Original ResearchFull Report: Clinical—LiverUse of Hy's Law and a New Composite Algorithm to Predict Acute Liver Failure in Patients With Drug-Induced Liver Injury
Section snippets
Patients and Methods
The study cohort encompassed all patients with idiosyncratic drug-induced liver injury entered into the Spanish DILI Registry since its foundation in April 1994 until August 2012. This prospective database contains detailed demographic, clinical, laboratory, imaging, and histologic (when available) information both at presentation and at follow-up evaluation of the patients included. Each case included in the study was evaluated by a clinician and remitted to the coordinating center where it
Demographic and Clinical Presentation of DILI Patients Who Did or Did Not Develop ALF/OLT
A total of 771 patients, who had 805 DILI episodes between April 1994 and August 2012, were included in the analysis. Thirty-two of these DILI patients (4%) developed ALF resulting in death (19; 59%), OLT (12; 38%), or recovery (1; 3%). In addition, 10 patients died within 6 months of DILI recognition of non–liver-related causes. The overall mean age was 54 years (range, 11–89 y), and 394 (51%) were men. The main causative drug group was antibiotics (36%), followed by nervous system (13%),
Discussion
Prediction of severe outcome at DILI recognition remains a challenge in clinical practice. Prompt discontinuation of the offending drug is a crucial step in DILI management, but it is not enough by itself to prevent further damage and even a fulminant outcome in some cases. Assessment of DILI severity is based on derangement in coagulation parameters and the development of encephalopathy.13, 18 However, these are delayed features and at this time point liver parenchymal mass is lost extensively
Acknowledgments
The authors are grateful to D. Ramon Hidalgo of the Servicio Central de Informatica de la Universidad de Malaga for his invaluable help in the statistical analyses.
The authors thank the following Collaborators for their contributions.
On behalf of the Safer and Faster Evidence-based Translation Consortium, the members of the DILI work package are as follows: R. J. Andrade, M. I. Lucena, M. Robels-Díaz, C. Stephens, G. A. Kullak-Ublick, T. Poynard, S. Ormarsdottir, M. Merz, and I.
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Conflicts of interest The authors disclose no conflicts.
Funding Supported by a research grant (Fondo de Investigación Sanitaria, PI12-00620), the Agencia Española del Medicamento, and the Innovative Medicines Initiative Safer and Faster Evidence-based Translation consortium (Framework Programme for Research and Technological Development (FP-7) grant agreement number 523 705, IMI-2008-T5). CIBERehd is funded by the Instituto de Salud Carlos III.
The personal views expressed in this article may not be understood nor quoted as being made on behalf of or reflecting the position of the Innovative Medicines Initiative or its membership companies. The funding sources had no involvement in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the manuscript for publication.