Comparative Risk Assessment of Severe Uterine Bleeding Following Exposure to Direct Oral Anticoagulants: A Network Study Across Four Observational Databases in the USA

James Weaver, Azza Shoaibi, Huy Q. Truong, Leila Larbi, Shujian Wu, Peter Wildgoose, Gowtham Rao, Amy Freedman, Lu Wang, Zhong Yuan () and Elliot Barnathan
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James Weaver: Janssen Research & Development, LLC
Azza Shoaibi: Janssen Research & Development, LLC
Huy Q. Truong: Janssen Research & Development, LLC
Leila Larbi: Janssen Research & Development, LLC
Shujian Wu: Janssen Research & Development, LLC
Peter Wildgoose: Janssen Research & Development, LLC
Gowtham Rao: Janssen Research & Development, LLC
Amy Freedman: Janssen Research & Development, LLC
Lu Wang: Janssen Research & Development, LLC
Zhong Yuan: Janssen Research & Development, LLC
Elliot Barnathan: Janssen Research & Development, LLC

Drug Safety, 2021, vol. 44, issue 4, No 10, 479-497

Abstract: Abstract Background Antithrombotic therapies are associated with an increased bleeding risk. Abnormal uterine bleeding data have been reported in clinical trials of patients with venous thromboembolism (VTE), but data are limited for patients with atrial fibrillation (AF). Objective Using real-world data from four US healthcare databases (October 2010 to December 2018), we compared the occurrence of severe uterine bleeding among women newly exposed to rivaroxaban, apixaban, dabigatran, and warfarin stratified by indication. Methods To reduce potential confounding, patients in comparative cohorts were matched on propensity scores. Treatment effect estimates were generated using Cox proportional hazard models for each indication, in each database, and only for pairwise comparisons that met a priori study diagnostics. If estimates were homogeneous (I2

Date: 2021
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DOI: 10.1007/s40264-021-01060-4

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