovascular event, compared with 8.3% taking placebo – representing a 30% relative risk reduction.
Just as importantly, the trial provided reassurance about safety. Adverse effects were ‘relatively uncommon and minor’, Prof Nelson said, occurring in only 2.7% of participants in both the atorvastatin and placebo groups.
The combination of efficacy and safety is particularly relevant when patients question whether a statin is still worthwhile as they get older.
‘We have demonstrated the benefits, and the harms, while not serious, are addressable,’ he said.
So should every patient over 70 take a statin?
Not quite.
The findings don’t amount to a blanket recommendation to commence a statin, but they do remove age as a reason to withhold treatment.
‘The [trial] population were healthy ageing individuals, so it’s reasonable to apply the results to that [cohort], but decision-making on an individual basis should still be made between the physician and the patient – with knowledge of their entire background and medical problems,’ Prof Nelson said.
STAREE enrolled participants into their 90s with no upper age limit, and results were consistent whether participants were under or over 75.
‘We should resist ageism where we decide not to treat somebody just because of their age. Patients really need a reason for not starting, or for stopping, a statin, rather than the other way around,’ he said.
How should pharmacists approach hesitant patients?
Concerns about cognitive decline are among the reasons some older patients remain hesitant about taking statins. But Prof Nelson said STAREE found no evidence to support these fears.
‘There was no statistically significant difference between those randomised to atorvastatin versus placebo when it came to dementia incidence or cognitive decline.’
A key strength of the STAREE trial is that it was conducted in the population pharmacists see every day: older Australians living in the community.
This can give clinicians confidence when applying the results to their patients.
‘There’s a saying in research that the study outcomes are directly implementable in the population from which they were drawn,’ Prof Nelson said. ‘The trial was conducted in Australia, among community-based Australians, so the confidence level can be quite high about the recommendations being evidence-based.’
For patients or family members reluctant to start a new long-term medicine, he said pharmacists can point to the trial directly: ‘A recent study has shown that statins are both effective and safe’,’ he said.
‘And the level of evidence is so much higher now into older age about the benefits and harms of statins.’
For patients already taking a statin before the age of 70, STAREE provides further support for continuing treatment where it remains clinically appropriate.
‘It strengthens the reason why it should be lifelong therapy – that suppression of LDL-C provides clinical benefit in quite advanced age.’
What should pharmacists watch for as statin use grows?
If statin use expands among older adults, pharmacists will need to consider polypharmacy, interactions and cumulative treatment burden.
STAREE did not specifically investigate drug interactions or polypharmacy. But Prof Nelson said he expects statin interactions in older patients to be broadly similar to those seen in younger populations.
‘We will be looking at all these other questions, but it takes time,’ he said
As for future prescribing guideline changes, Prof Nelson pointed to his work on the Aspirin in Reducing Events in the Elderly (ASPREE) trial as an example of how high-quality evidence can reshape clinical recommendations.
Before ASPREE, evidence around aspirin for primary prevention in older people was limited. But its findings subsequently contributed to major changes in international recommendations – and STAREE could have a similar impact on statin prescribing.
‘The count is over 300 scientific papers from ASPREE now, and that study was published 8 or 9 years ago,’ he said.
‘Because STAREE shows an overall benefit of therapy, it will likely strengthen recommendations and confidence in recommendations in the older population, especially those aged over 75.’
