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Ischemic and Thrombotic Events Associated with Concomitant Xa-inhibiting Direct Oral Anticoagulants and Antiepileptic Drugs: Analysis of the FDA Adverse Event Reporting System (FAERS).
CNS Drugs ( IF 7.4 ) Pub Date : 2019-12-01 , DOI: 10.1007/s40263-019-00677-5 Amichai Perlman 1, 2 , Maor Wanounou 3 , Rachel Goldstein 1, 3 , Lotan Choshen Cohen 3 , Daniel E Singer 4 , Mordechai Muszkat 3
CNS Drugs ( IF 7.4 ) Pub Date : 2019-12-01 , DOI: 10.1007/s40263-019-00677-5 Amichai Perlman 1, 2 , Maor Wanounou 3 , Rachel Goldstein 1, 3 , Lotan Choshen Cohen 3 , Daniel E Singer 4 , Mordechai Muszkat 3
Affiliation
INTRODUCTION
Factor Xa-inhibiting direct oral anticoagulants (FXa-DOACs) undergo hepatic metabolism via cytochrome P-450 (CYP450). Concomitant use of rifampicin, an inducer of these enzymes, with FXa-DOACs, has been shown to decrease FXa-DOAC concentrations in healthy subjects. Several common antiepileptic drugs (AEDs) are known to induce CYP450 enzymes as well. However, little is known regarding the impact of this potential interaction on treatment outcomes with FXa-DOACs.
METHODS
We analyzed adverse event cases submitted to the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) from January 2013 to December 2018. We compared the proportion of cases reporting thromboembolic and ischemic adverse events (TAIAEs) with the concomitant use of FXa-DOACs and enzyme-inducing AEDs to the proportion of cases with FXa-DOACs and other AEDs.
RESULTS
During this period, 9693 adverse event cases reported concomitant use of FXa-DOACs and AEDs. Almost all reports (> 99%) involved the use of rivaroxaban or apixaban. Compared with other AEDs, enzyme-inducing AEDs were associated with an 86% increase in the odds of reporting TAIAEs [reporting odds ratio (ROR) 1.86, 95% confidence interval (CI) 1.61-2.15; p < 0.0001]. In secondary separate analyses of rivaroxaban and apixaban, enzyme-inducing AEDs were similarly associated with increased reporting of a TAIAE (ROR 1.79, 95% CI 1.50-2.12, and ROR 1.88, 95% CI 1.41-2.48, respectively).
CONCLUSION
Using real world data, we observed an increase in the odds of reporting anticoagulation treatment failure among patients treated with FXa-DOACs and concomitant enzyme-inducing AEDs compared to those treated with other AEDs.
中文翻译：
与抑制Xa的直接口服抗凝药和抗癫痫药相关的缺血性和血栓性事件：FDA不良事件报告系统（FAERS）的分析。
简介抑制因子Xa的直接口服抗凝剂（FXa-DOAC）通过细胞色素P-450（CYP450）进行肝代谢。已显示，利福平（这些酶的诱导剂）与FXa-DOAC并用会降低健康受试者的FXa-DOAC浓度。已知几种常见的抗癫痫药（AED）也会诱导CYP450酶。但是，关于这种潜在相互作用对FXa-DOAC的治疗效果的影响知之甚少。方法我们分析了2013年1月至2018年12月提交给食品和药物管理局（FDA）不良事件报告系统（FAERS）的不良事件病例。我们比较了血栓栓塞性和缺血性不良事件（TAIAE）与同时使用FXa-DOAC和酶诱导AED的病例比例与FXa-DOAC和其他AED的病例比例。结果在此期间，有9693例不良事件病例报告了同时使用FXa-DOAC和AED。几乎所有报道（> 99％）都涉及利伐沙班或阿哌沙班的使用。与其他AED相比，诱导酶的AED与报告TAIAE的几率增加86％[报告比值比（ROR）1.86，95％置信区间（CI）1.61-2.15；p <0.0001]。在利伐沙班和阿哌沙班的第二次单独分析中，诱导酶的AED与TAIAE的报告增多相似（ROR 1.79，95％CI 1.50-2.12，ROR 1.88，95％CI 1.41-2.48）。结论使用现实世界的数据，
更新日期：2019-11-01
中文翻译：
与抑制Xa的直接口服抗凝药和抗癫痫药相关的缺血性和血栓性事件：FDA不良事件报告系统（FAERS）的分析。
简介抑制因子Xa的直接口服抗凝剂（FXa-DOAC）通过细胞色素P-450（CYP450）进行肝代谢。已显示，利福平（这些酶的诱导剂）与FXa-DOAC并用会降低健康受试者的FXa-DOAC浓度。已知几种常见的抗癫痫药（AED）也会诱导CYP450酶。但是，关于这种潜在相互作用对FXa-DOAC的治疗效果的影响知之甚少。方法我们分析了2013年1月至2018年12月提交给食品和药物管理局（FDA）不良事件报告系统（FAERS）的不良事件病例。我们比较了血栓栓塞性和缺血性不良事件（TAIAE）与同时使用FXa-DOAC和酶诱导AED的病例比例与FXa-DOAC和其他AED的病例比例。结果在此期间，有9693例不良事件病例报告了同时使用FXa-DOAC和AED。几乎所有报道（> 99％）都涉及利伐沙班或阿哌沙班的使用。与其他AED相比，诱导酶的AED与报告TAIAE的几率增加86％[报告比值比（ROR）1.86，95％置信区间（CI）1.61-2.15；p <0.0001]。在利伐沙班和阿哌沙班的第二次单独分析中，诱导酶的AED与TAIAE的报告增多相似（ROR 1.79，95％CI 1.50-2.12，ROR 1.88，95％CI 1.41-2.48）。结论使用现实世界的数据，
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