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Drug Safety Evaluations

Drug safety evaluation of dronedarone in atrial fibrillation

, MD & , MD
Pages 1023-1045 | Published online: 13 Sep 2012

Bibliography

  • Quaglino D, Ha HR, Duner E, Effects of metabolites and analogs of amiodarone on alveolar macrophages: structure-activity relationship. Am J Physiol Lung Cell Mol Physiol 2004;287:L438-47
  • MULTAQ® (DRONEDARONE). Briefing Document. Advisory Committee Meeting of the Cardiovascular and Renal Drugs Division of the US Food. and Drug Administration, March 18, 2009. Available from: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/CardiovascularandRenalDrugsAdvisoryCommittee/UCM134981.pdf [Accessed 10 October 2011]
  • Kathofer S, Thomas D, Karle CA. The novel drug dronedarone: comparison with amiodarone. Cardiovasc Drug Rev 2005;23:217-30
  • Tschuppert Y, Buclin T, Rothuizen LE, Effect of dronedarone on renal function in healthy subjects. Br J Clin Pharmacol 2007;64:785-91
  • Touboul P, Brugada J, Capucci A, Dronedarone for prevention of atrial fibrillation: a dose-ranging study. Eur Heart J 2003;24:1481-7
  • Singh BN, Connolly SJ, Crijns HJJ, Dronedarone for maintenance of sinus rhythm in atrial fibrillation or flutter. N Engl J Med 2007;357:987-99
  • Davy JM, Herold M, Hoglund C, Dronedarone for the control of ventricular rate in permanent atrial fibrillation: the Efficacy and safety of dronedarone for the control of ventricular rate during atrial fibrillation (ERATO) study. Am Heart J 2008;156:527; e1-9
  • Køber L, Torp-Pedersen C, McMurray JJ, Dronedarone study group. Increased mortality after dronedarone therapy for severe heart failure. N Engl J Med 2008;358:2678-87
  • Hohnloser SH, Connolly SJ, Crijns HJJ, Rationale and design of ATHENA: A placebo-controlled, doubleblind, parallel arm trial to assess the efficacy of dronedarone 400 mg bid for the prevention of cardiovascular hospitalization or death from any cause in patients with atrial fibrillation/atrial flutter. J Cardiovasc Electrophysiol 2008;19:69-73
  • Hohnloser SH, Crijns HJJ, van Eickels M, Effect of dronedarone on cardiovascular events in atrial fibrillation. N Engl J Med 2009;360:668-78
  • Connolly SJ, Crijns HJJ, Torp-Pedersen C, Analysis of stroke in ATHENA: a placebo-controlled, double-blind, parallel-arm trial to assess the efficacy of dronedarone 400 mg BID for the prevention of cardiovascular hospitalization or death from any cause in patients with atrial fibrillation/atrial flutter. Circulation 2009;120:1174-80
  • Hohnloser SH, Crijns HJJ, van Eickels M, Dronedarone in patients with congestive heart failure: insights from ATHENA. Eur Heart J 2010;31:1717-21
  • Le Heuzey JY, De Ferrari GM, Radzik D, A short-term, randomized, double-blind, parallel-group study to evaluate the efficacy and safety of dronedarone versus amiodarone in patients with persistent atrial fibrillation: the DIONYSOS study. J Cardiovasc Electrophysiol 2010;21:597-605
  • National Institute for health and Clinical Excellence: appraisal consultation document dronedarone for the treatment of atrial fibrillation. Available from: http://www.nice.org.uk/guidance/index.jsp?action=article&o=46768 [Accessed 12 January 2011]
  • National Institute for health and Clinical Excellence : atrial fibrillation - dronedarone: final appraisal determination. 16 July 2010. Available from: http://www.nice.org.uk/nicemedia/live/11750/49792/49792.pdf [Accessed 12 January 2011]
  • Kowey PR, Singh BN, Connolly SJ, Impact of dronedarone started rapidly after amiodarone discontinuation. J Am Coll Cardiol 2010;55:A1; E3
  • SDI, Vector One®: National (VONA) and Total Patient Tracker (TPT). July 2009 – June 2011. Extracted 18 July 2011
  • Moore TJ, Singh S, Furberg CD. The FDA and new safety warnings. Arch Intern Med 2012;172:78-80
  • The Institute for Safe Medication Practices. QuarterWatch: 2010 Quarter 1. Signals for Acetaminophen, dronedarone and Botulinum Toxin Products. Available from: http://www.ismp.org/quarterwatch/2010Q1.pdf [Accessed 12 February 2012]
  • The Institute for Safe Medication Practices. QuarterWatch: 2010 Quarter 2. Signals for Signals for Varenicline, Levofloxacin and Fentanyl. Available from: http://www.ismp.org/quarterwatch/2010Q2.pdf [Accessed 12 February 2012]
  • Joghetaei N, Weirich G, Huber W, Acute liver failure associated with dronedarone. Circ Arrhythm Electrophysiol 2011;4:592-3
  • Food and Drug Administration. FDA Drug Safety Communication: severe liver injury associated with the use of dronedarone (marketed as Multaq). Available from: http://www.fda.gov/Drugs/DrugSafety/ucm240011.htm [Accessed 23 March 2012]
  • European Medicine Agency: assessment report for MULTAQ. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Assessment_Report_-Variation/human/001043/WC500121610.pdf [Accessed 12 February 2012]
  • Reiffel JA. An important drug interaction between dronedarone and warfarin that may be extrapolated to other drugs that can alter gastrointestinal function. Am Heart J 2011;161:e5
  • Pogge EK, Haber SL. Elevated international normalized ratio associated with use of dronedarone and warfarin. Ann Pharmacother 2011;45:e46
  • Food and Drug Administration. Labeling revision: highlights of prescribing information (Multaq). Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022425s002lbl.pdf [Accessed 17 January 2012]
  • Siu CW, Wong Mp, Ho CM, fatal lung toxic effects related to dronedarone use. Arch Intern Med 2012;172:516-17
  • Connolly SJ, Camm AJ, Halperin JL, Dronedarone in high-risk permanent atrial fibrillation. N Engl J Med 2011;365:2268-76
  • Camm AJ, Kirchhof P, Lip GY, Guidelines for the management of atrial fibrillation: the task force for the management of atrial fibrillation of the European Society of Cardiology (ESC). Eur Heart J 2010;31:2369-429
  • Gautier P, Guillemare E, Marion A, Electrophysiologic characterization of dronedarone in guinea pig ventricular cells. J Cardiovasc Pharmacol 2003;41:191-202
  • Pantos C, Dritsas A, Mourouzis I, Thyroid hormone is a critical determinant of myocardial performance in patients with heart failure: potential therapeutic implications. Eur J Endocrinol 2007;157:515-20
  • Pantos C, Mourouzis I, Xinaris C, Thyroid hormone and ‘cardiac metamorphosis': potential therapeutic implications. Pharmacol Ther 2008;118:277-94
  • Dagres N, Varounis C, Iliodromitis EK, Dronedarone and the incidence of stroke in patients with paroxysmal or persistent atrial fibrillation: a systematic review and meta-analysis of randomized trials. Am J Cardiovasc Drugs 2011;11(6):395-400
  • Heusch G, Schulz R. Pleiotropic effects of dronedarone on ischemia/reperfusion Injury in heart and brain. Cardiovasc Drugs Ther 2012; Epub ahead of print
  • Hodeige D, Heyndrickx JP, Chatelain P, SR 33589, a new amiodarone-like antiarrhythmic agent: anti-adrenoceptor activity in anesthetized and conscious dogs. Eur J Pharmacol 1995;279:25-32
  • Engelhorn T, Schwarz MA, Heush G, Reduction of cerebral infarct size by dronedarone. Cardiovasc Drugs Ther 2011;25:523-9
  • Skyschally A, Heusch G. Reduction of myocardial infarct size by dronedarone in pigs-a pleiotropic action? Cardiovasc Drugs Ther 2011;25:197-201
  • Chirinos JA, Castrellon A, Zambrano JP, Digoxin use is associated with increased platelet and endothelial cell activation in patients with nonvalvular atrial fibrillation. Heart Rhythm 2005;2:525-9
  • Naccarelli G, Wolbrette D, Levin V, Safety and efficacy of dronedarone in the treatment of atrial fibrillation/flutter. Clin Med Insights Cardiol 2011;5:103-19
  • Burashnikov A, Sicouri S, Di Diego JM, Synergistic effect of the combination of ranolazine and dronedarone to suppress atrial fibrillation. J Am Coll Cardiol 2010;56:1216-24
  • Guillemare E, Marion A, Nisato D, Gautier P. Inhibitory effects of dronedarone on muscarinic K+ current in guinea pig atrial cells. J Cardiovasc Pharmacol 2000;36:802-5
  • Manning AS, Bruynickx C, Ramboux J, SR 33589, a New amiodarone-like agent: effect on ischemia- and reperfusion-induced arrhythmias in anesthetized rats. J Cardiovasc Pharmacol 1995;26:453-61
  • Rochetaing A, Barbé C, Kreher P. Beneficial effects of amiodarone and dronedarone (SR33589b), when applied during low-flow ischemia, on arrhythmia and functional parameters assessed during reperfusion in isolated rat hearts. J Cardiovasc Pharmacol 2001;38:500-11
  • Finance O, Manning A, Chatelain P. Effects of a new amiodarone-like agent, SR 33589, in comparison to amiodarone, D, L-sotalol, and lignocaine, on ischemia-induced ventricular arrhythmias in anesthetized pigs. J Cardiovasc Pharmacol 1995;26:570-6
  • Duray GZ, Torp-Pedersen C, Connolly SJ, Hohnloser SH. Effects of dronedarone on clinical outcomes in patients with lone atrial fibrillation: pooled post hoc analysis from the ATHENA/EURIDIS/ADONIS studies. J Cardiovasc Electrophysiol 2011;7:770-6
  • Wolbrette D, Gonzalez M, Samii S, Dronedarone for the treatment of atrial fibrillation and atrial flutter: approval and efficacy. Vasc Health Risk Manag 2010;6:517-23
  • Damy T, Pousset F, Caplain H, Pharmacokinetic and pharmacodynamic interactions between metoprolol and dronedarone in extensive and poor CYP2D6 metabolizers healthy subjects. Fundam Clin Pharmacol 2004;18:113-23
  • Tichy EM, Medwid AJ, Mills EA, Significant sirolimus and dronedarone interaction in a kidney transplant recipient. Ann Pharmacother 2010;44:1338-41

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