Evolocumab significantly reduces LDL-C in ACS patients: JACC

Switzerland: Evolocumab, potent low-density lipoprotein cholesterol-lowering drug, may cause early reduction of LDL-cholesterol levels in patients with acute coronary syndromes (ACS), finds a recent study published in the Journal of the American College of Cardiology.

The finding is significant as while in-hospital initiation of high-intensity statin therapy is recommended in patients with acute coronary syndromes, target levels of low-density lipoprotein cholesterol are frequently not attained.

Evolocumab, a fully human monoclonal antibody that inhibits PCSK9, has not been studied in the acute phase of acute coronary syndrome. Konstantinos C. Koskinas, Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Switzerland, and colleagues assessed the feasibility, safety, and LDL-C lowering efficacy of evolocumab initiated during the in-hospital phase of ACS.

The trial involved 308 patients hospitalized for ACS having increased levels of low-density lipoprotein cholesterol on a high-intensity statin for four weeks. They were randomly assigned in the ratio 1:1 to receive subcutaneous evolocumab 420 mg or matching placebo, administered in-hospital and after 4 weeks, on top of atorvastatin 40 mg. Most patients (78.2%) had not been on previous statin treatment.

The primary endpoint was the percentage change in calculated LDL-C from baseline to 8 weeks.

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Key findings include:

• Mean Low density lipoprotein cholesterol levels decreased from 3.61 mmol/L to 0.79 mmol/L at week 8 in the evolocumab group, and from 3.42 mmol/L to 2.06 mmol/L in the placebo group; the difference in mean percentage change from baseline was -40.7%.


• LDL-C levels <1.8 mmol/L were achieved at week 8 by 95.7% of patients in the evolocumab group vs. 37.6% in the placebo group.


• Adverse events and centrally adjudicated cardiovascular events were similar in both groups.

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These findings suggest that evolocumab is well-tolerated and highly effective at lowering low-density lipoprotein cholesterol levels below target levels in ACS patients.

"In this first randomized trial assessing a PCSK9 antibody in the very high-risk setting of ACS, evolocumab added to high-intensity statin therapy was well tolerated and resulted in a substantial reduction in low-density lipoprotein cholesterol levels, rendering >95% of patients within currently recommended target levels," concluded the authors.

To read the complete study log on to DOI: 10.1016/j.jacc.2019.08.010