THOUSAND OAKS, CA — Evolocumab (Repatha, Amgen), a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor for lowering LDL cholesterol, effectively modifies atherosclerotic plaque buildup in coronary arteries of patients when added to optimized statin therapy, according to top-line results announced today.
Evolocumab met its primary end point of change in percent atheroma volume (PAV) from baseline to week 78 compared with placebo, as determined by intravascular ultrasound, in the GLAGOV trial involving 968 patients with coronary artery disease, according to the announcement.
Secondary end points, also met, included any PAV reduction from baseline, change in total atheroma volume (TAV) from baseline to week 78, and any reduction in TAV.
In the phase 3 multicenter double-blind trial, CAD patients who were receiving optimized statin therapy and were undergoing coronary catheterization were randomized to either monthly evolocumab 420 mg or placebo subcutaneous injections.
Researchers identified no new safety concerns in the trial, with treatment-emergent adverse events comparable between groups.
Amgen is scheduled to present detailed results at the American Heart Association 2016 Scientific Sessions in November.
Evolocumab is one of two recently approved PCSK9 inhibitors for hypercholesterolemia. The other is alirocumab (Praluent, Sanofi/Regeneron).
In a recently published study previously covered by heartwire from Medscape, researchers questioned the cost-effectiveness of the two drugs for lowering LDL cholesterol.
The National Heart, Lung, and Blood Institute supported this research. The authors reported no relevant financial relationships.
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Heartwire from Medscape © 2016 Medscape, LLC
Cite this: Evolocumab Slows Coronary Plaque Growth by IVUS: Top-line Results - Medscape - Sep 20, 2016.