The jab that means never having to take statins again

Cholesterol-lowering jab that means never having to take statins again and a breakthrough pill that boosts survival are among astonishing new treatments set to transform the lives of British heart patients

  • Experts revealed the first injection to lower cholesterol could get NHS approval 
  • Trial results showed the drug, given twice yearly, cut levels by more than 50%
  • One person dies of heart or circulatory disease every three minutes in Britain

Imagine nipping to Boots for your annual flu jab – and while you’re at it, getting a once-a-year cholesterol ‘vaccine’.

Such a routine would mean that a daily dose of statins, currently taken by millions of Britons to reduce their risk of heart attacks and strokes, would be a thing of the past.

This scenario isn’t as far-fetched as it sounds.

Last week experts revealed that the first injection to lower cholesterol could receive NHS approval within 18 months. Stunning trial results showed that the drug, given twice a year, slashed levels in patients by more than 50 per cent.

It was just one of the announcements generating huge excitement at the American Heart Association’s annual Scientific Sessions in Philadelphia, where cardiologists from around the world shared the latest research – and results that will shape the health of millions of people.

In Britain, one person dies of heart or circulatory disease every three minutes – often a fatal heart attack.

Every 12 minutes, someone in the UK will have a stroke, while more than one million men and 900,000 women are living with chronic angina – debilitating chest pains caused by blocked heart arteries (stock image)

That’s 160,000 people every year.

Every 12 minutes, someone in the UK will have a stroke, while more than one million men and 900,000 women are living with chronic angina – debilitating chest pains caused by blocked heart arteries.

These are illnesses that will touch every one of us. But, from life-changing medication for heart-failure sufferers to the news that fewer people than ever will need bypass or stent surgery thanks to drug advances, and new tablets to lower the risk of a second heart attack, there is, according to the scientists, much to celebrate.

Here, with the help of heart experts, we reveal the new treatments and approaches on the horizon, and what they might mean for you.

STATINS NOT WORKING? TRY A CHOLESTEROL JAB

I can’t take statins, so I’m first in line for the jab 

Ideal candidate: Marianne Hodgson, who is waiting for the jab 

When Marianne Hodgson was told after a routine blood test that, at the age of 55, she had high cholesterol, it came as a surprise. 

The retired fashion company director and mother-of-three, now 69, recalled: ‘I was slim, and exercised regularly. But the doctor suggested statins, and I thought why not? 

‘My father had died with heart disease, despite being slim and healthy, in his 80s, so I wanted to do everything I could to reduce my risk.’ 

But almost straight away, Marianne, who lives in Oxfordshire and London with her financier husband Michael, also 69, began to feel unwell, and further blood tests revealed something more sinister. 

‘My liver had been damaged,’ said Marianne. ‘I recovered, but when I decided to try statins again last year, the same thing happened.’ 

This time she was referred to Professor Kausik Ray, who started her on another cholesterol-lowering pill, called ezetimibe, as she couldn’t take statins. 

‘He’s told me I’d be an ideal candidate for the new jab,’ says Marianne. ‘It’s a worry, as I know my cholesterol isn’t ideal – despite the fact I watch what I eat. I’ll be first in line for the injection, as soon as I can get it.’

It’s a case of the lower, the better when it comes to ‘bad’ LDL cholesterol levels in patients at high risk of a heart attack.

High levels of LDL contribute to damage inside the artery walls, leading to the build-up of plaques, which can block blood supply.

Statins can lower levels by 30 to 50 per cent. But while millions take the tablets, half stop doing so within a year.

Some blame the pills for muscle pain and memory problems.

Research suggests those who stop taking the tablets are almost twice as likely to suffer a heart attack or other coronary event within three years and 26 per cent more likely to have a stroke compared to those who carry on taking them.

So could a long-lasting cholesterol-lowering injection be the answer? That’s what heart experts are hoping.

Study results announced last week showed one such jab sent LDL levels plummeting by more than 50 per cent within two weeks.

‘This is going to change everything,’ said cardiologist Professor Kausik Ray, of Imperial College London, who has been leading UK trials of the drug, called inclisiran.

‘Patients can have a jab, and forget about the daily pills.’

The success of inclisiran has raised hopes of an option for patients who find it hard to stick to daily tablets.

The new trial looked at patients who were already on the maximum statins dose, but were failing to reach target LDL levels, as well as those who were ‘statin intolerant’ – unable to take the drugs due to side effects.

One shot of inclisiran was given to start with, then another after three months, with two more at six-month intervals. Cholesterol levels remained low and no significant side effects were seen. The study did not detect any reduction in heart attacks or other cardiac events, due to its short length.

HOW DOES IT AFFECT ME?

Prof Ray said: ‘The big problem with statins is that we know people don’t take their pills.

‘An injection, given twice a year, is more convenient. And, as the drug works in a specific way, acting only in the liver and not travelling around the body, there will be even fewer side effects than with statins.’

Inclisiran is one of a new wave of gene-silencing drugs. These drugs block RNA ‘messenger’ molecules that carry instructions within the cells.

The drug blocks the message that instructs the body to produce a protein called PCSK9, which interferes with the liver’s ability to remove cholesterol from the blood.

By reducing the amount of PCSK9 made, the liver sweeps LDL from the blood, dramatically lowering levels.

The drug, says Prof Ray, could become as easy to manufacture as statins.

This means inclisiran could be more affordable for the NHS than other recent cholesterol-lowering drugs, known as monoclonal antibodies.

These cost around £4,000 per year and involve 26 injections a year.

Statins, by comparison, cost as little as £20 per patient annually.

‘We are expecting inclisiran to be much cheaper than monoclonals, and to be approved for NHS use by 2021,’ added Prof Ray.

END OF STENT SURGERY FOR BLOCKED ARTERIES

Thousands of people may be spared from stent operations and bypass surgery, after a landmark study proved that these invasive options were no more effective than drugs in preventing heart attacks.

In fact, patients were slightly more likely to suffer a heart attack in the two years after a stent op than if they’d just received standard heart medication, such as blood-pressure and cholesterol-lowering tablets, researchers claimed last week.

At present, people suffering with symptoms of heart disease – including chest pain, dizziness or fatigue – who are found to have narrowing in the arteries supplying the heart may be offered an angioplasty.

This involves a tiny mesh tube, or stent, being inserted to hold open the narrowed artery and help blood flow properly. Every year, about 75,000 Britons have the procedure. Despite its simplicity, it carries risk.

Up to eight per cent of those undergoing angioplasty suffer a heart attack on the operating table. Post-operative internal bleeding is another common problem.

A further 17,000 have a heart bypass – a major operation, in which blood vessels are taken from elsewhere in the body and ‘plumbed in’ to the heart.

Narrowing of the arteries occurs as a result of the build-up of cholesterol and other substances, which results in the formation of lesions known as plaques.

But experts now know it is not the narrowing itself that is the problem. Plaques can burst, or rupture, causing a blood clot to form over these lesions.

It is this sudden clotting that can completely block the blood supply to the heart – and it is this that causes a heart attack, stroke or sudden cardiac death. During a heart attack, inserting a stent can save a patient’s life. But the new study – which followed more than 5,000 volunteers in 37 countries for five years – showed that inserting them didn’t actually prevent attacks, any better than taking standard drugs did.

HOW DOES IT AFFECT ME?

‘These findings challenge long-held beliefs, and will change the way we practise,’ said cardiologist Dr Robert Harrington, President of the American Heart Association.

‘Early studies into stents and other operations were done before we had really effective medicines to control cholesterol, blood pressure and clotting.

‘But now we do. We can now feel comfortable when we say to patients with stable heart disease, look, why don’t we try tablets first, and see how you do?

‘Surgery might not be needed.’

PILL SLASHES DEATHS IN HEART PATIENTS

David was in desperate need of a transplant …all he has to do now is take a daily pill

Pictured: David and Ann Young, Glasgow

Heart failure left David Young feeling ‘lifeless’.

The 77-year-old retired Hoover factory supervisor, who lives with his wife Anne, 70, in Glasgow, was housebound and often barely able to speak due to breathlessness.

His symptoms were so severe that he was on the waiting list for a heart transplant. But today he feels ‘brand new’ after being one of the first patients to benefit from dapagliflozin.

‘Not much of my heart was working,’ says David, who was first diagnosed in 2001 and also suffers from diabetes. ‘I lost all confidence to go anywhere by myself – you just worry that you won’t make it, and something would happen.’

David was started on dapagliflozin by his consultant, University of Glasgow cardiologist Prof Mark Petrie, just under two years ago. ‘The tablets make me go to the loo, to pass water. But that makes me feel better,’ he says.

‘My legs are less swollen, and they aren’t painful any more. I can walk about, do things by myself, and I don’t feel lifeless any more.

‘There have been no side effects I’ve noticed. It’s like I’m brand new.’

For Britain’s one million heart-failure patients, hope is often in short supply. But thousands are soon to benefit from a breakthrough pill that dramatically improves symptoms and boosts survival.

New hope comes in the form of a £35-a-month drug called dapagliflozin, that is already given to diabetics to reduce blood sugar levels but could now be repurposed after astonishing trial results.

‘No treatment has ever had such a large impact on quality of life and symptoms,’ said University of Glasgow cardiologist Professor John McMurray, who led the new study.

Heart failure occurs when the organ becomes too weak or stiff to pump blood around the body effectively, leading to debilitating fatigue and breathlessness. One in five sufferers dies within a year of diagnosis and just a third of patients survive more than ten years following diagnosis.

A major report last year suggested two in three cases were missed by GPs, who mistook it for asthma or ‘old age’, delaying treatment and increasing fatalities.

The results of the trial of almost 5,000 patients showed that treatment with dapagliflozin led to a significant 30 per cent reduction in urgent treatment visits and hospital admissions, and a remarkable 18 per cent lower risk of death from cardiovascular disease over two years.

Even those over the age of 75, with multiple health problems including diabetes and abnormal heart rhythm, experienced these benefits. There were few side effects, and importantly, people felt vastly better on the drug.

Prof McMurray said: ‘Patients were asked to fill in forms relating to frequency and severity of their symptoms, quality of life, and how their illness limited them. A treatment that gives a five-point improvement would be considered a success, but we saw some reporting a ten- or 15-point improvement. We’ve never seen anything like it.’

HOW DOES IT AFFECT ME?

Initially, dapagliflozin showed promise in diabetic patients who were also suffering heart failure. But trial results show it works for all those suffering one of the most common types of the heart disease, called heart failure with reduced ejection fraction, or HFrEF.

It is hoped further studies will show it also works for other types.

‘Heart failure is miserable, so this is very promising,’ said Dr Laura Corr, a consultant cardiologist who sees patients at her private clinic on Harley Street.

‘The drug makes people feel better, and importantly helps them stay out of hospital.

‘As ever, the NHS will have to negotiate a price, which will be the next big hurdle.’

Dapagliflozin has yet to get NHS approval for non-diabetic patients.

GOUT DRUG LOWERS RISK OF SECOND ATTACK

One million men and almost 500,000 women in Britain have survived a heart attack. The challenge for doctors is to make sure they don’t have another.

High cholesterol levels and inflammation in the blood vessels are both thought to increase the risk of a second attack – and cholesterol-lowering statins are often prescribed to reduce it.

They are thought to work in two ways: by lowering ‘bad’ LDL cholesterol and limiting inflammation, which in turn stabilises plaques that may have ruptured.

But for some time now, doctors have been looking for a drug specifically targeted at reducing inflammation, to see if it could offer further protection.

Now, the search may be over. A new study found colchicine – a cheap drug previously used to treat gout – slashed a heart attack survivor’s risk of death from heart disease, or having a cardiac arrest or heart attack, by 34 per cent.

Patients also had fewer strokes and attacks of chest pain requiring hospitalisation and were less likely to die of any cause than patients on standard treatments.

The three-year trial involved more than 4,700 heart patients, half given daily low-dose colchicine tablet, and the rest a placebo.

The volunteers were also on drugs normally prescribed to heart-attack survivors.

HOW DOES IT AFFECT ME?

Colchicine, a plant-derived medicine, is inexpensive, costing about £20 for a one-month supply.

‘We already give patients who have had a heart-attack pills for blood pressure, blood-thinners – aspirin – and cholesterol-lowering medication,’ Dr Corr says.

‘But we’ve known for years that heart disease is all about inflammation, so a drug that helps tackle that aspect is useful.

‘The benefit, in absolute terms, is small. Roughly seven per cent of patients on the placebo had a heart attack, while 5.5 per cent of those on colchicine had one.

‘But used in conjunction with other medicines, which also give small benefits, it adds up.

‘It’s exciting that an old, cheap drug can be used in a new way. This could become routine protocol.

‘On the other hand, there’s always a worry when people have too many pills to take, they just don’t do it.’

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