ODYSSEY EAST: Alirocumab efficacy and safety vs ezetimibe in high cardiovascular risk patients with hypercholesterolemia and on maximally tolerated statin in China, India, and Thailand
Yaling Han, Jiyan Chen, Vijay Kumar Chopra, Shuyang Zhang, Guohai Su, Changsheng Ma, Zhouqing Huang, Yingyan Ma, Zhuhua Yao, Zuyi Yuan, Qiang Zhao, Srun Kuanprasert, Marie T Baccara-Dinet, Garen Manvelian, Jianyong Li, Rui Chen, Yaling Han, Jiyan Chen, Vijay Kumar Chopra, Shuyang Zhang, Guohai Su, Changsheng Ma, Zhouqing Huang, Yingyan Ma, Zhuhua Yao, Zuyi Yuan, Qiang Zhao, Srun Kuanprasert, Marie T Baccara-Dinet, Garen Manvelian, Jianyong Li, Rui Chen
Abstract
Background: The proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab significantly reduces low-density lipoprotein cholesterol (LDL-C).
Objective: This study (ODYSSEY EAST) assessed the efficacy and safety of alirocumab vs ezetimibe in high cardiovascular risk patients from Asia.
Methods: Patients (n = 615) from China, India, and Thailand with hypercholesterolemia at high cardiovascular risk on maximally tolerated statin were randomized (2:1) to alirocumab (75 mg every 2 weeks [Q2W]; with dose increase to 150 mg Q2W at week 12 if week 8 LDL-C was >1.81 mmol/L [>70 mg/dL]) or ezetimibe (10 mg daily) for 24 weeks. The primary efficacy endpoint was percentage change in calculated LDL-C from baseline to week 24. Safety was assessed throughout.
Results: Baseline data were similar in both groups. LDL-C levels were reduced from baseline to week 24 by 56.0% and 20.3% in the alirocumab and ezetimibe groups, respectively (P < .0001 vs ezetimibe). Overall, 18.8% of alirocumab-treated patients received a dose increase to 150 mg Q2W. At week 24, 85.1% of alirocumab-treated and 40.5% of ezetimibe-treated patients reached LDL-C <1.81 mmol/L (<70 mg/dL, P < .0001 vs ezetimibe). Treatment-emergent adverse events occurred in 68.5% of alirocumab-treated and 63.1% of ezetimibe-treated patients, with upper respiratory tract infection the most common (alirocumab: 13.3%; ezetimibe: 14.1%). Injection-site reactions occurred more frequently in alirocumab-treated patients (2.7%) than in ezetimibe-treated patients (1.0%).
Conclusions: Alirocumab significantly reduced LDL-C vs ezetimibe in high cardiovascular risk patients from Asia and was generally well tolerated. These findings are consistent with previous ODYSSEY studies.
Trial registration: ClinicalTrials.gov NCT02715726.
Keywords: Alirocumab; Hypercholesterolemia; LDL-C; Lipid-lowering therapy; PCSK9.
Copyright © 2020 National Lipid Association. Published by Elsevier Inc. All rights reserved.
Source: PubMed