000 03647 am a22003613u 4500
042 _adc
100 1 0 _aBjörnsson, Einar S.
_eauthor
_91853
700 1 0 _aStephens, Camilla
_eauthor
_91854
700 1 0 _aAtallah, Edmond
_eauthor
_91855
700 1 0 _aRobles‐Diaz, Mercedes
_eauthor
_91856
700 1 0 _aAlvarez‐Alvarez, Ismael
_eauthor
_91857
700 1 0 _aGerbes, Alexander
_eauthor
_91858
700 1 0 _aWeber, Sabine
_eauthor
_91859
700 1 0 _aStirnimann, Guido
_eauthor
_91860
700 1 0 _aKullak‐Ublick, Gerd
_eauthor
_91861
700 1 0 _aCortez‐Pinto, Helena
_eauthor
_91862
700 1 0 _aGrove, Jane I.
_eauthor
_91863
700 1 0 _aLucena, M. Isabel
_eauthor
_91864
700 1 0 _aAndrade, Raul J.
_eauthor
_91865
700 1 0 _aAithal, Guruprasad P.
_eauthor
_91866
245 0 0 _aA new framework for advancing in drug‐induced liver injury research. The Prospective European DILI Registry
260 _bJohn Wiley and Sons Inc.,
_c2022-08-15.
500 _a/pmc/articles/PMC7614006/
500 _a/pubmed/35899490
520 _aBACKGROUND & AIMS: No multi‐national prospective study of drug‐induced liver injury (DILI) has originated in Europe. The design of a prospective European DILI registry, clinical features and short‐term outcomes of the cases and controls is reported. METHODS: Patients with suspected DILI were prospectively enrolled in the United Kingdom, Spain, Germany, Switzerland, Portugal and Iceland, 2016-2021. DILI cases or non‐DILI acute liver injury controls following causality assessment were enrolled. RESULTS: Of 446 adjudicated patients, 246 DILI patients and 100 had acute liver injury due to other aetiologies, mostly autoimmune hepatitis (n = 42) and viral hepatitis (n = 34). DILI patients (mean age 56 years), 57% women, 60% with jaundice and 3.6% had pre‐existing liver disease. DILI cases and non‐DILI acute liver injury controls had similar demographics, clinical features and outcomes. A single agent was implicated in 199 (81%) DILI cases. Amoxicillin‐clavulanate, flucloxacillin, atorvastatin, nivolumab/ipilimumab, infliximab and nitrofurantoin were the most commonly implicated drugs. Multiple conventional medications were implicated in 37 (15%) and 18 cases were caused by herbal and dietary supplements. The most common single causative drug classes were antibacterials (40%) and antineoplastic/immunomodulating agents (27%). Overall, 13 (5.3%) had drug‐induced autoimmune‐like hepatitis due to nitrofurantoin, methyldopa, infliximab, methylprednisolone and minocycline. Only six (2.4%) DILI patients died (50% had liver‐related death), and another six received liver transplantation. CONCLUSIONS: In this first multi‐national European prospective DILI Registry study, antibacterials were the most commonly implicated medications, whereas antineoplastic and immunomodulating agents accounted for higher proportion of DILI than previously described. This European initiative provides an important opportunity to advance the study on DILI.
540 _a© 2022 The Authors. Liver International published by John Wiley & Sons Ltd.
540 _ahttps://creativecommons.org/licenses/by/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
546 _aen
690 _aMetabolic & Toxic Liver Diseases
_91867
655 7 _aText
_2local
786 0 _nLiver Int
856 4 1 _uhttp://dx.doi.org/10.1111/liv.15378
_zConnect to this object online.
999 _c2071
_d2071