Drug-Induced Liver Injury: An Analysis of 461 Incidences Submitted to the Spanish Registry Over a 10-Year Period
| Autor: | B. García-Muñoz, M. Carmen Fernández, Luis Rodrigo, G. Pelaez, Manuel Romero-Gómez, J.M. Navarro, Joan Costa, Elena García-Ruiz, Rocío González-Grande, M. Isabel Lucena, Angeles Pizarro, Rafael Martín-Vivaldi, Javier Salmerón, Africa Borras, Ketevan Pachkoria, Raúl J. Andrade, Manuel Jimenez, Ramon Planas, Aina Soler, José Antonio Durán |
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| Rok vydání: | 2005 |
| Předmět: |
Adult
Male medicine.medical_specialty Adolescent Drug-Related Side Effects and Adverse Reactions Amoxicillin-Potassium Clavulanate Combination Risk Assessment Hy's law Age Distribution Fulminant hepatic failure Internal medicine Odds Ratio medicine Humans Registries Sex Distribution Survival analysis Aged Probability Proportional Hazards Models Retrospective Studies Aged 80 and over Analysis of Variance Hepatology Proportional hazards model business.industry Incidence Liver Diseases Incidence (epidemiology) Gastroenterology Retrospective cohort study Odds ratio Middle Aged Survival Analysis Anti-Bacterial Agents Surgery Transplantation Liver Spain Female Chemical and Drug Induced Liver Injury business Liver Failure |
| Zdroj: | Gastroenterology. 129:512-521 |
| ISSN: | 0016-5085 |
| DOI: | 10.1053/j.gastro.2005.05.006 |
| Popis: | 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.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.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).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. |
| Databáze: | OpenAIRE |
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