ArticleInternational journal of medical sciences2015
Evaluation of Dabigatran- and Warfarin-Associated Hemorrhagic Events Using the FDA-Adverse Event Reporting System Database Stratified by Age.
Article in International journal of medical sciences, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 2 of them syntheses that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 24 citations in OpenAlex.
- The Risk of Gastrointestinal Bleeding between Non-Vitamin K Antagonist Oral Anticoagulants and Vitamin K Antagonists in the Asian Atrial Fibrillation Patients: A Meta-Analysis.International journal of environmental research and public health · 2020Pooled it
- The association between non-vitamin K antagonist oral anticoagulants and gastrointestinal bleeding: a meta-analysis of observational studies.British journal of clinical pharmacology · 2016Pooled it
- The INGENIOUS trial: Impact of pharmacogenetic testing on adverse events in a pragmatic clinical trial.The pharmacogenomics journal · 2023Trial
- Lack of effect of Imrecoxib, an innovative and moderate COX-2 inhibitor, on pharmacokinetics and pharmacodynamics of warfarin in healthy volunteers.Scientific reports · 2019Trial
- Indication and adverse event profiles of denosumab and zoledronic acid: based on U.S. FDA adverse event reporting system (FAERS).Frontiers in pharmacology · 2023Article
- Detecting early safety signals of infliximab using machine learning algorithms in the Korea adverse event reporting system.Scientific reports · 2022Article
- Evaluation of rivaroxaban-, apixaban- and dabigatran-associated hemorrhagic events using the FDA-Adverse event reporting system (FAERS) database.International journal of clinical pharmacy · 2021Article
- Drug interactions of direct oral anticoagulants in elderly patients with cardiometabolic diseases.Current research in pharmacology and drug discovery · 2021Review
- Comparison of Safety Profiles of New Oral Anticoagulants with Warfarin Using the Japanese Spontaneous Reporting Database.Clinical drug investigation · 2019Article
- Adverse reaction profiles of hemorrhagic adverse reactions caused by direct oral anticoagulants analyzed using the Food and Drug Administration Adverse Event Reporting System (FAERS) database and the Japanese Adverse Drug Event Report (JADER) database.International journal of medical sciences · 2019Article
- Contraceptives as possible risk factors for postpartum depression: A retrospective study of the food and drug administration adverse event reporting system, 2004-2015.Nursing open · 2018Article
- Validation of knowledge and adherence assessment tools among patients on warfarin therapy in a Saudi hospital anticoagulant clinic.International journal of clinical pharmacy · 2018Article
- Thromboembolic adverse event study of combined estrogen-progestin preparations using Japanese Adverse Drug Event Report database.PloS one · 2017Article
- Drug-induced gingival hyperplasia: a retrospective study using spontaneous reporting system databases.Journal of pharmaceutical health care and sciences · 2017Article
- Age-related trends in injection site reaction incidence induced by the tumor necrosis factor-α (TNF-α) inhibitors etanercept and adalimumab: the Food and Drug Administration adverse event reporting system, 2004-2015.International journal of medical sciences · 2017Article
- Analysis of polypharmacy effects in older patients using Japanese Adverse Drug Event Report database.PloS one · 2017Article
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Corrections and comments
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Authors and funding
10 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Dabigatran and warfarin are oral anticoagulant drugs widely used for the prevention of stroke in patients with atrial fibrillation. The objective of this study was to evaluate the interaction between aging and dabigatran- and warfarin-induced gastrointestinal (GI) and nervous system hemorrhage using data available in the FDA Adverse Event Reporting System (FAERS) database. We analyzed reports of hemorrhagic events in the GI and nervous system recorded in the FAERS database between 2004 and 2014 using an adjusted reporting odds ratio (ROR). We demonstrated that dabigatran-associated GI hemorrhage was significantly increased in patients over the age of 80 years. The RORs of dabigatran increased with increasing age, although aging had little effect on warfarin-associated GI hemorrhage. The ROR for anticoagulant-associated nervous system hemorrhage was not significantly affected by aging, as compared to GI hemorrhage. Our results indicate that the excretion of dabigatran may be affected by aging, as compared to warfarin, likely due to renal function decline. Our results emphasize the need for physicians to closely monitor GI bleeding in aging patients, because it is closely related to renal function deterioration.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.