Medicines Co drug shows long-term cholesterol lowering in studyBy Sheila Mcguire Mar 21, 2017
Excitement about the drug has been building over the last three years, with scientists predicting it had the power to "switch off" heart disease.
The best dose turned out to be 300 mg given three months apart, which cut LDL-c by around 45% at nine months, and there have been no additional concerns about safety after the fatal heart attack in one patient reported previous year. However, there are various other types of drugs which are prescribed to patients suffering from high cholesterol.
It shows that for every 74 people given the drug for two years with statins, one heart attack, stroke or death would be prevented.
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.
ACC scientific program chair Jeffrey Kuvin, MD, called the trials results game changing but, turning to those devilish details, he added, "The question is, is it going to be actually able to change practice".
The drug reduced the rate of heart attacks 27 percent, stroke 21 percent, and stents and heart bypass procedures 22 percent.
The study, in the New England Journal of Medicine, tested Repatha on patients in 49 countries, 1,500 in Britain.
After an initial injection of 300 milligrams of inclisiran and another three months later, the drug is created to be taken just twice a year. Most had had a prior heart attack or stroke.
Benefits continued to accrue through the median 2.2 years of the study and the risk reduction grew over time, from 16% in the first year to 25% beyond the first year.
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The Amgen study, known a FOURIER, did demonstrate a statistically significant cardiovascular benefit for patients treated with Repatha, part of a new class of injected cholesterol lowering drugs known as PCSK9 inhibitors.
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. Doctors say some patients have had trouble getting a new cholesterol-lowering drug, Repatha, that costs $14,000 a year, because of the restrictions.
Stein noted that "these are the lowest lipid levels that have been achieved in a randomized controlled trial, I'm not surprised that it's not a ideal predictive relationship".
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.
Amgen also figures the numbers are impressive enough to make previously reluctant payers take notice, and the company is planning some new proposals, including that refund offer, that will put the Fourier data to work in payer negotiations.
Statins are now the standard treatment for high cholesterol, combined with exercise and healthy diet, as they reduce levels in the blood and therefore help to prevent heart attacks and stroke. Amgen estimates that about 11 million Americans are eligible to take the drug.
Others said they expected more from the $14,000-a-year drug.
Price could provide a stumbling block however. But in the Mizuho Securities conference call, participants agreed that a reasonable estimate of the direct hospital cost of treating a stroke is around $20,000 to $40,000, while the total lifetime costs are about $100,000 for an elderly patient, and up to $500,000 for a young 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.
But Dr Marc Sabatine of Harvard, who led the trial, said doctors should start to target cholesterol far more aggressively.
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