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. 2020 Jan-Feb;14(1):98-108.e8.
doi: 10.1016/j.jacl.2019.10.015. Epub 2019 Nov 18.

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  1 , Jiyan Chen  2 , Vijay Kumar Chopra  3 , Shuyang Zhang  4 , Guohai Su  5 , Changsheng Ma  6 , Zhouqing Huang  7 , Yingyan Ma  8 , Zhuhua Yao  9 , Zuyi Yuan  10 , Qiang Zhao  11 , Srun Kuanprasert  12 , Marie T Baccara-Dinet  13 , Garen Manvelian  14 , Jianyong Li  15 , Rui Chen  15
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Free article

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 et al. J Clin Lipidol. 2020 Jan-Feb.
Free article

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.

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