Real time identification of drug-induced liver injury (DILI) through daily screening of ALT results: a prospective pilot cohort study
Identification of drug-induced liver disease (DILI) is difficult, even among hospitalized patients. The aim of this pilot study was to assess the impact of a specific strategy for DILI screening. We prospectively compared the number of acute DILI cases identified in one week of a proactive strategy...
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| Published in: | PloS one Vol. 7; no. 8; p. e42418 |
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| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , |
| Format: | Journal Article |
| Language: | English |
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Public Library of Science
14-08-2012
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| Abstract | Identification of drug-induced liver disease (DILI) is difficult, even among hospitalized patients. The aim of this pilot study was to assess the impact of a specific strategy for DILI screening.
We prospectively compared the number of acute DILI cases identified in one week of a proactive strategy based on centralized elevated ALT values to those identified with a standard of care strategy for 24-week period based on referral cases to the hepatology unit. In the centralized strategy, a designated study biochemist identified patients with ALT greater than 3 times the upper limit of normal values (ULN) and notified the designated hepatologists, who then went to the patients' wards, analyzed the charts, and if necessary, interviewed the identified patients. During these two periods, patients with possible DILI were included after signing an informed consent in an ongoing European diagnostic study (SAFE-T consortium).
During the 24-week period of the standard strategy, 12 (0.04%) patients out of a total of 28,145 were identified as having possible DILI, and 11 of these accepted to be included in the protocol. During the one-week proactive period, 7 patients out of a total of 1407 inpatients (0.498%) [odds ratio vs. standard = 12.1 (95% CI, 3.9-32.3); P<0.0001] were identified with possible DILI, and 5 were included in the protocol.
A simple strategy based on the daily analysis of cases with ALT >3 ULN by designated biochemists and hepatologists identified 12 times more acute cases of drug-induced liver disease than the standard strategy. This pilot cohort is registered on the number AP-HP P110201/1/08-03-2011 and AFSSAPS B110346-70. |
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| AbstractList | Identification of drug-induced liver disease (DILI) is difficult, even among hospitalized patients. The aim of this pilot study was to assess the impact of a specific strategy for DILI screening.We prospectively compared the number of acute DILI cases identified in one week of a proactive strategy based on centralized elevated ALT values to those identified with a standard of care strategy for 24-week period based on referral cases to the hepatology unit. In the centralized strategy, a designated study biochemist identified patients with ALT greater than 3 times the upper limit of normal values (ULN) and notified the designated hepatologists, who then went to the patients' wards, analyzed the charts, and if necessary, interviewed the identified patients. During these two periods, patients with possible DILI were included after signing an informed consent in an ongoing European diagnostic study (SAFE-T consortium).During the 24-week period of the standard strategy, 12 (0.04%) patients out of a total of 28,145 were identified as having possible DILI, and 11 of these accepted to be included in the protocol. During the one-week proactive period, 7 patients out of a total of 1407 inpatients (0.498%) [odds ratio vs. standard = 12.1 (95% CI, 3.9-32.3); P<0.0001] were identified with possible DILI, and 5 were included in the protocol.A simple strategy based on the daily analysis of cases with ALT >3 ULN by designated biochemists and hepatologists identified 12 times more acute cases of drug-induced liver disease than the standard strategy. This pilot cohort is registered on the number AP-HP P110201/1/08-03-2011 and AFSSAPS B110346-70. Objective Identification of drug-induced liver disease (DILI) is difficult, even among hospitalized patients. The aim of this pilot study was to assess the impact of a specific strategy for DILI screening. Design We prospectively compared the number of acute DILI cases identified in one week of a proactive strategy based on centralized elevated ALT values to those identified with a standard of care strategy for 24-week period based on referral cases to the hepatology unit. In the centralized strategy, a designated study biochemist identified patients with ALT greater than 3 times the upper limit of normal values (ULN) and notified the designated hepatologists, who then went to the patients' wards, analyzed the charts, and if necessary, interviewed the identified patients. During these two periods, patients with possible DILI were included after signing an informed consent in an ongoing European diagnostic study (SAFE-T consortium). Results During the 24-week period of the standard strategy, 12 (0.04%) patients out of a total of 28,145 were identified as having possible DILI, and 11 of these accepted to be included in the protocol. During the one-week proactive period, 7 patients out of a total of 1407 inpatients (0.498%) [odds ratio vs. standard = 12.1 (95% CI, 3.9-32.3); P<0.0001] were identified with possible DILI, and 5 were included in the protocol. Conclusion A simple strategy based on the daily analysis of cases with ALT >3 ULN by designated biochemists and hepatologists identified 12 times more acute cases of drug-induced liver disease than the standard strategy. This pilot cohort is registered on the number AP-HP P110201/1/08-03-2011 and AFSSAPS B110346-70. Identification of drug-induced liver disease (DILI) is difficult, even among hospitalized patients. The aim of this pilot study was to assess the impact of a specific strategy for DILI screening. We prospectively compared the number of acute DILI cases identified in one week of a proactive strategy based on centralized elevated ALT values to those identified with a standard of care strategy for 24-week period based on referral cases to the hepatology unit. In the centralized strategy, a designated study biochemist identified patients with ALT greater than 3 times the upper limit of normal values (ULN) and notified the designated hepatologists, who then went to the patients' wards, analyzed the charts, and if necessary, interviewed the identified patients. During these two periods, patients with possible DILI were included after signing an informed consent in an ongoing European diagnostic study (SAFE-T consortium). During the 24-week period of the standard strategy, 12 (0.04%) patients out of a total of 28,145 were identified as having possible DILI, and 11 of these accepted to be included in the protocol. During the one-week proactive period, 7 patients out of a total of 1407 inpatients (0.498%) [odds ratio vs. standard = 12.1 (95% CI, 3.9-32.3); P<0.0001] were identified with possible DILI, and 5 were included in the protocol. A simple strategy based on the daily analysis of cases with ALT >3 ULN by designated biochemists and hepatologists identified 12 times more acute cases of drug-induced liver disease than the standard strategy. Objective Identification of drug-induced liver disease (DILI) is difficult, even among hospitalized patients. The aim of this pilot study was to assess the impact of a specific strategy for DILI screening. Design We prospectively compared the number of acute DILI cases identified in one week of a proactive strategy based on centralized elevated ALT values to those identified with a standard of care strategy for 24-week period based on referral cases to the hepatology unit. In the centralized strategy, a designated study biochemist identified patients with ALT greater than 3 times the upper limit of normal values (ULN) and notified the designated hepatologists, who then went to the patients' wards, analyzed the charts, and if necessary, interviewed the identified patients. During these two periods, patients with possible DILI were included after signing an informed consent in an ongoing European diagnostic study (SAFE-T consortium). Results During the 24-week period of the standard strategy, 12 (0.04%) patients out of a total of 28,145 were identified as having possible DILI, and 11 of these accepted to be included in the protocol. During the one-week proactive period, 7 patients out of a total of 1407 inpatients (0.498%) [odds ratio vs. standard = 12.1 (95% CI, 3.9–32.3); P<0.0001] were identified with possible DILI, and 5 were included in the protocol. Conclusion A simple strategy based on the daily analysis of cases with ALT >3 ULN by designated biochemists and hepatologists identified 12 times more acute cases of drug-induced liver disease than the standard strategy. This pilot cohort is registered on the number AP-HP P110201/1/08-03-2011 and AFSSAPS B110346-70. Identification of drug-induced liver disease (DILI) is difficult, even among hospitalized patients. The aim of this pilot study was to assess the impact of a specific strategy for DILI screening. We prospectively compared the number of acute DILI cases identified in one week of a proactive strategy based on centralized elevated ALT values to those identified with a standard of care strategy for 24-week period based on referral cases to the hepatology unit. In the centralized strategy, a designated study biochemist identified patients with ALT greater than 3 times the upper limit of normal values (ULN) and notified the designated hepatologists, who then went to the patients' wards, analyzed the charts, and if necessary, interviewed the identified patients. During these two periods, patients with possible DILI were included after signing an informed consent in an ongoing European diagnostic study (SAFE-T consortium). During the 24-week period of the standard strategy, 12 (0.04%) patients out of a total of 28,145 were identified as having possible DILI, and 11 of these accepted to be included in the protocol. During the one-week proactive period, 7 patients out of a total of 1407 inpatients (0.498%) [odds ratio vs. standard = 12.1 (95% CI, 3.9-32.3); P<0.0001] were identified with possible DILI, and 5 were included in the protocol. A simple strategy based on the daily analysis of cases with ALT >3 ULN by designated biochemists and hepatologists identified 12 times more acute cases of drug-induced liver disease than the standard strategy. This pilot cohort is registered on the number AP-HP P110201/1/08-03-2011 and AFSSAPS B110346-70. |
| Audience | Academic |
| Author | Poynard, Thierry Tilleul, Patrick Khayat, David Fautrel, Bruno Samson, Yves Amoura, Zahir Boulogne, Philippe Ramanujam, Nittia Bricaire, François Pierrot-Deseilligny, Charles Imbert-Bismut, Françoise Perazzo, Hugo Deckmyn, Olivier Bonnefont-Rousselot, Dominique M'Kada, Helmi Ratziu, Vlad Caen, Olivier Lyon Herson, Serge Leblond, Véronique Coriat, Pierre Delattre, Jean Yves Munteanu, Mona Delpech, Vincent Nicolas Ngo, Yen Schuppe-Koistinen, Ina |
| AuthorAffiliation | 13 Internal Medicine-2 GHPS, Paris, France 6 Hematology Unit, GHPS, Paris, France 12 Neurology-1 GHPS, Paris, France 11 Oncology Unit GHPS, Paris, France 17 Administrative Direction GHPS, Paris, France 14 Internal Medicine-1 GHPS, Paris, France 8 Cerebral Vascular Emergency Unit, GHPS, Paris, France 3 Biopredictive, Paris, France 7 Neurology-2 Unit, GHPS, Paris, France 2 AP-HP, University Pierre Marie Curie (UPMC) Liver Center, Paris, France 10 Infectious Disease Unit GHPS, Paris, France 4 Rheumatology Unit, GHPS, Paris, France 15 Pharmacology Unit, GHPS, Paris, France 18 Information Technology Unit GHPS, Paris, France 5 Astra Zeneca, Södertälje, Sweden 9 Neurology-4 GHPS, Paris, France 19 EA 4466, Faculté des Sciences Pharmaceutiques et Biologiques, Université Paris Descartes, Sorbonne Paris Cité, Paris, France Duke University, United States of America 1 Service de Biochimie Métabolique, Groupe Hospitalier Pitié-Salpêtrière (GHPS), Assistance Publique Hôpitaux de Paris (AP-HP), Paris, France 16 Intensiv |
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/22905129$$D View this record in MEDLINE/PubMed |
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| ContentType | Journal Article |
| Contributor | Poynard, Thierry Menegaux, Fabrice Khayat, David Lubetzki, Catherine Samson, Yves Goudot, Patrick Katlama, Christine Merrien, Jean-claude Mkada, Helmi Riou, Bruno Le Hoang, Phuc Deray, Gilbert Rufat, Pierre Dubois, Olivier Lyon Caen Bruno Francois, Bricaire Dominique, Mazier Mazeron, Jean Jacques Serge, Herson Basdevant, Arnaud Vernant, Jean Paul Similowski, Thomas Rudler, Marika Bachet, Jean Baptiste Gaujoux-Viala, Cécile Michel, Komajda Ratziu, Vlad Massard, Julien Devillier, Catherine Verny, Marc Quetin, Frederique Lefranc, Jean-Pierre Chastre, Jean Laurent, Hannoun Delpech, Vincent Nicolas Richard, François Touraine, Philippe Bourgeois, Pierre Koskas, Fabien Catonne, Yves Tilleul, Patrick Meininger, Vincent Danis, Martin Clément, Karine Fautrel, Bruno Pavie, Alain Amoura, Zahir Boulogne, Philippe Francois, Allilaire Jean Aurengo, Andre Hartemann, Agnes Cornu, Philippe Imbert-Bismut, Françoise Bruckert, Eric Leblond, Veronique Thabut, Dominique Bonnefont-Rousselot, Dominique Vaillant, Jean Christophe Deseilligny, Charles Pierrot Cohen, Dav |
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fullname: Similowski, Thomas – sequence: 39 givenname: Frederique surname: Quetin fullname: Quetin, Frederique – sequence: 40 givenname: Yves surname: Samson fullname: Samson, Yves – sequence: 41 givenname: Charles Pierrot surname: Deseilligny fullname: Deseilligny, Charles Pierrot – sequence: 42 givenname: Jean Yves surname: Delattre fullname: Delattre, Jean Yves – sequence: 43 givenname: Michel surname: Baulac fullname: Baulac, Michel – sequence: 44 givenname: Olivier Lyon Caen Bruno surname: Dubois fullname: Dubois, Olivier Lyon Caen Bruno – sequence: 45 givenname: David surname: Cohen fullname: Cohen, David – sequence: 46 givenname: Vincent surname: Meininger fullname: Meininger, Vincent – sequence: 47 givenname: Gilbert surname: Deray fullname: Deray, Gilbert – sequence: 48 givenname: David surname: Khayat fullname: Khayat, David – sequence: 49 givenname: Phuc surname: Le Hoang fullname: Le Hoang, Phuc – sequence: 50 givenname: Patrick surname: Tilleul fullname: Tilleul, Patrick – 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| Copyright | COPYRIGHT 2012 Public Library of Science M'Kada et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License: https://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. 2012 M'Kada et al 2012 M'Kada et al |
| Copyright_xml | – notice: COPYRIGHT 2012 Public Library of Science – notice: M'Kada et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License: https://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. – notice: 2012 M'Kada et al 2012 M'Kada et al |
| CorporateAuthor | Drug Induced Liver Injury Groupe Hospitalier Pitié-Salpêtrière Group Safer and Faster Evidence-based Translation Consortium for the Drug Induced Liver Injury Groupe Hospitalier Pitié-Salpêtrière (DILI-GHPS) Group and the Safer and Faster Evidence-based Translation (SAFE-T) Consortium |
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| DOI | 10.1371/journal.pone.0042418 |
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| Notes | Competing Interests: ISK is full-time employee of Astra-Zeneca. Thierry Poynard is the inventor of the liver injury biomarkers, FibroTest ActiTest, and has a capital interest in Biopredictive, the company marketing the tests. Patents belong to the public organization Assistance Publique Hôpitaux de Paris. Mona Munteanu and Yen Ngo are full-time employees of Biopredictive, the company marketing FibroTest (FibroSure in the USA). This does not alter the authors' adherence to all the PLoS ONE policies on sharing data and materials. Conceived and designed the experiments: TP HM. Performed the experiments: HM HP MM YN NR VR FIB BF VL JYD YS OLC FB DK CPD SH ZA PT OD PC VND PB DBR TP ISK. Analyzed the data: TP HM FIB MM. Wrote the paper: TP HM FIB MM. |
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| References | 21570476 - Drug Discov Today. 2011 Jul;16(13-14):600-8 18853438 - Hepatology. 2008 Nov;48(5):1680-9 11069443 - Br J Clin Pharmacol. 2000 Nov;50(5):479-84 17909388 - Med Care. 2007 Oct;45(10 Supl 2):S81-8 9555760 - JAMA. 1998 Apr 15;279(15):1200-5 15231615 - BMJ. 2004 Jul 3;329(7456):15-9 8229111 - J Clin Epidemiol. 1993 Nov;46(11):1331-6 18392678 - Dig Dis Sci. 2008 Jul;53(7):1977-82 19834119 - Gut. 2009 Nov;58(11):1555-64 20550481 - Biomark Med. 2010 Jun;4(3):475-83 19209224 - PLoS One. 2009;4(2):e4439 19903504 - Regul Toxicol Pharmacol. 2010 Apr;56(3):237-46 2785079 - Hepatology. 1989 May;9(5):679-85 9002493 - JAMA. 1997 Jan 22-29;277(4):307-11 20648003 - Am J Gastroenterol. 2010 Nov;105(11):2396-404 21539883 - Regul Toxicol Pharmacol. 2011 Aug;60(3):290-5 9581673 - Hepatology. 1998 May;27(5):1213-9 9517375 - Br J Clin Pharmacol. 1998 Mar;45(3):301-8 21619706 - BMC Health Serv Res. 2011;11:134 21963520 - J Hepatol. 2012 Feb;56(2):305-7 15726344 - Eur J Clin Pharmacol. 2005 Apr;61(2):135-43 |
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| Snippet | Identification of drug-induced liver disease (DILI) is difficult, even among hospitalized patients. The aim of this pilot study was to assess the impact of a... Objective Identification of drug-induced liver disease (DILI) is difficult, even among hospitalized patients. The aim of this pilot study was to assess the... Objective Identification of drug-induced liver disease (DILI) is difficult, even among hospitalized patients. The aim of this pilot study was to assess the... |
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| SubjectTerms | Adolescent Adult Aged Aged, 80 and over Alanine Transaminase - biosynthesis Alanine Transaminase - blood Algorithms Biomarkers Chemical and Drug Induced Liver Injury - diagnosis Chemical and Drug Induced Liver Injury - metabolism Cohort analysis Cohort Studies Comparative analysis Consortia Curie, Marie (1867-1934) Diagnostic systems Female Gastroenterology - methods Hepatitis Hepatology Hospital patients Hospitals Humans Informed consent Internal medicine Laboratories Liver Liver diseases Male Medical screening Medicine Middle Aged Necrosis Neurology Odds Ratio Patients Pharmaceutical industry Pilot Projects Prospective Studies Strategy |
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| Title | Real time identification of drug-induced liver injury (DILI) through daily screening of ALT results: a prospective pilot cohort study |
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