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Case Definition and Phenotype Standardization in Drug‐Induced Liver Injury
Author(s) -
Aithal GP,
Watkins PB,
Andrade RJ,
Larrey D,
Molokhia M,
Takikawa H,
Hunt CM,
Wilke RA,
Avigan M,
Kaplowitz N,
Bjornsson E,
Daly AK
Publication year - 2011
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2011.58
Subject(s) - medicine , terminology , intensive care medicine , standardization , drug , autoimmune hepatitis , causality (physics) , liver injury , drug development , chronic hepatitis , hepatitis , pharmacology , immunology , computer science , philosophy , linguistics , physics , virus , quantum mechanics , operating system
Drug‐induced liver injury (DILI) is the most frequent reason cited for the withdrawal of approved drugs from the market and accounts for up to 15% of the cases of acute liver failure. Investigators around the globe have begun to identify and study patients with DILI; several large registries and tissue banks are being established. In order to gain the maximum scientific benefit from these efforts, the definitions and terminology related to the clinical phenotypes of DILI must be harmonized. For this purpose, an international DILI Expert Working Group of clinicians and scientists reviewed current DILI terminology and diagnostic criteria so as to develop more uniform criteria that would define and characterize the spectrum of clinical syndromes that constitute DILI. Consensus was established with respect to the threshold criteria for definition of a case as being DILI, the pattern of liver injury, causality assessment, severity, and chronicity. Consensus was also reached on approaches to characterizing DILI in the setting of chronic liver diseases, including autoimmune hepatitis (AIH). Clinical Pharmacology & Therapeutics (2011) 89 6, 806–815. doi: 10.1038/clpt.2011.58