Dronedarone, amiodarone and other antiarrhythmic drugs, and acute liver injuries: a case-referent study
Autor: | Lamiae Grimaldi-Bensouda, Heiner Wedemeyer, Johannes Wiegand, Ansgar W. Lohse, Jacques Benichou, Michel Rossignol, Dominique Larrey, Lucien Abenhaim, Thierry Poynard, Eckart Schott, Matthias Andersen, Thomas Berg, Hans-Jörg Cordes, Helmut Diepolder, Martin Fähndrich, Andreas Geier, Uwe Göbel, Harald Grümmer, Seyed Hamid Jamali, Matthias Kahl, Thomas Krummenerl, Jan Lammertink, Peter Langmann, Ulrike Morgera, Claus Ulrich Niederau, Gregor Pelster, Mathias Plauth, Markus Reiser, Walter Rufle, Ingolf Schiefke, Thorsten Schlenker, Oliver Schwarze, Michael Schwerdtfeger, Alexander Seelhoff, Ulrich Spengler, Matthias Strohbach, Johannes Tebbe, Thomas Thomsen, Oliver Treml, Andreas von Aretin, Manfred Wiese, Ullrich Wruck |
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Přispěvatelé: | London School of Hygiene and Tropical Medicine (LSHTM), Hannover Medical School [Hannover] (MHH), University Hospital Leipzig, Universitaetsklinikum Hamburg-Eppendorf = University Medical Center Hamburg-Eppendorf [Hamburg] (UKE), Unité de biostatistiques [CHU Rouen], Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-CHU Rouen, Normandie Université (NU), McGill University = Université McGill [Montréal, Canada], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Cellules Souches, Plasticité Cellulaire, Médecine Régénératrice et Immunothérapies (IRMB), Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Institute of cardiometabolism and nutrition (ICAN), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), Charité - UniversitätsMedizin = Charité - University Hospital [Berlin], Leipzig University, University Hospital of Würzburg, This study received an unrestricted grant from Sanofi. The funderhad no role in study design, data collection and analysis, decision topublish, or preparation of the manuscript. |
Rok vydání: | 2017 |
Předmět: |
Male
medicine.medical_specialty Medizin Amiodarone 030204 cardiovascular system & hematology Logistic regression MESH: Chemical and Drug Induced Liver Injury Class iii antiarrhythmic Cohort Studies 03 medical and health sciences 0302 clinical medicine [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system Internal medicine Acute liver injury Medicine Humans In patient 030212 general & internal medicine Case-referent Medical prescription MESH: Cohort Studies Dronedarone Aged MESH: Aged MESH: Middle Aged MESH: Humans business.industry MESH: Amiodarone MESH: Dronedarone Odds ratio Drug-induced Middle Aged MESH: Case-Control Studies MESH: Male Antiarrhythmic drugs 3. Good health Case-Control Studies Disease risk Female MESH: Anti-Arrhythmia Agents Chemical and Drug Induced Liver Injury Cardiology and Cardiovascular Medicine business MESH: Female Anti-Arrhythmia Agents medicine.drug |
Zdroj: | International Journal of Cardiology International Journal of Cardiology, Elsevier, 2018, 266, pp.100-105. ⟨10.1016/j.ijcard.2018.04.007⟩ |
ISSN: | 1874-1754 0167-5273 |
Popis: | Background Spontaneous reports of acute liver injuries (ALI) in patients taking dronedarone triggered an EMA alert in 2011. This study aimed to assess the risk of ALI for class III antiarrhythmic drugs controlling for the use of other potential ALI-inducing drugs. Methods Between 2010 and 2014, consecutive ALI cases (≥50 years-old) were identified across Germany. ALI was defined as a new increase in at least one of the transaminases ≥3 times the upper limit of normal (ULN) or ≥2 ULN if alkaline phosphatase, with (“definite” case) or without (“biochemical” case) suggestive signs/symptoms of ALI, excluding other liver diseases. Recruited community controls were matched to cases on gender, age and inclusion date. Exposure to antiarrhythmic drugs and co-medication up to 2 years before ALI onset was informed by patients and confirmed by physicians' prescriptions. Adjusted Odds Ratios (aOR) were obtained from conditional multivariable logistic regressions, adjusted for a multivariate disease risk score and co-medication. Results 252 cases and 1081 matched controls were included (59.1% females; mean age: 64 years). Exposure to class III antiarrhythmic drugs was 4.0% in cases and 1.5% in controls, aOR = 3.6 (95% CI: 1.6–8.4). Associations with exposure to dronedarone and amiodarone were respectively 3.1 (95% CI: 0.7–14. 8) and 5.90 (1.7–20.0). Restricting the analysis to definite or severe ALI cases did not change these results. Conclusions Class III antiarrhythmic drugs were associated with ALI, amiodarone displaying the highest risk, and results were robust to case definitions. Continued vigilance is needed for patients taking these drugs. |
Databáze: | OpenAIRE |
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