Oral Apixaban for the Treatment of Acute Venous Thromboembolism
Oral Apixaban for the Treatment of Acute Venous Thromboembolism
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DOI：
10.1056/nejmoa1302507
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发表时间：
2013-08-29
影响因子：
158.5
通讯作者：
Weitz, Jeffrey I.
中科院分区：
文献类型：
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作者：
Agnelli, Giancarlo;Buller, Harry R.;Weitz, Jeffrey I.
背景阿哌沙班是一种固定剂量的口服 Xa 因子抑制剂，可以简化静脉血栓栓塞的治疗。方法在这项随机、双盲研究中，我们在 5395 名急性静脉血栓栓塞患者中比较了阿哌沙班（剂量为 10 mg，每日两次，持续 7 天，随后 5 mg，每日两次，持续 6 个月）与常规疗法（皮下注射依诺肝素，随后华法林）。主要疗效结局是复发性静脉血栓栓塞症状或与静脉血栓栓塞相关的死亡。主要安全性结局是单纯大出血和大出血加临床相关非大出血。结果阿哌沙班组 2609 例患者中有 59 例 (2.3%) 发生主要疗效结局，而常规治疗组 2635 例患者中有 71 例 (2.7%) (相对风险，0.84；95% 置信区间 [CI]，0.60 至 1.18；风险差异[阿哌沙班减去常规治疗]，-0.4 个百分点；95% CI，-1.3 至 0.4）。阿哌沙班不劣于常规治疗（P
BackgroundApixaban, an oral factor Xa inhibitor administered in fixed doses, may simplify the treatment of venous thromboembolism.MethodsIn this randomized, double-blind study, we compared apixaban (at a dose of 10 mg twice daily for 7 days, followed by 5 mg twice daily for 6 months) with conventional therapy (subcutaneous enoxaparin, followed by warfarin) in 5395 patients with acute venous thromboembolism. The primary efficacy outcome was recurrent symptomatic venous thromboembolism or death related to venous thromboembolism. The principal safety outcomes were major bleeding alone and major bleeding plus clinically relevant nonmajor bleeding.ResultsThe primary efficacy outcome occurred in 59 of 2609 patients (2.3%) in the apixaban group, as compared with 71 of 2635 (2.7%) in the conventional-therapy group (relative risk, 0.84; 95% confidence interval [CI], 0.60 to 1.18; difference in risk [apixaban minus conventional therapy], -0.4 percentage points; 95% CI, -1.3 to 0.4). Apixaban was noninferior to conventional therapy (P