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

研究成果: Article同行評審

1 引文 斯高帕斯(Scopus)

摘要

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.

原文English
頁(從 - 到)265-271
頁數7
期刊Journal of the Chinese Medical Association
82
發行號4
DOIs
出版狀態Published - 2019

All Science Journal Classification (ASJC) codes

  • 醫藥 (全部)

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