A breakthrough drug could prevent thousands of heart attacks (stock picture)
Thousands of heart attacks could be prevented thanks to a new drug hailed as the biggest breakthrough since statins.
In a landmark four-year trial, scientists found that the drug – given by injection every three months – cut the risk of heart attacks by 24 per cent.
The 10,000-patient study, involving 1,000 doctors in 39 countries, also suggested it could halve the risk of dying from lung cancer and prevent arthritis and gout.
Scientists last night hailed the results of the trial, saying the treatment marked ‘a new era of therapeutics’ that could save thousands of lives.
The drug – Canakinumab – works by reducing inflammation – a major new approach in heart medicine which until now has been dominated by cholesterol drugs.
For the last 30 years cholesterol-busting statins have been given to nearly all people deemed to be at risk of cardiovascular disease, in a bid to save them from heart attacks and strokes.
Yet half of the 200,000 people who have a heart attack in Britain each year do not have high cholesterol, meaning there is a desperate need for a different approach to treatment.
Experts have long thought that Inflammation – the body’s natural responses to infection or injury- might also play a major role in causing heart attacks and strokes, possibly because it causes inflammation in the arteries, increasing the risk of a blockage.
In a landmark four-year trial, scientists found that the drug – given by injection every three months – cut the risk of heart attacks by 24 per cent (stock picture)
The new trial, however, is the first definitive proof that cutting inflammation slashes heart risk.
Study leader Professor Paul Ridker of Harvard Medical School said the new drug opened up a ‘third front’ in the war on heart disease, following the previous focus on cholesterol and lifestyle.
Presenting his findings at the European Society of Cardiology congress in Barcelona yesterday, Professor Ridker said: ‘These findings represent the end game of more than two decades of research, stemming from a critical observation – half of heart attacks occur in people who do not have high cholesterol.
‘For the first time, we’ve been able to definitively show that lowering inflammation independent of cholesterol reduces cardiovascular risk.’
He added: ‘This has far-reaching implications. It tells us that by leveraging an entirely new way to treat patients – targeting inflammation – we may be able to significantly improve outcomes for certain very high-risk populations.’
Canakinumab is an antibody that attacks an immune-system protein called interleukin-1, which in high levels results in increased inflammation throughout the body.
The new trial trial involved high-risk patients who had already suffered a heart attack – a group in desperate need of help because a quarter of patients suffer a second attack within five years, even with statins.
All patients in the trial took statins as well, but the research team found the addition of Canakinumab cut the risk of repeat heart attacks by 24 per cent over and above the impact of the cholesterol drug.
People who took the drug were also 36 per cent less likely to be hospitalised with unstable angina, and 32 per cent less likely to require expensive interventional procedures such as bypass surgery.
Researchers reported a sharp rise in infections– a side effect linked to the fact inflammation protects against infection – which killed one in every 1,000 patients.
But they also found patients had a 51 per cent reduced risk of lung cancer deaths – a finding they said was ‘very exciting’ and needed further trials.
Gout and arthritis, which are linked to inflammation, also fell.
Drugs giant Novartis, which makes Canakinumab, last night said it would immediately apply for a medical licence to use the drug for heart disease.
Canakinumab is currently used for inflammatory problems, including rare forms of arthritis, at the cost of £9,928 per jab. That price is set high because the conditions are rare, so sales are relatively low.
But experts stressed the price – which would reach £40,000 a year for heart patients – would have to come down if it were to be made available on the NHS for the thousands of patients with heart problems who could benefit.
Professor Ridker, whose results are published in the prestigious New England Journal of Medicine, said the new drug would probably be given alongside statins, in a twin attack against cholesterol and inflammation.
Professor Ridker said: ‘In my lifetime, I’ve gotten to see three broad eras of preventative cardiology.
‘In the first, we recognised the importance of diet, exercise and smoking cessation. In the second, we saw the tremendous value of lipid-lowering drugs such as statins. Now, we’re cracking the door open on the third era.’
Co-author Dr Peter Libby of Brigham and Women’s Hospital in Boston, said: ‘This represents a milestone in a long journey implicating interleukin-1 in cardiovascular disease.
‘The results usher in a new era of therapeutics.’
British doctors last night said the breakthrough could pave the way for an entire new group of medicines.
Dr Derek Connolly, consultant interventional cardiologist at Birmingham City Hospital, said: ‘I think this is a novel and incredibly important finding. It could open the door to lots of other therapies and further development.’
He said Nice – the NHS drugs watchdog – would probably only allow it to be used for high-risk groups, at least at first.
‘Does this mean we are going to be immediately using this for everyone in the UK with heart disease? I do not think NICE will allow that.’
Initially the drug would probably be used for people who are known to have high levels of inflammation.
A screening blood test for ‘C-reactive protein’ molecules – which are markers of inflammation – could identify those who could benefit.
But in time, if the drug became cheaper or less costly alternatives are produced, it might become feasible to offer it to more people.
‘We now live in a world where antibodies are easy to produce,’ Dr Connolly said.
Professor Jeremy Pearson, associate medical director at the British Heart Foundation, said: ‘Nearly 200,000 people are hospitalised due to heart attacks every year in the UK.
‘Cholesterol-lowering drugs like statins are given to these people to reduce their risk of another heart attack and this undoubtedly saves lives. But we know that lowering cholesterol alone is not always enough.
‘These exciting and long-awaited trial results finally confirm that ongoing inflammation contributes to risk of heart disease, and could help save lives.
‘The findings suggest that existing anti-inflammatory drugs, such as Canakinumab, could be given along with cholesterol-lowering drugs to treat survivors and further reduce their risk of another heart attack.’