Spanish DILI Registry

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Evaluación de causalidad

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Rechallenge in drug-induced liver injury: the attractive hazard.   

Expert Opin Drug Saf. 2009, 8:709-714 Andrade RJ, Robles M, Lucena MI.University of Málaga, Vírgen de la Victoria University Hospital, Departamento de Medicina, Spain. andrade@uma.es 

Abstract

Progress in the understanding of drug-induced liver injury (DILI) is clearly hampered by the lack of specific markers of the disease. In this scenario, recrudescence of the liver injury upon re-exposure to the suspicious drug is considered the more reliable evidence of DILI. On-purpose re-exposure, however, entails both practical and ethical issues because the bulk of situations in clinical practice are non-immunoallergic DILI in which a provocation test frequently would give negative results. Besides, deliberate re-exposure with a drug that is not considered vital or essential is potentially harmful and, hence, hardly justified in DILI, and rechallenge is more commonly described in an unintentional basis. The causes, characteristics and consequences of rechallenge have been specifically addressed recently. For causality assessment, a positive rechallenge test carries the strong value, and is accordingly scored by clinical algorithms. Such clinical scales, however, reward drugs that are associated with a positive rechallenge response, but might be considered biased against those where re-administration fails to elicit a response or, more commonly, for which no rechallenge is attempted.

 
LETTERS AND COMMENTS
Is the Naranjo probability scale accurate enough to ascertain causality in drug-induced hepatotoxicity?
Miren García-Cortés MD, M Isabel Lucena MD PhD, Raúl J Andrade MD PhD, Raquel Camargo MD, Ramiro Alcántara MD
Evaluation of Naranjo Adverse Drug Reactions Probability Scale in causality assessment of drug-induced liver injury
M. GARCÍA-CORTÉS*, M. I. LUCENA, K. PACHKORIA, Y. BORRAZ, R. HIDALGO & R. J . ANDRADE* ON BEHALF OF THE SPANISH GROUP FOR THE STUDY OF DRUG-INDUCED LIVER DISEASE (GRUPO DE ESTUDIO PARA LAS HEPATOPATÍAS ASOCIADAS A MEDICAMENTOS, GEHAM)

Causality assessment in hepatotoxicity is challenging. The current standard liver-specific Council for International Organizations of Medical Sciences ⁄ Roussel Uclaf Causality Assessment Method scale is complex and difficult to implement in daily practice. The Naranjo Adverse Drug Reactions Probability Scale is a simple and widely used nonspecific scale, which has not been specifically evaluated in drug-induced liver injury.

Editorial: Reexposure in hepatotoxicity: Concept testing or therapeutic accident?
R. J. ANDRADE ET AL.

Hepatotoxicity is a potentially dreadful drug-related adverse event both because of its financial impact during drug development and its influence on morbidity and mortality, and has been a challenge to clinicians, pharmacologists, toxicologists, pharmaceutic companies, and regulatory authorities for decades. To gastroenterologists and hepatologists toxic liver disease is also a disconcerting issue given the high number of substances that may induce such response, the heterogeneity of clinical manifestations, and our present inability to establish a definite diagnosis in most cases...

Análisis de dos escalas órgano-específicas para la evaluación de causalidad (CIOMS y M&V)

LUCENA MI, CAMARGO R, ANDRADE RJ, PEREZ-SANCHEZ JC, SANCHEZ DE LA CUESTA F. Comparison of two clinical scales for causality assessment in hepatotoxicity.Hepatology 2001; 33: 123-30 - IF: 10.446

Esta aportación supone el análisis de todos los casos de hepatotoxicidad incluidos en el Registro Español coordinado por la solicitante de esta evaluación, durante sus primeros 10 años de funcionamiento. Un total de 461 casos de enfermedad hepática de 570 analizados fueron relacionados con hepatotoxicidad, siguiendo un protocolo estructurado. El fármaco responsable del mayor número de episodios de hepatotoxicidad fue la amoxicilina-clavulánico con el 12.8% del total de la cohorte. La lesión de tipo hepatocelular fue la más frecuente, ocurriendo en el 58% de los casos, se correlacionó de forma inversa con la edad, y tuvo la peor evolución. Un 11.7% de los pacientes con ictericia y lesión hepatocelulal fallecieron. En el análisis multivariante el sexo femenino, la lesión hepatocelular y una bilirrubina elevada en el momento de la presentación se asociaron de manera independiente con el riesgo de desarrollo de fallo hepático fulminante. El crecimiento del Registro a lo largo de los años nos permitió realizar el presente análisis. En realidad nuestro proyecto ha sido pionero en esta materia a nivel internacional y por ello, fue publicado en la revista mas importante de la especialidad, Gastroenterology (IF 12. 386). Permitió validar la ley de Zimmerman formulada a final de los años 70, a partir de observaciones de casos aislados de hepatotoxicidad comunicados a la FDA o incidentes en los ensayos clínicos, en la cual se predecía una mortalidad o su marcador subrogado, el transplante hepático hepático, de aproximadamente el 10% en pacientes con enfermedad hepática tóxica idiosincrásica, que tuviesen ictericia en la presentación y lesión del tipo hepatocellular. Nuestro estudio encontró una figura del 11.7% , lo que suponía la validación por vez primera de esta ley. Otra importante observación es la correlación inversa de la lesión hepatocelular con la edad.

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