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May 26th, 2017

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Powerful heart drug sharply cuts risk for cardiac patients on statins

 Lenny Bernstein

By Lenny Bernstein The Washington Post

Published March 20, 2017

Balaam and Dostoevsky

People taking statins for heart disease saw major benefits when doctors added a powerful, newer drug to their treatment regimen, according to a major study released at the start of an American College of Cardiology conference in Washington.


The addition of the cholesterol-busting drug evolocumab, from a class known as PCSK9 inhibitors, reduced the risk of deaths, heart attacks, strokes and hospitalization for chest pain, according to a team of researchers from around the globe, who also published their results Friday in the New England Journal of Medicine.


Evolocumab works by lowering LDL, or "bad" cholesterol. The researchers found an average decline of 59 percent in LDL levels among the 14,000 people in 49 countries who were put on the drug for 48 weeks, when compared with an almost identical number of patients who received a placebo.


And when the researchers looked at the most serious possible outcomes for heart patients - deaths, heart attacks and strokes - the study showed a 20 reduction of those events.


"The data from our trial provide insight into the benefit of decreasing LDL cholesterol levels to median levels lower than those in previous trials," wrote the researchers, led by Marc Sabatine of Brigham and Women's Hospital in Boston.


A second study of another PCSK9 inhibitor, bococizumab, was much less successful and was terminated, they reported Friday. It showed widely varying effects on LDL cholesterol levels and had no benefit for people with LDL levels below 100, although patients with higher LDL levels did see significant benefits. Pfizer, the drug's manufacturer, halted development of bococizumab in November.


The evolocumab study was funded by Amgen, the pharmaceutical company that makes the drug, which is marketed as Repatha. Amgen announced in February that the drug was a success, but details of the research were not released until Friday.


The Food and Drug Administration approved the first PCSK9 inhibitors in 2015, but only for people with heterozygous familial hypercholesterolemia, an inherited disorder that can severely elevate LDL levels, or for patients who have had heart attacks and other serious cardiovascular problems but still cannot reach target LDL levels using statins.

Taken by injection, PCSK9 inhibitors cost about $10,000 a year, far more than statins, which are now available in generic form and are in millions of home medicine cabinets around the world. But some people cannot take them without significant side effects such as muscle pain, and in most people they do not lower LDL cholesterol as significantly as the new drugs.


The average age of the patients in the study was 63, and three-quarters of them were men. More than 80 percent had suffered heart attacks, and some had histories of stroke and peripheral artery disease. Nearly all were taking modest or large doses of statins.


The researchers found no safety issues among those who were given PCSK9 inhibitors.

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