Published: Tue, March 21, 2017
Health Care | By Jeffery Armstrong

New Drug Lowers Heart Attack Risk

New Drug Lowers Heart Attack Risk

In a trial of more than 27,000 patients, researchers found that taking monthly or twice-monthly injections of the medication, called evolocumab, on top of statins could cut cholesterol levels by nearly 60 per cent on average in patients with an underlying risk of cardiovascular disease. But any new cholesterol drug faces stiff competition from cheaper statins, which have been used to control LDL levels for decades.

There researchers after evaluation found out that the use of the drug reduced the he drug reduced average low-density lipoproteins (LDL) from 92 to 30.

Researchers from Imperial College London and their colleagues, who conducted the trial, say the twice-a-year treatment could be safely given with or without statins, depending on individual patient needs.

Unfortunately, evolocumab did not reduce a person's overall risk of death, or their risk of dying from heart disease, noted Dr. Gregg Stone, director of cardiovascular research and education at NewYork-Presbyterian/Columbia University Medical Center.

Some doctors hailed the results as major progress against heart disease.

According to the Centers for Disease Control and Prevention, around 610,000 people die each year in the United States as a outcome of heart disease.

"And therefore it is hard to be certain about the actual extent of the longer-term benefit, including the impact on dying from heart disease, as well as longer-term safety".

Stubbornly high cholesterol is a key risk factor.

The new study provides much stronger evidence that it saves lives. The discussion encompassed a review of the data, how the benefits project into the real world population, and the company's evolving value-based pricing/approach with payers.

Amgen and Sanofi/Regeneron have been hoping that new data showing that reductions in LDL cholesterol (LDL-c) are mirrored by significant reductions in the cardiovascular complications of high cholesterol will drive uptake, and Amgen reported the results of its outcomes trial-Fourier-at the American College of Cardiology (ACC) meeting over the weekend. Repatha and a similar drug, Praluent, were approved in 2015 for people with inherited risk for high cholesterol, or heart disease that had already caused a problem such as a heart attack.

Sean Harper, executive vice president at Amgen, added: 'This is a game changer for high-risk patients'.

Researchers had the participants continue with their statins while half were given injectable Repatha and the other half given a placebo.

In order to reach their findings, the researchers conducted the study on around 27,564 patients, out of which almost 80 percent of them had suffered from a heart attack.

In addition, the patients treated with evolocumab had a 15 per cent reduction in the risk of major cardiovascular events, defined as cardiovascular death, myocardial infarction, stroke, hospitalisation for unstable angina, or coronary revascularisation. The benefits were seen across all subtypes of patients, even in those who started with low levels of cholesterol. There were no additional side effects beyond those seen with statins alone.

Last May NHS watchdog NICE approved Repatha and a similar drug called Praluent on the basis of early trials.

Evolocumab is part of a new class of drugs called PCSK9 inhibitors, which are monoclonal antibodies that help lower cholesterol.

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.

Sabatine said that evolocumab, which costs about $14,000 a year, has been on the market for about two years now. Statins cost only £20 a year per patient.

'These results, I think, will mean the guidelines are adjusted slightly, but unless the price comes down it won't mean we give it to anyone by any means'.

"In general, the drugs will probably be reserved for patients at high risk who will have a bigger treatment effect", Stone said.

The upshot? The data showed that the lower LDL goes, the lower CV risks go, and extremely low LDL levels aren't unsafe.

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