Real Time Identification of Drug-Induced Liver Injury (DILI) through Daily Screening of ALT Results: A Prospective Pilot Cohort Study

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 and for the Drug Induced Liver Injury Groupe Hospitalier Pitié-Salpêtrière (DILI-GHPS) Group and the Safer and Faster Evidence-based Translation (SAFE-T) Consortium

PLOS ONE, 2012, vol. 7, issue 8, 1-7

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); P 3 ULN by designated biochemists and hepatologists identified 12 times more acute cases of drug-induced liver disease than the standard strategy.

Date: 2012
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Persistent link: https://EconPapers.repec.org/RePEc:plo:pone00:0042418

DOI: 10.1371/journal.pone.0042418

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