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2. Incidence and predictors of hepatocellular carcinoma in patients with autoimmune hepatitis

Author

van Gerven, N., van Erpecum, K., Ouden, J den, Brouwer, J., Vrolijk, J., Gevers, T.J., Drenth, J., Guichelaar, M., Bouma, G., Schreuder, T.C.M.A., van der Wouden, E.J., Baak, L.C., Stadhouders, P., Klemt-Kropp, M., Verhagen, M., Bhalla, A., Kuijvenhoven, J., Almasio, P., Alvarez, F., Andrade, R., Arikan, C., Assis, D., Bardou-Jacquet, E., Biewenga, M., Cancado, E., Cazzagon, N., Chazouillères, O., Colloredo, G., Cuarterolo, M., Dalekos, G., Debray, D., Robles-Díaz, M., Dyson, J., Efe, C., Engel, B., Ferri, S., Fontana, R., Gatselis, N., Gerussi, A., Halilbasic, E., Halliday, N., Heneghan, M., Hirschfield, G., van Hoek, B., Hørby Jørgensen, M., Indolfini, G., Iorio, R., Invernizzi, P., Jeong, S., Jones, D., Kelly, D., Kerkar, N., Lacaille, F., Lammert, C., Leggett, B., Lenzi, M., Levy, C., Liberal, R., Lleo, A., Lohse, A., Lopez, S. Ines, de Martin, E., McLin, V., Mieli-Vergani, G., Milkiewicz, P., Mohan, N., Muratori, L., Nebbia, G., van Nieuwkerk, C., Oo, Y., Ortega, A., Páres, A., Pop, T., Pratt, D., Purnak, T., Ranucci, G., Rushbrook, S., Schramm, C., Stättermayer, A., Swain, M., Tanaka, A., Taubert, R., Terrabuio, D., Terziroli, B., Trauner, M., Valentino, P., van den Brand, F., Vergani, D., Villamil, A., Wahlin, S., Ytting, H., Zachou, K., Zeniya, M., Colapietro, Francesca, Maisonneuve, Patrick, Lytvyak, Ellina, Beuers, Ulrich, Verdonk, Robert C., van der Meer, Adriaan J., van Hoek, Bart, Kuiken, Sjoerd D., Brouwer, Johannes T., Muratori, Paolo, Aghemo, Alessio, Carella, Francesco, van den Berg, Ad P., Zachou, Kalliopi, Dalekos, George N., Di Zeo-Sánchez, Daniel E., Robles, Mercedes, Andrade, Raul J., Montano-Loza, Aldo J., van den Brand, Floris F., Slooter, Charlotte D., Macedo, Guilherme, Liberal, Rodrigo, de Boer, Ynto S., and Lleo, Ana

Published
2024
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3. Systematic review of response criteria and endpoints in autoimmune hepatitis by the International Autoimmune Hepatitis Group

Author

Almasio, P., Alvarez, F., Andrade, R., Arikan, C., Assis, D., Bardou-Jacquet, E., Biewenga, M., Cancado, E., Cazzagon, N., Chazouillères, O., Colloredo, G., Cuarterolo, M., Dalekos, G., Debray, D., Robles-Díaz, M., Drenth, J., Dyson, J., Efe, C., Engel, B., Ferri, S., Fontana, R., Gatselis, N., Gerussi, A., Halilbasic, E., Halliday, N., Heneghan, M., Hirschfield, G., van Hoek, B., Hørby Jørgensen, M., Indolfini, G., Iorio, R., Jeong, S., Jones, D., Kelly, D., Kerkar, N., Lacaille, F., Lammert, C., Leggett, B., Lenzi, M., Levy, C., Liberal, R., Lleo, A., Lohse, A., Ines Lopez, S., de Martin, E., McLin, V., Mieli-Vergani, G., Milkiewicz, P., Mohan, N., Muratori, L., Nebbia, G., van Nieuwkerk, C., Oo, Y., Ortega, A., Páres, A., Pop, T., Pratt, D., Purnak, T., Ranucci, G., Rushbrook, S., Schramm, C., Stättermayer, A., Swain, M., Tanaka, A., Taubert, R., Terrabuio, D., Terziroli, B., Trauner, M., Valentino, P., van den Brand, F., Villamil, A., Wahlin, S., Ytting, H., Zachou, K., Zeniya, M., Pape, Simon, Snijders, Romée J.A.L.M., Gevers, Tom J.G., Chazouilleres, Oliver, Dalekos, George N., Hirschfield, Gideon M., Lenzi, Marco, Trauner, Michael, Manns, Michael P., Vierling, John M., Montano-Loza, Aldo J., Lohse, Ansgar W., Schramm, Christoph, Drenth, Joost P.H., and Heneghan, Michael A.

Published
2022
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4. 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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5. Herbal and Dietary Supplement-Induced Liver Injuries in the Spanish DILI Registry

Author

Andrade, RJ, Lucena, MI, Stephens, C, García-Cortés, M, Robles-Díaz, M, Medina-Cáliz, I, Sanabria, J, García-Muñoz, B, Alcántara, R, Moreno, I, Gonzalez-Jimenez, A, Ortega-Alonso, A, Sanjuán-Jiménez, R, Quirós, M, Martín-Reyes, F, Papineau, A, Jiménez-Pérez, M, González-Grande, R, Fernández, MC, Peláez, G, Casado, M, González-Sánchez, M, Romero-Gómez, M, Calle-Sanz, R, Millán-Domínguez, R, Fombuena, B, Gallego, R, Rojas, L, Rojas, A, Ampuero, J, del Campo, JA, Gil Gómez, A, Vilar, E, Castiella, A, Zapata, EM, Zubiaurre, L, Navarro, JM, Méndez-Sánchez, IM, Chaves, A, Soriano, G, Guarner, C, Román, EM, Hallal, H, García-Oltra, E, Titos-Arcos, JC, Pérez-Martínez, A, Sánchez-Cobarro, C, Egea-Caparrós, JM, Arenas, J, Gomez-Osua, MI, Gómez-García, A, Esandi, FJ, Blanco, S, Martínez-Odriozola, P, Otazua, P, Salmerón, J, Gila, A, Quiles, R, González, JM, Lorenzo, S, Prieto, M, Conde, I, Amiel, Berenguer, M, García-Eliz, M, Primo, J, Molés, JR, Garayoa, A, Carrascosa, M, Gómez- Domínguez, E, Montané, E, Arellano, AL, Barriocanal, AM, Sanz, Y, Morillas, RM, Sala, M, Masnou, H, Farré, M, Bruguera, M, Gines, P, Lens, S, García, JC, Aldea-Perona, A, Hernández-Guerra, M, Moreno-San Fiel, M, Boada-Fernández del Campo, C, Tejedor, M, González-Ferrer, R, Fernández, C, Fernández-Gil, M, Montero, JL, de la Mata, M, Fuentes-Olmo, J, Fernández-Bonilla, EM, González-Gallego, J, Jorquera, F, Moreno, JM, Martínez-Rodenas, P, Garrido, M, Rendón, P, Vergara, M, Sánchez Delgado, J, García Samaniego, J, Madejón, A, Cabriada, JL, Crespo, J, Giráldez Gallego, A, Cuaresma, M, Ruíz, R, Medina-Caliz, Inmaculada, Garcia-Cortes, Miren, Gonzalez-Jimenez, Andres, Cabello, Maria R., Robles-Diaz, Mercedes, Sanabria-Cabrera, Judith, Sanjuan-Jimenez, Rocio, Ortega-Alonso, Aida, García-Muñoz, Beatriz, Moreno, Inmaculada, Jimenez-Perez, Miguel, Fernandez, M Carmen, Ginés, Pere, Prieto, Martin, Conde, Isabel, Hallal, Hacibe, Soriano, German, Roman, Eva, Castiella, Agustin, Blanco-Reina, Encarnacion, Montes, Maria R., Quiros-Cano, Marta, Martin-Reyes, Flores, Lucena, M. Isabel, and Andrade, Raul J.

Published
2018
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6. Systematic review of response criteria and endpoints in autoimmune hepatitis by the International Autoimmune Hepatitis Group

Author

Pape, S, Snijders, R, Gevers, T, Chazouilleres, O, Dalekos, G, Hirschfield, G, Lenzi, M, Trauner, M, Manns, M, Vierling, J, Montano-Loza, A, Lohse, A, Schramm, C, Drenth, J, Heneghan, M, Almasio, P, Alvarez, F, Andrade, R, Arikan, C, Assis, D, Bardou-Jacquet, E, Biewenga, M, Cancado, E, Cazzagon, N, Colloredo, G, Cuarterolo, M, Debray, D, Robles-Diaz, M, Dyson, J, Efe, C, Engel, B, Ferri, S, Fontana, R, Gatselis, N, Gerussi, A, Halilbasic, E, Halliday, N, van Hoek, B, Horby Jorgensen, M, Indolfini, G, Iorio, R, Jeong, S, Jones, D, Kelly, D, Kerkar, N, Lacaille, F, Lammert, C, Leggett, B, Levy, C, Liberal, R, Lleo, A, Ines Lopez, S, de Martin, E, Mclin, V, Mieli-Vergani, G, Milkiewicz, P, Mohan, N, Muratori, L, Nebbia, G, van Nieuwkerk, C, Oo, Y, Ortega, A, Pares, A, Pop, T, Pratt, D, Purnak, T, Ranucci, G, Rushbrook, S, Stattermayer, A, Swain, M, Tanaka, A, Taubert, R, Terrabuio, D, Terziroli, B, Valentino, P, van den Brand, F, Villamil, A, Wahlin, S, Ytting, H, Zachou, K, Zeniya, M, Pape S., Snijders R. J. A. L. M., Gevers T. J. G., Chazouilleres O., Dalekos G. N., Hirschfield G. M., Lenzi M., Trauner M., Manns M. P., Vierling J. M., Montano-Loza A. J., Lohse A. W., Schramm C., Drenth J. P. H., Heneghan M. A., Almasio P., Alvarez F., Andrade R., Arikan C., Assis D., Bardou-Jacquet E., Biewenga M., Cancado E., Cazzagon N., Colloredo G., Cuarterolo M., Dalekos G., Debray D., Robles-Diaz M., Drenth J., Dyson J., Efe C., Engel B., Ferri S., Fontana R., Gatselis N., Gerussi A., Halilbasic E., Halliday N., Heneghan M., Hirschfield G., van Hoek B., Horby Jorgensen M., Indolfini G., Iorio R., Jeong S., Jones D., Kelly D., Kerkar N., Lacaille F., Lammert C., Leggett B., Levy C., Liberal R., Lleo A., Lohse A., Ines Lopez S., de Martin E., McLin V., Mieli-Vergani G., Milkiewicz P., Mohan N., Muratori L., Nebbia G., van Nieuwkerk C., Oo Y., Ortega A., Pares A., Pop T., Pratt D., Purnak T., Ranucci G., Rushbrook S., Stattermayer A., Swain M., Tanaka A., Taubert R., Terrabuio D., Terziroli B., Valentino P., van den Brand F., Villamil A., Wahlin S., Ytting H., Zachou K., Zeniya M., Pape, S, Snijders, R, Gevers, T, Chazouilleres, O, Dalekos, G, Hirschfield, G, Lenzi, M, Trauner, M, Manns, M, Vierling, J, Montano-Loza, A, Lohse, A, Schramm, C, Drenth, J, Heneghan, M, Almasio, P, Alvarez, F, Andrade, R, Arikan, C, Assis, D, Bardou-Jacquet, E, Biewenga, M, Cancado, E, Cazzagon, N, Colloredo, G, Cuarterolo, M, Debray, D, Robles-Diaz, M, Dyson, J, Efe, C, Engel, B, Ferri, S, Fontana, R, Gatselis, N, Gerussi, A, Halilbasic, E, Halliday, N, van Hoek, B, Horby Jorgensen, M, Indolfini, G, Iorio, R, Jeong, S, Jones, D, Kelly, D, Kerkar, N, Lacaille, F, Lammert, C, Leggett, B, Levy, C, Liberal, R, Lleo, A, Ines Lopez, S, de Martin, E, Mclin, V, Mieli-Vergani, G, Milkiewicz, P, Mohan, N, Muratori, L, Nebbia, G, van Nieuwkerk, C, Oo, Y, Ortega, A, Pares, A, Pop, T, Pratt, D, Purnak, T, Ranucci, G, Rushbrook, S, Stattermayer, A, Swain, M, Tanaka, A, Taubert, R, Terrabuio, D, Terziroli, B, Valentino, P, van den Brand, F, Villamil, A, Wahlin, S, Ytting, H, Zachou, K, Zeniya, M, Pape S., Snijders R. J. A. L. M., Gevers T. J. G., Chazouilleres O., Dalekos G. N., Hirschfield G. M., Lenzi M., Trauner M., Manns M. P., Vierling J. M., Montano-Loza A. J., Lohse A. W., Schramm C., Drenth J. P. H., Heneghan M. A., Almasio P., Alvarez F., Andrade R., Arikan C., Assis D., Bardou-Jacquet E., Biewenga M., Cancado E., Cazzagon N., Colloredo G., Cuarterolo M., Dalekos G., Debray D., Robles-Diaz M., Drenth J., Dyson J., Efe C., Engel B., Ferri S., Fontana R., Gatselis N., Gerussi A., Halilbasic E., Halliday N., Heneghan M., Hirschfield G., van Hoek B., Horby Jorgensen M., Indolfini G., Iorio R., Jeong S., Jones D., Kelly D., Kerkar N., Lacaille F., Lammert C., Leggett B., Levy C., Liberal R., Lleo A., Lohse A., Ines Lopez S., de Martin E., McLin V., Mieli-Vergani G., Milkiewicz P., Mohan N., Muratori L., Nebbia G., van Nieuwkerk C., Oo Y., Ortega A., Pares A., Pop T., Pratt D., Purnak T., Ranucci G., Rushbrook S., Stattermayer A., Swain M., Tanaka A., Taubert R., Terrabuio D., Terziroli B., Valentino P., van den Brand F., Villamil A., Wahlin S., Ytting H., Zachou K., and Zeniya M.

Abstract

Background & Aims: Autoimmune hepatitis (AIH) has been well characterised and codified through the development of diagnostic criteria. These criteria have been adapted and simplified and are widely used in clinical practice. However, there is a need to update and precisely define the criteria for both treatment response and treatment. Methods: A systematic review was performed and a modified Delphi consensus process was used to identify and redefine the response criteria in autoimmune hepatitis. Results: The consensus process initiated by the International Autoimmune Hepatitis Group proposes that the term ‘complete biochemical response’ defined as ‘normalization of serum transaminases and IgG below the upper limit of normal’ be adopted to include a time point at 6 months after initiation of treatment. An insufficient response by 6 months was a failure to meet the above definition. Non-response was defined as ‘<50% decrease of serum transaminases within 4 weeks after initiation of treatment’. Remission is defined as liver histology with a Hepatitis Activity Index <4/18. Intolerance to treatment was agreed to stand for ‘any adverse event possibly related to treatment leading to potential drug discontinuation’. Conclusions: These definitions provide a simple and reproducible framework to define treatment response and non-response, irrespective of the therapeutic intervention. A consensus on endpoints is urgently required to set a global standard for the reporting of study results and to enable inter-study comparisons. Future prospective database studies are needed to validate these endpoints. Lay summary: Consensus among international experts on response criteria and endpoints in autoimmune hepatitis is lacking. A consensus on endpoints is urgently required to set a global standard for the reporting of study results and to enable the comparison of results between clinical trials. Therefore, the International Autoimmune Hepatitis Group (IAIHG) herein presents

Published
2022

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

Author

Weersink, RA, 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, MI, Andrade, RJ, Antonijoan Arbós R.M., and Gonzalez-Gallego, J.

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.

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, 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

15. FRI-406 - Altered intestinal permeability in patients with drug-induced liver injury and other forms of acute liver injury: a sequential analysis of serum levels of LBP, CD14 and CD163

Author

Di Zeo-Sánchez, Daniel E., Villanueva, Marina, Cueto-Sanchez, Alejandro, Bandera, Jose Pinazo, Cortes, Miren Garcia, del Campo Herrera, Enrique, Bodoque-García, Ana, Matilla, Gonzalo, Robles-Díaz, M, Lucena, Maria Isabel, Andrade, Raul J., and Stephens, Camilla

Published
2023
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16. OS-007 - Prior drug allergies are associated with worse outcome in patients with idiosyncratic drug-induced liver injury: an analysis from the Spanish DILI registry

Author

Solis-Munoz, Pablo, Medina-Cáliz, Inmaculada, Flores, Rocio Romero, Zoubek, Miguel, Sanabria-Cabrera, Judith, Robles-Díaz, M, Cortes, Miren Garcia, Ortega-Alonso, Aida, Bandera, Jose Pinazo, Cabello, MR, Andrade, Raul J., Lucena, Maria Isabel, Niu, Hao, and Alvarez-Alvarez, Ismael

Published
2023
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17. Herbal and Dietary Supplement-Induced Liver Injuries in the Spanish DILI Registry

Author

Medina-Caliz, I, Garcia-Cortes, M, Gonzalez-Jimenez, A, Cabello, MR, Robles-Diaz, M, Sanabria-Cabrera, J, Sanjuan-Jimenez, R, Ortega-Alonso, A, Garcia-Munoz, B, Moreno, I, Jimenez-Perez, M, Fernandez, MC, Gines, P, Prieto, M, Conde, I, Hallal, H, Soriano, G, Roman, E, Castiella, A, Blanco-Reina, E, Montes, MR, Quiros-Cano, M, Martin-Reyes, F, Lucena, MI, and Andrade, RJ

Subjects
Re-challenge, Hepatotoxicity, Clinical Presentation, Herbal Signature
Abstract

BACKGROUND & AIMS: There have been increasing reports of liver injury associated with use of herbal and dietary supplements, likely due to easy access to these products and beliefs among consumers that they are safer or more effective than conventional medications. We aimed to evaluate clinical features and outcomes of patients with herbal and dietary supplement-induced liver injuries included in the Spanish DILI Registry. METHODS: We collected and analyzed data on demographic and clinical features, along with biochemical parameters, of 32 patients with herbal and dietary supplement-associated liver injury reported to the Spanish DILI registry from 1994 through 2016. We used analysis of variance to compare these data with those from cases of liver injury induced by conventional drugs or anabolic androgenic steroid-containing products. RESULTS: Herbal and dietary supplements were responsible for 4% (32 cases) of the 856 DILI cases in the registry; 20 cases of DILI (2%) were caused by anabolic androgenic steroids. Patients with herbal and dietary supplement-induced liver injury were a mean age of 48 years and 63% were female; they presented a mean level of alanine aminotransferase 37-fold the upper limit of normal, 28% had hypersensitivity features, and 78% had jaundice. Herbal and dietary supplement-induced liver injury progressed to acute liver failure in 6% of patients, compared with none of the cases of anabolic androgenic steroid-induced injury and 4% of cases of conventional drugs. Liver injury after repeat exposure to the same product that caused the first DILI episode occurred in 9% of patients with herbal and dietary supplement-induced liver injury vs none of the patients with anabolic androgenic steroid-induced injury and 6% of patients with liver injury from conventional drugs. CONCLUSION: In an analysis of cases of herbal and dietary supplement-induced liver injury in Spain, we found cases to be more frequent among young women than older patients or men, and to associate with hepatocellular injury and high levels of transaminases. Herbal and dietary supplement-induced liver injury is more severe than other types of DILI and re-exposure is more likely. Increasing awareness of the hepatoxic effects of herbal and dietary supplements could help physicians make earlier diagnoses and reduce the risk of serious liver damage.

Published
2018

22. The value of serum aspartate aminotransferase and gamma-glutamyl transpetidase as biomarkers in hepatotoxicity

Author

Robles-Diaz, M, Garcia-Cortes, M, Medina-Caliz, I, Gonzalez-Jimenez, A, Gonzalez-Grande, R, Navarro, JM, Castiella, A, Zapata, EM, Romero-Gomez, M, Blanco, S, Soriano, G, Hidalgo, R, Ortega-Torres, M, Clavijo, E, Bermudez-Ruiz, PM, Lucena, MI, Andrade, RJ, and Spanish DILI Registry Faster Evide

Subjects
hepatotoxicity, aspartate aminotransferase, R ratio value, drug-induced liver injury, gamma-glutamyl transpeptidase, pattern of injury
Abstract

Background & AimsThe current definition of the pattern of liver injury in hepatotoxicity (DILI) is given by the R (ratio) value, dividing alanine aminotransferase (ALT) and alkaline phosphatase (ALP) in upper limits of normal at DILI onset. We aimed to explore the validity of using aspartate aminotransferase (AST) and gamma-glutamyl transpeptidase (GGT) as biomarkers of hepatocelullar and cholestatic damage, respectively, when calculating the R value. MethodsClinical, laboratory and histological data from 588 DILI episodes included in the Spanish DILI Registry were analyzed. Linear regression analysis was performed to establish the most appropriate cut-off points for hepatocellular and cholestatic patterns when calculating R with AST and GGT. ResultsThe overall agreement between ALT/ALP and AST/ALP was 76%, with 96%, 61% and 41% agreement in the hepatocellular (R5), cholestatic (R2) and mixed groups respectively (P

Published
2015

25. Use of Hy's Law and a New Composite Algorithm to Predict Acute Liver Failure in Patients With Drug-Induced Liver Injury

Author

Robles-Diaz M, Lucena MI, Kaplowitz N, Stephens C, Medina-Cáliz I, González-Jimenez A, Ulzurrun E, Gonzalez AF, Fernandez MC, Romero-Gómez M, Jimenez-Perez M, Bruguera M, Prieto M, Bessone F, Hernandez N, Arrese M, Andrade RJ, Spanish DILI Registry, SLatinDILI Network, and Safer and Faster Evidence-based Translation Consortium

Subjects
Idiosyncratic Hepatotoxicity, Progression, digestive, oral, and skin physiology, Prognostic Risk Factor, Prediction
Abstract

BACKGROUND & AIMS: Hy's Law, which states that hepatocellular drug-induced liver injury (DILI) with jaundice indicates a serious reaction, is used widely to determine risk for acute liver failure (ALF). We aimed to optimize the definition of Hy's Law and to develop a model for predicting ALF in patients with DILI. METHODS: We collected data from 771 patients with DILI (805 episodes) from the Spanish DILI registry, from April 1994 through August 2012. We analyzed data collected at DILI recognition and at the time of peak levels of alanine aminotransferase (ALT) and total bilirubin (TBL). RESULTS: Of the 771 patients with DILI, 32 developed ALF. Hepatocellular injury, female sex, high levels of TBL, and a high ratio of aspartate aminotransferase (AST):ALT were independent risk factors for ALF. We compared 3 ways to use Hy's Law to predict which patients would develop ALF; all included TBL greater than 2-fold the upper limit of normal (x ULN) and either ALT level greater than 3 x ULN, a ratio (R) value (ALT x ULN/alkaline phosphatase x ULN) of 5 or greater, or a new ratio (nR) value (ALT or AST, whichever produced the highest x ULN/alkaline phosphatase x ULN value) of 5 or greater. At recognition of DILI, the R- and nR-based models identified patients who developed ALF with 67% and 63% specificity, respectively, whereas use of only ALT level identified them with 44% specificity. However, the level of ALT and the nR model each identified patients who developed ALF with 90% sensitivity, whereas the R criteria identified them with 83% sensitivity. An equal number of patients who did and did not develop ALF had alkaline phosphatase levels greater than 2 x ULN. An algorithm based on AST level greater than 17.3 x ULN, TBL greater than 6.6 x ULN, and AST:ALT greater than 1.5 identified patients who developed ALF with 82% specificity and 80% sensitivity. CONCLUSIONS: When applied at DILI recognition, the nR criteria for Hy's Law provides the best balance of sensitivity and specificity whereas our new composite algorithm provides additional specificity in predicting the ultimate development of ALF.

Published
2014

26. 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-Caliz, I., Gonzalez-Jimenez, A., Robles-Diaz, M., Stephens, C., Cabello, M., Garcia-Munoz, B., Garcia-Cortes, M., Alcantara, R., Gonzalez-Grande, R., Jimenez, M., Rendon, P., Navarro, J. M., Mendez, I. M., Bessone, F., Gines, P., Alfaro, I., Brahm, J. R., Parana, R., Schinoni, M. I., Prieto, M., Garcia-Eliz, M., Romero-Gomez, M., Calle-Sanz, R., Gonzalez-Ramirez, A. F., Crespillo, A., Lucena, M. I., and Andrade, R. J.

Published
2014

27. 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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29. 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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30. 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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31. Idiosyncratic Drug-Induced Liver Injury: A 20-Year Update of the Cases Enrolled By the Spanish Dili Registry

Author

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

Published
2017
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34. 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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37. 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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38. Metabolic risk factors affect clinical Phenotype and outcome of Hepatotoxicity (DILI)

Author

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

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

Author

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

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

Author

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

Published
2015
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43. 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., González-Jiménez, A., Robles-Díaz, M., Stephens, C., Cabello, M., García-Muñoz, B., García-Cortés, M., Alcántara, R., González-Grande, R., Jiménez, M., Rendón, P., Navarro, J.M., Méndez, I.M., Bessone, F., Ginés, P., Alfaro, I., Brahm, J.R., Paraná, R., Schinoni, M.I., Prieto, M., García-Eliz, M., Romero-Gómez, M., Calle-Sanz, R., González-Ramirez, A.F., Crespillo, A., Lucena, M.I., and Andrade, R.J.

Published
2014
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48. The impact of age on phenotype presentation and severity in patients with idiosyncratic drug-induced liver injury (DILI)

Author

Slim, Mahmoud, Robles-Diaz, M., Ortega, A., Garcia-Cortes, Miren, Medina-Caliz, I., Garcia-Munoz, Beatriz, Sanjuan-Jimenez, R., Gonzalez-Jimenez, A., Ibanez, Vanessa Luque, Sanabria, Judith, Fernandez, Maria Carmen, Castiella, Augustin, Zapata, Eva, Hallal, Hacibe, Montane, Eva, Soriano, German, Roman, Eva, Navarro, J. M., Jimenez, Miguel, Martin Prieto, Conde, Isabel, Aldea, A., Moreno, Jose M., Romero-Gomez, Manuel, Gomez-Dominguez, Elena, Lucena, M. Isabel, and Andrade, Raul

49. PROSPECTIVE DRUG-INDUCED LIVER INJURY REGISTRY: CLINICAL CHARACTERISTICS AND OUTCOMES OF 915 CASES

Author

Slim, M., Sanabria, J., Robles-Diaz, M., Medina-Caliz, I., Sanjuan-Jimenez, R., Gonzalez-Jimenez, A., Ortega, A., Garcia-Cortes, M., Garcia-Munoz, B., Fernandez, M. C., Castiella, A., Zapata, E., Hallal, H., Conde, I., Martin Prieto, Montane, E., Maria Morillas, R., Soriano, G., Roman, E., Navarro, J. M., Jimenez, M., Aldea, A., Hernandez-Guerra, M., Gines, P., Blanco, S., Moreno, J. M., Romero-Gomez, M., Gomez-Dominguez, E., Andrade, R., and Lucena, M.

50. CHRONICITY IN IDIOSYNCRATIC DRUG-INDUCED LIVER INJURY (DILI): CAUSATIVE DRUGS AND RISK FACTSORS

Author

Robles-Diaz, M., Medina-Caliz, I., Garcia-Munoz, B., Stephens, C., Gonzalez-Jimenez, A., Garcia-Cortes, M., Ortega-Alonso, A., Hidalgo, R., Fernandez, M. C., Romero-Gomez, M., Calle-Sanz, R., Fombuena, B., Navarro, J. M., Hallal, H., Barriocanal, A. M., Montane, E., Blanco, S., Castiella, A., Zapata, E. M., Jimenez-Perez, M., Moreno-Planas, J. M., Soriano, G., Guarner, C., Roman, E. M., Primo, J., Aldea, A., Martin Prieto, Andrade, R. J., and Lucena, M.

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