Safety and efficacy of dronedarone in the treatment of atrial fibrillation/flutter

Clinical Medicine Insights: Cardiology

Volumn 5, Issue , 2011, Pages 103-119

  Naccarelli, Gerald V ^a   Wolbrette, Deborah L ^a   Levin, Vadim ^b   Samii, Soraya ^a   Banchs, Javier E ^a   Penny Peterson, Erica ^a   Gonzalez, Mario D ^a  

^a PENN STATE COLLEGE OF MEDICINE   (United States)

^b Lehigh valley Hospital Electrophysiology Laboratory   (United States)

Author keywords

Amiodarone; Atrial fbrillation; Dronedarone

Indexed keywords

AMIODARONE; ANGIOTENSIN RECEPTOR ANTAGONIST; ANTICOAGULANT AGENT; ATORVASTATIN; CALCIUM CHANNEL BLOCKING AGENT; CALCIUM CHANNEL L TYPE; CYTOCHROME P450 2C9; CYTOCHROME P450 2D6; CYTOCHROME P450 3A4; CYTOCHROME P450 INHIBITOR; DABIGATRAN; DIGOXIN; DILTIAZEM; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; DRONEDARONE; DRUG METABOLITE; LIDOCAINE; METOPROLOL; PLACEBO; PRAVASTATIN; RANOLAZINE; ROSUVASTATIN; SIMVASTATIN; SODIUM CHANNEL; SOTALOL; VERAPAMIL; WARFARIN;

ACUTE CORONARY SYNDROME; ACUTE HEART FAILURE; ANTIARRHYTHMIC ACTIVITY; BETA ADRENERGIC RECEPTOR BLOCKING; BLEEDING; BRADYCARDIA; BRAIN HEMORRHAGE; BRAIN ISCHEMIA; CARDIOVERSION; CONGESTIVE HEART FAILURE; CREATININE BLOOD LEVEL; DEFIBRILLATOR; DIARRHEA; DISTRIBUTION VOLUME; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CONTRAINDICATION; DRUG DOSE COMPARISON; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG EXCRETION; DRUG FATALITY; DRUG HALF LIFE; DRUG INDICATION; DRUG METABOLISM; DRUG MONITORING; DRUG POTENCY; DRUG PROTEIN BINDING; DRUG SAFETY; DRUG STRUCTURE; DRUG TOLERABILITY; DRUG WITHDRAWAL; EYE TOXICITY; FIRST PASS EFFECT; FOOD; FOOD DRUG INTERACTION; GASTROINTESTINAL SYMPTOM; HEART ARREST; HEART ARRHYTHMIA; HEART ATRIOVENTRICULAR NODE; HEART ATRIUM FIBRILLATION; HEART ATRIUM FLUTTER; HEART ELECTROPHYSIOLOGY; HEART REPOLARIZATION; HEART VENTRICLE ARRHYTHMIA; HEART VENTRICLE FIBRILLATION; HEMOGLOBIN BLOOD LEVEL; HIGH RISK PATIENT; HOSPITALIZATION; HUMAN; HYPERTHYROIDISM; INTERNATIONAL NORMALIZED RATIO; INTERSTITIAL LUNG DISEASE; LIPID DIET; LIVER DYSFUNCTION; LIVER FUNCTION TEST; LIVER TOXICITY; LOW DRUG DOSE; LUNG TOXICITY; MORTALITY; NAUSEA; NEUROTOXICITY; NONHUMAN; PNEUMONIA; POTASSIUM CURRENT; QT INTERVAL; QT PROLONGATION; RECOMMENDED DRUG DOSE; RECURRENCE RISK; REVIEW; RISK REDUCTION; SIDE EFFECT; SKIN TOXICITY; SODIUM CURRENT; STROKE; SYNCOPE; SYSTOLIC BLOOD PRESSURE; TACHYCARDIA; TERATOGENICITY; THYROID DISEASE; TORSADE DES POINTES; TRANSIENT ISCHEMIC ATTACK; VASODILATATION;

EID: 84855287667     PISSN: 11795468     EISSN: 11795468     Source Type: Journal    
DOI: 10.4137/CMC.S6677     Document Type: Review

References (65)

1. Hodeige D, Heyndrickx JP, Chatelain P, Manning A. SR33589, a new amiodarone-like anti-arrhythmic agent: anti-adrenoceptor activity in anesthetized and conscious dogs. Eur J Pharmacol. 1995;279:25-32.
2. Hynes J, Wolbrette DL, Luck JC, Khan M, Samii S, Naccarelli G V. A review of the pharmacokinetics, electrophysiology and clinical effcacy of dronedarone. Future Cardiology. 2005;2(1):135-144.
3. Wegener FT, Ehrlich JR, Hohnloser SH. Dronedarone: An emerging agent with rhythm- and rate-controlling effects. J Cardiovasc Electrophysiol. 2006;17:S17-20.
4. Zareba KM. Dronedarone: a new antiarrhythmic agent. Drugs Today. 2006; 42:75-86.
5. Patel C, Yan GX, Kowey PR. New drugs and technology: Dronedarone. Circulation. 2009;120:636-44.
6. Zimetbaum PJ. Dronedarone for atrial fbrillation-an odyssey. N Engl J Med. 2009;360:1811-3.
7. Wolbrette D, Gonzalez M, Samii S, Banchs J, Penny-Peterson E, Naccarelli G. Dronedarone for the treatment of atrial fbrillation and futter: approval and effcacy. Vasc Health Risk Management. 2010;6:517-23.
8. Patel DP, Bhuriya R, Patel DD, Singh PP, Arora RR. Dronedarone for atrial fbrillation: A new therapeutic agent. Vasc Health Risk Management. 2009; 5:635-42.
9. Dreskovich CD, O'Dell KM. Dronedarone for atrial fbrillation: An update of clinical evidence. Formulary. 2010;45:275-83.
10. Camm AJ, Savelieva I. Dronedarone: a new option in atrial fbrillation. Future Prescriber. 2009;10:24-32.
11. Manning A, Thisse V, Hodeige D, et al. SR33589, a new Amiodarone-like Antiarrhythmic Agent: Electrophysiological Effects in Anesthetized Dogs. J Cardiovasc Pharmacol. 2000;25:252-61.
12. Sun W, Sarma JS, Singh BN. Electrophysiological Effects of Dronedarone (SR33589), a Noniodinated Benzofuran Derivative, in the Rabbit Heart. Comparison with Amiodarone. Circulation. 1999;100:2276-81.
13. Sun W, Sarma JS, Singh BN: Chronic and Acute Effects of Dronedarone on the Action Potential of Rabbit Atrial Muscle Preparations: Comparison with Amiodarone. J Cardiovasc Pharmacol. 2002;39:677-84.
14. Varró A, Takács J, Németh M, et al. Electrophysiological effects of drone-darone (SR33589), a noniodinated amiodarone derivative in the canine heart: comparison with amiodarone. Br J Pharmacol. 2001;133:625-34.
15. Gautier P, Guillemare E, Marion A, et al. Electrophysiologic Characterization of Dronedarone in Guinea Pig Ventricular Cells. J Cardiovasc Pharmacol. 2003;41:191-202.
16. + Current in Guinea Pig Atrial Cells. J Cardiovasc Pharmacol. 2000;36:802-5.
17. Altomare C, Barbuti A, Viscomi C, et al. Effects of dronedarone on Acetylcholine-activated current in rabbit SAN cells. Br J Pharmacol. 2000;130:1315-20.
18. Rocchetti M, Bertrand JP, Nisato D, et al. Cellular electrophysiological study of dronedarone, a new amiodarone-like agent, in Guinea pig sinoatrial node. Nauyn Schmiedebergs Arch Pharmacol. 1998;358(1 Suppl 2):R617.
19. + current, HERG and KvLQT1/minK potassium channels. Br J Pharmacol. 2003;140:996-1002.
20. Hodeige D, Heyndrickx JP, Chatelain P, Manning A. SR33589, a new amiodarone-like antiarrhythmic agent: anti-adrenoceptor activity in anaesthetized and conscious dogs. Eur J Pharmacol. 1995;279:25-32.
21. Lalevée N, Barrére-Lemaire S, Gautier P, et al. Effects of Amiodarone and Dronedarone on Voltage-Dependent Sodium Current in Human cardiomyocytes. J Cardiovasc Electrophysiol. 2003;14:885-90.
22. Verduyn SC, Vos MA, Leunissen HD, et al. Evaluation of the Acute Electrophysiological Effects of Intravenous Dronedarone, an Amiodarone-Like Agent, with Special Emphasis on Ventricular Repolarization and Acquired Torsade de Pointes Arrhythmias. J Cardiovasc Pharmacol. 1999; 33:212-22.
23. Djandjighian L, Planchenault J, Finance O, et al. Hemodynamic and anti-adrenergic effects of dronedarone and amiodarone in animals with a healed myocardial infarction. J Cardiovasc Pharmacol. 2000;36(3):376-83.
24. Manning AS, Bruynickx C, Ramboux J, et al. SR 33589, a New Amiodarone-Like Agent: Effect on Ischemia- and Reperfusion-Induced Arrhythmias in Anesthetized Rats. J Cardiovasc Pharmacol. 1995;26:453-61.
25. Rochetaing A, Barbé C, Kreher P. Benefcial 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.
26. 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.
27. Dorian P. Clinical pharmacology of dronedarone: Implications for the therapy of atrial fbrillation. J Cardiovasc Pharm Therap. 2010;15(4S): 15S-18S.
28. Tschuppert Y, Buclin T, Rothuizen LE, et al. Effect of dronedarone on renal function in healthy subjects. Br J Clin Pharmacol. 2007;64:785-91.
29. Vallakati A, Chandra PA, Pednekar M, Frankel R, Shani J. Dronedarone-induced digoxin toxicity: New drug, new interactions. Am J Therap. 2011; E published.
30. Shirolkar SC, Fiuzat M, Becker RC. Dronedarone and vitamin K antagonists: A review of drug-drug interactions. Am Heart J. 2010;160:577-82.
31. Le Heuzey JY, De Ferrari GM, Radzik D, Santini M, Zhu J, Davy JM. A short-term, randomized, double-blind, parallel-group study to evaluate the effcacy and safety of dronedarone versus amiodarone in patients with persistent atrial fbrillation: The DIONYSOS study. J Cardiovasc Electrophysiol. 2010;21:597-605.
32. Damy T, Pousset F, Caplain H, Hulot JS, Lechat P. Pharmacokinetic and pharmacodynamic interactions between metoprolol and dronedarone in extensive and poor CYP2D6 metabolizers healthy subjects. Fundam Clin Pharmacol. 2004;18(1):113-123.
33. Touboul P, Brugada J, Capucci A, Crÿns HJ, Edvardsson N, Hohnloser SH. Dronedarone for prevention of atrial fbrillation: a dose-ranging study. Eur Heart J. 2003;24:1481-1487.
34. Singh BN, Connolly SJ, Crijns HJ, et al. Dronedarone for maintenance of sinus rhythm in atrial fbrillation or futter. N Engl J Med. 2007;357: 987-999.
35. Davy JM, Herold M, Hoglund C, et al. Dronedarone for the control of ventricular rate in permanent atrial fbrillation: The Effcacy and safety of dronedarone for the control of ventricular rate during atrial fbrillation (ERATO) study. Am Heart J. 2008;156:527-9.
36. Køber L, Torp-Pedersen C, McMurray JJ, et al. Increased mortality after dronedarone therapy for severe heart failure. N Engl J Med. 2008;358: 2678-2687.
37. Levine TB, Giles T, Radzik D, Ghali JK. Effect of dronedarone on exercise capacity and cardiac function in patients with severe left ventricular dysfunction and compensated heart failure. Cardiovasc Drugs Ther. 201;5-6: 449-458.
38. Hohnloser SH, Crijns HJGM, van Eickels M, et al; For the ATHENA Investigators. Effect of dronedarone on cardiovascular events in atrial fbrillation. N Engl J Med. 2009;360:668-678.
39. Multaq package insert. 2011.
40. Connolly SJ, Crijns HJGM, Torp-Pedersen C, et al; For the ATHENA Investigators. Analysis of stroke in ATHENA: a placebo-controlled, double-blind, parallel-arm trial to assess the effcacy of dronedarone 400 mg BID for the prevention of cardiovascular hospitalization or death from any cause in patients with atrial fbrillation/atrial futter. Circulation. 2009;120:1174-1180.
41. Christiansen CB, Torp-Pedersen C, Køber L. Impact of dronedarone in atrial fbrillation and futter on stroke reduction. Clin Intervent Age. 2010;5:63-69.
42. Mason P, Jacob RF, Kubant R, Jacoby AM, Mizuno Y, Malinski T. Dronedarone enhances rat aortic and glomerular endothelial nitric oxide release in a dose-dependent manner. J Am Collcardiol. 2011;57(15):E1431 (abstract).
43. Torp-Pedersen C, Crijns HJGM, Gaudin C, Page R, Connolly SJ, Hohnloser SH; for the ATHENA Invesitgators. Impact of dronedarone on hospitalization burden in patients with atrial fbrillation: Results from the ATHENA trial. Europace 2011: E published.
44. 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; E published.
45. Naccarelli GV. Post-ATHENA and beyond. J Intervention Card Electrophysiol. 2011;31:55-60.
46. Naccarelli GV, Johnston S, Lin J, Patel P, Schulman K. Cost Burden of cardiovascular hospitalization and mortality in ATHENA-like patients with atrial fbrillation/atrial futter in the United States. Clin Cardiol. 2010; 33(5):270-9.
47. Bauernfeind T, Erkapic D, Hohnloser SH. Innovative pharmacologic approaches to managing atrial fbrillation: The importance of reducing cardiovascular hospitalizations. J Inn Card Rhythm Manage. 2011;2: 173-7.
48. Hohnloser SH, Crijns HJGM, van Eickels M, et al; For the ATHENA Investigators. Dronedarone in patients with congestive heart failure: insights from ATHENA. Eur Heart J. 2010;31(14):1717-21.
49. Naccarelli G V, Wolbrette DL, Samii S, Banchs JE, Penny-Peterson E, Gonzalez M. Appropriate vs. Inappropriate Use of Dronedarone: Lessons Learned from Controlled Studies and Regulatory Review. J Cardiovasc Pharmacol Ther. 2010;15(4S):24S-30S.
50. AFFIRM Investigators. A comparison of rate control and rhythm control in patients with atrial fbrillation. The Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) Investigators. N Engl J Med. 2002;347:1825-33.
51. Roy D, Talajic M, Nattel S, et al. Rhythm control versus rate control for atrial fbrillation and heart failure. N Engl J Med. 2008;358:2667-77.
52. Wyse DG, Slee A, Epstein AE, et al; And AFFIRM Investigators. Alternative endpoints for mortality in studies of patients with atrial fbrillation: the AFFIRM study experience. Heart Rhythm. 2004;1:531-7.
53. Slee A, Rathod S, Saksena S. Impact of a composite outcome analysis in evaluating atrial fbrillation treatment strategies: A current reassessment of the AFFIRM study. Circulation. 2009;120:S-692.
54. Singh D, Cingolani E, Daimond GA, Kaul S. Dronedarone for atrial fbril-lation. Have we expanded the antiarrhythmic armamentarium? J Am Coll Cardiol. 2010;55:1569-76.
55. Page R, Connolly SJ, Crijns HJGM, et al. Rhythm- and rate-controlling effects of dronedarone in patients with atrial fbrillation (from the ATHENA trial). Am J Cardiol. 2011;107:1019-22.
56. Piccini JP, Hasselblad V, Peterson ED, Washam JB, Califf RM, Kong DF. Comparative effcacy of dronedarone and amiodarone for the maintenance of sinus rhythm in patients with atrial fbrillation. J Am Coll Cardiol. 2009;54:1089-95.
57. Freemantle N, Lafuente-Lafuente C, Mitchell S, Eckert L, Reynolds M. Mixed treatment comparison of dronedarone, amiodarone, sotalol, fecainide, and propafenone, for the management of atrial fbrillation. Europace. 2011;13:329-45.
58. Shukla A, Durand JB. Comparison of dronedarone and sotalol in preventing atrial fbrillation recurrence and maintaining sinus rhythm: A meta-analysis. Heart Rhythm. 2011;8(5):1547.
59. Burashnikov A, Belardinelli L, Antzelevitch C. Acute dronedarone is inferior to amiodarone in terminating and preventing atrial fbrillation in canine atria. Heart Rhythm. 2010;7(9):1273-1279. J Am Coll Cardiol. 2010;56:1216-24.
60. Burashnikov A, Sicour S, Di Diego JM, Belardinelli L, Antzelevitch C. Synergistic effect of the combination of ranolazine and dronedarone to suppress atrial fbrillation. J Am Coll Cardiol. 2010;56:1216-1224.
61. Shaaraoui M, Freudenberger R, Lavin V, Marchlinski FE. Suppression of ventricular tachycardia with dronedarone: A case report. J Cardiovasc Electrophysiol. 2011;22:201-202.
62. Aimond F, Beck L, Gauthier P, et al. Cellular and in vivo electrophysio-logic effects of dronedarone in normal and postmyocardial infarction rats. J Pharmacol Exp Ther. 2000;292:415-424.
63. FDA drug safety communication 7/21/2011.
64. Wann LS, Curtis AB, January CT, et al. 2011 ACCF/AHA/HRS focused update on the management of patients with atrial fbrillation (updating the 2006 guideline): A report of the American College of Cardiology Foundation/ American Heart Association Task Force on practice guidelines. Circulation. 2011;123:104-23.
65. Camm AJ, Kirchhof P, Lip GY, et al. Guidelines for the management of atrial fbrillation: The Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Eur Heart J. 2010;31:2369-2429.