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
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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