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Article

Valproic Acid-Induced Liver Injury: A Case-Control Study from a Prospective Pharmacovigilance Program in a Tertiary Hospital

Department of Clinical Pharmacology, La Paz University Hospital-IdiPAZ, Autonomous University of Madrid, 28046 Madrid, Spain
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Authors to whom correspondence should be addressed.
Academic Editors: Johannes Van Den Anker, Antonio J. Carcas-Sansuán and Alberto M. Borobia Pérez
J. Clin. Med. 2021, 10(6), 1153; https://doi.org/10.3390/jcm10061153
Received: 16 January 2021 / Revised: 1 March 2021 / Accepted: 4 March 2021 / Published: 10 March 2021
(This article belongs to the Special Issue Practice and Research in Clinical Pharmacology)
Introduction: Valproic acid (VPA) is an antiepileptic drug extensively used for treating partial and generalised seizures, acute mania and as prophylaxis for bipolar disorder. Drug-induced liver injury (DILI) persists as a significant issue related to fatal outcomes by VPA. The aim of this study was to increase our knowledge about this condition and to better identify patients affected. Methods: We conducted an observational retrospective case-control study that identified cases of DILI by VPA from the Pharmacovigilance Programme from our Laboratory Signals at La Paz University Hospital from January 2007 to December 2019. From the Therapeutic VPA Monitoring program, two control groups were assigned, VPA-tolerant patients and the other with patients who developed mild VPA-related liver injury but who did not meet the DILI criteria, matched for date, age and sex. Results: A total of 60 patients were included in the study: 15 cases of DILI, 30 VPA-tolerant controls and 15 controls with mild liver injury. Mean age for the cases was 45.7 years, 4 (26.7%) were women and 5 (33.34%) were children under 18 years, of them 3 (20%) were fatal. Polytherapy with other antiepileptic drugs (p = 0.047) and alcohol consumption (p < 0.001) were associated with a greater risk of developing DILI by VPA. A diagnosis of epileptic seizure was more frequently related to DILI when compared with the VPA-tolerant controls (p < 0.001). The cases developed hepatocellular liver injury (p < 0.001), while the mild hepatic damage controls had a higher rate of cholestatic liver injury (p < 0.001). The laboratory lactate dehydrogenase values were statistically higher (even at baseline) in patients with DILI than in both control groups (p = 0.033 and p = 0.039). Conclusions: VPA hepatotoxicity remains a considerable problem. This study offers interesting findings for characterising VPA-induced liver injury and at-risk patients. View Full-Text
Keywords: valproic acid; drug-induced liver injury; adverse drug reaction; case-control study valproic acid; drug-induced liver injury; adverse drug reaction; case-control study
MDPI and ACS Style

Meseguer, E.S.; Elizalde, M.U.; Borobia, A.M.; Ramírez, E. Valproic Acid-Induced Liver Injury: A Case-Control Study from a Prospective Pharmacovigilance Program in a Tertiary Hospital. J. Clin. Med. 2021, 10, 1153. https://doi.org/10.3390/jcm10061153

AMA Style

Meseguer ES, Elizalde MU, Borobia AM, Ramírez E. Valproic Acid-Induced Liver Injury: A Case-Control Study from a Prospective Pharmacovigilance Program in a Tertiary Hospital. Journal of Clinical Medicine. 2021; 10(6):1153. https://doi.org/10.3390/jcm10061153

Chicago/Turabian Style

Meseguer, Enrique S., Mikel U. Elizalde, Alberto M. Borobia, and Elena Ramírez. 2021. "Valproic Acid-Induced Liver Injury: A Case-Control Study from a Prospective Pharmacovigilance Program in a Tertiary Hospital" Journal of Clinical Medicine 10, no. 6: 1153. https://doi.org/10.3390/jcm10061153

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