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Published on: September 9, 2012
Adverse events of direct factor Xa inhibitors: a disproportionality analysis of the FAERS database
Yating Qian1, Xinxia Zhao1, Danyi Liu1
1School of Pharmaceutical Sciences, Zhengzhou University, Zhengzhou, Henan, China.
Insights
Rivaroxaban, apixaban, and edoxaban are direct oral anticoagulants (DOACs) used for atrial fibrillation (AF). Rivaroxaban poses the highest hemorrhage risk, while apixaban is linked to death and cardiac/cerebral events, and edoxaban to kidney issues.
Area of Science:
- Pharmacovigilance
- Cardiovascular Medicine
- Hematology
Background:
- Direct oral anticoagulants (DOACs) like rivaroxaban, apixaban, and edoxaban are crucial for preventing stroke and venous thromboembolic events in atrial fibrillation (AF).
- Understanding the comparative safety profiles of these DOACs is essential for optimal patient care.
Purpose of the Study:
- To assess and compare adverse event reports for rivaroxaban, apixaban, and edoxaban.
- To identify specific risks, including hemorrhagic and non-hemorrhagic events, associated with each DOAC.
Main Methods:
- Utilized the FDA Adverse Event Reporting System (FAERS) database from 2018-2022.
- Employed disproportionality analysis methods including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), and Information Component (IC).
Main Results:
- Rivaroxaban demonstrated the most significant risk of hemorrhage.
- Apixaban was associated with a higher incidence of death, cardiac, and cerebral adverse events.
- Edoxaban showed a more prominent risk concerning kidney and urinary system adverse events.
Conclusions:
- Hemorrhage is a key risk with factor Xa inhibitors, particularly rivaroxaban.
- Apixaban and edoxaban are also associated with significant non-hemorrhagic adverse events.
- Clinical practice should increase attention to non-hemorrhagic adverse events for all DOACs.
Objectives:
Direct factor Xa inhibitors rivaroxaban, apixaban, and edoxaban, commonly used direct oral anticoagulant (DOAC), are widely used to prevent and treat stroke and venous thromboembolic events in patients with atrial fibrillation (AF). This study aimed to assess and compare reports of adverse events associated with rivaroxaban, apixaban, and edoxaban, including hemorrhagic and non-hemorrhagic events.
Methods:
Reporting odds ratio (ROR), proportional reporting ratio (PRR), Medications and Health Care Products Regulatory Agency (MHRA), and the information component (IC) were used to perform a risk assessment of adverse event reports in the FDA Adverse Event Reporting System (FAERS) database for the years 2018-2022.
Results:
Combined with disproportionality analysis in different backgrounds, the salient risks of the three-factor Xa inhibitors varied. Rivaroxaban had the most significant risk of hemorrhage, apixaban had a higher incidence and risk of death, cardiac and cerebral adverse events, and edoxaban showed a more prominent risk in the kidneys and urinary system.
Conclusion:
Hemorrhage is a common risk with factor Xa inhibitors, with rivaroxaban being the most significant. Apixaban and edoxaban also showed significant association with non-hemorrhagic adverse events, and increased attention to non-hemorrhagic adverse events is needed in clinical use.
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