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Less abnormal uterine bleeding with dabigatran than warfarin in women treated for acute venous thromboembolism.
J Thromb Haemost. 2018 Jul 05;:
Authors: Huisman MV, Ferrreira M, Feuring M, Fraessdorf M, Klok FA
Abstract
INTRODUCTION: While 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 to 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 in adverse events, in female patients aged 18-50 years treated with dabigatran were compared with those 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 0.39-0.90; p=0.015). In the dabigatran-treated patients, 3 (0.5%) suffered major bleeding (MB) versus 5 (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%) to receive warfarin (HR 0.53; 95% CI, 0.34-0.83). None of the bleeding events were 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. This article is protected by copyright. All rights reserved.
PMID: 29974611 [PubMed - as supplied by publisher]