Clinical Pharmacy and Translational Science, University of Tennessee, Memphis.
Clinical Pharmacy and Translational Science, University of Tennessee, Memphis.
Am J Med. 2019 Jan;132(1):38-41. doi: 10.1016/j.amjmed.2018.06.028. Epub 2018 Jul 25.
The use of direct oral anticoagulants over traditional warfarin has increased in the United States over the past 10 years because of advantages such as ease of use, predictable pharmacokinetic response, and safety. In 2015, the U.S. Food and Drug Administration approved idarucizumab (Praxbind) for the reversal of the direct thrombin inhibitor dabigatran, but no reversal agent has been available for oral factor Xa (FXa) inhibitors until recently. Andexanet alfa was approved in May 2018, under the brand name ANDEXXA, for the reversal of 2 of FXa inhibitors, apixaban and rivaroxaban, when life-threatening or uncontrolled bleeding occurs. This accelerated approval was based on change in anti-FXa activity from baseline that indicated a reversal of the anticoagulant effect. Any expanded Food and Drug Administration indication will be contingent on results demonstrating improved hemostasis and efficacy for reversing other FXa inhibitors.
在过去的 10 年中，由于直接口服抗凝剂具有使用方便、药代动力学反应可预测和安全性高等优点，其在美国的使用量超过了传统的华法林。2015 年，美国食品和药物管理局批准idarucizumab（Praxbind）逆转直接凝血酶抑制剂达比加群，但直到最近才有一种逆转剂可用于口服因子 Xa（FXa）抑制剂。andexanet alfa 于 2018 年 5 月以 ANDDEXXA 的品牌名称获得批准，用于逆转 2 种 FXa 抑制剂，即阿哌沙班和利伐沙班，当发生危及生命或无法控制的出血时。这种加速批准是基于基线时抗 FXa 活性的变化，表明抗凝作用得到逆转。任何扩大的食品和药物管理局适应证都将取决于结果，这些结果表明对于逆转其他 FXa 抑制剂的止血和疗效有改善。
