A cholesterol-lowering PCSK9 inhibitor has shown that it significantly reduced the chance that a high-risk patient would have a heart attack or stroke by 20%, according to a study published in the New England Journal of Medicine, and presented at the annual meeting of the American College of Cardiology.
Amgen announced that the evolocumab (Repatha) cardiovascular outcomes study, FOURIER, established for the first time that maximally reducing low-density lipoprotein cholesterol (LDL-C) levels with evolocumab, beyond what is possible with the current best therapy alone, leads to a further reduction in major cardiovascular events, including heart attacks, strokes and coronary revascularizations.
“This is the first cardiovascular outcomes trial assessing a PCSK9 inhibitor. Fourier was designed to see whether or not events could be reduced with LDL-C reduction from evolocumab,” says Seth J. Baum, MD, FACC, FACPM, FAHA, FNLA, FASPC, president, American Society for Preventive Cardiology. “The answer is yes.”
FOURIER evaluated more than 27,000 individuals with a history of atherosclerotic cardiovascular disease (ASCVD) and requiring greater LDL-C reduction on maximally tolerated statin therapy. The median baseline LDL-C was 92 mg/dL. On evolocumab, subjects decreased their LDL-C to a median of 30 mg/dL. The study met both composite primary and secondary end points. There was a statistically significant reduction in the composite of non-fatal heart attacks, strokes, and cardiovascular death.
“FOURIER demonstrates unequivocally that reducing the LDL-C of high-risk individuals can save people from experiencing heart attacks and strokes,” says Baum. “The lower the LDL, the better. This occurred safely and without any significant adverse events from evolocumab.
“Payers need to follow the package insert for evolocumab and start approving the medication when doctors prescribe it for their patients,” Baum says. “If payers continue to create barriers to access, they will be withholding a drug that can decrease heart attacks and strokes.”