New cholesterol drug cuts heart attack, stroke risk more than 20%
- Author: Santos West Mar 21, 2017,
Mar 21, 2017, 0:31
Elevated levels of low-density lipoprotein (LDL) cholesterol can lead to cardiovascular disease and blood vessel blockage, leading to an increased risk heart attacks and stroke in patients.
At the end of the treatment period, researchers found that on average, patients taking evolocumab plus statins were able to reduce their LDL cholesterol levels by an average of 59 per cent, from 92 mg/dL to 30 mg/dL, compared to those taking placebo plus statins.
Prof Peter Sever, from Imperial College London - which led the United Kingdom branch of the study, said: "This is one of the most important trials of cholesterol-lowering since the first statin trial, published 20 years ago". Symphony Health data shows that commercial insurers rejected nearly three-fourths of PCSK9 requests a year ago, and Medicare coverage was denied at a rate of 61%.
The study conducted on the large worldwide trial on 27,000 patients indicates that the drug can be used very soon by millions of people across the world.
The Fourier trial tested Repatha in patients at high risk of a cardiovascular event, a group in which Amgen sees a high unmet need, with no real advances in treatment in more than a decade.
People with higher chances of heart attack and strokes are often advised by their doctors to reduce their cholesterol levels by adapting a healthy lifestyle and with the assistance of some common cholesterol reducing dugs.
"What this trial shows is that if you achieve these really low levels of cholesterol, you get the additional benefit, and you get that without any apparent adverse effects".
Millions of people consume drugs called statins to minimize the amount of bad cholesterol. Those on the highest tier might include specialty medicines that could cost the patient hundreds of dollars even with coverage.
The new study provides much stronger evidence that it saves lives. The question now is whether physicians and health-care payers will consider that benefit great enough to warrant the annual price tag of roughly US$14,000.
However, the findings, published in the New England Journal of Medicine, found that the drug had no impact on the rate of cardiovascular mortality.
An innovative new drug can prevent heart attacks and strokes by cutting bad cholesterol to unprecedented levels, doctors say.
The study demonstrated that the effect of Repatha on the primary endpoint of executive function was non-inferior to placebo.
Patients either took statins alone, or took Repatha - also known as evolocumab - alongside their statins.
Separately, Repatha cut heart attacks by 27 per cent and stroke by 21 per cent. Eventually, inclisiran could help to reduce the risk of heart attacks and stroke related to high cholesterol.
But, it has been created to target a protein in the liver with the name PCSK9.
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.
Amgen reported sales of $141m for Repatha last year, its first full year on the market after picking up FDA approval in August 2015, which is considered a slow start for a product once tipped to be a multibillion dollar brand.
"This [result] is probably a little less than we had been hoping for", said Rind, chief medical officer at the Boston-based Institute for Clinical and Economic Review, which evaluates drugs' cost effectiveness.
'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'.
Cardiologists have always been taught that CV patients have three risk factors that can be handled with treatment: high blood pressure, smoking and high LDL cholesterol, Levy said.
The British Heart Foundation said the results have shown considerable advancement in fighting against the biggest killer in the world.