Cited by 37

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Potential benefit and lack of serious risk from corticosteroids in drug-induced liver injury: an international, multicentre, propensity score-matched analysis

Niu, Hao, Ma, Jiayi, Medina‐Caliz, Inmaculada, Robles‐Diaz, Mercedes, Bonilla‐Toyos, Elvira, Ghabril, Marwan, Lucena, Mª Isabel, Alvarez‐Alvarez, Ismael, Andrade, Raul J.·2023·Alimentary Pharmacology & Therapeutics

Abstract

Summary: Background: The use of corticosteroids to treat patients with idiosyncratic drug‐induced liver injury (DILI) relies on empirical clinical decisions. Aim: To investigate the relationship between corticosteroids and risk of acute liver failure (ALF) in patients with DILI and to assess if corticosteroid therapy was associated with improved outcomes in DILI patients. Methods: We analysed bona fide idiosyncratic DILI cases from the Spanish DILI Registry and Indiana University School of Medicine. Patients treated with corticosteroids were compared to those who did not receive any treatment. Nearest neighbour propensity score matching analyses were conducted. Results: We enrolled 724 patients, 106 under corticosteroid therapy, in whom there was over‐representation of more severe injury and autoimmune features, and 618 who did not receive any treatment. In an analysis of 80 pairs of propensity score‐matched patients, corticosteroid administration was not associated with an increased risk of developing ALF (odds ratio = 0.65; 95% confidence interval [CI]: 0.18–2.40; p = 0.518). Furthermore, in an additional analysis, a Cox regression model that included 41 propensity score‐matched pairs showed that patients receiving corticosteroids had a significantly higher normalisation rate of liver enzymes than untreated patients (hazard ratio [HR] = 1.84; 95% CI: 1.02–3.32; p = 0.043), particularly in patients with serious injury who did not resolve within 30 days (HR = 2.79; 95% CI: 1.20–6.50; p = 0.018). Conclusion: Corticosteroid therapy did not worsen outcome in DILI patients. Indeed, corticosteroid administration was associated with a greater rate of normalisation of liver enzymes in patients with serious DILI.

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  • Some studies have suggested that corticosteroids ameliorate liver injury, while others have suggested that they increase adverse events without significant benefits.

    “While some studies have suggested that corticosteroids ameliorate liver injury [187][188][189][190][191], others have suggested that they increase adverse events without significant benefits [192,193].”
  • A prednisone taper of 40-60 mg/d over 1-3 months may improve normalization of liver enzymes for immune-mediated DILI.

    “while 40-60 mg/d prednisone taper over 1-3 months may improve normalization of liver enzyme for iDILI [82,191].”
  • An international collaborative study of all DILI cases retrieved from two prospective DILI registries using propensity score-matching analysis found that the benefit from steroid therapy (increase in the normalisation rate of liver biochemistry) was more evident in patients with severe DILI (nR-based Hy's law) without disease resolution within 30 days of stopping the implicated drug.

    “An international collaborative study of all DILI cases retrieved from two prospective DILI registries using propensity score-matching analysis found that the benefit from steroid therapy (increase in the normalisation rate of liver biochemistry) was more evident in patients with severe DILI (nR-based Hy’s law) without disease resolution within 30 days of stopping the implicated drug.”

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Research works printed but not linked: 27

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Metadata

Authors
Niu, H., Ma, J., Medina‐Caliz, I., Robles‐Diaz, M., Bonilla‐Toyos, E., Ghabril, M., Lucena, M. I., Alvarez‐Alvarez, I., & Andrade, R. J.
Affiliations
  • Servicios de Aparato Digestivo y Farmacología Clínica, Hospital Universitario Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga y Plataforma en Nanomedicina‐IBIMA Plataforma BIONAND Universidad de Málaga Málaga Spain
  • Division of Gastroenterology/Hepatology, Department of Medicine Indiana University School of Medicine Indianapolis Indiana USA
Venue
Alimentary Pharmacology & Therapeutics
Publisher
Wiley
Published
2022-12-22
Volume
57
Issue
8
Pages
886-896
ISSN
  • 0269-2813
  • 1365-2036
Cited by
37
References
5
Language
en
Funders
  • Consejería de Economía, Innovación, Ciencia y Empleo, Junta de Andalucía (PI‐0310‐2018, POSTDOC_21_00780)
  • European Cooperation in Science and Technology (CA17112)
  • Instituto de Salud Carlos III (CD20/00083, PI18/00901, PI19/00883, PI21/01248, PT20/000127)
  • Agencia Española de Medicamentos y Productos Sanitarios

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