埃多克萨班剂量,度,抗Xa因子活性和结果之间的关联:对随机,双盲ENGAGE AF-TIMI 48试验数据的分析
Christian T Ruff1, Robert P Giugliano1, Eugene Braunwald1
1Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Lancet (London, England)
|March 15, 2015
概括
在心房患者中减少埃多克萨班的剂量可以防止药物度过高和出血风险. 根据临床因素量身定制edoxaban剂量,优化了患者中风预防的结果.
科学领域:
- 药理学和临床治疗学
- 心血管医学 心血管医学
背景情况:
- 新的口服抗凝剂 (NOAC),如埃多克萨班,旨在固定剂量用于心房 (AF) 中风预防,避免对维生素K对手进行常规监测.
- 人们对药物度监测的必要性存在担忧,以防止与NOAC水平升高相关的出血风险.
- ENGAGE AF-TIMI 48试验将爱多沙班治疗方案与华法林进行了比较,并为患有增加爱多沙班暴露风险的患者进行了剂量降低.
研究的目的:
- 评估ENGAGE AF-TIMI 48试验中的埃多克萨班剂量调整是否可以防止药物度过高.
- 评估剂量调整是否减轻了以edoxaban治疗的AF患者出血事件的风险.
主要方法:
- 来自随机,双盲ENGAGE AF-TIMI 48试验的数据分析,该试验涉及心房的患者.
- 埃多克萨班剂量,血度和抗Xa因子 (FXa) 活性的相关性,将疗效和安全性结果与华法林进行比较.
- 剂量减少标准包括特定的肌素清除率,体重和同时服用的药物;随机分类是1:1:1对华法林或更高/更低剂量的edoxaban.
主要成果:
- 符合剂量降低标准的患者出现中风,出血和死亡率较高.
- 减少埃多克萨班剂量使药物平均暴露率降低了20-35%,而抗FXa活性降低了20-25%.
- 尽管活性降低,剂量调整后的爱多沙班与华法林相比保持了有效性,并显著提高了安全性,特别是减少了重大出血事件.
结论:
- 根据临床因素调整爱多沙班剂量,可以有效地防止药物度过高.
- 这一策略优化了个体患者对血栓栓塞和出血事件的风险.
- 埃多克萨班的治疗窗口在严重出血方面似乎比在血栓塞栓症方面更窄.
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