Published: Tue, March 21, 2017
Medicine | By Daryl Nelson

Amgen's Repatha cardio data fails to impress

Amgen's Repatha cardio data fails to impress

Now, this new phase 2 clinical trial has confirmed the effectiveness of injecting inclisiran for reducing cholesterol that can be taken alone or potentially combined with statins for maximum effect.

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". It is why millions of people take drugs called statins to reduce the amount of bad cholesterol.

The results of a large global trial on 27,000 patients paved the way for the drug to become available to millions of people.

It shows that for every 74 people given the drug for two years alongside statins, one heart attack, stroke or death would be prevented.

"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".

Repatha, administered by patients via an injection pen, blocks a protein that interferes with the liver's ability to remove cholesterol from the blood. It shows in high risk patients, there's no number. Speaking with the BBC, following trials, the lead scientist behind the new study Professor Peter Sever, who works at Imperial College London, said: "It is much more effective than statins", adding: "The end result was cholesterol levels came down and down and down and we've seen cholesterol levels lower than we have ever seen before in the practice of medicine".

Researchers knew there was a general relationship between cholesterol levels and cardiovascular disease risk, but "there was sort of a question of whether, when you get to very low [cholesterol] levels, that relationship would fall off", says William Hiatt, a physician specializing in vascular medicine at the University of Colorado in Denver and a member of an FDA advisory committee that reviewed the drugs.

In addition, Amgen noted that there was no statistical difference between Repatha and placebo on the other cognitive domains tested: working memory, memory function and psychomotor speed - the secondary endpoints. After a follow-up period of around two years, it showed that the risk of heart attack, stroke and coronary revascularisation was cut by 27%, 21% and 22%, respectively. Eventually, inclisiran could help to reduce the risk of heart attacks and stroke related to high cholesterol.

The investigation analyzed data from 27,000 patients, part of whom found that their low-density lipoprotein (LDL) cholesterol levels went down by around 60 percent.

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Inclisiran can reduce cholesterol by an additional 30 percent to 50 percent on top of statins, Ray's team found.

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

But, it has been created to target a protein in the liver with the name PCSK9.

The cost varies, but it is thought to cost the UK's NHS about £2,000 per year per patient where it is already being given to people who do not respond to statins.

Sabatine said that evolocumab, which costs about $14,000 a year, has been on the market for about two years now.

Now that the data on evolocumab are in, some health-care payers such as insurance companies and government programmes might be more willing to shoulder the treatment's steep cost.

'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'.

British Heart Foundation medical director Nilesh Samani said the trial was a significant advance.

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