In FOURIER, 27,500 patients were enrolled into the trial and randomly allocated to treatment with either an optimised regimen of statin drugs or statins plus Repatha.
Researchers from Imperial College London in the United Kingdom and colleagues, who conducted the trial, said the twice-a-year treatment could be safely given with or without statins, depending on individual patient needs.
While doctors said they were relieved that Repatha is safe, doctors such as David Rind said they had hoped the study would show that the injectable medication reduces heart attacks and other serious complications by 30 percent or more, given its success in early studies. The sanction was done without any evidence it showed great results in reducing cholesterol.
In all, Krumholz believes that Amgen did a "solid" job with its study and getting Repatha to market, despite the new questions posed.
It shows that for every 74 people given the drug for two years alongside statins, one heart attack, stroke or death would be prevented.
However, Prof Sever said: "They will probably not [replace statins], there are an bad lot of people with really quite high cholesterol out there and we'll probably need more than one drug to get their levels down".
A powerful cholesterol drug cuts the risk of heart attacks by a quarter, a landmark trial has found. Those on the highest tier might include specialty medicines that could cost the patient hundreds of dollars even with coverage.
And if guidelines are changed on the back of the new results, thousands more could benefit.
Amgen Inc. presented detailed data for the FOURIER cardiovascular outcomes trial of its Repatha (evolocumab) at the American College of Cardiology (ACC) annual meeting today. About 10% of patients taking the drug had a heart attack or stroke, or died of heart disease during the trial. Half of these patients were given optimal quantity of statins along with Repatha, and the other half were given a placebo.
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Those who took both were less likely to suffer a heart attack or stroke than if they took statins alone. In fact, the magnitude of the risk reduction in the hard MACE composite endpoint grew over time, from 16 percent in the first year to 25 percent beyond the first year.
On Friday, for the first time, we saw the full data from the FOURIER clinical trial of Amgen's cholesterol-lowering antibody, evolocumab (Repatha™).
The benefit of Repatha was seen on those tested within six months. We also asked patients and their physicians to provide their assessments and found no differences between evolocumab and placebo.
The drugs work by blocking a protein that affects the liver's ability to remove cholesterol from the blood.
Heart disease and stroke are the number one killers worldwide, taking 15 million lives in 2015, according to the World Health Organization.
Nearly 14,000 patients were recruited to the treatment arm of the study, receiving the drug over a 48-week period. 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.
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.
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 EBBINGHAUS study, a double-blind, placebo-controlled randomized non-inferiority trial, included a cohort of 1,204 patients.