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Idiosyncratic DILI: Analysis of 46,266 Cases Assessed for Causality by RUCAM and Published From 2014 to Early 2019.
Front Pharmacol. 2019; 10:730.FP

Abstract

One of the most difficult challenges in clinical hepatology is the diagnosis of a drug-induced liver injury (DILI). The timing of the events, exclusion of alternative causes, and taking into account the clinical context should be systematically assessed and scored in a transparent manner. RUCAM (Roussel Uclaf Causality Assessment Method) is a well-established diagnostic algorithm and scale to assess causality in patients with suspected DILI. First published in 1993 and updated in 2016, RUCAM is now the worldwide most commonly used causality assessment method (CAM) for DILI. The following manuscript highlights the recent implementation of RUCAM around the world, by reviewing the literature for publications that utilized RUCAM, and provides a review of "best practices" for the use of RUCAM in cases of suspected DILI. The worldwide appreciation of RUCAM is substantiated by the current analysis of 46,266 DILI cases, all tested for causality using RUCAM. These cases derived from 31 reports published from 2014 to early 2019. Their first authors came from 10 countries, with China on top, followed by the US, and Germany on the third rank. Importantly, all RUCAM-based DILI reports were published in high profile journals. Many other reports were published earlier from 1993 up to 2013 in support of RUCAM. Although most of the studies were of high quality, the current case analysis revealed shortcomings in few studies, not at the level of RUCAM itself but rather associated with the work of the users. To ensure in future DILI cases a better performance by the users, a list of essential elements is proposed. As an example, all suspected DILI cases should be evaluated 1) by the updated RUCAM to facilitate result comparisons, 2) according to a prospective study protocol to ensure complete data sets, 3) after exclusion of cases with herb induced liver injury (HILI) from a DILI cohort to prevent confounding variables, and 4) according to inclusion of DILI cases with RUCAM-based causality gradings of highly probable or probable, in order to increase the specificity of the results. In conclusion, RUCAM benefits from its high appreciation and performs well provided the users adhere to published recommendations to prevent confounding variability.

Authors+Show Affiliations

Department of Internal Medicine II, Division of Gastroenterology and Hepatology, Klinikum Hanau, Academic Teaching Hospital of the Medical Faculty, Goethe University Frankfurt, Germany.

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

31396080

Citation

Teschke, Rolf. "Idiosyncratic DILI: Analysis of 46,266 Cases Assessed for Causality By RUCAM and Published From 2014 to Early 2019." Frontiers in Pharmacology, vol. 10, 2019, p. 730.
Teschke R. Idiosyncratic DILI: Analysis of 46,266 Cases Assessed for Causality by RUCAM and Published From 2014 to Early 2019. Front Pharmacol. 2019;10:730.
Teschke, R. (2019). Idiosyncratic DILI: Analysis of 46,266 Cases Assessed for Causality by RUCAM and Published From 2014 to Early 2019. Frontiers in Pharmacology, 10, 730. https://doi.org/10.3389/fphar.2019.00730
Teschke R. Idiosyncratic DILI: Analysis of 46,266 Cases Assessed for Causality By RUCAM and Published From 2014 to Early 2019. Front Pharmacol. 2019;10:730. PubMed PMID: 31396080.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Idiosyncratic DILI: Analysis of 46,266 Cases Assessed for Causality by RUCAM and Published From 2014 to Early 2019. A1 - Teschke,Rolf, Y1 - 2019/07/23/ PY - 2019/04/02/received PY - 2019/06/05/accepted PY - 2019/8/10/entrez PY - 2019/8/10/pubmed PY - 2019/8/10/medline KW - Roussel Uclaf Causality Assessment Method (RUCAM) KW - drug-induced liver injury (DILI) KW - idiosyncratic DILI KW - intrinsic DILI KW - liver adaption KW - pharmacovigilance SP - 730 EP - 730 JF - Frontiers in pharmacology JO - Front Pharmacol VL - 10 N2 - One of the most difficult challenges in clinical hepatology is the diagnosis of a drug-induced liver injury (DILI). The timing of the events, exclusion of alternative causes, and taking into account the clinical context should be systematically assessed and scored in a transparent manner. RUCAM (Roussel Uclaf Causality Assessment Method) is a well-established diagnostic algorithm and scale to assess causality in patients with suspected DILI. First published in 1993 and updated in 2016, RUCAM is now the worldwide most commonly used causality assessment method (CAM) for DILI. The following manuscript highlights the recent implementation of RUCAM around the world, by reviewing the literature for publications that utilized RUCAM, and provides a review of "best practices" for the use of RUCAM in cases of suspected DILI. The worldwide appreciation of RUCAM is substantiated by the current analysis of 46,266 DILI cases, all tested for causality using RUCAM. These cases derived from 31 reports published from 2014 to early 2019. Their first authors came from 10 countries, with China on top, followed by the US, and Germany on the third rank. Importantly, all RUCAM-based DILI reports were published in high profile journals. Many other reports were published earlier from 1993 up to 2013 in support of RUCAM. Although most of the studies were of high quality, the current case analysis revealed shortcomings in few studies, not at the level of RUCAM itself but rather associated with the work of the users. To ensure in future DILI cases a better performance by the users, a list of essential elements is proposed. As an example, all suspected DILI cases should be evaluated 1) by the updated RUCAM to facilitate result comparisons, 2) according to a prospective study protocol to ensure complete data sets, 3) after exclusion of cases with herb induced liver injury (HILI) from a DILI cohort to prevent confounding variables, and 4) according to inclusion of DILI cases with RUCAM-based causality gradings of highly probable or probable, in order to increase the specificity of the results. In conclusion, RUCAM benefits from its high appreciation and performs well provided the users adhere to published recommendations to prevent confounding variability. SN - 1663-9812 UR - https://www.unboundmedicine.com/medline/citation/31396080/Idiosyncratic_DILI:_Analysis_of_46266_Cases_Assessed_for_Causality_by_RUCAM_and_Published_From_2014_to_Early_2019_ L2 - https://doi.org/10.3389/fphar.2019.00730 DB - PRIME DP - Unbound Medicine ER -
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