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題名 | A Subanalysis of Taiwanese Patients from ODYSSEY South Korea and Taiwan Study Evaluating the Efficacy and Safety of Alirocumab= |
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作者 | 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; |
期刊 | Journal of the Chinese Medical Association |
出版日期 | 20190400 |
卷期 | 82:4 2019.04[民108.04] |
頁次 | 頁265-271 |
分類號 | 418.227 |
語文 | eng |
關鍵詞 | Alirocumab; High cardiovascular risk; Low-density lipoprotein cholesterol; Taiwanese; |
英文摘要 | 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 (75mg every 2 weeks; with dose increased to 150mg at Week 12 if LDL-C ≥ 70mg/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 70mg/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. |
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