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Dyslipidaemia Global Newsletter #3
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Dyslipi
Dyslipi

Long-term evolocumab in patients with established atherosclerotic cardiovascular
disease.

O’Donoghue ML, et al. J Circulation. 2022 Aug 29. Doi: 10.1161/CIRCULATIONAHA.122.061620. Online ahead of print..
The Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk (FOURIER) trial found that in
patients with established atherosclerotic CV disease on statin therapy, treatment with evolocumab for a median of 2.2 years reduced
the risk of the primary composite outcome of CV death, MI, stroke, hospitalization for unstable angina, or coronary revascularization
by 15% and the key secondary composite outcome of CV death, MI, or stroke by 20%. Evolocumab, a fully human monoclonal
antibody, PCSK9 inhibitor, has previously be shown to reduce LDL-C by ~60%.

In this open-label extension study of evolocumab in 6635 patients with atherosclerotic CV disease who completed the FOURIER
study (FOURIER-OLE), the incidence of adverse events of interest did not increase over a median of five years and a maximum
exposure of more than eight years. Some early epidemiologic studies raised concerns that very low LDL-C may be associated with
an increased risk of hemorrhagic stroke and neurocognitive effects. The current study did not see any increased risk of adverse
events of interest over time and did not exceed observed rates in the placebo arm during the parent study. In addition, patients who
were originally randomized to evolocumab had 15–20% lower risk of MACE and 23% lower risk of CV death than those randomized
to placebo.

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