Statin therapy is safe and effective in older people over 75 years and reduces major cardiovascular events such as heart attacks and strokes, finds new research by University of Sydney’s Clinical Trials Centre.
Published today in The Lancet, the study compared the effects of statin therapy (cholesterol-lowering medication) in nearly 187,000 people who had taken part in 28 large clinical trials. Participants were divided into six different age groups ranging from under 55 years to over 75 years to assess the effects of statins on major vascular events (heart attacks, strokes, coronary revascularisations), cancer incidence and deaths.
Statins help lower the level of low-density lipoprotein (LDL) cholesterol in the blood and are prescribed to millions of people globally. Having a high level of LDL cholesterol can lead to hardening and narrowing of the arteries and cardiovascular disease.
“Statin therapy has been shown to prevent cardiovascular disease in a wide range of people, but there has been uncertainty about its efficacy and safety among older people over 75 years,” said lead investigator, Professor Anthony Keech, Deputy Director of the NHMRC Clinical Trials Centre at the University of Sydney.
“Our study summarised all the available evidence from major trials to help clarify this issue, and found that there were significant reductions in major vascular events in each of the six age groups considered, including in patients aged over 75 years at the start of treatment.”
Most individual statin trials previously considered "elderly" people those aged over 65 years of age. Due to advances in medicine, including the development of pivotal treatments such as statins, life expectancies are now much greater. As a consequence, questions around the effectiveness of treatments in the elderly have focused on even older age groups.
The researchers found that statin treatment reduced the risk of a major vascular event by about a quarter for each millimole per litre reduction in LDL cholesterol, with similar benefits across all ages – even those over 75 years. They also found that statin therapy did not increase the risk of deaths from non-cardiovascular disease, or the risk of cancer, at any age.
Cardiovascular risk reductions were observed irrespective of age, in people with or without known vascular disease at the start of the trials. The evidence was less definitive among people aged over 75 without pre-existing vascular disease (those who were prescribed statin therapy for the ‘primary prevention’ of heart attacks and strokes). New randomised trials are now studying the effects of statins in more depth in apparently healthy older people.
Our analysis found that statin therapy appears to be just as effective in people aged over 75 years as it is in younger people. We now have definitive evidence that statins benefit older people who have suffered a heart attack or stroke.
“This study will provide reassurance and guidance for doctors and patients alike that people are not automatically "too old" for treatments like statins to be effective.”
Co-investigator Professor Colin Baigent, Director of the Medical Research Council Population Health Research Unit at the University of Oxford, added: “The risk of heart attacks and strokes increases markedly with age, and yet statins are not utilised as widely in older people as they should be.
“Since the risk of heart attack and stroke increases with age, the potential benefits are likely to be even greater for older people.
“Therefore, there is a need to ensure that patients at risk of cardiovascular disease due to their age are offered statin therapy where there is good reason to believe that it will be beneficial. Anyone with concerns about whether statin therapy is suitable for them should discuss this with their GP.”
Dr Fulcher added: “Fewer healthy older people were represented in these clinical trials, so more information in this group of people would help confirm the same benefits that we see in our overall trials population. A new randomised trial in Australia, called STAREE, is specifically exploring whether statin treatment can prolong survival free of disability in a healthy elderly population.”
The study was conducted by the Cholesterol Treatment Trialists’ (CTT) Collaboration, a joint initiative coordinated between the National Health and Medical Research Council (NHMRC) Clinical Trials Centre, University of Sydney, Australia and the Clinical Trial Service Unit & Epidemiological Studies Unit (CTSU), Nuffield Department of Population Health, University of Oxford, on behalf of academic researchers representing major statin trials worldwide. The work was funded by the UK Medical Research Council (MRC), Australian National Health and Medical Research Council (NHMRC) and the British Heart Foundation (BHF).
The findings of the LIPID study changed heart health in Australia forever by significantly reducing the prevalence of strokes and heart attacks. The trial led directly to changes in clinical practice around the world, as well as statins being subsidised by the PBS.