Marion Pierson-Marchandise1, Valérie Gras1, Julien Moragny1, Joelle Micallef2, Louise Gaboriau3, Sylvie Picard4, Gabriel Choukroun5,6, Kamel Masmoudi1, Sophie Liabeuf1,6. 1. Regional Pharmacovigilance Centre, Division of Clinical Pharmacology, Amiens University Hospital, Amiens, France. 2. Centre Régional de Pharmacovigilance, Service de Pharmacologie clinique et pharmacovigilance Aix Marseille Université, Institut de Neurosciences Timone, CNRS 7289 - 264, rue Saint Pierre, 13385, Marseille, France. 3. Regional Pharmacovigilance Centre, Lille University Hospital, Lille, France. 4. Regional Pharmacovigilance Centre, Rennes University Hospital, Rennes, France. 5. Nephrology Department, Amiens University Hospital and Jules Verne University of Picardy, Amiens, France. 6. INSERM U1088, Jules Verne University of Picardy, Amiens, France.
Abstract
AIMS: Acute kidney injury (AKI) is associated with a high hospitalization rate, accelerated long-term decline in kidney function and a high mortality rate. Adverse drug reactions (ADRs) constitute one of the most important modifiable factors in the context of AKI. Most studies of drug-induced AKI have focused on a sole drug class. The objective of the present study was to establish a comprehensive overview of drug-induced AKI on the basis of spontaneously reported ADRs in the French national pharmacovigilance database (FPVD). METHODS: We performed a case-noncase study of drug-induced AKI. Cases corresponded to the reports of AKI recorded in the FPVD between 1 January 2015 and 31 December 2015. The noncases corresponded to all other spontaneously reported ADRs (excluding AKI) recorded in the FPVD during the same period. Data were expressed as the reporting odds ratio (ROR) and the 95% confidence interval. RESULTS: Of the 38 782 ADRs recorded in the FPVD during the study period, 3.2% were classified as cases of AKI. A total of 1254 patients experienced AKI (males: 55%; mean age ± standard deviation: 68.7 ± 15.0 years). Overall, 15.2% of the patients required renal replacement therapy. Two or more concomitantly administered drugs were involved in 66% of the cases of AKI. The most frequently implicated drug classes were antibacterial agents for systemic use (29.5%), diuretics (18.5%), agents acting on the renin-angiotensin system (16.3%), antineoplastic agents (10.2%) and anti-inflammatory agents (5.4%). Gentamicin, eplerenone, spironolactone, candesartan, cisplatin and acyclovir had the highest RORs (>10). CONCLUSION: A comprehensive study of a national pharmacovigilance database enabled us to identify the drug classes that most frequently induced AKI. Even though most of the identified drugs were already known to induce AKI, the present work should raise physicians' awareness of the compounds responsible for triggering this potentially life-threatening condition.
AIMS: Acute kidney injury (AKI) is associated with a high hospitalization rate, accelerated long-term decline in kidney function and a high mortality rate. Adverse drug reactions (ADRs) constitute one of the most important modifiable factors in the context of AKI. Most studies of drug-induced AKI have focused on a sole drug class. The objective of the present study was to establish a comprehensive overview of drug-induced AKI on the basis of spontaneously reported ADRs in the French national pharmacovigilance database (FPVD). METHODS: We performed a case-noncase study of drug-induced AKI. Cases corresponded to the reports of AKI recorded in the FPVD between 1 January 2015 and 31 December 2015. The noncases corresponded to all other spontaneously reported ADRs (excluding AKI) recorded in the FPVD during the same period. Data were expressed as the reporting odds ratio (ROR) and the 95% confidence interval. RESULTS: Of the 38 782 ADRs recorded in the FPVD during the study period, 3.2% were classified as cases of AKI. A total of 1254 patients experienced AKI (males: 55%; mean age ± standard deviation: 68.7 ± 15.0 years). Overall, 15.2% of the patients required renal replacement therapy. Two or more concomitantly administered drugs were involved in 66% of the cases of AKI. The most frequently implicated drug classes were antibacterial agents for systemic use (29.5%), diuretics (18.5%), agents acting on the renin-angiotensin system (16.3%), antineoplastic agents (10.2%) and anti-inflammatory agents (5.4%). Gentamicin, eplerenone, spironolactone, candesartan, cisplatin and acyclovir had the highest RORs (>10). CONCLUSION: A comprehensive study of a national pharmacovigilance database enabled us to identify the drug classes that most frequently induced AKI. Even though most of the identified drugs were already known to induce AKI, the present work should raise physicians' awareness of the compounds responsible for triggering this potentially life-threatening condition.
Authors: Laurie A Tomlinson; Gary A Abel; Afzal N Chaudhry; Charles R Tomson; Ian B Wilkinson; Martin O Roland; Rupert A Payne Journal: PLoS One Date: 2013-11-06 Impact factor: 3.240
Authors: Solène M Laville; Valérie Gras-Champel; Julien Moragny; Marie Metzger; Christian Jacquelinet; Christian Combe; Denis Fouque; Maurice Laville; Luc Frimat; Bruce M Robinson; Bénédicte Stengel; Ziad A Massy; Sophie Liabeuf Journal: Clin J Am Soc Nephrol Date: 2020-07-01 Impact factor: 8.237