Drug-induced liver injury: an analysis of 461 incidences submitted to the Spanish registry over a 10-year period. Export

@article{citeulike:3082282, abstract = {BACKGROUND \& AIMS: Progress in the understanding of susceptibility factors to drug-induced liver injury (DILI) and outcome predictability are hampered by the lack of systematic programs to detect bona fide cases. METHODS: A cooperative network was created in 1994 in Spain to identify all suspicions of DILI following a prospective structured report form. The liver damage was characterized according to hepatocellular, cholestatic, and mixed laboratory criteria and to histologic criteria when available. Further evaluation of causality assessment was centrally performed. RESULTS: Since April 1994 to August 2004, 461 out of 570 submitted cases, involving 505 drugs, were deemed to be related to DILI. The antiinfective group of drugs was the more frequently incriminated, amoxicillin-clavulanate accounting for the 12.8\% of the whole series. The hepatocellular pattern of damage was the most common (58\%), was inversely correlated with age (P < .0001), and had the worst outcome (Cox regression, P < .034). Indeed, the incidence of liver transplantation and death in this group was 11.7\% if patients had jaundice at presentation, whereas the corresponding figure was 3.8\% in nonjaundiced patients (P < .04). Factors associated with the development of fulminant hepatic failure were female sex (OR = 25; 95\% CI: 4.1-151; P < .0001), hepatocellular damage (OR = 7.9; 95\% CI: 1.6-37; P < .009), and higher baseline plasma bilirubin value (OR = 1.15; 95\% CI: 1.09-1.22; P < .0001). CONCLUSIONS: Patients with drug-induced hepatocellular jaundice have 11.7\% chance of progressing to death or transplantation. Amoxicillin-clavulanate stands out as the most common drug related to DILI.}, address = {Unidad de Hepatolog\'{\i}a y Grupo de Estudio para las Hepatopat\'{\i}as Asociadas a Medicamentos, Coordinating Centre, Hospital Universitario Virgen de la Victoria, Facultad de Medicina, Campus Universitario de Teatinos s/n, M\'{a}laga, Spain. andrade@uma.es}, author = {Andrade, R. J. and Lucena, M. I. and Fern\'{a}ndez, M. C. and Pelaez, G. and Pachkoria, K. and Garc\'{\i}a-Ruiz, E. and Garc\'{\i}a-Mu\~{n}oz, B. and Gonz\'{a}lez-Grande, R. and Pizarro, A. and Dur\'{a}n, J. A. and Jim\'{e}nez, M. and Rodrigo, L. and Romero-Gomez, M. and Navarro, J. M. and Planas, R. and Costa, J. and Borras, A. and Soler, A. and Salmer\'{o}n, J. and Martin-Vivaldi, R. and {}}, citeulike-article-id = {3082282}, citeulike-linkout-0 = {http://dx.doi.org/10.1016/j.gastro.2005.05.006}, citeulike-linkout-1 = {http://view.ncbi.nlm.nih.gov/pubmed/16083708}, citeulike-linkout-2 = {http://www.hubmed.org/display.cgi?uids=16083708}, doi = {10.1016/j.gastro.2005.05.006}, issn = {0016-5085}, journal = {Gastroenterology}, keywords = {drug, liver}, month = {August}, number = {2}, pages = {512--521}, posted-at = {2008-08-04 21:50:56}, priority = {2}, title = {Drug-induced liver injury: an analysis of 461 incidences submitted to the Spanish registry over a 10-year period.}, url = {http://dx.doi.org/10.1016/j.gastro.2005.05.006}, volume = {129}, year = {2005} }

TY - JOUR ID - citeulike:3082282 L3 - citeulike-article-id:3082282 N2 - BACKGROUND & AIMS: Progress in the understanding of susceptibility factors to drug-induced liver injury (DILI) and outcome predictability are hampered by the lack of systematic programs to detect bona fide cases. METHODS: A cooperative network was created in 1994 in Spain to identify all suspicions of DILI following a prospective structured report form. The liver damage was characterized according to hepatocellular, cholestatic, and mixed laboratory criteria and to histologic criteria when available. Further evaluation of causality assessment was centrally performed. RESULTS: Since April 1994 to August 2004, 461 out of 570 submitted cases, involving 505 drugs, were deemed to be related to DILI. The antiinfective group of drugs was the more frequently incriminated, amoxicillin-clavulanate accounting for the 12.8% of the whole series. The hepatocellular pattern of damage was the most common (58%), was inversely correlated with age (P < .0001), and had the worst outcome (Cox regression, P < .034). Indeed, the incidence of liver transplantation and death in this group was 11.7% if patients had jaundice at presentation, whereas the corresponding figure was 3.8% in nonjaundiced patients (P < .04). Factors associated with the development of fulminant hepatic failure were female sex (OR = 25; 95% CI: 4.1-151; P < .0001), hepatocellular damage (OR = 7.9; 95% CI: 1.6-37; P < .009), and higher baseline plasma bilirubin value (OR = 1.15; 95% CI: 1.09-1.22; P < .0001). CONCLUSIONS: Patients with drug-induced hepatocellular jaundice have 11.7% chance of progressing to death or transplantation. Amoxicillin-clavulanate stands out as the most common drug related to DILI. IS - 2 JF - Gastroenterology SN - 0016-5085 AD - Unidad de Hepatología y Grupo de Estudio para las Hepatopatías Asociadas a Medicamentos, Coordinating Centre, Hospital Universitario Virgen de la Victoria, Facultad de Medicina, Campus Universitario de Teatinos s/n, Málaga, Spain. andrade@uma.es EP - 521 TI - Drug-induced liver injury: an analysis of 461 incidences submitted to the Spanish registry over a 10-year period. VL - 129 SP - 512 KW - drug KW - liver AU - Andrade, RJ AU - Lucena, MI AU - Fernández, MC AU - Pelaez, G AU - Pachkoria, K AU - García-Ruiz, E AU - García-Muñoz, B AU - González-Grande, R AU - Pizarro, A AU - Durán, JA AU - Jiménez, M AU - Rodrigo, L AU - Romero-Gomez, M AU - Navarro, JM AU - Planas, R AU - Costa, J AU - Borras, A AU - Soler, A AU - Salmerón, J AU - Martin-Vivaldi, R PY - 2005/08// UR - http://dx.doi.org/10.1016/j.gastro.2005.05.006 ER -