1 University of Florida Colleges of Pharmacy and Medicine, Gainesville, FL, USA.
2 University of Florida College of Pharmacy, Gainesville, FL, USA.
Ann Pharmacother. 2019 Sep;53(9):940-946. doi: 10.1177/1060028019835209. Epub 2019 Feb 27.
The purpose of this article is to review the available clinical trial data for andexanet alfa and its role in clinical practice. A MEDLINE/PubMed search was conducted (January 2000 to January 2019) using the keyword for clinical trials. References of identified articles were searched by hand for additional citations. We included English-language articles related to the Food and Drug Administration (FDA) approval of andexanet alfa or provided novel information regarding this drug entity. The findings of the review show that andexanet alfa may be a safe and effective option for the reversal of apixaban and rivaroxaban. With the approval of this reversal agent, patients and providers can feel safer when using apixaban and rivaroxaban, which in turn may increase the use of these anticoagulant agents. The new FDA approval of andexanet alfa will allow safer use of oral anticoagulants and will likely further the use of direct oral anticoagulants for anticoagulant needs. Reversing enoxaparin-/edoxaban-induced bleeding with this agent should be limited because there is no FDA approval owing to the fact that only phase II trial data available.
本文旨在回顾andexanet alfa 的现有临床试验数据及其在临床实践中的作用。通过使用关键词进行 MEDLINE/PubMed 检索（2000 年 1 月至 2019 年 1 月）。通过手动检索已确定文章的参考文献，以获取其他引文。我们纳入了与 andexanet alfa 的食品和药物管理局 (FDA) 批准相关的英语文章，或提供了有关该药物实体的新信息。综述结果表明，andexanet alfa 可能是逆转依达赛珠单抗和利伐沙班的安全有效的选择。随着这种逆转剂的批准，患者和提供者在使用依达赛珠单抗和利伐沙班时可以感到更安全，这反过来又可能增加这些抗凝剂的使用。andexanet alfa 的新 FDA 批准将允许更安全地使用口服抗凝剂，并可能进一步将直接口服抗凝剂用于抗凝需求。由于仅提供 II 期试验数据，因此不建议使用该药物逆转依诺肝素/依多沙班引起的出血，因为尚未获得 FDA 批准。
