Evolocumab regresses atherosclerosis in CAD
Adding evolocumab to optimised statin therapy results in statistically significant regression of atherosclerosis in patients with coronary artery disease, according to results from the GLAGOV phase 3 trial.
The study evaluated whether the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor) would modify atherosclerotic plaque build-up in the coronary arteries of patients already treated with optimised statin therapy, as measured by intravascular ultrasound (IVUS) at baseline and week 78.
Treatment with evolocumab resulted in a statistically significant regression from baseline in percentage atheroma volume (PAV), which is the proportion of arterial lumen occupied by plaque. Patients in the evolocumab arm had a 0.95% decrease vs baseline in PAV compared with an increase of 0.05% vs baseline in patients receiving optimised statin therapy plus placebo (p0.0001). In addition, adding evolocumab yielded plaque regression in PAV for a greater percentage of patients than for those receiving placebo (64.3 % vs 47.3%, respectively, p0.0001).
Patients in the evolocumab arm had a mean decrease in normalised total atheroma volume (TAV), which is a measure of plaque volume, of 5.8mm³ compared with 0.9mm³ seen in the placebo arm (p0.0001). Additionally, adding evolocumab gave plaque regression in TAV for a greater percentage of patients than placebo (61.5% versus 48.9%, respectively, p=0.0002).
“Based on previous studies, we did not know if the study would show additional plaque regression at LDL-C levels 1.55 mmol/L (60 mg/dL),” said Stephen Nicholls, Professor of Cardiology (South Australian Health & Medical Researc Institute, Adelaide, Australia). “One of the most compelling results is the continued reduction of plaque at LDL-C levels well below commonly accepted thresholds.”
No new safety concerns were identified with the incidence of treatment-emergent adverse events being comparable among both groups.
The study shows that LDL-C reduction with a PCSK9 inhibitor can regress coronary atherosclerotic disease compared to statins alone.
Nicholls SJ, et al. Effect of evolocumab on progression of coronary disease in statin-treated patients: The GLAGOV randomised clinical trial. JAMA 2016, published online 13 December www.ncbi.nlm.nih.gov/pubmed/27846344
Evolocumab summary of product characteristics available at: www.medicines.org.uk/emc/medicine/30627