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

Author

Listed:
  • 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)

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

Suggested Citation

  • James Weaver & Azza Shoaibi & Huy Q. Truong & Leila Larbi & Shujian Wu & Peter Wildgoose & Gowtham Rao & Amy Freedman & Lu Wang & Zhong Yuan & Elliot Barnathan, 2021. "Comparative Risk Assessment of Severe Uterine Bleeding Following Exposure to Direct Oral Anticoagulants: A Network Study Across Four Observational Databases in the USA," Drug Safety, Springer, vol. 44(4), pages 479-497, April.
    • Handle: RePEc:spr:drugsa:v:44:y:2021:i:4:d:10.1007_s40264-021-01060-4
    DOI: 10.1007/s40264-021-01060-4
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