A review of the appropriate and inappropriate use of dronedarone: Lessons learned from controlled studies and regulatory submission

Journal of Cardiovascular Pharmacology and Therapeutics

Volumn 15, Issue 4 SUPPL., 2010, Pages

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

^a PENN STATE COLLEGE OF MEDICINE   (United States)

Author keywords

antiarrhythmic drugs; congestive heart failure; dronedarone

Indexed keywords

DILTIAZEM; DOFETILIDE; DRONEDARONE; METOPROLOL; SOTALOL; VERAPAMIL; AMIODARONE; CREATININE; DIGOXIN; PIPERANOMETOZINE; PLACEBO; SIMVASTATIN; WARFARIN;

BRADYCARDIA; CARDIAC PATIENT; CARDIOVASCULAR RISK; DIARRHEA; DRUG EFFICACY; DRUG MEGADOSE; DRUG SAFETY; DRUG USE; DRUG WITHDRAWAL; HEART ATRIUM FIBRILLATION; HEART ATRIUM FLUTTER; HEART LEFT VENTRICLE EJECTION FRACTION; HUMAN; NAUSEA; PHARMACODYNAMICS; PRIORITY JOURNAL; QT INTERVAL; QT PROLONGATION; REVIEW; SINUS RHYTHM; ANTIARRHYTHMIC ACTIVITY; ANTIHYPERTENSIVE ACTIVITY; ARTICLE; ATRIAL FIBRILLATION; CREATININE BLOOD LEVEL; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG COMPETITION; DRUG CONTRAINDICATION; DRUG EFFECT; DRUG ELIMINATION; DRUG HALF LIFE; DRUG MECHANISM; DRUG METABOLISM; DRUG STRUCTURE; FIBROSING ALVEOLITIS; FOOD; FOOD DRUG INTERACTION; GASTROINTESTINAL DISEASE; HEART FAILURE; HEART VENTRICLE TACHYCARDIA; HOSPITALIZATION; LUNG TOXICITY; MORTALITY; PATIENT SELECTION; PLEIOTROPY; PNEUMONIA; RASH; SIDE EFFECT; SLEEP DISORDER; THYROID DISEASE; TORSADE DES POINTES;

AMIODARONE; ANTI-ARRHYTHMIA AGENTS; ATRIAL FIBRILLATION; ATRIAL FLUTTER; CONTROLLED CLINICAL TRIALS AS TOPIC; HEART FAILURE; HUMANS; RECURRENCE; RISK FACTORS;

EID: 78651406988     PISSN: 10742484     EISSN: 19404034     Source Type: Journal    
DOI: 10.1177/1074248410368276     Document Type: Review

References (29)

1. Cohen M., Naccarelli GV Pathophysiology and disease progression of atrial fibrillation: importance of achieving and maintaining sinus rhythm. J Cardiovas Electrophysiol. 2008 ; 19 (8). 885-890.
2. Krahn AD, Manfreda J., Tate RB, Mathewson FA, Cuddy TE The natural history of atrial fibrillation: incidence, risk factors, and prognosis in the Manitoba Follow-Up Study. Am J Med. 1995 ; 98 (5). 476-484.
3. Benjamin EJ, Wolf PA, D'Agostino RB, Silbershatz H., Kannel WB, Levy D. Impact of Atrial Fibrillation on the Risk of Death: the Framingham Heart Study. Circulation. 1998 ; 98 (10). 946-952.
4. Ahrq, Health Care Cost Utilization (HCUP) Survey & US Census, 2000-2006.
5. Naccarelli GV, Wolbrette DL, Khan M., et al. Old and new antiarrhythmic drugs for converting and maintaining sinus rhythm in atrial fibrillation: comparative efficacy and results of trials. Am J Cardiol. 2003 ; 91 (6A). 15D - 26D.
6. Affirm Investigators. A comparison of rate control and rhythm control in patients with atrial fibrillation. The Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) Investigators. N Engl J Med. 2002 ; 347 (23). 1825-1833.
7. Roy D., Talajic M., Nattel S., et al. Rhythm control versus rate control for atrial fibrillation and heart failure. N Engl J Med. 2008 ; 358 (25). 2667-2677.
8. Wyse DG, Slee A., Epstein AE,, et al. for the AFFIRM Investigators. Alternative endpoints for mortality in studies of patients with atrial fibrillation: the AFFIRM study experience. Heart Rhythm. 2004 ; 1 (5). 531-537.
9. Zimetbaum PJ Dronedarone for atrial fibrillation-an odyssey. N Engl J Med. 2009 ; 360 (18). 1811-1813.
10. Naccarelli GV, Wolbrette DL, Dell'Orfano JT, Patel HM, Luck JC A decade of clinical trial developments in postmyocardial infarction, congestive heart failure, and sustained ventricular tachyarrhymia patients: from CAST to AVID and beyond. J Cardiovasc Electrophysiol. 1998 ; 9 (8). 864-891.
11. Hohnloser SH, Crijns HJ, van Eickels M., et al. Effect of dronedarone on cardiovascular events in atrial fibrillation. N Engl J Med. 2009 ; 360: 668-678.
12. Fuster V., Ryden LA, Asinger RW, et al. ACC/AHA/ESC guidelines for the management of patients with atrial fibrillation: executive summary: a report of the American College of Cardiology/ American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines and Policy Conferences (Committee to Develop Guidelines for the Management of Patients With Atrial Fibrillation) developed in collaboration with the North American Society of Pacing and Electrophysiology. Circulation. 2001 ; 104 (17). 2118-2150. (Pubitemid 33028911)
13. Patel C., Kowey PR Dronedarone. Circulation. 2009 ; 120 (7). 636-644.
14. Touboul P., Brugada J., Capucci A., Crijns HJ, Edvardsson N., Hohnloser SH Dronedarone for prevention of atrial fibrillation: a dose-ranging study. Eur Heart J. 2003 ; 24 (16). 1481-1487.
15. Singh BN, Connolly SJ, Crijns HJ, et al. Dronedarone for maintainance of sinus rhythm in atrial fibrillation/or flutter. N Engl J Med. 2007 ; 357 (3). 987-999.
16. Davy JM, Herold M., Hoglund C., et al. 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 (3). 527.e1-527.e9.
17. Køber L., Torp-Pedersen C., McMurray JJ, et al. Increased mortality after dronedarone therapy for severe heart failure. N Engl J Med. 2008 ; 358 (25). 2678-2687.
18. 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 (22). 2276-2281.
19. Kowey P. Preliminary Data Show Dronedarone Safer Alternative to Amiodarone. Late-breaking Clinical Trial Session at the 25th Annual Session of the Heart Rhythm Society, San Francisco, May 2004 ; 19-22.
20. Torp-Pedersen C., Moller M., Bloch-Thomsom PE,, et al. for the Danish Investigations of Arrhythmia and Mortality on Dofetilide Study Group. Dofetilide in patients with congestive heart failure and left ventricular dysfunction. N Engl J Med. 1999 ; 341 (12). 857-865.
21. Feldman AM, Bristow MR, Parmley WW,, et al. for the Vesnarinone Study Group. Effects of vesnarinone on morbidity and mortality in patients with heart failure. N Eng J Med. 1993 ; 329 (3). 149-155.
22. Cohn J., Goldstein SO, Greenberg BH,, et al. for the Vesnarinone Trial Investigators. A dose-dependent increase in mortality with vesnarinone among patients with severe heart failure. N Engl J Med. 1998 ; 339 (25). 1810-1816.
23. Multaq [package insert] Bridgewater, NJ: Sanofi-Aventis ; 2009.
24. 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 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 (13). 1174-1180.
25. 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 (5). 677-684.
26. Lalevée N., Barrére-Lemaire S., Gautier P., Richard S. Effects of amiodarone and dronedarone on voltage-dependent sodium current in human cardiomyocytes. J Cardiovasc Electrophysiol. 2003 ; 14 (8). 885-890.
27. Varró A., Takács J., Németh M., et al. Electrophysiological effects of dronedarone (SR 33589), a noniodinated amiodarone derivative in the canine heart: comparison with amiodarone. Br J Pharmacol. 2001 ; 133 (5). 625-634.
28. Gautier P., Guillemare E., Marion A., Bertrand JP, Tourneur Y., Nisato D. Electrophysiologic characterization of dronedarone in guinea pig ventricular cells. J Cardiovasc Pharmacol. 2003 ; 41 (2). 191-202.
29. Goldschlager N., Epstein AE, Naccarelli GV, et al. A practical guide for clinicians who treat patients with amiodarone: 2007. Heart Rhythm. 2007 ; 4 (9). 1250-1259.