ArticleClinical drug investigation2019
Comparison of Safety Profiles of New Oral Anticoagulants with Warfarin Using the Japanese Spontaneous Reporting Database.
Article in Clinical drug investigation, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
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Who cites it
7 citing papers in PubMed, 13 citations in OpenAlex.
- Gastrointestinal adverse events associated with axitinib: pharmacovigilance analysis of the Japanese adverse drug event report database.Pharmacological reports : PR · 2026Article
- Disproportionality analysis of hematologic adverse events associated with trastuzumab deruxtecan using the Japanese pharmacovigilance database.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026Article
- Cardiac adverse events associated with axitinib: A real-world pharmacovigilance study based on the Japanese adverse drug event report database.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026Article
- Disproportionality Analysis of Pulmonary Adverse Events Associated with Trastuzumab Deruxtecan Using the Japanese Adverse Drug Event Report Database.Clinical drug investigation · 2025Observational
- Association of Clopidogrel with Interstitial Lung Disease: Gaining Insight Through the Japanese Pharmacovigilance Database.Vascular health and risk management · 2024Article
- A Pharmacovigilance Study of Drug-Induced Glaucoma Utilizing the Japanese Adverse Event Reporting System.Clinical ophthalmology (Auckland, N.Z.) · 2023Article
- Article
Corrections and comments
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Authors and funding
6 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe development of new oral anticoagulants (NOACs) has led to an alternative to treatment with warfarin. However, real-world data on comparing safety profiles of NOACs and warfarin are insufficient. PURPOSE: The purpose of this study was to compare safety profiles of warfarin and NOACs using a spontaneous reporting system database. PATIENTS AND
methodsAdverse event reports spontaneously submitted to the Pharmaceuticals and Medical Devices Agency (Japan) between April 2011 and January 2017 were analysed. We performed disproportionality analyses, calculating the reporting odds ratio (ROR) with 95% confidence interval (CI).
resultsThe database comprised 3445 reports associated with warfarin, and 14,269 reports with NOACs. A large number of bleeding complications were detected with the use of both warfarin and NOACs. As for cerebral haemorrhage, the signal scores were greater for NOACs as a class (ROR 25.1, 95% CI 23.3-27) and individual agents (edoxaban: ROR 23.6, 95% CI 18.6-29.9; rivaroxaban ROR 23.9, 95% CI 21.4-26.8; apixaban ROR 28.1, 95% CI 25.4-31.1) than for warfarin (ROR 18.9, 95% CI 16.4-21.7), but showed the lowest value for dabigatran (ROR 9.26, 95% CI 7.76-11). Gastrointestinal haemorrhage had stronger signals for NOACs (ROR 19.4, 95% CI 17.8-21.1) than warfarin (ROR 12.2, 95% CI 10.2-14.6). With respect to calciphylaxis, the association with warfarin was noteworthy (ROR 190; 95% CI, 126-287), but no reports were detected involving NOACs.
conclusionOur results may provide useful information for treatment with oral anticoagulants, although further studies with more data are needed.
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