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GLAGOV imaging study of evolocumab meets primary, secondary endpoints
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Amgen announced that the GLAGOV trial evaluating the effect of evolocumab on CAD has met its primary and secondary endpoints.
Data from the phase 3 study will be presented at the American Heart Association Scientific Sessions in November, the company stated in a press release.
The multicenter, double blind, randomized, placebo-controlled trial consisted of 968 patients on optimized background statin therapy undergoing cardiac catheterization. The patients were randomly assigned to a regimen of evolocumab 420 mg (Repatha, Amgen) or placebo monthly subcutaneous injections, according to the release.
The primary endpoint of the trial was percentage percent atheroma volume change at baseline as determined by IVUS between baseline and 78 weeks compared with placebo.
Secondary endpoints included reduction from baseline in percent atheroma volume regression, change in total atheroma volume from baseline to 78 weeks and regression in total atheroma volume from baseline.
The incidence of treatment-emergent adverse events was comparable between those treated with evolocumab and placebo, and there were no new safety concerns, according to the release.
“We are pleased with the positive results of this landmark study showing that Repatha modifies the underlying process of atherosclerosis,” Sean E. Harper, MD, executive vice president of Research and Development at Amgen, said in the release. “We strongly believe in the potential of Repatha to aid in the fight against [CVD], and we are excited to share these data with the scientific community at the AHA Scientific Sessions.”
Disclosure: Harper is an employee of Amgen.