Comments on the Glagov study
Authors:
Tomáš Kovárník; Jan Pudil; Kristýna Bayerová
Authors‘ workplace:
II. interní klinika kardiologie a angiologie 1. LF UK a VFN v Praze
Published in:
AtheroRev 2017; 2(2): 93-97
Category:
clinical studies
Overview
The GLAGOV study has asked the question whether the dramatic decreases in LDL-cholesterol levels, as demonstrated by the previous studies on evolocumab, will also lead to the decrease in volumes of coronary atherosclerotic plaques. Patients with both stable and acute forms of ischemic heart disease (unstable angina and non-ST-segment-elevation myocardial infarction) were included in the study. Coronary plaques were assessed with intravascular ultrasound and, in part of the patients, also through virtual histology in order to assess the composition of atherosclerotic plaques. There were 970 patients randomized in the study, who were treated with a stable statin dose, randomized in the ratio of 1 : 1 for the treatment with evolocumab in the subcutaneous dose of 420 mg once a month, or for placebo application for a period of 78 weeks. The primary goal was the absolute change in the relative plaque volume (percent atheroma volume – PAV). In the branch treated with evolocumab the PAV was reduced by 0.95 %, whereas in the placebo branch the PAV progressed by 0.05 %. This difference was statistically highly significant (CI 95% -1.8 to -0.64 %; p < 0.001). The secondary goal was to reach a difference in the total atheroma volume – TAVnorm. In the patients treated with evolocumab in combination with statins the TAV decreased by 5.8 mm3, whereas in the group treated only by statins it progressed by 0.9 mm3. This difference was again statistically highly significant (CI 95% -7.3 to -2.5 mm3; p < 0.001). The study has shown a statistically significant decrease in the volume of atherosclerotic plaques in the patients who had evolocumab added to their statin therapy. The study was not intended to monitor clinical consequences of these morphological changes which have been proven in the recently published FOURIER study.
Key words:
evolocumab, intravascular ultrasound, coronary atherosclerosis
Sources
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