A new class of cholesterol-reducing drugs has been shown in experimental studies to reduce the risk of cardiovascular events such as heart attack and stroke by roughly 50 percent compared to standard treatment. The drugs, known as PCSK9 inhibitors, have been shown in numerous clinical trials to substantially lower levels of “bad” LDL cholesterol in the bloodstream. Standard treatments for cholesterol range from changes in diet to drugs, like statins.
The results were presented at the annual meeting of the American College of Cardiology. Unlike traditional statins, which block the production of LDL cholesterol in the liver, PCSK9 inhibitors are antibodies that target the PCSK9 protein responsible for maintaining LDL cholesterol in the bloodstream. The most common (but still rare) side-effects have been neurocognitive problems, such as confusion, which the FDA said should be closely monitored to ensure that these are not more severe than anticipated.
Dr. Marc Sabatine, lead investigator for Amgen Inc’s PCSK9 clinical study, said that results for the drugs were
very consistent… it appears that cutting LDL by 61 percent translates to a roughly 50 percent reduction in cardiovascular events.”
The FDA is expected to decide on approval for the drug being developed by Sanofi SA and Regeneron Pharmaceuticals, Praluent, by July 24. The regulatory deadline for Amgen’s Repatha is August 27. Definitive data for both drugs are not expected until the conclusion of larger trials in 2017. The drugs are intended for patients who cannot tolerate other drugs, those whose cholesterol is not controlled by other drugs, and people with a genetic predisposition for high cholesterol.
Read more here- “Experimental cholesterol drugs cut heart risk, but questions remain,” (Deena Beasley, Reuters)