Evolocumab is a monoclonal antibody that blocks PCSK9 («Proproteine Convertase Subtilisine/Kexine type 9»). It exerts a rapid, potent and sustained reduction of LDL cholesterol (LDL-c) levels in combination with statin therapy. It was first reimbursed for the treatment of familial hypercholesterolaemia. The FOURIER trial and its extension FOURIER-OLE among patients with atherosclerotic cardiovascular disease and residual hypercholesterolaemia despite statin therapy demonstrated that evolocumab significantly reduces the incidence of major cardiovascular adverse events (- 15 %, P <0.001). There was a monotonic relationship between the reduction in clinical events and the diminution of LDL-c levels even down to the lowest concentrations. The safety profile of evolocumab was excellent, also in patients with very low LDL-c levels. Because of these favorable results, evolocumab (Repatha®) is now reimbursed, under conditions, for the secondary prevention of atherosclerotic cardiovascular disease.
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