In a large, long-term clinical trial evolocumab reduced heart risk.
Adding the PCSK9 inhibitor evolocumab (Repatha/Amgen) to statin therapy reduced by 15% the incidence of major adverse cardiovascular events in patients with vascular disease.
In a late-breaking clinical trial presented today at the American College of Cardiology Scientific Sessions in Washington, DC, a study known as FOURIER, researchers formally presented detailed results that elaborated on the basic findings already announced by Amgen.
A second study of the drug known as EBBINGHAUS, dealing with the drug’s impact on cognitive function in these patients will be presented at the meeting March 18.
The international FOURIER study enrolled patients with high cholesterol (LDL-C of greater than 70 mg/dL) or non-high-density lipoprotein cholesterol of greater than 100 mg/dL as well as clinically evident cardiovascular disease.
It was conducted at 1,272 study locations. Patients got Repatha subcutaneous 140 mg every two weeks plus a statin. A placebo group whose members got only the statin.
Researcher Marc Sabatine, MD, of Brigham and Women’s Hospital in Boston and colleagues said 27, 564 patients were enrolled with a mean age of 62.5 years and 75% of them were men.
Most (81%) had a history of myocardial infarction.
At 48 weeks, according to research results published in the New England Journal of Medicine, “relative to placebo evolocumab treatment reduced the risk of the primary end point by 15% and the key secondary end point by 20% across key subgroups.
The primary endpoint was the composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization.
“The data from our trial provide insight into the benefit of decreasing LDL cholesterol levels to median levels lower than those in previous trials,” the team wrote.
A relatively new class of drugs, PCSK9 or subtilisin--kexin9, inhibit a protein associated with the uptake of cholesterol by the liver. It is used mostly for patients who are resistant to statins or who cannot tolerate them. It is also used to treat patients with familial hypercholesterolemia, a genetic condition that results in dangerously high levels of cholesterol.
In the FOURIER study, the drug taken along with with statin therapy reduced LDL cholesterol levels to a median of 30 mg per deciliter and reduced the risk of cardiovascular events.
The results were highly anticipated, the ACC noted in a news release, because of the size and length of the trial.
Evolocumab was approved by the US Food and Drug Administration in 2016.