A randomized trial evaluating the efficacy and safety of alirocumab in South Korea and Taiwan (ODYSSEY KT)
DC Field | Value | Language |
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dc.contributor.author | Koh, Kwang Kon | - |
dc.contributor.author | Nam, Chang Wook | - |
dc.contributor.author | Chao, Ting-Hsing | - |
dc.contributor.author | Liu, Ming-En | - |
dc.contributor.author | Wu, Chiung-Jen | - |
dc.contributor.author | Kim, Dong-Soo | - |
dc.contributor.author | Kim, Chong-Jin | - |
dc.contributor.author | Li, Ivy | - |
dc.contributor.author | Li, Jianyong | - |
dc.contributor.author | Baccara-Dinet, Marie T. | - |
dc.contributor.author | Hsiao, Pi-Jung | - |
dc.contributor.author | Chiang, Chern-En | - |
dc.date.available | 2020-02-27T11:42:28Z | - |
dc.date.created | 2020-02-06 | - |
dc.date.issued | 2018-02 | - |
dc.identifier.issn | 1933-2874 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/4081 | - |
dc.description.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. | - |
dc.language | 영어 | - |
dc.language.iso | en | - |
dc.publisher | ELSEVIER SCIENCE INC | - |
dc.relation.isPartOf | JOURNAL OF CLINICAL LIPIDOLOGY | - |
dc.subject | HIGH CARDIOVASCULAR-RISK | - |
dc.subject | HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA | - |
dc.subject | INHIBITOR ALIROCUMAB | - |
dc.subject | MONOCLONAL-ANTIBODY | - |
dc.subject | PCSK9 | - |
dc.subject | STATINS | - |
dc.subject | CHOLESTEROL | - |
dc.subject | RATIONALE | - |
dc.subject | EZETIMIBE | - |
dc.subject | DISEASE | - |
dc.title | A randomized trial evaluating the efficacy and safety of alirocumab in South Korea and Taiwan (ODYSSEY KT) | - |
dc.type | Article | - |
dc.type.rims | ART | - |
dc.description.journalClass | 1 | - |
dc.identifier.wosid | 000426022400021 | - |
dc.identifier.doi | 10.1016/j.jacl.2017.09.007 | - |
dc.identifier.bibliographicCitation | JOURNAL OF CLINICAL LIPIDOLOGY, v.12, no.1, pp.162 - 172 | - |
dc.identifier.scopusid | 2-s2.0-85033775379 | - |
dc.citation.endPage | 172 | - |
dc.citation.startPage | 162 | - |
dc.citation.title | JOURNAL OF CLINICAL LIPIDOLOGY | - |
dc.citation.volume | 12 | - |
dc.citation.number | 1 | - |
dc.contributor.affiliatedAuthor | Koh, Kwang Kon | - |
dc.type.docType | Article | - |
dc.subject.keywordAuthor | Alirocumab | - |
dc.subject.keywordAuthor | PCSK9 | - |
dc.subject.keywordAuthor | LDL-C | - |
dc.subject.keywordAuthor | South Korea | - |
dc.subject.keywordAuthor | Taiwan | - |
dc.subject.keywordAuthor | ODYSSEY phase 3 | - |
dc.subject.keywordAuthor | Hypercholesterolemia | - |
dc.subject.keywordAuthor | Lipid lowering | - |
dc.subject.keywordAuthor | Placebo-controlled | - |
dc.subject.keywordAuthor | Maximally tolerated statin | - |
dc.subject.keywordPlus | HIGH CARDIOVASCULAR-RISK | - |
dc.subject.keywordPlus | HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA | - |
dc.subject.keywordPlus | INHIBITOR ALIROCUMAB | - |
dc.subject.keywordPlus | MONOCLONAL-ANTIBODY | - |
dc.subject.keywordPlus | PCSK9 | - |
dc.subject.keywordPlus | STATINS | - |
dc.subject.keywordPlus | CHOLESTEROL | - |
dc.subject.keywordPlus | RATIONALE | - |
dc.subject.keywordPlus | EZETIMIBE | - |
dc.subject.keywordPlus | DISEASE | - |
dc.relation.journalResearchArea | Pharmacology & Pharmacy | - |
dc.relation.journalWebOfScienceCategory | Pharmacology & Pharmacy | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
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