New drug breakthrough dramatically cuts cholesterol
Mar 21 2017
The Amgen drug and a similar one, sold by Sanofi and Regeneron, were approved by the U.S. Food and Drug Administration in 2015 with the hope - and expectation - that they would lower the risk of heart attacks and strokes, and not just reduce levels of LDL cholesterol, the unsafe kind.
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". Therefore, in order to find out if the claims held some truth, a study was conducted to note the effects of this new drug sponsored by Amgen, the maker of Repatha. Dr. Donald Lloyd-Jones, preventive medicine chief at Northwestern University and an American Heart Association spokesman, called the results modest and "not quite what we hoped or expected".
The results of the large global trial of a drug on 27,000 patients means the drug could soon be used by millions, reports the foreign media.
It shows that for every 74 people given the drug for two years with statins, one heart attack, stroke or death would be prevented.
How Effective Is Repatha In Lowering Cholesterol Levels?
But for some people statins are not strong enough to reduce their levels, meaning the risk to their heart remains.
Stubbornly high cholesterol is a key risk factor.
And if guidelines are changed on the back of the new results, thousands more could benefit. The detailed results from EBBINGHAUS were presented at a Late-Breaking Clinical Trials Session at the American College of Cardiology 66th Annual Scientific Session (ACC.17) in Washington, D.C. He suggests that high-risk patients, or those who can't tolerate statins, talk to their doctor about possibly taking the cholesterol drug as an alternative.
The average age of the patients in the study was 63, and three-quarters of them were men.
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. 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.
There was also a statistically significant 15 per cent reduction in the risk of the extended MACE composite endpoint, which included hospitalization for unstable angina, coronary revascularization, heart attack, stroke or cardiovascular death. Despite this, the patients who took evolocumab saw their bad cholesterol levels fall even further. There were no additional side effects beyond those seen with statins alone. The drugs work by blocking a protein that affects the liver's ability to remove cholesterol from the blood.
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 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.
But Harvard's Dr Marc Sabatine, who led the trial, said high cholesterol must be treated "more aggressively, and now we have a new validated means to do so".
Prof Sir Nilesh Samani, the medical director at the British Heart Foundation, said: "This trial is a significant advance".
The upshot? The data showed that the lower LDL goes, the lower CV risks go, and extremely low LDL levels aren't unsafe.