SynthesisDrug safety2021
Comparative Risk Assessment of Severe Uterine Bleeding Following Exposure to Direct Oral Anticoagulants: A Network Study Across Four Observational Databases in the USA.
Synthesis in Drug safety, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04394234 (Comparative Risk Assessment of Severe Uterine Bleeding Following Exposure to Direct Oral Anticoagulants), which is not on this map. Cited by 6 papers.
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The trial behind it
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Comparative Risk Assessment of Severe Uterine Bleeding Following Exposure to Direct Oral Anticoagulants: A Network Study Across 4 US Observational Databases
Who cites it
6 citing papers in PubMed.
- Heavy Menstrual Bleeding in Women Treated with Direct Oral Anticoagulants: Results of the Prospective HEMBLED Registry.Thrombosis and haemostasis · 2026Trial
- From study design to executable code: automating target trial emulation with large language models.JAMIA open · 2026Article
- The necessity of validity diagnostics when drawing causal inferences from observational data: lessons from a multi-database evaluation of the risk of non-infectious uveitis among patients exposed to RemicadeBMC medical research methodology · 2024Article
- Article
- How do anticoagulants impact menstrual bleeding and quality of life? - The PERIOD study.Research and practice in thrombosis and haemostasis · 2023Article
- Do women with venous thromboembolism bleed more than men during anticoagulation? Data from the real-life, prospective START-Register.Therapeutic advances in drug safety · 2021Article
Corrections and comments
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Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAntithrombotic 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).
objectiveUsing 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.
methodsTo 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 (I
resultsData from 363,919 women newly exposed to a direct oral anticoagulant or warfarin with a prior diagnosis of AF (60.8%) or VTE (39.2%) were analyzed. Overall incidence of severe uterine bleeding was low in the populations exposed to direct oral anticoagulants, although relatively higher in the younger VTE population vs the AF population (unadjusted incidence rates: 2.8-33.7 vs 1.9-10.0 events/1000 person-years). In the propensity score-matched AF population, a suggestive, moderately increased risk of severe uterine bleeding was observed for rivaroxaban relative to warfarin [hazard ratios and 95% confidence intervals from 0.83 (0.27-2.48) to 2.84 (1.32-6.23) across databases with significant heterogeneity], apixaban [pooled hazard ratio 1.45 (0.91-2.28)], and dabigatran [2.12 (1.01-4.43)], which were sensitive to the time-at-risk period. In the propensity score-matched VTE population, a consistent increased risk of severe uterine bleeding was observed for rivaroxaban relative to warfarin [2.03 (1.19-3.27)] and apixaban [2.25 (1.45-3.41)], which were insensitive to the time-at-risk period.
conclusionsFor women who need antithrombotic therapy, personalized management strategies with careful evaluation of benefits and risks are required. CLINICALTRIALS. GOV REGISTRATION: NCT04394234; registered in May 2020.
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