Medicine

New 'gene silencer' cholesterol drug can 'switch off' heart disease

New 'gene silencer' cholesterol drug can 'switch off' heart disease

The worldwide team, which includes researchers from Imperial College London, says the drug could provide added benefit to patients already taking statins by further reducing the levels of low-density lipoprotein (LDL) cholesterol in their blood.

"The drug was safe and well-tolerated", said lead study author Marc Sabatine, chair of cardiovascular medicine at Brigham and Women's Hospital in Boston.

Amgen research and development executive vice president Dr Sean Harper said: "This is a game changer for high-risk patients".

However, some of them expect more from the pricey drug.

Professor Peter Sever of Imperial College London, whose results were presented to the American College of Cardiology yesterday, said: 'This is one of the most important trials of cholesterol-lowering since the first statin trial published 20 years ago. But the Medicines Co drug works in a different way than the two already on the market, utilizing a technology known as RNA interference, or RNAi, that blocks PCSK9 production at its source in the liver.

There was also a statistically significant 15 per cent reduction in the risk of the extended MACE composite endpoint, which included hospitalization for unstable angina, coronary revascularization, heart attack, stroke or cardiovascular death.

Previous research had raised the possibility that evolocumab, sold under the brand name Repatha by Amgen, may have a damaging effect on memory and cognitive function.

Amgen believes that multiple components go into the analysis, namely quality of life, lifespan, baseline event rate, efficacy of the drug, and cost (medical and drug).

It was observed that administering the drug reduced average low-density lipoproteins (LDL) from 92 to 30. If a patient has a heart attack or stroke while taking Repatha as prescribed, Amgen will refund the cost of treatment.


Patients treated with injectable drug Repatha were 27 per cent less likely to have a heart attack and 21 per cent less likely to have a stroke over two years than if they had been taking statins alone.

Experts not involved in the study described it as "exciting" and "major", but urged caution due to the high cost of the medication.

The remarkable results are rooted in the drug's ability to cut levels of "bad" LDL cholesterol, which furs the arteries and causes heart problems. Repatha comes for a whopping $14,000 for a year.

Yet Repatha's high cost could burden the US health system, said Dr. Steve Miller, senior vice president and chief medical officer at Express Scripts, a pharmacy benefit manager.

However, Prof Sever said: "They will probably not [replace statins], there are an very bad lot of people with really quite high cholesterol out there and we'll probably need more than one drug to get their levels down".

Anti-PCSK9 antibodies are the jewel in the crown of modern genomic medicine, illustrating what many hope will be a paradigm for future drug discovery. It shows in high risk patients, there's no number. But the evidence of a benefit is strong enough that he will discuss the drug as an option with his patients, he adds.

More doctors seem to be not so captivated by Repatha.

But they were approved only for those with a genetic condition that means they have dangerously high cholesterol, and people with heart disease who can not cope with the side effects of statins.

In addition, inclisiran appears to maintain its effectiveness longer, meaning that patients wouldn't have to come to the doctor as often for cholesterol-blocking shots, said Dr. James Underberg, an internist with NYU Langone Medical Center in New York City.


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