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Evolocumab regresses atherosclerosis in CAD

Evolocumab regresses atherosclerosis in CAD

Publication date: Wednesday, 04 January 2017
Contributor(s): Jeremy Bray

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. 

ACTION

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

Topics covered:
Category: Evidence in Practice
Edition: Volume 1 Number 12 PCCJ Online 2016
Contributor(s): Jeremy Bray

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