A powerful cholesterol drug cuts the risk of heart attacks by a quarter, a landmark trial has found.
Bad cholesterol is the main culprit in the heart world. Since PCSK9 is a protease that breaks down the LDL receptor, itself the major clearance mechanism for cholesterol from the blood, blocking PCSK9 increases the level of LDL receptor and therefore dramatically reduces circulating cholesterol, and in particular the triglyceride-rich lipoproteins, such as LDL, that are implicated in causing cardiovascular disease.
Fuster also noted that in absolute numbers, the drug saved about two percent of lives.
The company collaborated with several institutions, including Brigham and Women's Hospital in Boston and Imperial College London, to enroll about 27,000 patients with a history of cardiovascular disease who were already taking statins.
"This is one of the most important trials of cholesterol-lowering since the first statin trial, published 20 years ago", said Professor Peter Sever, from the National Heart and Lung institute at Imperial, who led the United Kingdom arm of the trial involving 1,500 patients across 75 centers.
Peter Bach, for instance, director of the Center for Health Policy and Outcomes at Memorial Sloan-Kettering, emphasized that the number of CV events prevented would be too small for payers to save much money.
However, Prof Sever said: "They will probably not [replace statins], there are an very 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". JP Morgan also had the opportunity to speak with several doctors at the conference who further confirmed its view that, while Repatha is clearly a safe and effective drug, penetration may (at least in the near term) remain confined to more advanced patients, potentially making it hard to meet prevailing commercial expectations (details below).
Repatha cut by 20 percent the combined risk of having either a heart attack, stroke or a heart-related death.
"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". "There are a lot of people already on optimal doses of statins who have levels of cholesterol that could be lowered further", explained Professor Sever.
'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'.
Last May NHS watchdog NICE approved Repatha and a similar drug called Praluent on the basis of early trials. Amgen estimates that about 11 million Americans are eligible to take the drug.
However, some heart experts question whether the pricey medications, one of which costs roughly $14,000 a year to take, perform well enough to make them worth the extra money.
Price could provide a stumbling block however.
"This is very expensive stuff", said Valentin Fuster, physician in chief at Mount Sinai Medical Hospital in NY. That happened to almost 6 percent of people on Repatha versus more than 7 percent on the dummy drug.
'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'.
Reacting to the offer, multiple doctors were mostly critical about the deal, stating that it may be a lose-lose situation for both the patient and their insurance provider.
'We now have definitive data that by adding evolocumab to a background of statin therapy, we can significantly improve cardiovascular outcomes and do so safely, ' he said.
However, new drug evolocumab changes the way the liver works to also cut bad cholesterol.
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