达比加特兰治疗心房患者的长期多中心观察性研究 (RELY-ABLE) 研究
Stuart J Connolly1, Lars Wallentin, Michael D Ezekowitz
1Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Canada.connostu@phri.ca
Circulation
|June 18, 2013
概括
在心房患者长期使用达比加特兰时,两剂量都显示出类似的中风和死亡率. 然而,150毫克的剂量与110毫克的剂量相比,与较大的出血风险有关.
科学领域:
- 心脏病学 心脏病学
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
背景情况:
- 随机评估长期抗凝治疗 (RE-LY) 试验先前确定了达比加乙酸的有效性和安全性,用于预防心房患者的中风.
- 需要扩展对达比加特兰的随访数据,并直接比较其两种剂量方案.
研究的目的:
- 在心房患者中评估两剂大比加特兰乙酸盐 (150毫克和110毫克每天两次) 的长期安全性和有效性.
- 延长随访期超出最初的RE-LY试验,继续治疗达比加的患者.
主要方法:
- 在心房患者长期多中心延长达比加特兰治疗 (RELY-ABLE) 试验中,从RE-LY试验中招募了继续服用达比加特兰剂量的患者.
- 随访延长至RE-LY后28个月,在5851名注册患者中,随访时间中位数为2.3年.
- 对达比加特兰两剂的中风,全身栓塞,大出血和死亡的发病率进行了分析.
主要成果:
- 在两种剂量之间,中风或全身血栓塞率是可比的:150毫克每年1.46%和110毫克每年1.60% (HR 0.91;95% CI,0.69-1.20).
- 与大比加特兰150毫克 (3.74%/年) 与110毫克 (2.99%/年) 相比,主要出血率更高 (HR 1.26;95% CI,1.04-1.53).
- 两组的死亡率相似:150毫克的死亡率为3.02%/年,110毫克的死亡率为3.10%/年 (HR 0.97;95% CI,0.80-1.19).
结论:
- 在长达2.3年的达比加特兰治疗中,每日两次服用150毫克和110毫克时,中风和死亡的发生率相似.
- 与150毫克剂量相比,110毫克剂量观察到明显更高的重大出血发病率.
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