Opin vísindi
A new framework for advancing in drug-induced liver injury research. The Prospective European DILI Registry
- Opin vísindi
- →
- IRIS
- →
- IRIS
- →
- Skoða verk
JavaScript is disabled for your browser. Some features of this site may not work without it.
| Titill: | A new framework for advancing in drug-induced liver injury research. The Prospective European DILI Registry |
| Höfundur: |
... 4 fleiri höfundar Sýna alla höfunda |
| Útgáfa: | 2023-01-01 |
| Tungumál: | Enska |
| Umfang: | 12 |
| Deild: | Office of Division of Clinical Services I Faculty of Medicine |
| Birtist í: | Liver International; 43(1) |
| ISSN: | 1478-3223 |
| DOI: | 10.1111/liv.15378 |
| Efnisorð: | Meltingarlæknisfræði; drug aetiologies; drug-induced autoimmune-like hepatitis; drug-induced liver injury; outcomes; prospective study; Prospective Studies; Nitrofurantoin; Immunomodulating Agents; Humans; Middle Aged; Male; Anti-Bacterial Agents; Infliximab; Chemical and Drug Induced Liver Injury/epidemiology; Female; Registries; Hepatology |
| URI: | https://hdl.handle.net/20.500.11815/3939 |
Tilvitnun:Björnsson , E S , Stephens , C , Atallah , E , Robles-Diaz , M , Alvarez-Alvarez , I , Gerbes , A , Weber , S , Stirnimann , G , Kullak-Ublick , G , Cortez-Pinto , H , Grove , J I , Lucena , M I , Andrade , R J & Aithal , G P 2023 , ' A new framework for advancing in drug-induced liver injury research. The Prospective European DILI Registry ' , Liver International , vol. 43 , no. 1 , pp. 115-126 . https://doi.org/10.1111/liv.15378
|
|
Útdráttur:Background & 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.
|
|
Athugasemdir:Funding Information: The Prospective European DILI Registry (Pro‐Euro‐DILI), a European‐wide, multicentric, prospective registry of patients with DILI and non‐DILI acute liver injury controls, was established in 2016 with initial support from the European Association for the Study of the Liver (EASL). Ethical approval was obtained in each participant's country and centre. Data collection and biobanking of biological samples were coordinated by the Biomedical Research Institute of Malaga (Spain), and the Nottingham Digestive Diseases Center of the University of Nottingham (United Kingdom), respectively. Since 2019, the Pro‐Euro‐DILI Registry has become a part of the DILI work package in the ‘Translational Safety Biomarker Pipeline’ (TransBioLine) Consortium project, funded by the Innovative Medicines Initiative (IMI)‐2 of the European Union and the European Federation of Pharmaceutical Industries & Associations (EFPIA). 12 Funding Information: This article is based upon work from COST Action “CA17112 – Prospective European Drug-Induced Liver Injury Network” supported by COST (European Cooperation in Science and Technology). www.cost.eu. The views expressed are those of the authors and not necessarily those of the National Health Service (NHS), the NIHR or the Department of Health. We thank all our research participants. We are grateful to the study teams at the following participating centres: University of Malaga-IBIMA (Miren García Cortés, Aída Ortega Alonso, José Pinazo Bandera, Enrique del Campo Herrera, Judith Sanabria Cabrera, Inmaculada Medina Cáliz, Elvira Bonilla Toyos, Marina Villanueva Paz, Hao Niu, Daniel Di Zeo Sánchez, Antonio Segovia Zafra, Alejandro Cueto Sánchez, Gonzalo Matilla Cabello, Jesús Aranda López); Hospital La Fe, Valencia (Martín Prieto, Isabel Conde Amiel); University Hospital Munich, Munich (Jullian Allgeier); University Hospital Zurich, Zurich (Christoph Jüngst, Mia Zahorecz, Andreas E. Kremer, Roopa Jayarama-Naidu); University Hospital Inselspital, Bern (Gia Thu Ly, Annalisa Berzigotti, Nasser Semmo, Susana G. Rodrigues, Maria G. Delgado); University of Basel, Basel (Christine Bernsmeier); Landspitali University Hospital, Reykjavik (Magdalena Sigurdardottir); Clínica Universitária de Gastrenterologia, Faculdade de Medicina, Universidade de Lisboa, Lisbon (Beatrice Mainoli, Sofia Carvalhana, Rita Baião, Ana Craciun, Raquel Ortigão, Inês Rodrigues, Miguel Moura); University of Nottingham and Nottingham University Hospitals NHS Trust, Nottingham (Melanie Lingaya, Amy Fortnum, Davor Kresnik); King's Mill Hospital, Sutton-in-Ashfield (Sharat Misra); University Hospitals Birmingham, Birmingham (Ahmed Elsharkawy); Brighton and Sussex University Hospitals, Brighton (Sumita Verma); Cambridge Addenbrooks Hospital, Cambridge (Bill Griffiths); Chesterfield Royal Hospital, Chesterfield (Keith Dear); Hampshire Hospitals, Hampshire (John Ramage, Benjamin White); Portsmouth Hospitals, Portsmouth (Andrew Fowell); Royal Cornwall Hospital, Truro (Hyder Hussaini); University Hospital Southampton, Southampton (Janisha.Patel); Derriford Hospital, Plymouth (Matthew Cramp). Funding Information: Set up of the Prospective European Drug‐Induced Liver Injury Registry (Pro‐Euro‐DILI Registry) was supported by an award to RJA and GPA from the EASL Registry Research Grants Programme. JIG and GPA are supported by National Institute of Health Research Nottingham Digestive Diseases Biomedical Research Unit and Nottingham Biomedical Research Centre [BRC‐1215‐20003]. RJA and MIL receive support from AEMPS. IAA holds a Sara Borrell contract (CD20/00083) funded by ISCiii. CIBERehd is funded by ISCiii. This article is based upon work from COST Action “CA17112 ‐ Prospective European Drug‐Induced Liver Injury Network” supported by COST (European Cooperation in Science and Technology). www.cost.eu . All authors of this manuscript are members of COST Action CA17112. Funding Information: The Pro‐Euro‐DILI is a part of the Transbioline Consortium. The TransBioLine project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 821283. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA. Funding Information: This article is based upon work from COST Action “CA17112 – Prospective European Drug‐Induced Liver Injury Network” supported by COST (European Cooperation in Science and Technology). www.cost.eu . The views expressed are those of the authors and not necessarily those of the National Health Service (NHS), the NIHR or the Department of Health. We thank all our research participants. We are grateful to the study teams at the following participating centres: University of Malaga‐IBIMA (Miren García Cortés, Aída Ortega Alonso, José Pinazo Bandera, Enrique del Campo Herrera, Judith Sanabria Cabrera, Inmaculada Medina Cáliz, Elvira Bonilla Toyos, Marina Villanueva Paz, Hao Niu, Daniel Di Zeo Sánchez, Antonio Segovia Zafra, Alejandro Cueto Sánchez, Gonzalo Matilla Cabello, Jesús Aranda López); Hospital La Fe, Valencia (Martín Prieto, Isabel Conde Amiel); University Hospital Munich, Munich (Jullian Allgeier); University Hospital Zurich, Zurich (Christoph Jüngst, Mia Zahorecz, Andreas E. Kremer, Roopa Jayarama‐Naidu); University Hospital Inselspital, Bern (Gia Thu Ly, Annalisa Berzigotti, Nasser Semmo, Susana G. Rodrigues, Maria G. Delgado); University of Basel, Basel (Christine Bernsmeier); Landspitali University Hospital, Reykjavik (Magdalena Sigurdardottir); Clínica Universitária de Gastrenterologia, Faculdade de Medicina, Universidade de Lisboa, Lisbon (Beatrice Mainoli, Sofia Carvalhana, Rita Baião, Ana Craciun, Raquel Ortigão, Inês Rodrigues, Miguel Moura); University of Nottingham and Nottingham University Hospitals NHS Trust, Nottingham (Melanie Lingaya, Amy Fortnum, Davor Kresnik); King's Mill Hospital, Sutton‐in‐Ashfield (Sharat Misra); University Hospitals Birmingham, Birmingham (Ahmed Elsharkawy); Brighton and Sussex University Hospitals, Brighton (Sumita Verma); Cambridge Addenbrooks Hospital, Cambridge (Bill Griffiths); Chesterfield Royal Hospital, Chesterfield (Keith Dear); Hampshire Hospitals, Hampshire (John Ramage, Benjamin White); Portsmouth Hospitals, Portsmouth (Andrew Fowell); Royal Cornwall Hospital, Truro (Hyder Hussaini); University Hospital Southampton, Southampton (Janisha.Patel); Derriford Hospital, Plymouth (Matthew Cramp). Publisher Copyright: © 2022 The Authors. Liver International published by John Wiley & Sons Ltd. © 2022 The Authors. Liver International published by John Wiley & Sons Ltd. © 2022 The Authors. Liver International published by John Wiley & Sons Ltd.
|
|
