1. Real time identification of drug-induced liver injury (DILI) through daily screening of ALT results: a prospective pilot cohort study
- Author
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Helmi M'Kada, Hugo Perazzo, Mona Munteanu, Yen Ngo, Nittia Ramanujam, Bruno Fautrel, Françoise Imbert-Bismut, Vlad Ratziu, Ina Schuppe-Koistinen, Véronique Leblond, Jean Yves Delattre, Yves Samson, Olivier Lyon Caen, François Bricaire, David Khayat, Charles Pierrot-Deseilligny, Serge Herson, Zahir Amoura, Patrick Tilleul, Olivier Deckmyn, Pierre Coriat, Vincent Nicolas Delpech, Philippe Boulogne, Dominique Bonnefont-Rousselot, Thierry Poynard, Drug Induced Liver Injury Groupe Hospitalier Pitié-Salpêtrière Group, and Safer and Faster Evidence-based Translation Consortium
- Subjects
Male ,Epidemiology ,lcsh:Medicine ,Pilot Projects ,Toxicology ,Cohort Studies ,Liver disease ,Informed consent ,Pathology ,Odds Ratio ,Prospective Studies ,Prospective cohort study ,lcsh:Science ,Aged, 80 and over ,Multidisciplinary ,biology ,Liver Diseases ,Drug Information ,Gastroenterology ,Alanine Transaminase ,Middle Aged ,Medicine ,Female ,Chemical and Drug Induced Liver Injury ,Molecular Pathology ,Algorithms ,Cohort study ,Research Article ,Adult ,medicine.medical_specialty ,Drugs and Devices ,Clinical Pathology ,Referral ,Adolescent ,Acute Liver Failure ,Predictive Toxicology ,Gastroenterology and Hepatology ,Necrosis ,Adverse Reactions ,Diagnostic Medicine ,Internal medicine ,medicine ,Humans ,Aged ,business.industry ,Pharmacoepidemiology ,lcsh:R ,Odds ratio ,Hepatology ,medicine.disease ,Surgery ,Biomarker Epidemiology ,Alanine transaminase ,biology.protein ,lcsh:Q ,business ,Biomarkers ,General Pathology - Abstract
Objective Identification of drug-induced liver disease (DILI) is difficult, even among hospitalized patients. The aim of this pilot study was to assess the impact of a specific strategy for DILI screening. Design We prospectively compared the number of acute DILI cases identified in one week of a proactive strategy based on centralized elevated ALT values to those identified with a standard of care strategy for 24-week period based on referral cases to the hepatology unit. In the centralized strategy, a designated study biochemist identified patients with ALT greater than 3 times the upper limit of normal values (ULN) and notified the designated hepatologists, who then went to the patients' wards, analyzed the charts, and if necessary, interviewed the identified patients. During these two periods, patients with possible DILI were included after signing an informed consent in an ongoing European diagnostic study (SAFE-T consortium). Results During the 24-week period of the standard strategy, 12 (0.04%) patients out of a total of 28,145 were identified as having possible DILI, and 11 of these accepted to be included in the protocol. During the one-week proactive period, 7 patients out of a total of 1407 inpatients (0.498%) [odds ratio vs. standard = 12.1 (95% CI, 3.9–32.3); P3 ULN by designated biochemists and hepatologists identified 12 times more acute cases of drug-induced liver disease than the standard strategy. This pilot cohort is registered on the number AP-HP P110201/1/08-03-2011 and AFSSAPS B110346-70.
- Published
- 2012