Amgen announced positive topline results from the Phase 3 GLAGOV trial evaluating the effect of Repatha (evolocumab) on atherosclerotic plaque build-up in patients with coronary artery disease (CAD) receiving optimized statin therapy and undergoing coronary catheterization.
GLAGOV (GLobal Assessment of Plaque ReGression with a PCSK9 AntibOdy as Measured by IntraVascular Ultrasound) is a multicenter, double-blind, randomized, placebo-controlled, serial coronary intravascular imaging trial designed to measure the impact of Repatha treatment on coronary atheroma volume in 968 CAD patients undergoing cardiac catheterization and on optimized background statin therapy. Patients either received Repatha 420mg SC once a month or placebo injections. The primary endpoint was change in percent atheroma volume (PAV) from baseline to Week 78 vs. placebo, as determined by intravascular ultrasound (IVUS), a high-resolution imaging tool that allows for the quantification of coronary atheroma in the coronary arteries. Secondary endpoints included change in total atheroma volume (TAV) from baseline to Week 78 and regressions in the PAV and TAV (any reduction from baseline).
Preliminary data analysis showed that the study met both its primary and secondary endpoints. The GLAGOV trial is the first study to demonstrate that treatment with aproprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor to lower LDL cholesterol results in favorable outcomes on underlying atherosclerotic disease on top of optimized statin therapy. Detailed results from the study will be presented at the American Heart Association (AHA) Scientific Sessions 2016.
Repatha, a PCSK9 inhibitor, is currently indicated as adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic CV disease, who require additional lowering of LDL cholesterol. It is also indicated as adjunct to diet and other LDL-lowering therapies, in patients with homozygous familial hypercholesterolemia (HoFH) requiring additional lowering of LDL-C.
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