The Neurology Unit, San Giacomo Hospital, ASL Alessandria, Novi Ligure, Italy.
The Neurology Unit, Guglielmo da Saliceto Hospital, AUSLPC, Piacenza, Italy.
Clin Ther. 2024 Jul;46(7):e26-e30. doi: 10.1016/j.clinthera.2024.06.002. Epub 2024 Jul 6.
Although prescription of direct oral anticoagulants (DOACs) for epileptic patients on anti-seizure medications (ASMs) is on the increase, international guidelines pose strict restrictions because this may lead to pharmacologic interactions. However, current evidence on their clinical relevance remains scanty. This retrospective, case-control study assessed the frequency of ischemic/hemorrhagic events and epileptic seizures involving DOAC-ASM cotherapy in the real world, compared with DOAC and ASM monotherapy, in age- and gender-matched controls.
Data on patients who had been prescribed a concomitant DOAC and ASM therapy for at least 6 months were extracted from the database of the Pharmaceutical Service of the Alessandria Province (Italy). After exclusions, the case group included 124 patients, 44 on valproic acid (VPA) and 80 on levetiracetam (LEV) concomitant with a DOAC, and it was compared with the DOAC-control and ASM-control groups. The clinical and laboratory data were extracted from the electronic archives of the hospitals in the same province.
Two (1.6%) ischemic and 2 (1.6%) major hemorrhagic events were observed in the case group. Four (3.2%) ischemic and no hemorrhagic events occurred in the DOAC-control group. There were no statistically significant differences in the ischemic and hemorrhagic events between the case group (patients on concomitant LEV or VPA who were prescribed a DOAC) and the DOAC-control group, and there was no difference in the recurrence rate of epileptic seizures between the case group and the ASM-control group.
Although this study has some limits, mainly the small sample size, our findings indicate that neither LEV nor VPA concomitant treatment significantly affects the effects of DOACs in a real-world setting.
尽管抗癫痫药物（ASM）治疗的癫痫患者开具直接口服抗凝剂（DOAC）的情况有所增加，但国际指南对此严格限制，因为这可能导致药物相互作用。然而，目前关于其临床相关性的证据仍然很少。这项回顾性病例对照研究评估了在真实世界中 DOAC-ASM 联合治疗与 DOAC 和 ASM 单药治疗相比，涉及 DOAC-ASM 联合治疗的缺血性/出血性事件和癫痫发作的频率，同时与年龄和性别匹配的对照组进行比较。
从意大利亚历山德里亚省（意大利）药学服务数据库中提取了至少接受了 6 个月的同时处方 DOAC 和 ASM 治疗的患者的数据。排除后，病例组包括 124 例患者，44 例接受丙戊酸（VPA）治疗，80 例接受左乙拉西坦（LEV）治疗，并与 DOAC 对照组和 ASM 对照组进行比较。临床和实验室数据从同一省份的医院电子档案中提取。
在病例组中观察到 2 例（1.6%）缺血性和 2 例（1.6%）大出血事件。DOAC 对照组中观察到 4 例（3.2%）缺血性和无出血性事件。病例组（同时服用 LEV 或 VPA 并开具 DOAC 的患者）与 DOAC 对照组在缺血性和出血性事件方面无统计学差异，病例组与 ASM 对照组的癫痫发作复发率也无差异。
尽管本研究存在一些局限性，主要是样本量小，但我们的研究结果表明，LEV 或 VPA 联合治疗在真实环境中不会显著影响 DOAC 的效果。
