title: Evaluation of Dabigatran- and Warfarin-Associated Hemorrhagic Events Using the FDA-Adverse Event Reporting System Database Stratified by Age.
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.
authors.affiliation: 1. Laboratory of Drug Informatics, Gifu Pharmaceutical University ; 2. Medical Database Co., LTD.
authors.forename: Junko
authors.initials: J
authors.lastname: Abe
authors.affiliation: 1. Laboratory of Drug Informatics, Gifu Pharmaceutical University.
authors.forename: Ryogo
authors.initials: R
authors.lastname: Umetsu
authors.affiliation: 1. Laboratory of Drug Informatics, Gifu Pharmaceutical University.
authors.forename: Yamato
authors.initials: Y
authors.lastname: Kato
authors.affiliation: 1. Laboratory of Drug Informatics, Gifu Pharmaceutical University.
authors.forename: Natsumi
authors.initials: N
authors.lastname: Ueda
authors.affiliation: 1. Laboratory of Drug Informatics, Gifu Pharmaceutical University.
authors.forename: Yoko
authors.initials: Y
authors.lastname: Nakayama
authors.affiliation: 1. Laboratory of Drug Informatics, Gifu Pharmaceutical University.
authors.forename: Yukiya
authors.initials: Y
authors.lastname: Suzuki
authors.affiliation: 1. Laboratory of Drug Informatics, Gifu Pharmaceutical University.
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Suzuki
authors.affiliation: 3. Laboratory of Pharmaceutical and Medical Chemistry, Gifu Pharmaceutical University.
authors.forename: Hideko
authors.initials: H
authors.lastname: Nagasawa
authors.affiliation: 4. Department of Biomedical Informatics, Gifu University Graduate School of Medicine, JAPAN.
authors.forename: Yasutomi
authors.initials: Y
authors.lastname: Kinosada
authors.affiliation: 1. Laboratory of Drug Informatics, Gifu Pharmaceutical University.
authors.forename: Mitsuhiro
authors.initials: M
authors.lastname: Nakamura
mesh_terms: D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000375:Aging / Q000502:physiology; D000925:Anticoagulants / Q000009:adverse effects* / Q000493:pharmacokinetics; D000991:Antithrombins / Q000009:adverse effects* / Q000493:pharmacokinetics; D001281:Atrial Fibrillation / Q000188:drug therapy; D000069604:Dabigatran / Q000009:adverse effects* / Q000493:pharmacokinetics; D016208:Databases, Factual; D005260:Female; D006471:Gastrointestinal Hemorrhage / Q000139:chemically induced; D006470:Hemorrhage / Q000139:chemically induced*; D006801:Humans; D020300:Intracranial Hemorrhages / Q000139:chemically induced; D007668:Kidney / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D014481:United States; D014486:United States Food and Drug Administration; D014859:Warfarin / Q000009:adverse effects* / Q000493:pharmacokinetics
chemical_list: D000925:Anticoagulants; D000991:Antithrombins; D014859:Warfarin; D000069604:Dabigatran
keywords: adverse event reporting system; dabigatran; hemorrhagic events; warfarin