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Nephrotoxicity of direct factor Xa inhibitors: a pharmacovigilance study using real-world data from the Federal
Xitong Zhang1, Bing Lv2, Bin Liu3
1Department of Anesthesiology, Jilin Cancer Hospital, No. 1066, Jinhu Road, High-tech Zone, Changchun 130000, China.
Background:
Factor Xa inhibitors (FXaIs) may induce nephrotoxicity despite their FDA approval for thrombotic diseases, which has raised concerns due to its severe consequences. This study utilizes the FAERS database to assess the potential link between direct FXaIs and nephrotoxicity.
Methods:
Data from the FAERS database, spanning from the third quarter of 2011 to the fourth quarter of 2023, were used to perform a disproportionality analysis on Apixaban, Edoxaban, and Rivaroxaban. Disproportionality analysis and statistical processing were conducted using R software.
Results:
Descriptive analysis revealed that males and individuals aged 65-85 are more susceptible to nephrotoxic adverse events. The disproportionality analysis indicated that all three drugs are associated with acute renal failure and renovascular disorders, with Edoxaban showing the strongest correlation.
Conclusions:
This study quantitatively analysed the relative risk of nephrotoxic adverse reactions associated with direct FXaIs, emphasizing the importance of renal function monitoring for these medications. The results indicate that Edoxaban has a significant association with nephrotoxicity, necessitating closer attention to its use and recommending additional renal function tests and drug concentration testing for high-risk patients.
Insights
Direct Factor Xa inhibitors (FXaIs) like Edoxaban may cause kidney damage. Monitoring renal function is crucial, especially for high-risk patients, due to potential nephrotoxicity risks.
Area of Science:
- Pharmacovigilance
- Nephrology
- Cardiology
Background:
- Direct Factor Xa inhibitors (FXaIs) are approved for thrombotic diseases but may cause nephrotoxicity.
- Severe consequences of FXaI-induced nephrotoxicity necessitate further investigation.
Purpose of the Study:
- To assess the potential link between direct FXaIs and nephrotoxicity using the FAERS database.
- To quantitatively analyze the relative risk of nephrotoxic adverse reactions associated with direct FXaIs.
Main Methods:
- Utilized the FAERS database from Q3 2011 to Q4 2023.
- Performed disproportionality analysis on Apixaban, Edoxaban, and Rivaroxaban using R software.
Main Results:
- Males and individuals aged 65-85 are more susceptible to nephrotoxic events.
- Apixaban, Edoxaban, and Rivaroxaban are associated with acute renal failure and renovascular disorders.
- Edoxaban demonstrated the strongest correlation with nephrotoxicity.
Conclusions:
- Direct FXaIs are associated with nephrotoxicity, underscoring the need for renal function monitoring.
- Edoxaban shows a significant association with nephrotoxicity, requiring closer attention.
- Recommend renal function and drug concentration testing for high-risk patients.
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