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Multicentre and multidisciplinary registry of prospective drug-induced liver injury cases
Spain (IFMSA-SPAIN)-University of Malaga, Malaga
Department of Pharmacology and Pediatrics
Maria Isabel Lucena Gonzalez
Judith Sanabria, Mercedes Robles, Inmaculada Medina, Maria Rosario Cabello, Andres Gonzalez, Camilla Stephens, Mahmoud Slim, Rocio Sanjuan, Sanam Mirwani
Type of Research Project
- Clinical Project with Laboratory work
What is the background of the project?
Idiosyncratic drug-induced liver injury (DILI) is an acute adverse hepatic reaction to a medication used in its therapeutic dose and that is unexpected from the known pharmacological action of the agent. The incidence of DILI is between 2.4 and 8.4 per 100,000 person years in population based studies. Despite its rarity, idiosyncratic DILI accounts for 7-15% of the cases of acute liver failure in Europe and is the most frequent reason for the market withdrawal of an approved drug. In addition, DILI occurs in association with a large number of drugs and shows heterogeneity. There are no markers that can effectively pre-empt and prevent DILI or monitor the severity and course of the adverse event.
What is the aim of the project?
To collect, store and catalogue biological samples and clinical data, to form a large international patient/control cohort available for subsequent detailed analysis by consortium members which can also be used in current and future epidemiologic and mechanistic studies. Students will know how to analize demographic, clinical and biochemical parameters in drug-induced liver injury cases included in the Registry and realized phenotypic studies.
What techniques and methods are used?
- Data collected in structured protocol - DILI criteria (Aithal, 2011) - Causality criteria by CIOMS/RUCAM - Biobank. Sampling collection and alliquoting - Descriptive statistic in excel
What is the role of the student?
- The student will observe the practical experiments but will be highly involved in the analysis of the results
- The tasks will be done under supervision
What are the tasks expected to be accomplished by the student?
The student is expected to be included in the search and characterization of drug effects. They are expected to get knowledge about the safety of drugs and also be able to identify risk factors regarding the use of pharms. The student will be provided with pharmacopidemiological data on which they will learn to apply statistical techniques, after which they will have acquired computer skills. With this data they will learn about causality assessment and diagnosis of DILI cases. After that, they will be tough how to prepare a scientific text and will get familiar with scientific literature.
Will there be any theoretical teaching provided (preliminary readings, lectures, courses, seminars etc)
There is theoretical teaching provided. Preliminary readings, lectures and seminars.
What is expected from the student at the end of the research exchange? What will be the general outcome of the student?
- No specific outcome is expected
What skills are required of the student? Is there any special knowledge or a certain level of studies needed?
Are there any legal limitations in the student’s involvement
Type of students accepted
This project accepts: - Medical students - Graduated students (less than 6 months) - Pre-Medical students from the American-British system
- 1. Andrade RJ; Lucena MI; Fernandez MC; et al. Drug-induced liver injury: an analysis of 461 incidences submitted to the Spanish registry over a 10-year period. Gastroenterology 2005; 129: 512?21.
- 2. Lucena MI; et al. Phenotypic characterization of idiosyncratic drug-induced liver injury: The influence of age and sex. Hepatology 2009. 49(6): 2001-2009.
- 3. Aithal GP; Watkins PB; Andrade RJ; et al. Case definition and phenotype standardization in drug-induced liver injury. Clin Pharmacol Ther 2011; 89: 806-15.
- 4. Robles-Diaz M; Lucena MI; Kaplowitz N; et al. Use of Hy's law and a new composite algorithm to predict acute liver failure in patients with drug-induced liver injury. Gastroenterology 2014; 147: 109-18.
- 5. Robles-Diaz M; Gonzalez-Jimenez A; Medina-Caliz I et al. Distinct phenotype of hepatotoxicity associated with illicit use of anabolic androgenic steroids. Aliment Pharmacol Ther. 2015 Jan;41(1):116-25. Also; it has been awarded a leader publication in the following number of the magazine: J. Neuberger. Editorial: showing due DILI-gence - the lessons from anabolic steroids. Aliment Pharmacol Ther 2015; 41: 320--24.
- 6. Inmaculada Medina-Caliz*; Mercedes Robles-Diaz*; Beatriz Garcia-Munoz; Camilla Stephens; Aida Ortega-Alonso; Miren Garcia-Cortes; Andres Gonzalez-Jimenez; Judith A Sanabria-Cabrera; Inmaculada Moreno; M Carmen Fernandez; Manuel Romero-Gomez; Jose M Navarro; Ana Maria Barriocanal; Eva Montane; Hacibe Hallal; Sonia Blanco; German Soriano; Eva M Roman; Elena Gomez-Dominguez; Agustin Castiella; Eva M Zapata; Miguel Jimenez-Perez; Jose M Moreno; Ana Aldea-Perona; Manuel Hernandez-Guerra; Martin Prieto; Miguel E Zoubek; Neil Kaplowitz; M Isabel Lucena; Raul J Andrade. Definition and risk factors for chronicity following acute idiosyncratic drug-induced liver injury. J Hepatol 2016 Sep;65(3):532-42.
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