Eight weeks of treatment with evolocumab added to a regimen of high-intensity statins in patients with acute coronary syndrome reduced significantly LDL cholesterol levels and was safe, compared with statins + placebo, according to the EVOPACS study presented last Saturday at the European Society of Cardiology (ESC) Congress 2019 Scientific Sessions in Paris and simultaneously published in J Am Coll Cardiol.
The clinical impact of reducing LDL cholesterol early with evolocumab initiated in the acute setting warrants further investigation, since this trial lacked statistical power to differentiate clinical events.
Both evolocumab and the other available PCSK9 inhibitor, alirocumab, are approved by the US Food and Drug Administration (FDA) for the prevention of cardiovascular events in adults with established cardiovascular disease, but not in an acute setting. EVOPACS is the first trial to test a PCSK9 inhibitor in acute patients.
In this study, researchers randomized 308 patients admitted with acute coronary syndromes (37% with ST-segment elevation myocardial infarction [STEMI]) receiving high-intensity statins to either evolocumab 420 mg as soon as possible after the index event (within 24 hours for STEMI patients and 72 hours for non-ST-segment elevation myocardial infarction [NSTEMI] patients) or placebo. About 84% of patients underwent angioplasty, 7% underwent surgery, and 9% were managed with medical therapy.
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After 8 weeks, the evolocumab group had a 40.7% greater reduction in LDL cholesterol levels compared with the placebo group.
Evolocumab also impacted other lipid measurements compared with the placebo, reducing total cholesterol by 26.5%, apolipoprotein B by 34.2%, non-HDL cholesterol by 34.6%, and triglycerides by 20%, and increasing HDL cholesterol by almost 5%.
Laboratory results appear promising, but clinical results are not as evident and these drugs are quite costly. Consequently, by now, this seems to be merely an interesting study that is somewhat removed from our daily clinical practice.
Original Title: Evolocumab for early reduction of LDL-cholesterol levels in patients with acute coronary syndromes (EVOPACS).
Reference: Koskinas KC et al. J Am Coll Cardiol. 2019; Epub ahead of print.
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