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2. Roadmap to DILI research in Europe. A proposal from COST action ProEuroDILINet

Author

Lucena, M.I., Villanueva-Paz, M., Alvarez-Alvarez, I., Aithal, G.P., Björnsson, E.S., Cakan-Akdogan, G., Cubero, F.J., Esteves, F., Falcon-Perez, J.M., Fromenty, B., Garcia-Ruiz, C., Grove, J.I., Konu, O., Kranendonk, M., Kullak-Ublick, G.A., Miranda, J.P., Remesal-Doblado, A., Sancho-Bru, P., Nelson, L., Andrade, R.J., Daly, A.K., and Fernandez-Checa, J.C.

Published
2024
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3. Comprehensive analysis and insights gained from long-term experience of the Spanish DILI Registry

Author

Andrade, R.J., Lucena, M.I., Stephens, C., Cortés, M. García, Robles-Díaz, M., Ortega-Alonso, A., Pinazo, J., Muñoz, B. García, Alcántara, R., Hernández, A., Escaño, M.D. García, del Campo, E., Medina-Cáliz, I., Sanabria-Cabrera, J., González-Jiménez, A., Sanjuán-Jiménez, R., Cueto, A., Álvarez-Álvarez, I., Bonilla, E., Di Zeo, D., Niu, H., Villanueva, M., Papineau, A., Pérez, M. Jiménez, Grande, R. González, Ortega, S. López, Santaella, I., Ocaña, A., Palomino, P., Fernández, M.C., Peláez, G., Porcel, A., Casado, M., Sánchez, M. González, Romero-Gómez, M., Millán-Domínguez, R., Fombuena, B., Gallego, R., Ampuero, J., Campo, J.A. del, Calle-Sanz, R., Rojas, L., Rojas, A., Gómez, A. Gil, Vilar, E., Soriano, G., Guarner, C., Román, E.M., Manuitt, M.A. Quijada, Arbos, R.M. Antonijoan, Delgado, J. Sánchez, Gómez, M. Vergara, Hallal, H., Oltra, E. García, Arcos, J.C. Titos, Martínez, A. Pérez, Cobarro, C. Sánchez, Caparrós, J.M. Egea, Castiella, A., Zapata, E., Arenas, J., García, A. Gómez, Esandi, F.J., Blanco, S., Odriozola, P. Martínez, Crespo, J., Iruzubieta, P., Cabezas, J., Gallego, A. Giráldez, Rodríguez Seguel, E. del P., Cuaresma, M., Gallego, J. González, Jorquera, F., Campos, S. Sánchez, Otazua, P., de Juan Gómez, A., Salmerón, J., Gila, A., Quiles, R., González, J.M., Lorenzo, S., Prieto, M., Amiel, I. Conde, Berenguer, M., García-Eliz, M., Primo, J., Molés, J.R., Garayoa, A., Carrascosa, M., Domínguez, E. Gómez, Cuevas, L., Farré, M., Montané, E., Barriocanal, A.M., Arellano, A.L., Sanz, Y., Morillas, R.M., Sala, M., Ridaura, H. Masnou, Bruguera, M., Gines, P., Lens, S., García, J.C., Mariño, Z., Guerra, M. Hernández, Sanfiel, J.M. Moreno, Fernández del Campo, C. Boada, Tejedor, M., Ferrer, R. González, Fernández, C., Gil, M. Fernández, Montero, J.L., Mata, M. de la, Olmo, J. Fuentes, Bonilla, E.M. Fernández, Moreno, J.M., Martínez-Rodenas, P., Garrido, M., Oliva, C., Rendón, P., Samaniego, J. García, Madejón, A., Calleja, J.L., Porras, J.L. Martínez, Cabriada, J.L., Pérez-Moreno, J.M., Lara, C., Stephens, Camilla, Robles-Diaz, Mercedes, Medina-Caliz, Inmaculada, Garcia-Cortes, Miren, Ortega-Alonso, Aida, Sanabria-Cabrera, Judith, Gonzalez-Jimenez, Andres, Alvarez-Alvarez, Ismael, Slim, Mahmoud, Jimenez-Perez, Miguel, Gonzalez-Grande, Rocio, Fernández, M. Carmen, Casado, Marta, Soriano, German, Román, Eva, Hallal, Hacibe, Romero-Gomez, Manuel, Castiella, Agustin, Conde, Isabel, Prieto, Martin, Moreno-Planas, Jose Maria, Giraldez, Alvaro, Moreno-Sanfiel, J. Miguel, Kaplowitz, Neil, Lucena, M. Isabel, and Andrade, Raúl J.

Published
2021
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4. Lack of complete biochemical response in autoimmune hepatitis leads to adverse outcome: First report of the IAIHG retrospective registry

Author

Slooter, C.D., Brand, F.F. van den, Lleo, A., Colapietro, F., Lenzi, M., Muratori, P., Kerkar, N., Dalekos, G.N., Zachou, K., Lucena, M.I., Robles-Díaz, M., Zeo-Sánchez, D.E. Di, Andrade, R.J., Montano-Loza, A.J., Lytvyak, E., Lissenberg-Witte, Birgit I., Maisonneuve, P., Bouma, G., Macedo, G., Drenth, J.P.H., Liberal, R., Boer, Y.S. de, Slooter, C.D., Brand, F.F. van den, Lleo, A., Colapietro, F., Lenzi, M., Muratori, P., Kerkar, N., Dalekos, G.N., Zachou, K., Lucena, M.I., Robles-Díaz, M., Zeo-Sánchez, D.E. Di, Andrade, R.J., Montano-Loza, A.J., Lytvyak, E., Lissenberg-Witte, Birgit I., Maisonneuve, P., Bouma, G., Macedo, G., Drenth, J.P.H., Liberal, R., and Boer, Y.S. de

Abstract

Contains fulltext : 305452.pdf (Publisher’s version ) (Closed access), BACKGROUND AND AIMS: The International Autoimmune Hepatitis Group retrospective registry (IAIHG-RR) is a web-based platform with subjects enrolled with a clinical diagnosis of autoimmune hepatitis (AIH). As prognostic factor studies with enough power are scarce, this study aimed to ascertain data quality and identify prognostic factors in the IAIHG-RR cohort. METHODS: This retrospective, observational, multicenter study included all patients with a clinical diagnosis of AIH from the IAIHG-RR. The quality assessment consisted of external validation of completeness and consistency for 29 predefined variables. Cox regression was used to identify risk factors for liver-related death and liver transplantation (LT). RESULTS: This analysis included 2559 patients across 7 countries. In 1700 patients, follow-up was available, with a completeness of individual data of 90% (range: 30-100). During a median follow-up period of 10 (range: 0-49) years, there were 229 deaths, of which 116 were liver-related, and 143 patients underwent LT. Non-White ethnicity (HR 4.1 95% CI: 2.3-7.1), cirrhosis (HR 3.5 95% CI: 2.3-5.5), variant syndrome with primary sclerosing cholangitis (PSC) (HR 3.1 95% CI: 1.6-6.2), and lack of complete biochemical response within 6 months (HR 5.7 95% CI: 3.4-9.6) were independent prognostic factors. CONCLUSIONS: The IAIHG-RR represents the world's largest AIH cohort with moderate-to-good data quality and a relevant number of liver-related events. The registry is a suitable platform for patient selection in future studies. Lack of complete biochemical response to treatment, non-White ethnicity, cirrhosis, and PSC-AIH were associated with liver-related death and LT.

Published
2024

5. Roadmap to DILI research in Europe. A proposal from COST action ProEuroDILINet

Author

Lucena, M.I et al., Daly, AK, Fernández-Checa, JC, Cubero Palero, Francisco Javier, Lucena, M.I et al., Daly, AK, Fernández-Checa, JC, and Cubero Palero, Francisco Javier

Abstract

In the current article the aims for a constructive way forward in Drug-Induced Liver Injury (DILI) are to highlight the most important priorities in research and clinical science, therefore supporting a more informed, focused, and better funded future for European DILI research. This Roadmap aims to identify key challenges, define a shared vision across all stakeholders for the opportunities to overcome these challenges and propose a high-quality research program to achieve progress on the prediction, prevention, diagnosis and management of this condition and impact on healthcare practice in the field of DILI. This will involve 1. Creation of a database encompassing optimised case report form for prospectively identified DILI cases with well-characterised controls with competing diagnoses, biological samples, and imaging data; 2. Establishing of preclinical models to improve the assessment and prediction of hepatotoxicity in humans to guide future drug safety testing; 3. Emphasis on implementation science and 4. Enhanced collaboration between drug-developers, clinicians and regulatory scientists. This proposed operational framework will advance DILI research and may bring together basic, applied, translational and clinical research in DILI., Depto. de Inmunología, Oftalmología y ORL, Fac. de Medicina, TRUE, pub

Published
2024

6. P16-38: A systematic review of control compounds tested for validation of Drug-Induced Liver Injury (DILI) in vitro models

Author

Segovia-Zafra, A., primary, Villanueva-Paz, M., additional, Serras, A.S., additional, Matilla-Cabello, G., additional, Bodoque, A., additional, Di Zeo-Sánchez, D.E., additional, Niu, H., additional, Álvarez-Álvarez, I., additional, Godek, S., additional, Milisav, I., additional, Fernández-Checa, J.C., additional, Lucena, M.I., additional, Cubero, F.J., additional, Miranda, J.P., additional, Nelson, L., additional, and Andrade, R.J., additional

Published
2023
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9. Therapeutic management of idiosyncratic drug-induced liver injury and acetaminophen hepatotoxicity in the paediatric population: a systematic review

Author

Arıkan, Çiğdem (ORCID 0000-0002-0794-2741 & YÖK ID 240198), Niu, H.; Atallah, E.; Alvarez-Alvarez, I.; Medina-Caliz, I.; Aithal, G.P.; Andrade, R.J.; Lucena, M.I., Koç University Research Center for Translational Medicine (KUTTAM) / Koç Üniversitesi Translasyonel Tıp Araştırma Merkezi (KUTTAM), Koç University Hospital, School of Medicine, Arıkan, Çiğdem (ORCID 0000-0002-0794-2741 & YÖK ID 240198), Niu, H.; Atallah, E.; Alvarez-Alvarez, I.; Medina-Caliz, I.; Aithal, G.P.; Andrade, R.J.; Lucena, M.I., Koç University Research Center for Translational Medicine (KUTTAM) / Koç Üniversitesi Translasyonel Tıp Araştırma Merkezi (KUTTAM), Koç University Hospital, and School of Medicine

Abstract

Introduction: Drug-induced liver injury (DILI) is a rare but serious adverse event that can progress to acute liver failure (ALF). The evidence for treatment of DILI in children is scarce. Objective We aimed to comprehensively review the available literature on the therapies for both acetaminophen overdose (APAP) and idiosyncratic DILI in the paediatric population. Methods: we included original articles conducted in a paediatric population (< 18 years) in which a therapeutic intervention was described to manage APAP or idiosyncratic DILI. Findings were summarized based on age groups (preterm newborn neonates, term and post-term neonates, infants, children and adolescents). Results: overall, 25 publications (fifteen case reports, six case series and four retrospective cohort studies) were included, including a total of 140 paediatric DILI cases, from preterm newborn neonates to adolescents. N-acetylcysteine was used to treat 19 APAP cases. N-acetylcysteine (n = 14), ursodeoxycholic acid (n = 3), corticosteroids (n = 31), carnitine (n = 16) and the combination of glycyrrhizin, reduced glutathione, polyene phosphatidylcholine and S-adenosylmethionine (n = 31) were the therapeutic options for treating idiosyncratic DILI. The molecular adsorbent recirculating system was used in the management of either APAP (n = 4) or idiosyncratic DILI (n = 2), while 20 paediatric ALF cases received continuous renal replacement therapy. Conclusions: this systematic review identified DILI in the paediatric population who have received specific treatment. These interventions appear to be mainly extrapolated from low-quality evidence from the adult population. Thus, there is a need for high-quality studies to test the efficacy of known and novel therapies to treat DILI specifically addressed to the paediatric population., European Union (EU); Instituto de Salud Carlos III (ISCIII); Fondo Europeo de Desarrollo Regional-FEDER; Consejería de Salud de Junta de Andalucía; Junta de Andalucia; COST Action; Prospective European Drug-Induced Liver Injury Network; Agencia Española del Medicamento; CIBERehd; Plataforma ISCIII Ensayos Clínicos; Sara Borrell; ISCIII

Published
2022

11. Comprehensive analysis and insights gained from long-term experience of the Spanish DILI Registry

Author

Stephens, Camilla, primary, Robles-Diaz, Mercedes, additional, Medina-Caliz, Inmaculada, additional, Garcia-Cortes, Miren, additional, Ortega-Alonso, Aida, additional, Sanabria-Cabrera, Judith, additional, Gonzalez-Jimenez, Andres, additional, Alvarez-Alvarez, Ismael, additional, Slim, Mahmoud, additional, Jimenez-Perez, Miguel, additional, Gonzalez-Grande, Rocio, additional, Fernández, M. Carmen, additional, Casado, Marta, additional, Soriano, German, additional, Román, Eva, additional, Hallal, Hacibe, additional, Romero-Gomez, Manuel, additional, Castiella, Agustin, additional, Conde, Isabel, additional, Prieto, Martin, additional, Moreno-Planas, Jose Maria, additional, Giraldez, Alvaro, additional, Moreno-Sanfiel, J. Miguel, additional, Kaplowitz, Neil, additional, Lucena, M. Isabel, additional, Andrade, Raúl J., additional, Andrade, R.J., additional, Lucena, M.I., additional, Stephens, C., additional, Cortés, M. García, additional, Robles-Díaz, M., additional, Ortega-Alonso, A., additional, Pinazo, J., additional, Muñoz, B. García, additional, Alcántara, R., additional, Hernández, A., additional, Escaño, M.D. García, additional, del Campo, E., additional, Medina-Cáliz, I., additional, Sanabria-Cabrera, J., additional, González-Jiménez, A., additional, Sanjuán-Jiménez, R., additional, Cueto, A., additional, Álvarez-Álvarez, I., additional, Bonilla, E., additional, Di Zeo, D., additional, Niu, H., additional, Villanueva, M., additional, Papineau, A., additional, Pérez, M. Jiménez, additional, Grande, R. González, additional, Ortega, S. López, additional, Santaella, I., additional, Ocaña, A., additional, Palomino, P., additional, Fernández, M.C., additional, Peláez, G., additional, Porcel, A., additional, Casado, M., additional, Sánchez, M. González, additional, Romero-Gómez, M., additional, Millán-Domínguez, R., additional, Fombuena, B., additional, Gallego, R., additional, Ampuero, J., additional, Campo, J.A. del, additional, Calle-Sanz, R., additional, Rojas, L., additional, Rojas, A., additional, Gómez, A. Gil, additional, Vilar, E., additional, Soriano, G., additional, Guarner, C., additional, Román, E.M., additional, Manuitt, M.A. Quijada, additional, Arbos, R.M. Antonijoan, additional, Delgado, J. Sánchez, additional, Gómez, M. Vergara, additional, Hallal, H., additional, Oltra, E. García, additional, Arcos, J.C. Titos, additional, Martínez, A. Pérez, additional, Cobarro, C. Sánchez, additional, Caparrós, J.M. Egea, additional, Castiella, A., additional, Zapata, E., additional, Arenas, J., additional, García, A. Gómez, additional, Esandi, F.J., additional, Blanco, S., additional, Odriozola, P. Martínez, additional, Crespo, J., additional, Iruzubieta, P., additional, Cabezas, J., additional, Gallego, A. Giráldez, additional, Rodríguez Seguel, E. del P., additional, Cuaresma, M., additional, Gallego, J. González, additional, Jorquera, F., additional, Campos, S. Sánchez, additional, Otazua, P., additional, de Juan Gómez, A., additional, Salmerón, J., additional, Gila, A., additional, Quiles, R., additional, González, J.M., additional, Lorenzo, S., additional, Prieto, M., additional, Amiel, I. Conde, additional, Berenguer, M., additional, García-Eliz, M., additional, Primo, J., additional, Molés, J.R., additional, Garayoa, A., additional, Carrascosa, M., additional, Domínguez, E. Gómez, additional, Cuevas, L., additional, Farré, M., additional, Montané, E., additional, Barriocanal, A.M., additional, Arellano, A.L., additional, Sanz, Y., additional, Morillas, R.M., additional, Sala, M., additional, Ridaura, H. Masnou, additional, Bruguera, M., additional, Gines, P., additional, Lens, S., additional, García, J.C., additional, Mariño, Z., additional, Guerra, M. Hernández, additional, Sanfiel, J.M. Moreno, additional, Fernández del Campo, C. Boada, additional, Tejedor, M., additional, Ferrer, R. González, additional, Fernández, C., additional, Gil, M. Fernández, additional, Montero, J.L., additional, Mata, M. de la, additional, Olmo, J. Fuentes, additional, Bonilla, E.M. Fernández, additional, Moreno, J.M., additional, Martínez-Rodenas, P., additional, Garrido, M., additional, Oliva, C., additional, Rendón, P., additional, Samaniego, J. García, additional, Madejón, A., additional, Calleja, J.L., additional, Porras, J.L. Martínez, additional, Cabriada, J.L., additional, Pérez-Moreno, J.M., additional, and Lara, C., additional

Published
2021
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12. Clinical Characteristics and Outcome of Drug-Induced Liver Injury in the Older Patients: From the Young-Old to the Oldest-Old

Author

Weersink, R.A., Alvarez-Alvarez, I., Medina-Caliz, I., Sanabria-Cabrera, J., Robles-Diaz, M., Ortega-Alonso, A., Garcia-Cortes, M., Bonilla, E., Niu, H., Soriano, G., Jimenez-Perez, M., Hallal, H., Blanco, S., Kaplowitz, N., Lucena, M.I., Andrade, R.J., Weersink, R.A., Alvarez-Alvarez, I., Medina-Caliz, I., Sanabria-Cabrera, J., Robles-Diaz, M., Ortega-Alonso, A., Garcia-Cortes, M., Bonilla, E., Niu, H., Soriano, G., Jimenez-Perez, M., Hallal, H., Blanco, S., Kaplowitz, N., Lucena, M.I., and Andrade, R.J.

Abstract

Contains fulltext : 236538.pdf (Publisher’s version ) (Closed access), Older patients with hepatotoxicity have been scarcely studied in idiosyncratic drug-induced liver injury (DILI) cohorts. We sought the distinctive characteristics of DILI in older patients across age groups. A total of 882 DILI patients included in the Spanish DILI Registry (33% >/= 65 years) were categorized according to age: "young" (< 65 years); "young-old" (65-74 years); "middle-old" (75-84 years); and "oldest-old" (>/= 85 years). All elderly groups had an increasingly higher comorbidity burden (P < 0.001) and polypharmacy (P < 0.001). There was a relationship between jaundice and hospitalization (P < 0.001), and both were more prevalent in the older age groups, especially in the oldest-old (88% and 69%, respectively), and the DILI episode was more severe (P = 0.029). The proportion of females decreased across age groups from the young to the middle-old, yet in the oldest-old there was a distinct female predominance. Pattern of liver injury shifted towards cholestatic with increasing age among top culprit drugs amoxicillin-clavulanate, atorvastatin, levofloxacin, ibuprofen, and ticlopidine. The best cutoff point for increased odds of cholestatic DILI was 65 years. Older patients had increased non-liver-related mortality (P = 0.030) as shown by the predictive capacity of the Model for End-Stage Liver Disease score (odds ratio (OR) = 1.116; P < 0.001), and comorbidity burden (OR = 4.188; P = 0.001) in the 6-month mortality. Older patients with DILI exhibited an increasingly predominant cholestatic phenotype across a range of culprit drugs, other than amoxicillin-clavulanate, with increased non-liver-related mortality and require a different approach to predict outcome. The oldest DILI patients exhibited a particular phenotype with more severe DILI episodes and need to be considered when stratifying older DILI populations.

Published
2021

14. Clinical Characteristics and Outcome of Drug‐Induced Liver Injury in the Older Patients: From the Young‐Old to the Oldest‐Old

Author

Weersink, Rianne A., primary, Alvarez‐Alvarez, Ismael, additional, Medina‐Cáliz, Inmaculada, additional, Sanabria‐Cabrera, Judith, additional, Robles‐Díaz, Mercedes, additional, Ortega‐Alonso, Aida, additional, García‐Cortés, Miren, additional, Bonilla, Elvira, additional, Niu, Hao, additional, Soriano, German, additional, Jimenez‐Perez, Miguel, additional, Hallal, Hacibe, additional, Blanco, Sonia, additional, Kaplowitz, Neil, additional, Lucena, M. Isabel, additional, Andrade, Raúl J., additional, Andrade, R.J., additional, Lucena, M.I., additional, Stephens, C., additional, García Cortés, M., additional, Robles Díaz, M., additional, Ortega Alonso, A., additional, Pinazo, J., additional, García Muñoz, B., additional, Alcántara, R., additional, Hernández, A., additional, García‐Escaño, M.D., additional, Medina‐Cáliz, I., additional, Sanabria‐Cabrera, J., additional, Alvarez‐Alvarez, I., additional, Bonilla, E., additional, Niu, H., additional, Di‐Zeo, D., additional, Del Campo, E., additional, Jiménez Pérez, M., additional, González Grande, R., additional, López Ortega, S., additional, Santaella, I., additional, Ocaña, A., additional, Palomino, P., additional, Fernández, M.C., additional, Porcel, A., additional, Casado, M., additional, González Sánchez, M., additional, Romero‐Gómez, M., additional, Millán‐Domínguez, R., additional, Fombuena, B., additional, Gallego, R., additional, Ampuero, J., additional, del Campo, J.A., additional, Calle‐Sanz, R., additional, Rojas, L., additional, Rojas, A., additional, Gil Gómez, A., additional, Vilar, E., additional, Soriano, G., additional, Guarner, C., additional, Román, E.M., additional, Quijada Manuitt, M.A., additional, Antonijoan Arbos, R.M., additional, Farré, M., additional, Montané, E., additional, Arellano, A.L., additional, Barriocanal, A.M., additional, Sanz, Y., additional, Morillas, R.M., additional, Sala, M., additional, Masnou Ridaura, H., additional, Sánchez Delgado, J., additional, Vergara Gómez, M., additional, Hallal, H., additional, García Oltra, E., additional, Titos Arcos, J.C., additional, Pérez Martínez, A., additional, Sánchez Cobarro, C., additional, Egea Caparrós, J.M., additional, Castiella, A., additional, Arenas, J., additional, Gomez Osua, M.I., additional, Gómez García, A., additional, Esandi, F.J., additional, Blanco, S., additional, Martínez Odriozola, P., additional, Crespo, J., additional, Iruzubieta, P., additional, Cabezas, J., additional, Giráldez Gallego, A., additional, Rodríguez Seguel, E. del P., additional, Cuaresma, M., additional, Prieto, M., additional, Conde Amiel, I., additional, Berenguer, M., additional, García‐Eliz, M., additional, Moreno, J.M., additional, Martínez‐Rodenas, P., additional, Garrido, M., additional, Oliva, C., additional, Gómez Domínguez, E., additional, Cabrera, L., additional, Cuevas, L., additional, Bruguera, M., additional, Gines, P., additional, Lens, S., additional, García, J.C., additional, Mariño, Z., additional, Hernández Guerra, M., additional, Moreno San Fiel, M., additional, Boada Fernández del Campo, C., additional, Fuentes Olmo, J., additional, Fernández Bonilla, E.M., additional, Jorquera, F., additional, and González Gallego, J., additional

Published
2020
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16. Antiarrítmicos en el embarazo

Author

López-Torres, E., Seoane, J., Verges, C., González-Correa, J.A., Lucena, M.I., Abehsera, M., Doblas, P.A., Eguiluz, I., Monis, S., and Barber, M.A.

Published
2003
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19. Clinical Characteristics and Outcome of Drug‐Induced Liver Injury in the Older Patients: From the Young‐Old to the Oldest‐Old.

Author

Weersink, Rianne A., Alvarez‐Alvarez, Ismael, Medina‐Cáliz, Inmaculada, Sanabria‐Cabrera, Judith, Robles‐Díaz, Mercedes, Ortega‐Alonso, Aida, García‐Cortés, Miren, Bonilla, Elvira, Niu, Hao, Soriano, German, Jimenez‐Perez, Miguel, Hallal, Hacibe, Blanco, Sonia, Kaplowitz, Neil, Lucena, M. Isabel, Andrade, Raúl J., Andrade, R.J., Lucena, M.I., Stephens, C., and García Cortés, M.

Subjects
OLDER patients, TREATMENT effectiveness, LIVER injuries, AGE groups, COMORBIDITY, HEPATOTOXICOLOGY, PHENOTYPES
Abstract

Older patients with hepatotoxicity have been scarcely studied in idiosyncratic drug‐induced liver injury (DILI) cohorts. We sought the distinctive characteristics of DILI in older patients across age groups. A total of 882 DILI patients included in the Spanish DILI Registry (33% ≥ 65 years) were categorized according to age: "young" (< 65 years); "young‐old" (65–74 years); "middle‐old" (75–84 years); and "oldest‐old" (≥ 85 years). All elderly groups had an increasingly higher comorbidity burden (P < 0.001) and polypharmacy (P < 0.001). There was a relationship between jaundice and hospitalization (P < 0.001), and both were more prevalent in the older age groups, especially in the oldest‐old (88% and 69%, respectively), and the DILI episode was more severe (P = 0.029). The proportion of females decreased across age groups from the young to the middle‐old, yet in the oldest‐old there was a distinct female predominance. Pattern of liver injury shifted towards cholestatic with increasing age among top culprit drugs amoxicillin‐clavulanate, atorvastatin, levofloxacin, ibuprofen, and ticlopidine. The best cutoff point for increased odds of cholestatic DILI was 65 years. Older patients had increased non–liver‐related mortality (P = 0.030) as shown by the predictive capacity of the Model for End‐Stage Liver Disease score (odds ratio (OR) = 1.116; P < 0.001), and comorbidity burden (OR = 4.188; P = 0.001) in the 6‐month mortality. Older patients with DILI exhibited an increasingly predominant cholestatic phenotype across a range of culprit drugs, other than amoxicillin‐clavulanate, with increased non–liver‐related mortality and require a different approach to predict outcome. The oldest DILI patients exhibited a particular phenotype with more severe DILI episodes and need to be considered when stratifying older DILI populations. [ABSTRACT FROM AUTHOR]

Published
2021
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20. DRESS cases included in the Spanish and Latin-American DILI registries: clinical phenotype and outcome

Author

Medina-Caliz, I., primary, Almarza, M., additional, Stephens, C., additional, Robles-Díaz, M., additional, Sanabria-Cabrera, J., additional, Gonzalez-Jimenez, A., additional, Sanjuan-Jimenez, Rocío, additional, Ortega-Alonso, A., additional, Cortes, M.G., additional, García-Muñoz, B., additional, Quiros-Cano, M., additional, Martin-Reyes, F., additional, Cueto, A., additional, Fernández, M., additional, Ginès, P., additional, Gomez, M.R., additional, Soriano, G., additional, Prieto, M., additional, Conde, I., additional, Bessone, F., additional, Hernandez, N., additional, Arrese, M., additional, Cabello, M., additional, Lucena, M.I., additional, and Andrade, R.J., additional

Published
2018
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21. Independent cohort validation of hepatic metabolism, daily dose and comorbidities as features associated with delayed symptom onset in drug-induced liver injury

Author

González-Jiménez, A., primary, Medina-Caliz, I., additional, Robles-Díaz, M., additional, Bessone, F., additional, Hernandez, N., additional, Sánchez, A., additional, Arrese, M., additional, Filho, R.P., additional, Lizarzábal, M., additional, Tagle, M., additional, Lucena, M.I., additional, Stephens, C., additional, and Andrade, R.J., additional

Published
2018
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25. Idiosyncratic Drug-Induced Liver Injury: A 20-Year Update of the Cases Enrolled By the Spanish Dili Registry

Author

Slim, M., primary, Sanabria, J., additional, Robles-Díaz, M., additional, Medina-Cáliz, I., additional, Sanjuán-Jiménez, R., additional, González-Jiménez, A., additional, Ortega, A., additional, García-Cortés, M., additional, Garcia-Muñoz, B., additional, Fernandez, M.C., additional, Castiella, A., additional, Zapata, E., additional, Hallal, H., additional, Conde, I., additional, Prieto, M., additional, Montane, E., additional, Morillas, R. María, additional, Soriano, G., additional, Roman, E., additional, Navarro, J.M., additional, Jimenez, M., additional, Aldea, A., additional, Hernández-Guerra, M., additional, Gines, P., additional, Blanco, S., additional, Moreno, J.M., additional, Romero-Gomez, M., additional, Gomez-Dominguez, E., additional, Andrade, R., additional, and Lucena, M.I., additional

Published
2017
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28. Clinical characteristics and outcomes of elderly included in the Spanish Drug-Induced Liver Injury (DILI) Registry

Author

Slim, M., primary, Sanabria, J., additional, Robles-Díaz, M., additional, Medina-Cáliz, I., additional, González-Jiménez, A., additional, Ortega, A., additional, García-Cortés, M., additional, Garcia-Muñoz, B., additional, Sanjuán-Jiménez, R., additional, Fernandez, M.C., additional, Castiella, A., additional, Zapata, E., additional, Hallal, H., additional, Montane, E., additional, Soriano, G., additional, Roman, E., additional, Navarro, J.M., additional, Jimenez, M., additional, Prieto, M., additional, Conde, I., additional, Aldea, A., additional, Hernández-Guerra, M., additional, Moreno, J.M., additional, Romero-Gomez, M., additional, Gomez-Dominguez, E., additional, Lucena, M.I., additional, and Andrade, R.J., additional

Published
2017
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29. Comparison of cytokine profiles in idiosyncratic drug-induced liver injury, acute non-drug-induced hepatitis and controls

Author

Stephens, C., primary, Sanjuan-Jiménez, R., additional, Sanabria-Cabrera, J.A., additional, Battikhi, B., additional, Ortega-Alonso, A., additional, Robles-Díaz, M., additional, Jiménez-Pérez, M., additional, Medina-Cáliz, I., additional, Ruiz-Cabello, F., additional, Lucena, M.I., additional, and Andrade, R.J., additional

Published
2017
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30. FRI-522 - DRESS cases included in the Spanish and Latin-American DILI registries: clinical phenotype and outcome

Author

Medina-Caliz, I., Almarza, M., Stephens, C., Robles-Díaz, M., Sanabria-Cabrera, J., Gonzalez-Jimenez, A., Sanjuan-Jimenez, Rocío, Ortega-Alonso, A., Cortes, M.G., García-Muñoz, B., Quiros-Cano, M., Martin-Reyes, F., Cueto, A., Fernández, M., Ginès, P., Gomez, M.R., Soriano, G., Prieto, M., Conde, I., Bessone, F., Hernandez, N., Arrese, M., Cabello, M., Lucena, M.I., and Andrade, R.J.

Published
2018
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33. Trends in qualifying biomarkers in drug safety. Consensus of the 2011 meeting of the Spanish Society of Clinical Pharmacology

Author

Agúndez J.A.G., del Barrio J., Stephens C., Farré M., Andrade R.J., Badimon L., García-Martín E., Vilahur G., and Lucena M.I.

Subjects
lifestyle, drug safety, genetic association, drug recall, drug response, thiopurine methyltransferase, genetic analysis, mercaptopurine, drug metabolizing enzyme, environmental factor, genetic variability, genetic algorithm, TPMT gene, human, drug dose reduction, gene, medical society, drug accumulation, drug monitoring, pharmacogenomics, azathioprine, nonhuman, pathogenesis, disease predisposition, patient care, phenytoin, article, treatment response, drug targeting, personalized medicine, biological marker, toxic hepatitis, liver toxicity, drug metabolism, clinical practice, enzyme activity, drug efficacy, DNA polymorphism, protein analysis, drug blood level, genetic marker, trend study, maintenance drug dose
Abstract

In this paper we discuss the consensus view on the use of qualifying biomarkers in drug safety, raised within the frame of the XXIV meeting of the Spanish Society of Clinical Pharmacology held in Málaga (Spain) in October, 2011. The widespread use of biomarkers as surrogate endpoints is a goal that scientists have long been pursuing. Thirty years ago, when molecular pharmacogenomics evolved, we anticipated that these genetic biomarkers would soon obviate the routine use of drug therapies in a way that patients should adapt to the therapy rather than the opposite. This expected revolution in routine clinical practice never took place as quickly nor with the intensity as initially expected. The concerted action of operating multicenter networks holds great promise for future studies to identify biomarkers related to drug toxicity and to provide better insight into the underlying pathogenesis. Today some pharmacogenomic advances are already widely accepted, but pharmacogenomics still needs further development to elaborate more precise algorithms and many barriers to implementing individualized medicine exist. We briefly discuss our view about these barriers and we provide suggestions and areas of focus to advance in the field. © 2012 Agúndez, del Barrio, Padró, Stephens, Farré, Andrade, Badimon, García-Martín, Vilahur and Lucena.

Published
2012
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36. Hepatotoxicity Associated with Non-Steroidal Anti-Inflammatory Drugs. A Comparative Analysis among Ibuprofen, Diclofenac and Nimesulide fromthe Spanish and Latin-American Dili Registries

Author

Gonzalez-Jimenez, A., primary, Medina-Cáliz, I., additional, Robles-Díaz, M., additional, Zoubek, M.E., additional, Díaz-Jimenez, P., additional, Cabello, M.R., additional, Ortega-Alonso, A., additional, García-Cortes, M., additional, García-Muñoz, B., additional, Fernandez, M.C., additional, Slim, M., additional, Romero-Gómez, M., additional, Bessone, F., additional, Hernandez, N., additional, Arrese, M., additional, Montane, E., additional, Hallal, H., additional, Sanabria-Cabrera, J.A., additional, Sanjuan-Jimenez, R., additional, Lucena, M.I., additional, and Andrade, R.J., additional

Published
2016
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37. Metabolic risk factors affect clinical Phenotype and outcome of Hepatotoxicity (DILI)

Author

Sanabria-Cabrera, J., primary, Robles-Díaz, M., additional, Medina-Cáliz, I., additional, Stephens, C., additional, Ruíz, A., additional, González-Jiménez, A., additional, Ortega-Alonso, A., additional, García-Cortés, M., additional, García-Muñoz, B., additional, Romero-Gómez, M., additional, Fernández, M.C., additional, Hallal, H., additional, Soriano, G, additional, Román, E., additional, Blanco, S., additional, Castiella, A., additional, Zapata, E.M., additional, Navarro, J.M., additional, Jiménez, M., additional, Moreno-Planas, J.M., additional, Aldea, A., additional, Bessone, F., additional, Hernández, N., additional, Arrese, M., additional, Andrade, R.J., additional, and Lucena, M.I., additional

Published
2015
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38. Autoantibody presentation in Drug-Induced Liver Injury (DILI) and idiopathic Autoimmune Hepatitis (AIH): The influence of HLA alleles

Author

Stephens, C., primary, Ortega-Alonso, A., additional, Medina-Cáliz, I., additional, Robles-Díaz, M., additional, Castiella, A., additional, Otazua, P., additional, Zapata, E., additional, Gomez-Moreno, E.M., additional, López-Nevot, M.A., additional, Ruiz-Cabello, F., additional, Soriano, G., additional, Roman, E., additional, Hallal, H., additional, Andrade, R.J., additional, and Lucena, M.I., additional

Published
2015
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39. Distinguishing Drug-induced Autoimmune Hepatitis from idiopatic Autoimmune Hepatitis and Dili with Autoantibodies

Author

Ortega-Alonso, A., primary, Castiella, A., additional, Robles-Diaz, M., additional, Medina-Caliz, I., additional, Stephens, C., additional, Sanabria, J., additional, Gonzalez-Jimenez, A., additional, Garcia-Muñoz, B., additional, Garcia-Cortes, M., additional, Zapata, E.M., additional, Otazua, P., additional, Blanco, S., additional, Prieto, M., additional, Bessone, F., additional, Hernández, N., additional, Fernandez, M.C., additional, Hallal, H., additional, Primo, J., additional, Moreno-Planas, J.M., additional, Arrese, M., additional, Andrade, R.J., additional, and Lucena, M.I., additional

Published
2015
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40. Hepatotoxicity related to Herbals and Dietary Supplements (HDS): a cause for concern

Author

Medina-Cáliz, I., primary, Robles-Díaz, M., additional, Stephens, C., additional, González-Jiménez, A., additional, Sanabria-Cabrera, J., additional, Ortega-Alonso, A., additional, García-Cortés, M., additional, Mirwani, S., additional, Thorpe, B., additional, Jiménez-Pérez, M., additional, Fernández, M.C., additional, Navarro, J.M., additional, Montané, E., additional, Barriocanal, A.M., additional, Prieto, M., additional, García-Eliz, M., additional, Bessone, F., additional, Hernández, N., additional, Carrera, E., additional, Mengual, E., additional, Blanco, E., additional, Montes, M.R., additional, Bellido, I., additional, García-Muñoz, B., additional, Andrade, R.J., additional, and Lucena, M.I., additional

Published
2015
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41. P1097 : Distinguishing drug induced autoimmune hepatitis from idiopatic autoimmune hepatitis

Author

Ortega-Alonso, A., primary, Castiella, A., additional, Robles-Diaz, M., additional, Medina-Caliz, I., additional, Stephens, C., additional, Sanabria, J., additional, Gonzalez-Jimenez, A., additional, Garcia-Muñoz, B., additional, Garcia-Cortes, M., additional, Zapata, E.M., additional, Otazua, P., additional, Blanco, S., additional, Prieto, M., additional, Bessone, F., additional, Fernandez, M.C., additional, Hallal, H., additional, Primo, J., additional, Moreno-Planas, J.M., additional, Arrese, M., additional, Andrade, R.J., additional, and Lucena, M.I., additional

Published
2015
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42. P1098 : Influence of metabolic risk factors in hepatotoxicity (DILI) phenotype and outcome

Author

Robles-Díaz, M., primary, Medina-Cáliz, I., additional, Ruíz, A., additional, Sanabria, J., additional, Stephens, C., additional, González-Jiménez, A., additional, Ortega-Alonso, A., additional, García-Muñoz, B., additional, García-Cortés, M., additional, Romero-Gómez, M., additional, Peláez, G., additional, Hallal, H., additional, Soriano, G., additional, Román, E., additional, Blanco, S., additional, Castiella, A., additional, Zapata, E.M., additional, Navarro, J.M., additional, Jiménez, M., additional, Moreno-Planas, J.M., additional, Aldea, A., additional, Bessone, F., additional, Hernández, N., additional, Arrese, M., additional, Lucena, M.I., additional, and Andrade, R.J., additional

Published
2015
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44. FRI-444 - Clinical characteristics and outcomes of elderly included in the Spanish Drug-Induced Liver Injury (DILI) Registry

Author

Slim, M., Sanabria, J., Robles-Díaz, M., Medina-Cáliz, I., González-Jiménez, A., Ortega, A., García-Cortés, M., Garcia-Muñoz, B., Sanjuán-Jiménez, R., Fernandez, M.C., Castiella, A., Zapata, E., Hallal, H., Montane, E., Soriano, G., Roman, E., Navarro, J.M., Jimenez, M., Prieto, M., Conde, I., Aldea, A., Hernández-Guerra, M., Moreno, J.M., Romero-Gomez, M., Gomez-Dominguez, E., Lucena, M.I., and Andrade, R.J.

Published
2017
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47. P309 PROGNOSTIC MODEL FOR PREDICTING DRUG-INDUCED ACUTE LIVER FAILURE

Author

Andrade, R.J., primary, Robles-Díaz, M., additional, Stephens, C., additional, Medina-Cáliz, I., additional, González-Jiménez, A., additional, González, A.F., additional, Kaplowitz, N., additional, Fernández, M.C., additional, Romero-Gómez, M., additional, Jiménez-Pérez, M., additional, Bruguera, M., additional, Prieto, M., additional, Bessone, F., additional, Hernández, N., additional, Arrese, M., additional, and Lucena, M.I., additional

Published
2014
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48. P310 ANABOLIC ANDROGENIC STEROIDS (AAS) ILLICIT USE IS A RAPIDLY GROWING CAUSE OF DRUG-INDUCED LIVER INJURY (DILI): A PROSPECTIVE SERIES FROM THE SPANISH–LATIN-AMERICAN DILI REGISTRY

Author

Medina-Cáliz, I., primary, González-Jiménez, A., additional, Robles-Díaz, M., additional, Stephens, C., additional, Cabello, M., additional, García-Muñoz, B., additional, García-Cortés, M., additional, Alcántara, R., additional, González-Grande, R., additional, Jiménez, M., additional, Rendón, P., additional, Navarro, J.M., additional, Méndez, I.M., additional, Bessone, F., additional, Ginés, P., additional, Alfaro, I., additional, Brahm, J.R., additional, Paraná, R., additional, Schinoni, M.I., additional, Prieto, M., additional, García-Eliz, M., additional, Romero-Gómez, M., additional, Calle-Sanz, R., additional, González-Ramirez, A.F., additional, Crespillo, A., additional, Lucena, M.I., additional, and Andrade, R.J., additional

Published
2014
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50. THU-311 - Hepatotoxicity Associated with Non-Steroidal Anti-Inflammatory Drugs. A Comparative Analysis among Ibuprofen, Diclofenac and Nimesulide fromthe Spanish and Latin-American Dili Registries

Author

Gonzalez-Jimenez, A., Medina-Cáliz, I., Robles-Díaz, M., Zoubek, M.E., Díaz-Jimenez, P., Cabello, M.R., Ortega-Alonso, A., García-Cortes, M., García-Muñoz, B., Fernandez, M.C., Slim, M., Romero-Gómez, M., Bessone, F., Hernandez, N., Arrese, M., Montane, E., Hallal, H., Sanabria-Cabrera, J.A., Sanjuan-Jimenez, R., Lucena, M.I., and Andrade, R.J.

Published
2016
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