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A randomized trial evaluating the efficacy and safety of alirocumab in South Korea and Taiwan (ODYSSEY KT)

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Author(s)
Kwang Kon KohChang Wook NamTing-Hsing ChaoMing-En LiuChiung-Jen WuDong-Soo KimChong-Jin KimIvy LiJianyong LMarie T. Baccara-DinetPi-Jung HsiaoChern-En Chiang
Keimyung Author(s)
Nam, Chang Wook
Department
Dept. of Internal Medicine (내과학)
Journal Title
Journal of Clinical Lipidology
Issued Date
2018
Volume
12
Issue
1
Keyword
AlirocumabHypercholesterolemiaLDL-CMaximally tolerated statinODYSSEY phase 3PCSK9Placebo-controlledSouth KoreaTaiwanLipid lowering
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.
Keimyung Author(s)(Kor)
남창욱
Publisher
School of Medicine (의과대학)
Citation
Kwang Kon Koh et al. (2018). A randomized trial evaluating the efficacy and safety of alirocumab in South Korea and Taiwan (ODYSSEY KT). Journal of Clinical Lipidology, 12(1), 162-172.e6. doi: 10.1016/j.jacl.2017.09.007
Type
Article
ISSN
1933-2874
DOI
10.1016/j.jacl.2017.09.007
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/41044
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
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