A NEW drug has outperformed statins and has been shown to lower “bad cholesterol” to unprecedented levels, cutting the risk of heart attacks by more than 20 per cent in what is being called a “game-changer” for high-risk patients.
The breakthrough came after a two-year worldwide trial of evolocumab – manufactured as Repatha by American multinational Amgen – that involved more than 27,000 people being treated with the new drug in conjunction with statins.
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Study results published yesterday compared the use of the new drug to reduce levels of bad cholesterol – low-density lipoprotein, or LDL – with optimised statin therapy, the current favoured treatment.
They showed for the first time that reducing LDL levels beyond what is currently possible led to “a further reduction in major cardiovascular events”.
These major events include heart attacks, strokes and coronary bypasses.
Sean Harper, executive vice president of research and development at Amgen, said: “This is a game-changer for high-risk patients.
“Even though these patients were optimally treated with the latest therapies, they were still at high risk for an additional cardiac event.
"It’s remarkable to see such a large impact in reducing cardiac events given that this patient population was only on evolocumab for about two years.”
Professor Peter Sever, of Imperial College London, and a member of the study’s executive committee, said this “is probably the most important trial result of a cholesterol-lowering drug in over 20 years”.
Statins are a group of medicines that help lower low-density lipoprotein cholesterol levels in the blood, and are commonly used in heart patients. However, they have been linked to the development of diabetes.
Evolocumab is self-administered with an injection pen, and works by blocking the protein that interferes with the liver’s ability to remove cholesterol from the blood.
Patients treated with the drug saw levels of bad cholesterol drop by 60 per cent more than if they had been taking statins on their own.
They were also 20 per cent less likely to suffer a heart attack, stroke or die from cardiovascular disease in the course of the trial.
Benefits from the treatment were recorded from as early as six months into the trial and continued throughout the study.
In Scotland, there has been a steady downward trend in the number of deaths from coronary heart disease (CHD) over the last decade, but in 2015 there were still 7,142 deaths where it was the underlying cause.
Dr Isla Mackenzie, who led the trial in Dundee, said the new drug – which is already available on the NHS in Scotland – would be good news for those at high risk of cardiovascular events.
She told The National: “It was a global trial and we had a small input into that, but it certainly has significance for Scotland because of the high levels of heart disease here.
“It’s an injectable drug that can be self-administered by patients and it blocks an enzyme called PCSK9. Blocking this enzyme leads to a reduction in blood cholesterol levels.
“The Scottish Medicines Consortium reviewed this drug in January, before the trial results, and it has been accepted for what’s called restricted use in NHS Scotland.
“It’s for patients with familial high cholesterol who still have high LDL cholesterol levels, people who have a high risk because they’ve had previous cardiovascular events and if their LDL cholesterol is above a certain level, and also people who’ve had more than one type of cardiovascular disease and still have high cholesterol.”
She added: “The other message is that statins are still the mainstay of therapy. Where else this might have a place in the future is with patients who are statin-intolerant and can’t take them because of some of the side-effects.”
Evolocumab costs about £4,400 per patient per year – though the NHS receives an undisclosed discount – while statins only cost the health service about £20 per patient per year.
“Patients have to have a defined set of characteristics to receive this on NHS Scotland, so the first-line treatment will probably be statins for most people,” said Mackenzie.
“This drug may be used as an add-on to statins or used in patients who’ve not been able to take statins.”
The trial was led by Dr Marc Sabatine, of Harvard Medical School, who said: “We now have definitive data that by adding evolocumab to a background of statin therapy, we can significantly improve cardiovascular outcomes and do so safely.
“We need to treat LDL cholesterol more aggressively, and now we have a new validated means to do so.”