Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands.
Department of Internal Medicine, Hospital Garcia de Orta, Almada, Portugal.
J Thromb Haemost. 2018 Sep;16(9):1775-1778. doi: 10.1111/jth.14226. Epub 2018 Aug 11.
Essentials Factor Xa inhibitors cause more abnormal menstrual bleeding (AUB) than vitamin-K antagonists (VKA). We analyzed data of AUB in women, evaluating dabigatran versus VKA. We observed a 41% lower risk of AUB in women on dabigatran compared to those on VKA. Our findings of lower AUB risk on dabigatran should be corroborated in future studies.
Introduction Although direct oral anticoagulants (DOACs) are associated with a better safety profile than warfarin in patients with acute venous thromboembolism (VTE), direct factor Xa inhibitors involve a higher risk of abnormal uterine bleeding (AUB). We aimed to determine the risk of AUB during anticoagulation with dabigatran compared with warfarin. Methods Post-hoc analysis of the pooled RE-COVER studies and the RE-MEDY trial. Incidences of AUB, based on a defined preferred terms search for adverse events, in female patients aged 18-50 years treated with dabigatran, were compared with those in women treated with warfarin. Results Of the 2964 women included in the above-mentioned trials, 1280 women were in the relevant age category (18-50 years) and included in the current analysis. A total of 643 patients were randomized to treatment with dabigatran and 637 to treatment with warfarin. The overall rate of AUB was 8.1%, 5.9% for the women treated with dabigatran and 9.6% in those treated with warfarin, for an odds ratio for dabigatran-treated patients of 0.59 (95% confidence interval [CI], 0.39-0.90; P = 0.015). In the dabigatran-treated patients, three (0.5%) suffered major bleeding (MB) vs. five (0.8%) in the warfarin-treated patients (HR, 0.65; 95% CI, 0.15-2.72). MB or non-major relevant bleeding occurred in 30 (4.7%) patients randomized to receive dabigatran and 57 (8.9%) randomized to receive warfarin (HR, 0.53; 95% CI, 0.34-0.83). None of the bleeding events was fatal. Conclusion Dabigatran treatment was associated with a significantly (41%) lower risk of AUB than warfarin. Future studies in daily practice are needed to corroborate these findings.
尽管直接口服抗凝剂（DOAC）与维生素 K 拮抗剂（VKA）相比，在急性静脉血栓栓塞症（VTE）患者中具有更好的安全性，但直接因子 Xa 抑制剂会增加异常子宫出血（AUB）的风险。我们旨在确定与华法林相比，达比加群在抗凝治疗中引起 AUB 的风险。
RE-COVER 研究和 RE-MEDY 试验的事后分析。根据不良事件的定义首选术语搜索，比较了年龄在 18-50 岁的接受达比加群治疗的女性患者和接受华法林治疗的女性患者的 AUB 发生率。
在上述试验中，共纳入 2964 例女性患者，其中 1280 例年龄在 18-50 岁之间，包括在本次分析中。643 例患者被随机分配至达比加群治疗组，637 例患者被随机分配至华法林治疗组。总的 AUB 发生率为 8.1%，达比加群组为 5.9%，华法林组为 9.6%，达比加群组患者的比值比为 0.59（95%置信区间 [CI]，0.39-0.90；P = 0.015）。在达比加群治疗的患者中，有 3 例（0.5%）发生大出血（MB），而华法林治疗的患者中有 5 例（0.8%）（HR，0.65；95%CI，0.15-2.72）。接受达比加群治疗的患者中有 30 例（4.7%）和接受华法林治疗的患者中有 57 例（8.9%）发生 MB 或非主要相关出血（HR，0.53；95%CI，0.34-0.83）。无出血事件致命。
与华法林相比，达比加群治疗显著降低 AUB 风险（41%）。需要在日常实践中进行进一步的研究以证实这些发现。
