The Phase 3 GLAGOV (Global assessment of plaque regression with a PCSK9 antibody as measured by intravascular iltrasound) trial has met both its primary and secondary endpoints. The study is a large serial coronary intravascular imaging trial that is designed to test whether treatment with the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor evolocumab (Repatha, Amgen) modifies atherosclerotic plaque build-up in the coronary arteries of patients already treated with optimised statin therapy. Detailed results of the trial be presented at the 2016 American Heart Association scientific sessions (12–16 November, New Orleans, USA).
A press release reports that GLAGOV is a Phase 3, multicentre, double-blind, randomised, placebo-controlled trial evaluating the impact of evolocumab on coronary atheroma volume in 968 patients with coronary artery disease receiving optimised statin therapy and undergoing coronary catheterisation. Patients were randomised to receive either monthly evolocumab 420mg or placebo subcutaneous injections
The primary endpoint was change in percent atheroma volume from baseline to week 78 compared to placebo, as determined by intravascular ultrasound (IVUS). Secondary endpoints included percent atheroma volume regression (any reduction from baseline); change in total atheroma volume from baseline to week 78; and regression (any reduction from baseline) in total atheroma volume.
Further to the study’s positive top-line results, no new safety concerns were identified in the GLAGOV trial. The incidence of treatment-emergent adverse events was comparable among both groups.
Sean E Harper, executive vice president of Research and Development at Amgen, comments: “We are pleased with the positive results of this landmark study showing that Repatha modifies the underlying process of atherosclerosis. We strongly believe in the potential of Repatha to aid in the fight against cardiovascular disease, and we are excited to share these data with the scientific community at the AHA Scientific Sessions.”