Comparison of adverse drug reactions between Edoxaban and rivaroxaban based on the U.S.food and drug administration data
Objective To use the Open U.S.Food and Drug Administration(OpenFDA)website to search for oral antico-agulant drugs such as Edoxaban and rivaroxaban,and to explore the adverse drug reactions(ADR)signals of Edoxaban and rivaroxaban.The ADR related information of the two drugs was compared and analyzed to provide references for their safe and reasonable clinical use.Methods Based on the U.S.FDA Adverse Event Reporting System,data mining was performed on the ADR reports of rivaroxaban and Edoxaban reported from January 1,2015 to March 31,2022 in the FDA's public data open project.Relevant ADR reports were analyzed and mapped to their corresponding System Organ Classes(SOC).Meanwhile,basic information such as gender,age,and severe adverse reactions of the reported cases was statistically compiled.Results There were 1 417 ADR reports with Edoxaban as a concomitant and suspected drug,and 104 695 ADR reports with rivaroxaban as a concomitant and suspected drug.The age range is mainly between 60 and 80 years old(41.07％and 31.64％,respectively).The SOC of both ADR signals were mainly concentrated in various neu-rological diseases,gastrointestinal diseases,and various examinations;Some perferred terms(PTs)not mentioned in the manual were also extracted from the data,such as cerebrovascular accidents,cerebral infarction,black stools,diarrhea,constipation,and changes in weight.Conclusion In practical clinical applications,a comprehensive analysis of past ADR related information of rivaroxaban and Edoxaban should be conducted in conjunction with the OpenFDA database,and medication should be used in combination with the actual situation of patients,providing references for rational and safe clinical medication.
idoshabanrivaroxabanadverse event reporting systemadverse drug reactionssignal miningproportional reporting ratio methodreport ratio method
NETL
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万方数据
