PCSK9 inhibitor impacts plaque progression in phase 3 imaging study
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News - Sep. 20, 2016The Phase 3 GLAGOV (GLobal Assessment of Plaque ReGression with a PCSK9 AntibOdy as Measured by IntraVascular Ultrasound) trial evaluating the effect of evolocumab on coronary artery disease (CAD) met its primary and secondary endpoints. The GLAGOV study is a large serial coronary intravascular imaging trial designed to test whether treatment with the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor evolocumab modifies atherosclerotic plaque build-up in the coronary arteries of patients already treated with optimised statin therapy.
"We are pleased with the positive results of this landmark study showing that evolocumab modifies the underlying process of atherosclerosis," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen.
GLAGOV is a Phase 3, multicenter, double-blind, randomised, placebo-controlled trial evaluating the impact of evolocumab on coronary atheroma volume in 968 patients with CAD receiving optimised statin therapy and undergoing coronary catheterisation. Patients were randomised to receive either monthly evolocumab 420 mg or placebo subcutaneous injections.
The primary endpoint was change in percent atheroma volume (PAV) from baseline to week 78 compared to placebo, as determined by intravascular ultrasound (IVUS). Secondary endpoints included PAV regression (any reduction from baseline); change in total atheroma volume (TAV) from baseline to week 78; and regression (any reduction from baseline) in TAV.
No new safety concerns were identified in the GLAGOV trial. The incidence of treatment-emergent adverse events was comparable among both groups.
Detailed results from the Phase 3 GLAGOV trial will be presented during the upcoming American Heart Association (AHA) Scientific Sessions 2016 on Tuesday, Nov. 15, 2016.
Press release Amgen Sept 20, 2016
"We are pleased with the positive results of this landmark study showing that evolocumab modifies the underlying process of atherosclerosis," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen.
GLAGOV is a Phase 3, multicenter, double-blind, randomised, placebo-controlled trial evaluating the impact of evolocumab on coronary atheroma volume in 968 patients with CAD receiving optimised statin therapy and undergoing coronary catheterisation. Patients were randomised to receive either monthly evolocumab 420 mg or placebo subcutaneous injections.
The primary endpoint was change in percent atheroma volume (PAV) from baseline to week 78 compared to placebo, as determined by intravascular ultrasound (IVUS). Secondary endpoints included PAV regression (any reduction from baseline); change in total atheroma volume (TAV) from baseline to week 78; and regression (any reduction from baseline) in TAV.
No new safety concerns were identified in the GLAGOV trial. The incidence of treatment-emergent adverse events was comparable among both groups.
Detailed results from the Phase 3 GLAGOV trial will be presented during the upcoming American Heart Association (AHA) Scientific Sessions 2016 on Tuesday, Nov. 15, 2016.
Press release Amgen Sept 20, 2016
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