title: One-Year Efficacy and Safety of Evolocumab in Japanese Patients　- A Pooled Analysis From the Open-Label Extension OSLER Studies.
abstract: Evolocumab, a fully human monoclonal antibody against PCSK9, significantly reduced low-density lipoprotein-cholesterol (LDL-C) levels in Japanese patients by up to 76% when administered with a statin. We evaluated the efficacy and safety of 1 year of evolocumab in a pooled analysis of patients from the 12-week YUKAWA studies who continued into the open-label extension (OLE) OSLER studies.
  
  
  
  YUKAWA-1 and YUKAWA-2 were conducted in hypercholesterolemic, high-cardiovascular-risk Japanese patients who were receiving statin therapy. Patients completing these studies were eligible for an OLE study. At OLE entry, patients were re-randomized 2:1 to evolocumab+standard of care (SOC) or SOC alone (OSLER-1: evolocumab 420 mg monthly; OSLER-2: evolocumab 140 mg biweekly or 420 mg monthly). A 1-year analysis was performed on patients enrolled from the YUKAWA studies into OSLER. At parent-study baseline (YUKAWA-1 or YUKAWA-2 patients continuing into OSLER), mean (SD) age was 61 (10) years; 39% were female; mean (SD) baseline LDL-C (on statin) was 119.7 (33.0) mg/dL. Overall rates of adverse events were comparable between evolocumab+SOC and SOC alone. In YUKAWA patients receiving evolocumab+SOC, mean (SE) reductions in LDL-C from parent-study baseline to OLE 1 year were 69.1% (1.2%; OSLER-1) and 65.1% (2.2%; OSLER-2).
  
  
  
  In a pooled 1-year analysis of Japanese patients in the ongoing OSLER studies, treatment with evolocumab+SOC was well tolerated and resulted in sustained LDL-C reductions at 1 year.
authors.affiliation: Division of Cardiology, Department of Medicine, Nihon University School of Medicine.
authors.forename: Atsushi
authors.initials: A
authors.lastname: Hirayama
authors.affiliation: Departments of Community Medicine and Cardiovascular Medicine, Osaka University Graduate School of Medicine.|Rinku General Medical Center.
authors.forename: Shizuya
authors.initials: S
authors.lastname: Yamashita
authors.affiliation: Amgen Astellas BioPharma K.K.
authors.forename: Hyoe
authors.initials: H
authors.lastname: Inomata
authors.affiliation: Amgen Inc.
authors.forename: Helina
authors.initials: H
authors.lastname: Kassahun
authors.affiliation: Amgen Inc.
authors.forename: Marcoli
authors.initials: M
authors.lastname: Cyrille
authors.affiliation: Amgen Inc.
authors.forename: Andrea
authors.initials: A
authors.lastname: Ruzza
authors.affiliation: Life Science and Bioethics Research Center, Tokyo Medical and Dental University.
authors.forename: Masayuki
authors.initials: M
authors.lastname: Yoshida
authors.affiliation: Department of Cardiovascular Medicine, The University of Tokyo Hospital.
authors.forename: Arihiro
authors.initials: A
authors.lastname: Kiyosue
authors.affiliation: Amgen Inc.
authors.forename: Yuhui
authors.initials: Y
authors.lastname: Ma
authors.affiliation: Teikyo Academic Research Center, Teikyo University.
authors.forename: Tamio
authors.initials: T
authors.lastname: Teramoto
mesh_terms: D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D044466:Asian People; D008078:Cholesterol, LDL / Q000097:blood*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D006937:Hypercholesterolemia / Q000097:blood* / Q000188:drug therapy*; D007564:Japan; D008297:Male; D008875:Middle Aged
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D008078:Cholesterol, LDL; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; C577155:evolocumab
keywords: Dyslipidemia; Hyperlipidemia; LDL-C; Lipid-lowering therapy; PCSK9 inhibition