New Cholesterol Inhibitor Drug, PCSK9, Shows a Lot of Promise, Study  

The drugs, known as PCSK9 inhibitors had doctors calling the result “encouraging” at the annual meeting of the American College of Cardiology, where the studies were presented.

A study of about 4,500 patients with continuous treatment for almost a year after completion of earlier trials of Amgen Inc’s Repatha concluded that 0.95% of patients given the drug and standard therapy suffered a cardiovascular event, compared with 2.18% of the group receiving standard treatment, which ranged from dietary changes to drugs such as statins.

A cardiovascular “event” in the study is define as death, heart attack, stroke or “mini-stroke,” unstable chest pain or heart failure requiring hospitalization, or the need for a procedure to restore blood flow to the heart.

Side effects in patients treated with Repatha includes neurocognitive problems – something the US Food and Drug Administration said should be monitored closely.

Amgen’s head of cardiovascular and metabolic therapies, Scott Wasserman, told Reuters, “We have been looking at this throughout our clinical program.   We have not identified what we believe is a safety issue.”

A rival PCSK9 drug being developed by Sanofi SA and Regeneron Pharmaceuticals Inc.  neurocognitive side effects were also more common in the treatment arm of an 18-month, 2,300-patient trial .

The drug, Praluent, was shown to reduce the risk of cardiovascular problems from 3.3% for placebo patients to 1.7% for the treatment group. “Events” in this trial were defined only as death, heart attack, stroke and chest pain requiring hospitalization.



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