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Are statins no longer necessary after the age of 70? Here’s what the studies say

The team of doctors and fact-checking experts from the National Medical Association addresses the main health concerns

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4' min read

Translated by AI
Versione italiana

4' min read

Translated by AI
Versione italiana

On 29 September, we mark World Heart Day, which was established to raise awareness of cardiovascular diseases, which remain the leading cause of death worldwide, even amongst the elderly.

Statins, drugs that lower LDL cholesterol, have been a cornerstone of prevention for decades. However, most of the studies demonstrating their effectiveness have mainly involved middle-aged people. For those over the age of 70 who have never had a heart attack or a stroke, therefore, the true benefit of statins for cardiovascular prevention had not been fully established.

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A study presented in August at the European Society of Cardiology Congress and published in the New England Journal of Medicine, the STAREE study, sought to provide a direct answer to this question, with results that should be interpreted with care.

Have statins also been studied in older people?

In the large-scale studies that have made statins some of the most widely used medicines in the world, people over the age of 70 were almost always in the minority.

A Cochrane systematic review, which pooled 18 randomised trials and nearly 57,000 participants, calculated that the average age of those involved was just 57 years. In this predominantly middle-aged population, statins reduced both mortality and serious cardiovascular events.

However, it was less clear to what extent this benefit actually applied to those over the age of 70 or 75. An analysis of 28 randomised trials, involving nearly 187,000 participants, had confirmed the effectiveness of statins even in older people taken as a whole. But in primary prevention alone – that is, in people with no history of cardiovascular disease – the evidence became less certain as age increased.

What new findings did the STAREE study reveal?

The STAREE study recruited 9,971 Australian participants aged 70 or over who were living independently and had no history of cardiovascular disease, diabetes or dementia. The average age was around 75, and just over half were women. Participants were randomly assigned to receive either a daily dose of a statin or a placebo.

After a follow-up period of 5.9 years, a major cardiovascular event – death from cardiovascular causes, a non-fatal heart attack, a stroke or the need for coronary artery bypass surgery – had occurred in 6.0 per cent of those assigned to the statin and in 8.3 per cent of those assigned to the placebo. In relative terms, the risk was 30% lower.

The absolute difference – which is the most useful measure for understanding what the result actually means in practice – was therefore approximately 2.3 events per 100 people. The benefit mainly concerned events such as heart attacks, strokes and coronary revascularisation procedures.

Did the study also show an effect on the risk of dementia?

Unfortunately not. The other main aim of the study was to find out whether statins enabled people to live longer without dementia or persistent physical disability.

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Having high levels of LDL cholesterol is, in fact, a risk factor not only for cardiovascular disease, but also for dementia.

In the STAREE study, however, the composite endpoint of mortality, dementia or physical disability occurred in 12.8 per cent of those treated with statins and in 13.6 per cent of those treated with placebo: a difference that was not statistically significant. Nor was overall mortality alone found to differ significantly between the two groups.

With regard to dementia, specifically, no convincing benefit of statins has emerged; however, the number of events recorded in the study does not allow us to rule out, with certainty, moderate differences between the groups.

A result that is not statistically significant does not, in fact, prove that statins are definitely neutral with regard to dementia. However, a previously published Cochrane review had also failed to find sufficient evidence to conclude that starting a statin in old age prevents cognitive decline or dementia. Therefore, based on current knowledge, it is not appropriate to take these medicines with the specific aim of reducing the risk of dementia.

What are the risks and side effects you should be aware of?

In the STAREE study, serious adverse events were rare and similar in both groups (2.7 per cent).

Muscle, liver and diabetes-related side effects, however, were found to be more common with statins, though these were mostly mild or moderate in severity. Muscle pain remains the side effect most commonly reported by patients, but the risk actually attributable to the drug – after taking into account what is also observed with the placebo – is estimated at around 5 per cent or less.

Severe muscle damage (rhabdomyolysis), on the other hand, is extremely rare, with only a few cases per million people treated.

So, should statins be prescribed for older people or not?

Not necessarily, and the answer depends on each individual’s medical history. The Mario Negri Institute for Pharmacological Research points out that, for people over the age of 80 and in the context of primary prevention, the balance between benefits and risks should be reassessed on a case-by-case basis, taking into account frailty, life expectancy and other medicines being taken.

It should also be noted that, in order to be enrolled in the STAREE trial, participants had to demonstrate that they were taking one tablet daily without fail during a four-week trial period prior to randomisation: a detail that highlights just how much actual adherence to treatment, outside an experimental setting, is a real issue that needs to be addressed in consultation with one’s GP.

For this reason, it is incorrect to say that statins are ‘no longer needed’ after the age of 70.

The STAREE study shows that, in relatively healthy older people with no history of cardiovascular disease, a statin can reduce the risk of heart attack, stroke and other cardiovascular events. However, this does not mean that everyone over the age of 70 should start taking one.

The overall benefit is relatively small and must be weighed against the side effects, the number of other medicines being taken, the person’s frailty, their life expectancy and, above all, their own preferences.

You should therefore discuss this with your GP, without starting or stopping treatment on your own.

This applies in particular to those who have been taking statins for years: they should not stop taking them on their own when they turn 70, as discontinuing treatment or taking them only occasionally undermines their long-term effectiveness. Even if muscle pain or other symptoms occur, it is best not to stop taking the medication on your own initiative, but to discuss this with your doctor, who may consider a lower dose, a different statin or another medication.

Read the full article on the Fnomceo website dottoremaeveroche

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