A case/non-case study of a national pharmacovigilance database to explore drug-induced acute kidney injury.
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| Titel: | A case/non-case study of a national pharmacovigilance database to explore drug-induced acute kidney injury. |
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| Autoren: | Oliveira CL; iMED, Research Institute for Medicines, Faculty of Pharmacy, Universidade de Lisboa, Av. Professor Gama Pinto, 1649-003, Lisbon, Portugal.; Hospital Vila-Franca de Xira, Vila Franca de Xira, Portugal., Fernandez-Llimos F; UCIBIO-Applied Molecular Biosciences Unit, i4HB-Institute for Health and Bioeconomy, Laboratory of Pharmacology, Faculty of Pharmacy, Universidade of Porto, Porto, Portugal., Alves da Costa F; iMED, Research Institute for Medicines, Faculty of Pharmacy, Universidade de Lisboa, Av. Professor Gama Pinto, 1649-003, Lisbon, Portugal. fpcs@ff.ulisboa.pt., Aguiar JP; iMED, Research Institute for Medicines, Faculty of Pharmacy, Universidade de Lisboa, Av. Professor Gama Pinto, 1649-003, Lisbon, Portugal., Duarte-Ramos F; iMED, Research Institute for Medicines, Faculty of Pharmacy, Universidade de Lisboa, Av. Professor Gama Pinto, 1649-003, Lisbon, Portugal.; EPIUnit, Epidemiology Unit, Laboratory for Integrative and Translational Research in Population Health (ITR), Universidade do Porto, Porto, Portugal. |
| Quelle: | International journal of clinical pharmacy [Int J Clin Pharm] 2025 Dec; Vol. 47 (6), pp. 1730-1738. Date of Electronic Publication: 2025 May 26. |
| Publikationsart: | Journal Article |
| Sprache: | English |
| Info zur Zeitschrift: | Publisher: Springer Country of Publication: Netherlands NLM ID: 101554912 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2210-7711 (Electronic) NLM ISO Abbreviation: Int J Clin Pharm Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: Dordrecht : Springer |
| MeSH-Schlagworte: | Pharmacovigilance* , Acute Kidney Injury*/chemically induced , Acute Kidney Injury*/epidemiology , Acute Kidney Injury*/diagnosis , Databases, Factual*/trends , Adverse Drug Reaction Reporting Systems*/statistics & numerical data , Drug-Related Side Effects and Adverse Reactions*/epidemiology , Drug-Related Side Effects and Adverse Reactions*/diagnosis, Humans ; Male ; Middle Aged ; Female ; Aged ; Adult ; Portugal/epidemiology ; Aged, 80 and over ; Young Adult ; Adolescent |
| Abstract: | Competing Interests: Conflicts of interest: FAC is an associate editor for IJCP but was not involved in handling the manuscript. The remaining authors have no conflicts of interests to declare. Background: Monitoring safety throughout a medicine's lifecycle is essential. Pharmacovigilance systems are rich sources contributing to this aim in a real world context. Aim: To identify and estimate disproportionality rates associated with the drugs that are most frequently reported to induce acute kidney injury (AKI). Method: A case/non-case study was conducted, using data extracted in 2022 from the Portuguese National Pharmacovigilance Database for the period between 01/01/2009 and 12/31/2020. Cases were identified using the 'Acute Renal Failure' standardized MedDRA query, all remaining reports were considered non-cases, and a random sample without replacement of 4 non-cases per case was extracted. Data were expressed as the reporting odds ratio (ROR) and the 95% confidence interval. Results: During this 11-year period, 352 AKI cases were identified, representing 0.7% of the 53,505 reports received. A total of 559 different drugs were considered 'suspect' in these AKI cases. Three therapeutic subgroups (ATC2) showed a significant ROR: antithrombotic agents (ROR 6.72; 95% CI 2.23-20.22), antivirals for systemic use (ROR 4.02; 95% CI 2.76-5.87), and antineoplastic drugs (ROR 2.14; 95% CI 1.48-3.11). Additionally, we identified individual drugs with significant RORs where no class effect was observed, namely mycophenolic acid, ciclosporin, tacrolimus, simvastatin, prednisolone, vancomycin, and deferasirox. In total, eleven drugs were identified as potentially associated with the occurrence of AKI. Conclusion: This study highlights the importance of clinical pharmacy activities in closely monitoring renal function of people with known risk factors or those prescribed medications known to increase the risk of AKI. Some of the medications identified require further investigation to validate their association with AKI. (© 2025. The Author(s).) |
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| Contributed Indexing: | Keywords: Acute kidney injury; Adverse drug reaction reporting systems; Patient safety; Pharmacoepidemiology; Pharmacovigilance; Risk management |
| Entry Date(s): | Date Created: 20250526 Date Completed: 20251119 Latest Revision: 20251122 |
| Update Code: | 20251122 |
| PubMed Central ID: | PMC12630246 |
| DOI: | 10.1007/s11096-025-01940-0 |
| PMID: | 40418435 |
| Datenbank: | MEDLINE |
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Nájsť tento článok vo Web of Science | Abstract: | Competing Interests: Conflicts of interest: FAC is an associate editor for IJCP but was not involved in handling the manuscript. The remaining authors have no conflicts of interests to declare.<br />Background: Monitoring safety throughout a medicine's lifecycle is essential. Pharmacovigilance systems are rich sources contributing to this aim in a real world context.<br />Aim: To identify and estimate disproportionality rates associated with the drugs that are most frequently reported to induce acute kidney injury (AKI).<br />Method: A case/non-case study was conducted, using data extracted in 2022 from the Portuguese National Pharmacovigilance Database for the period between 01/01/2009 and 12/31/2020. Cases were identified using the 'Acute Renal Failure' standardized MedDRA query, all remaining reports were considered non-cases, and a random sample without replacement of 4 non-cases per case was extracted. Data were expressed as the reporting odds ratio (ROR) and the 95% confidence interval.<br />Results: During this 11-year period, 352 AKI cases were identified, representing 0.7% of the 53,505 reports received. A total of 559 different drugs were considered 'suspect' in these AKI cases. Three therapeutic subgroups (ATC2) showed a significant ROR: antithrombotic agents (ROR 6.72; 95% CI 2.23-20.22), antivirals for systemic use (ROR 4.02; 95% CI 2.76-5.87), and antineoplastic drugs (ROR 2.14; 95% CI 1.48-3.11). Additionally, we identified individual drugs with significant RORs where no class effect was observed, namely mycophenolic acid, ciclosporin, tacrolimus, simvastatin, prednisolone, vancomycin, and deferasirox. In total, eleven drugs were identified as potentially associated with the occurrence of AKI.<br />Conclusion: This study highlights the importance of clinical pharmacy activities in closely monitoring renal function of people with known risk factors or those prescribed medications known to increase the risk of AKI. Some of the medications identified require further investigation to validate their association with AKI.<br /> (© 2025. The Author(s).) |
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| ISSN: | 2210-7711 |
| DOI: | 10.1007/s11096-025-01940-0 |