Long-Term Evolocumab in Patients With Established Atherosclerotic Cardiovascular Disease

In FOURIER (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk), the proprotein convertase subtilisin-kexin type 9 inhibitor evolocumab reduced low-density lipoprotein cholesterol (LDL-C) and risk of cardiovascular events and was safe and well tolerated ove...

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Published in:	Circulation (New York, N.Y.) N.Y.), 2022-10, Vol.146 (15), p.1109-1119
Main Authors:	O'Donoghue, Michelle L, Giugliano, Robert P, Wiviott, Stephen D, Atar, Dan, Keech, Anthony, Kuder, Julia F, Im, KyungAh, Murphy, Sabina A, Flores-Arredondo, Jose H, López, J Antonio G, Elliott-Davey, Mary, Wang, Bei, Monsalvo, Maria Laura, Abbasi, Siddique, Sabatine, Marc S
Format:	Article
Language:	eng
Subjects:	Antibodies, Monoclonal - adverse effects Antibodies, Monoclonal, Humanized Anticholesteremic Agents - adverse effects Atherosclerosis - chemically induced Atherosclerosis - drug therapy Cardiovascular Diseases - chemically induced Cardiovascular Diseases - drug therapy Cholesterol, LDL Humans Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use Myocardial Infarction - epidemiology PCSK9 Inhibitors Proprotein Convertase 9 Stroke - epidemiology Subtilisins - therapeutic use Treatment Outcome
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Summary:	In FOURIER (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk), the proprotein convertase subtilisin-kexin type 9 inhibitor evolocumab reduced low-density lipoprotein cholesterol (LDL-C) and risk of cardiovascular events and was safe and well tolerated over a median of 2.2 years of follow-up. However, large-scale, long-term data are lacking. The parent FOURIER trial randomized 27 564 patients with atherosclerotic cardiovascular disease and LDL-C ≥70 mg/dL on statin to evolocumab versus placebo. Patients completing FOURIER at participating sites were eligible to receive evolocumab in 2 open-label extension studies (FOURIER-OLE [FOURIER Open-Label Extension]) in the United States and Europe; primary analyses were pooled across studies. The primary end point was the incidence of adverse events. Lipid values and major adverse cardiovascular events were prospectively collected. A total of 6635 patients were enrolled in FOURIER-OLE (3355 randomized to evolocumab and 3280 to placebo in the parent study). Median follow-up in FOURIER-OLE was 5.0 years; maximum exposure to evolocumab in parent plus FOURIER-OLE was 8.4 years. At 12 weeks in FOURIER-OLE, median LDL-C was 30 mg/dL, and 63.2% of patients achieved LDL-C 8 years that did not exceed those observed in the original placebo arm during the parent study and led to further reductions in cardiovascular events compared with delayed treatment initiation. URL: https://www. gov; Unique identifiers: NCT02867813 and NCT03080935.
ISSN:	0009-7322 1524-4539