Published: Tue, March 21, 2017
Health Care | By Kelly Miles

Evolocumab, added to statins may help lower cholesterol

Evolocumab, added to statins may help lower cholesterol

If all 325,000 eligible people in the United Kingdom were to be treated, 2,200 potentially fatal heart emergencies would be avoided every year. After diving deeper into the data, we think it will be sufficient to change treatment guidelines, and our assumptions for net USA prices-going from roughly $10,000 today to $8,000 annually over the next couple of years as payers loosen restrictions-still hold.

Amgen presented the detailed results from EBBINGHAUS at a Late-Breaking Clinical Trials Session at the American College of Cardiology 66th Annual Scientific Session in Washington, D.C. 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.

The study, also published in the prestigious New England Journal of Medicine, involved testing Repatha on patients in 49 countries, 1,500 of them in Britain.

Repatha shots are given once or twice in a month while patients take statins regularly. Dr. Hlatky says the biggest issue is whether the cut heart attacks and strokes enough to be worth the higher price.

This reduction in risk improved over time, increasing from 16 per cent in the first year to 25 per cent after the first year, the researchers said. The agency authorized its use when accompanied by a healthy diet and a statins treatment in patients with Homozygous Familial Hypercholesterolemia (HoFH), Atherosclerotic Cardiovascular Disease, and people in need of reducing their LDL cholesterol levels.

The benefit of Repatha was seen on those tested within six months. Despite this, the patients who took evolocumab saw their bad cholesterol levels fall even further.

"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".

Heart disease and stroke are the number one killers worldwide, taking 15 million lives in 2015, according to the World Health Organization.

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But Amgen is willing to cut a deal with payers who will drop barriers to coverage which have limited Repatha's commercial success to date.

Inclisiran belongs to a new class of medicines that block a protein known as PCSK9, which prevents the removal of LDL from the blood.

Overall 325,000 in Britain are eligible, although only a few have yet been given the drugs.

A second study of another PCSK9 inhibitor, bococizumab, was much less successful and was terminated, they reported Friday.

Nearly 14,000 patients were recruited to the treatment arm of the study, receiving the drug over a 48-week period. Statins cost only £20 a year per patient. He noted that access to Repatha and other similar drugs has mostly been hard, which he believes is a "critically important" issue, as there may be millions of people considering taking these drugs for their heart problems. We think stronger uptake will follow guideline and prescribing label changes (which should push payers to open access), as well as new risk-sharing contracts with payers (which will likely imply a lower net price). "We have another tool to significantly reduce heart attacks and stokes", said Sabatine from Brigham and Women's Hospital in Boston. A quarter of the people on the new drug had LDL level 19.

Professor Sir Nilesh Samani, medical director at the British Heart Foundation, said the trial was a 'significant advance, ' adding: 'While statins have had a significant impact in reducing the risk of heart disease for millions of people, they are not tolerated by everyone and only reduce cholesterol by a certain amount'.

The investigation arose after the drug was approved by the U.S. Food and Drug Administration before making a deep study including real patients.

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