A subanalysis of Taiwanese patients from ODYSSEY South Korea and Taiwan study evaluating the efficacy and safety of alirocumab

Ting-Hsing Chao, Pi Jung Hsiao, Ming En Liu, Chiung Jen Wu, Fu Tien Chiang, Zhih Cherng Chen, Ching Pei Chen, Hung I. Yeh, Tsong Hai Lee, Chern En Chiang

Research output: Contribution to journalArticle

Abstract

Background: Alirocumab can provide significant reductions in low-density lipoprotein cholesterol (LDL-C). However, data regarding its efficacy and safety in Asians are limited. Methods: A subgroup analysis of Taiwanese patients (n = 116) in a randomized trial evaluating the efficacy and safety of alirocumab in South Korea and Taiwan (ODYSSEY KT, clinicaltrials.gov Identifier: NCT02289963) was performed. Patients with hypercholesterolemia at high cardiovascular risk on maximally tolerated statin were randomized to alirocumab (75 mg every 2 weeks; with dose increased to 150 mg at Week 12 if LDL-C ≥ 70 mg/dL at Week 8) or placebo for 24 weeks. The primary efficacy endpoint was the percent change in LDL-C from baseline to Week 24. Safety was assessed for a total of 32 weeks. Results: At Week 24, the percent change in calculated LDL-C in the alirocumab group (n = 57) was −51%, whereas that in the placebo group (n = 59) was 2.5%. Alirocumab significantly improved other lipid parameters, including non-high-density lipoprotein cholesterol, apolipoprotein B and A1, lipoprotein (a), high-density lipoprotein cholesterol, and total cholesterol. A significantly higher proportion of patients in the alirocumab group reached an LDL-C target below 70 mg/dL than those in the placebo group (81.3% vs 15.4%). The incidence of treatment-emergent adverse events was comparable between both groups. Conclusion: Alirocumab treatment provided a favorable effect on LDL-C levels and other lipid parameters, and was generally well-tolerated in patients from Taiwan. The results of current analysis were consistent with the overall ODYSSEY phase 3 program.

Original languageEnglish
Pages (from-to)265-271
Number of pages7
JournalJournal of the Chinese Medical Association
Volume82
Issue number4
DOIs
Publication statusPublished - 2019 Jan 1

Fingerprint

Republic of Korea
Taiwan
LDL Cholesterol
Safety
Placebos
Lipids
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Lipoprotein(a)
Apolipoprotein A-I
Apolipoproteins B
alirocumab
Hypercholesterolemia
HDL Cholesterol
Cholesterol
Incidence
Therapeutics

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

Chao, Ting-Hsing ; Hsiao, Pi Jung ; Liu, Ming En ; Wu, Chiung Jen ; Chiang, Fu Tien ; Chen, Zhih Cherng ; Chen, Ching Pei ; Yeh, Hung I. ; Lee, Tsong Hai ; Chiang, Chern En. / A subanalysis of Taiwanese patients from ODYSSEY South Korea and Taiwan study evaluating the efficacy and safety of alirocumab. In: Journal of the Chinese Medical Association. 2019 ; Vol. 82, No. 4. pp. 265-271.
@article{4ab11348ece249748871148fd8235a1f,
title = "A subanalysis of Taiwanese patients from ODYSSEY South Korea and Taiwan study evaluating the efficacy and safety of alirocumab",
abstract = "Background: Alirocumab can provide significant reductions in low-density lipoprotein cholesterol (LDL-C). However, data regarding its efficacy and safety in Asians are limited. Methods: A subgroup analysis of Taiwanese patients (n = 116) in a randomized trial evaluating the efficacy and safety of alirocumab in South Korea and Taiwan (ODYSSEY KT, clinicaltrials.gov Identifier: NCT02289963) was performed. Patients with hypercholesterolemia at high cardiovascular risk on maximally tolerated statin were randomized to alirocumab (75 mg every 2 weeks; with dose increased to 150 mg at Week 12 if LDL-C ≥ 70 mg/dL at Week 8) or placebo for 24 weeks. The primary efficacy endpoint was the percent change in LDL-C from baseline to Week 24. Safety was assessed for a total of 32 weeks. Results: At Week 24, the percent change in calculated LDL-C in the alirocumab group (n = 57) was −51{\%}, whereas that in the placebo group (n = 59) was 2.5{\%}. Alirocumab significantly improved other lipid parameters, including non-high-density lipoprotein cholesterol, apolipoprotein B and A1, lipoprotein (a), high-density lipoprotein cholesterol, and total cholesterol. A significantly higher proportion of patients in the alirocumab group reached an LDL-C target below 70 mg/dL than those in the placebo group (81.3{\%} vs 15.4{\%}). The incidence of treatment-emergent adverse events was comparable between both groups. Conclusion: Alirocumab treatment provided a favorable effect on LDL-C levels and other lipid parameters, and was generally well-tolerated in patients from Taiwan. The results of current analysis were consistent with the overall ODYSSEY phase 3 program.",
author = "Ting-Hsing Chao and Hsiao, {Pi Jung} and Liu, {Ming En} and Wu, {Chiung Jen} and Chiang, {Fu Tien} and Chen, {Zhih Cherng} and Chen, {Ching Pei} and Yeh, {Hung I.} and Lee, {Tsong Hai} and Chiang, {Chern En}",
year = "2019",
month = "1",
day = "1",
doi = "10.1097/JCMA.0000000000000062",
language = "English",
volume = "82",
pages = "265--271",
journal = "Journal of the Chinese Medical Association",
issn = "1726-4901",
publisher = "Elsevier Taiwan LLC",
number = "4",

}

A subanalysis of Taiwanese patients from ODYSSEY South Korea and Taiwan study evaluating the efficacy and safety of alirocumab. / Chao, Ting-Hsing; Hsiao, Pi Jung; Liu, Ming En; Wu, Chiung Jen; Chiang, Fu Tien; Chen, Zhih Cherng; Chen, Ching Pei; Yeh, Hung I.; Lee, Tsong Hai; Chiang, Chern En.

In: Journal of the Chinese Medical Association, Vol. 82, No. 4, 01.01.2019, p. 265-271.

Research output: Contribution to journalArticle

TY - JOUR

T1 - A subanalysis of Taiwanese patients from ODYSSEY South Korea and Taiwan study evaluating the efficacy and safety of alirocumab

AU - Chao, Ting-Hsing

AU - Hsiao, Pi Jung

AU - Liu, Ming En

AU - Wu, Chiung Jen

AU - Chiang, Fu Tien

AU - Chen, Zhih Cherng

AU - Chen, Ching Pei

AU - Yeh, Hung I.

AU - Lee, Tsong Hai

AU - Chiang, Chern En

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Background: Alirocumab can provide significant reductions in low-density lipoprotein cholesterol (LDL-C). However, data regarding its efficacy and safety in Asians are limited. Methods: A subgroup analysis of Taiwanese patients (n = 116) in a randomized trial evaluating the efficacy and safety of alirocumab in South Korea and Taiwan (ODYSSEY KT, clinicaltrials.gov Identifier: NCT02289963) was performed. Patients with hypercholesterolemia at high cardiovascular risk on maximally tolerated statin were randomized to alirocumab (75 mg every 2 weeks; with dose increased to 150 mg at Week 12 if LDL-C ≥ 70 mg/dL at Week 8) or placebo for 24 weeks. The primary efficacy endpoint was the percent change in LDL-C from baseline to Week 24. Safety was assessed for a total of 32 weeks. Results: At Week 24, the percent change in calculated LDL-C in the alirocumab group (n = 57) was −51%, whereas that in the placebo group (n = 59) was 2.5%. Alirocumab significantly improved other lipid parameters, including non-high-density lipoprotein cholesterol, apolipoprotein B and A1, lipoprotein (a), high-density lipoprotein cholesterol, and total cholesterol. A significantly higher proportion of patients in the alirocumab group reached an LDL-C target below 70 mg/dL than those in the placebo group (81.3% vs 15.4%). The incidence of treatment-emergent adverse events was comparable between both groups. Conclusion: Alirocumab treatment provided a favorable effect on LDL-C levels and other lipid parameters, and was generally well-tolerated in patients from Taiwan. The results of current analysis were consistent with the overall ODYSSEY phase 3 program.

AB - Background: Alirocumab can provide significant reductions in low-density lipoprotein cholesterol (LDL-C). However, data regarding its efficacy and safety in Asians are limited. Methods: A subgroup analysis of Taiwanese patients (n = 116) in a randomized trial evaluating the efficacy and safety of alirocumab in South Korea and Taiwan (ODYSSEY KT, clinicaltrials.gov Identifier: NCT02289963) was performed. Patients with hypercholesterolemia at high cardiovascular risk on maximally tolerated statin were randomized to alirocumab (75 mg every 2 weeks; with dose increased to 150 mg at Week 12 if LDL-C ≥ 70 mg/dL at Week 8) or placebo for 24 weeks. The primary efficacy endpoint was the percent change in LDL-C from baseline to Week 24. Safety was assessed for a total of 32 weeks. Results: At Week 24, the percent change in calculated LDL-C in the alirocumab group (n = 57) was −51%, whereas that in the placebo group (n = 59) was 2.5%. Alirocumab significantly improved other lipid parameters, including non-high-density lipoprotein cholesterol, apolipoprotein B and A1, lipoprotein (a), high-density lipoprotein cholesterol, and total cholesterol. A significantly higher proportion of patients in the alirocumab group reached an LDL-C target below 70 mg/dL than those in the placebo group (81.3% vs 15.4%). The incidence of treatment-emergent adverse events was comparable between both groups. Conclusion: Alirocumab treatment provided a favorable effect on LDL-C levels and other lipid parameters, and was generally well-tolerated in patients from Taiwan. The results of current analysis were consistent with the overall ODYSSEY phase 3 program.

UR - http://www.scopus.com/inward/record.url?scp=85064239640&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85064239640&partnerID=8YFLogxK

U2 - 10.1097/JCMA.0000000000000062

DO - 10.1097/JCMA.0000000000000062

M3 - Article

VL - 82

SP - 265

EP - 271

JO - Journal of the Chinese Medical Association

JF - Journal of the Chinese Medical Association

SN - 1726-4901

IS - 4

ER -