A randomized trial evaluating the efficacy and safety of alirocumab in South Korea and Taiwan (ODYSSEY KT)
- Authors
- Koh, Kwang Kon; Nam, Chang Wook; Chao, Ting-Hsing; Liu, Ming-En; Wu, Chiung-Jen; Kim, Dong-Soo; Kim, Chong-Jin; Li, Ivy; Li, Jianyong; Baccara-Dinet, Marie T.; Hsiao, Pi-Jung; Chiang, Chern-En
- Issue Date
- Feb-2018
- Publisher
- ELSEVIER SCIENCE INC
- Keywords
- Alirocumab; PCSK9; LDL-C; South Korea; Taiwan; ODYSSEY phase 3; Hypercholesterolemia; Lipid lowering; Placebo-controlled; Maximally tolerated statin
- Citation
- JOURNAL OF CLINICAL LIPIDOLOGY, v.12, no.1, pp.162 - 172
- Journal Title
- JOURNAL OF CLINICAL LIPIDOLOGY
- Volume
- 12
- Number
- 1
- Start Page
- 162
- End Page
- 172
- URI
- https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/4081
- DOI
- 10.1016/j.jacl.2017.09.007
- ISSN
- 1933-2874
- Abstract
- BACKGROUND: Alirocumab, a fully human monoclonal antibody to proprotein convertase subtilisin/kexin type 9, has been shown to provide significant reductions in low-density lipoprotein cholesterol (LDL-C). Data about its efficacy and safety in patients from South Korea and Taiwan are limited. OBJECTIVE: ODYSSEY KT assessed the efficacy and safety of alirocumab in patients from South Korea and Taiwan. METHODS: Patients with hypercholesterolemia at high cardiovascular risk who were on maximally tolerated statin were randomized (1:1) to alirocumab (75 mg every 2 weeks, with dose increase to 150 mg every 2 weeks at week 12 if LDL-C >= 70 mg/dL at week 8) or placebo for 24 weeks. The primary efficacy endpoint was percentage change in LDL-C from baseline to week 24. Safety was assessed throughout. RESULTS: At week 24, alirocumab changed LDL-C levels by 57.1% (placebo: +6.3%). In the alirocumab group, 9 patients (9.5%) received dose increase at week 12. At week 24, 85.8% of patients in the alirocumab group reached LDL-C <70 mg/dL (placebo: 14.2%; P <= .0001 vs placebo). Alirocumab significantly improved non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B, total cholesterol, lipoprotein (a), and HDL-C vs placebo (P <= .05). Two consecutive calculated LDL-C values <25 mg/dL were recorded in 27.8% of alirocumab-treated patients. Overall, 58.8% (alirocumab) and 61.8% (placebo) of patients experienced treatment-emergent adverse events; 2.1% and 1.0% discontinued treatment due to treatment-emergent adverse events, respectively. CONCLUSION: Alirocumab significantly improved LDL-C, apolipoprotein B, non-HDL-C, lipoprotein (a), HDL-C, and total cholesterol in Asian patients. Alirocumab was generally well tolerated. These findings are consistent with ODYSSEY findings to date. (C) 2017 National Lipid Association. Published by Elsevier Inc.
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