Lancet Haematol:依度沙班预防VTE复发的安全性和有效性研究

2016-06-21 Mechront 译 MedSci原创

随机试验事后分析显示,静脉血栓栓塞患者使用口服抗凝剂Edoxaban进行预防复发性静脉血栓栓塞的延长治疗时,与华法林相比,有更少的主要出血事件。因此每日依度沙班(Savaysa, Daiichi Sankyo)可以作为预防VTE复发的抗凝治疗华法林替代药物。 俄克拉何马大学健康科学中心公共卫生学院医学和流行病学教授Gary Raskob博士及其同事对随机、非劣效性Hokusai-VTE试验进

随机试验事后分析显示,静脉血栓栓塞患者使用口服抗凝剂Edoxaban进行预防复发性静脉血栓栓塞的延长治疗时,与华法林相比,有更少的主要出血事件。因此每日依度沙班(Savaysa, Daiichi Sankyo)可以作为预防VTE复发的抗凝治疗华法林替代药物。

俄克拉何马大学健康科学中心公共卫生学院医学和流行病学教授Gary Raskob博士及其同事对随机、非劣效性Hokusai-VTE试验进行了事后分析,比较延长治疗时依度沙班与华法林相比的风险效益。

在试验中,将8292例急性VTE患者随机分配到依度沙班组(n = 3633)或华法林组(n = 3594)治疗3-12个月。不论个别治疗时间,统一在12个月记录研究结果。每个时间间隔的VTE复发率(3个月、3-6个月、6-12个月、第12个月)和3-12个月的累积发生率作为主要疗效终点。临床相关出血发生率作为主要安全终点。

治疗分析显示,依度沙班和华法林组的3个月发性VTE的发病率分别为1.1%(44/4118)和1.2%(51/4122)。超过3个月仍有87%(n = 7227)的患者继续治疗。

3-6个月的时间阶段依度沙班和华法林组的VTE发生率分别为 0.7% (8/1076) 和0.5%(5/1084)。6-12个月两组的该数据分别为0.2%(2/896)和0.8%(7/851)。第12个月,两组的数据分别为0.1%(1/1661)和0.1%(2/1659)。两组的复发性VTE累积发病率分别为0.3%和0.4%(HR = 0.78; 95% CI, 0.36-1.72)。

依度沙班和华法林组临床相关出血的累积发生率为3.9%合4.1%(HR = 0.97; 95% CI, 0.77-1.22);大出血的累积发生率为0.3%和0.7%(HR = 0.45; 95% CI, 0.22-0.92)。

依度沙班和华法林组分别有10人和9人死亡,分别有0和2例死亡原因是出血。

意向治疗分析产生了类似的结果。

“我们需要更多的直接口服抗凝药物和维生素K拮抗剂相比较的安全性和有效性数据,”Raskob及其同事写道。“总之,VTE患者使用依度沙班继续治疗超过3个月的VTE复发率较低,因此每天一次依度沙班似乎可以作为华法林的替代治疗。”

原始出处:

Raskob G, et al.Extended duration of anticoagulation with edoxaban in patients with venous thromboembolism: a post-hoc analysis of the Hokusai-VTE study.Lancet Haematol. 2016;doi:2352-3026(16)00023-5.

Edoxaban safe, effective for extended prevention of recurrent VTE.Healio.June 20, 2016

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    2016-12-31 howi
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    2017-03-25 changfy
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    2016-06-23 fengyi812

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