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Drug-Induced Liver Injury Network (DILIN) prospective study: rationale, design and conduct.

Abstract

BACKGROUND

Drug-induced liver injury (DILI) is an uncommon adverse drug reaction of increasing importance to the medical community, pharmaceutical industry, regulatory agencies and the general public.

OBJECTIVES

The Drug-Induced Liver Injury Network (DILIN) was established to advance understanding and research into DILI by initiating a prospective registry of patients with bona fide DILI for future studies of host clinical, genetic, environmental and immunological risk factors. The DILIN was also charged with developing standardized nomenclature, terminology and causality assessment instruments.

METHODS

Five clinical sites, a data coordinating centre and senior scientists from the National Institute of Diabetes and Digestive and Kidney Diseases initiated the DILIN prospective study in September 2004. Eligible patients are required to meet minimal laboratory or histological criteria within 6 months of DILI onset and have other competing causes of liver injury excluded. Patients in the general community setting with pre-existing HIV, hepatitis B virus or hepatitis C virus infections and/or abnormal baseline liver biochemistries are eligible for enrollment. In addition, subjects with liver injury due to herbal products are eligible to participate. Control patients without DILI are also to be recruited in the future.

RESULTS

All referred subjects undergo an extensive review of available laboratory, pathology and imaging studies. Subjects who meet pre-defined eligibility criteria at the 6-month study visit are followed for 2 years to better define the natural history of chronic DILI. Causality assessment is determined by a panel of three hepatologists who independently assign a causality score ranging from 1 (definite) to 5 (unlikely) as well as a severity score ranging from 1 (mild) to 5 (fatal). During the first 3 years, 367 subjects were enrolled into the DILIN prospective study.

CONCLUSION

DILIN is a multicentre research network charged with improving our understanding of the aetiologies, risk factors and outcomes of DILI in the US. The network is meeting the targeted enrollment of ten patients per month and is developing a repository of clinical data and biological samples for future studies of DILI pathogenesis and outcome.

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  • Authors+Show Affiliations

    ,

    Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, Michigan 48109-0362, USA. rfontana@med.umich.edu

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    Source

    Drug safety 32:1 2009 pg 55-68

    MeSH

    Chemical and Drug Induced Liver Injury
    Drug-Related Side Effects and Adverse Reactions
    Follow-Up Studies
    Humans
    National Institute of Diabetes and Digestive and Kidney Diseases (U.S.)
    Prospective Studies
    Registries
    Research Design
    Risk Factors
    Severity of Illness Index
    Terminology as Topic
    United States

    Pub Type(s)

    Clinical Trial
    Journal Article
    Multicenter Study
    Research Support, N.I.H., Extramural

    Language

    eng

    PubMed ID

    19132805

    Citation

    Fontana, Robert J., et al. "Drug-Induced Liver Injury Network (DILIN) Prospective Study: Rationale, Design and Conduct." Drug Safety, vol. 32, no. 1, 2009, pp. 55-68.
    Fontana RJ, Watkins PB, Bonkovsky HL, et al. Drug-Induced Liver Injury Network (DILIN) prospective study: rationale, design and conduct. Drug Saf. 2009;32(1):55-68.
    Fontana, R. J., Watkins, P. B., Bonkovsky, H. L., Chalasani, N., Davern, T., Serrano, J., & Rochon, J. (2009). Drug-Induced Liver Injury Network (DILIN) prospective study: rationale, design and conduct. Drug Safety, 32(1), pp. 55-68. doi:10.2165/00002018-200932010-00005.
    Fontana RJ, et al. Drug-Induced Liver Injury Network (DILIN) Prospective Study: Rationale, Design and Conduct. Drug Saf. 2009;32(1):55-68. PubMed PMID: 19132805.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Drug-Induced Liver Injury Network (DILIN) prospective study: rationale, design and conduct. AU - Fontana,Robert J, AU - Watkins,Paul B, AU - Bonkovsky,Herbert L, AU - Chalasani,Naga, AU - Davern,Timothy, AU - Serrano,Jose, AU - Rochon,James, AU - ,, PY - 2009/1/10/entrez PY - 2009/1/10/pubmed PY - 2009/4/8/medline SP - 55 EP - 68 JF - Drug safety JO - Drug Saf VL - 32 IS - 1 N2 - BACKGROUND: Drug-induced liver injury (DILI) is an uncommon adverse drug reaction of increasing importance to the medical community, pharmaceutical industry, regulatory agencies and the general public. OBJECTIVES: The Drug-Induced Liver Injury Network (DILIN) was established to advance understanding and research into DILI by initiating a prospective registry of patients with bona fide DILI for future studies of host clinical, genetic, environmental and immunological risk factors. The DILIN was also charged with developing standardized nomenclature, terminology and causality assessment instruments. METHODS: Five clinical sites, a data coordinating centre and senior scientists from the National Institute of Diabetes and Digestive and Kidney Diseases initiated the DILIN prospective study in September 2004. Eligible patients are required to meet minimal laboratory or histological criteria within 6 months of DILI onset and have other competing causes of liver injury excluded. Patients in the general community setting with pre-existing HIV, hepatitis B virus or hepatitis C virus infections and/or abnormal baseline liver biochemistries are eligible for enrollment. In addition, subjects with liver injury due to herbal products are eligible to participate. Control patients without DILI are also to be recruited in the future. RESULTS: All referred subjects undergo an extensive review of available laboratory, pathology and imaging studies. Subjects who meet pre-defined eligibility criteria at the 6-month study visit are followed for 2 years to better define the natural history of chronic DILI. Causality assessment is determined by a panel of three hepatologists who independently assign a causality score ranging from 1 (definite) to 5 (unlikely) as well as a severity score ranging from 1 (mild) to 5 (fatal). During the first 3 years, 367 subjects were enrolled into the DILIN prospective study. CONCLUSION: DILIN is a multicentre research network charged with improving our understanding of the aetiologies, risk factors and outcomes of DILI in the US. The network is meeting the targeted enrollment of ten patients per month and is developing a repository of clinical data and biological samples for future studies of DILI pathogenesis and outcome. SN - 0114-5916 UR - https://www.unboundmedicine.com/medline/citation/19132805/Drug_Induced_Liver_Injury_Network__DILIN__prospective_study:_rationale_design_and_conduct_ L2 - https://dx.doi.org/10.2165/00002018-200932010-00005 DB - PRIME DP - Unbound Medicine ER -