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Evolocumab to impact coronary disease in statin-treated patients: Glasgov Trial
Overview
Coronary diseases are much fatal as the buildup of plaque in the arteries that supply oxygen-rich blood to heart creates blockage. Plaque causes a narrowing or blockage that could result in a heart attack. several medications are being tested for the same.
The GLAGOV multicenter, double-blind, placebo-controlled, randomized clinical trial sought to determine whether treatment with a PCSK9 inhibitor modifies coronary atherosclerosis disease progression, as determine by intravascular ultrasound (IVUS). Proprotein convertase subtilisin kexin (PCSK9) inhibitors produce incremental low-density lipoprotein cholesterol (LDL-C) lowering in statin-treated patients, but whether these effects slow progression or induce regression of coronary atherosclerosis has not been evaluated.
A total of 968 patients (mean age, 60 years; 72% male) presenting for coronary angiography were enrolled in this trial, which was conducted at 197 academic and community hospitals in North America, Europe, South America, Asia, Australia, and South Africa. Those with angiographic disease (20-50% stenosis in a target coronary vessel) were randomly assigned to receive monthly evolocumab 420 mg subcutaneously or matching subcutaneous placebo injection for 76 weeks, in addition to a stable, optimized statin dose.
This is the first clinical trial, according to authors to show incremental effects on regression in patients who had been treated with moderate or intensive statin therapy prior to entry into the study. It is also the first to demonstrate a reduction in atherosclerotic disease progression by IVUS for a nonstatin LDL-C-lowering therapy concluded the auhors.