Hemorrhage Risk Profiles among Different Antithrombotic Regimens: Evidence from a Real-World Analysis of Postmarketing Surveillance Data

Autor: Yang-Zhong BaiMa, Xue Sun, Bi Ze, Wei Zuo, Luo-Bo GeSang, Ling-Jun Zhang, Bin Zhao
Rok vydání: 2020
Předmět:
Adult
Male
0301 basic medicine
medicine.medical_specialty
Adolescent
Postmarketing surveillance
Hemorrhage
030204 cardiovascular system & hematology
Young Adult
03 medical and health sciences
Adverse Event Reporting System
chemistry.chemical_compound
0302 clinical medicine
Fibrinolytic Agents
Internal medicine
Antithrombotic
Product Surveillance
Postmarketing
medicine
Adverse Drug Reaction Reporting Systems
Humans
Pharmacology (medical)
Adverse effect
Aged
Retrospective Studies
Aged
80 and over
Pharmacology
Rivaroxaban
United States Food and Drug Administration
business.industry
Bayes Theorem
General Medicine
Middle Aged
Clopidogrel
United States
030104 developmental biology
chemistry
Betrixaban
Drug Therapy
Combination
Female
Apixaban
Cardiology and Cardiovascular Medicine
business
Platelet Aggregation Inhibitors
Factor Xa Inhibitors
medicine.drug
Zdroj: Cardiovascular Drugs and Therapy. 36:103-112
ISSN: 1573-7241
0920-3206
DOI: 10.1007/s10557-020-07110-w
Popis: Although the use of direct oral anticoagulants (DOACs) has been reported in patients with atrial fibrillation (AF), there is currently no consensus on the occurrence or characteristics of the hemorrhage risk in different antithrombotic regimens. Disproportionality and Bayesian analyses were performed in mining data of suspected hemorrhagic events after antithrombotic drug use from the FDA Adverse Event Reporting System (FAERS) from January 2004 to September 2019. The time to onset and fatality rate of hemorrhage following different antithrombotic regimens were also compared. A total of 84,998 reports of hemorrhage-related adverse events with the use of antithrombotic drugs were identified. The patients included were mostly from the Americas (80.87%) and Europe (13.22%), with most data submitted by nonhealthcare professionals. Among the seven antithrombotic drug monotherapies, betrixaban had the highest association with hemorrhage based on the highest reporting odds ratio (ROR, 829.95; 95% CI = 113.61-6063.15), proportional reporting ratio (PRR, 24.68, χ2 = 804.24), and multi-item gamma Poisson shrinker (MGPS, 24.68, 95% one-sided CI = 4.67). The combination therapies of clopidogrel plus new oral anticoagulants had higher RORs, PRRs, and empirical Bayesian geometric means (EBGMs) than the antithrombotic drug monotherapies. Hemorrhage associated with rivaroxaban plus clopidogrel appeared to have an earlier onset (171 days vs 219 days, 95% two-sided CI =68.68-27.34, p
Databáze: OpenAIRE
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