Pharmacokinetic and pharmacodynamic profile of dronedarone, a new antiarrhythmic agent for the treatment of atrial fibrillation

Bibliography

• Go AS, Hylek EM, Philips KA, et al. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention. The anticoagulation and risk factors in atrial fibrillation (ATRIA) Study. JAMA 2001;285:2370-5
   PubMed Web of Science ®Google Scholar
• Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation is an independent risk factor for stroke. Stroke 1991;22:983-8
   PubMed Web of Science ®Google Scholar
• Singh BN, Singh SN, Reda DJ, et al. Amiodarone versus sotalol for atrial fibrillation. N Engl J Med 2005;352:1861-72
   PubMed Web of Science ®Google Scholar
• Singh BN. Atrial fibrillation: epidemiologic considerations and rationale for conversion and maintenance of sinus rhythm. J Cardiovasc Pharmacol Ther 2003;8(Suppl 1):813-26
   Google Scholar
• Hodeige D, Heynfricks JP, Chatelain P, et al. SR 33589: a new amiodarone-like antiarrhythmic agent. Antiadrenoceptor activity in anaesthetized and conscious dogs. Eur J Pharmacol 1995;279:25-32
   PubMed Web of Science ®Google Scholar
• Heijman J, Heusch G, Dobrev D. Pleiotropic effects of antiaarhythmic agents: dronedarone in the treatment of atrial fibrillation. Clin Med Insights Cardiol 2013;7:127-40
   PubMedGoogle Scholar
• Piccini YP, Hasselblad W, Peterson ED, et al. Comparative efficacy of dronedarone and amiodarone for the maintenance of sinus rhythm in patients with atrial fibrillation. J Am Coll Cardiol 2009;54:1089-95
   PubMed Web of Science ®Google Scholar
• Touboul P, Brugada J, Cappucci A, et al. Dronedarone for prevention of atrial fibrillation: a dose-ranging study. Eur Heart J 2003;24:1481-7
   PubMed Web of Science ®Google Scholar
• Patel C, Yan GX, Kowey PR. Dronedarone. Circulation 2009;120(7):636-44
   PubMed Web of Science ®Google Scholar
• Damy T, Pousset F, Caplain H, et al. Pharmacokinetic and pharmacodynamic interactions between metoprolol and dronedarone in extensive and poor CYP2D6 metabolizers healthy subjects. Fundam Clin Pharmacol 2004;18:113-23
   PubMed Web of Science ®Google Scholar
• Multaq [package insert]. Sanofi-aventis U.S; Bridgewater, NJ: 2011
   Google Scholar
• Gandhi PK, Gentry WM, Bottorff MB. Dabigatran-dronedarone interaction in a spontaneous reporting system. J Am Pharm Assoc 2013;53(4):414-19
   Google Scholar
• Heidbuchel H, Verhamme P, Alings M, et al. EHRA Practical Guide on the use of new oral anticoagulants in patients with non-valvular atrial fibrillation: executive summary. Eur Heart J 2013;34(27):2094-106
   PubMed Web of Science ®Google Scholar
• Walenga JM, Adiguzel C. Drug and dietary interactions of the new and emerging oral anticoagulants. Int J Clin Pract 2010;64:956-67
   PubMed Web of Science ®Google Scholar
• Mendell J, Zahir H, Matsushima N, et al. Drug-drug interaction studies of cardiovascular drug involving P.glycoprotein, an efflux transporter, on the pharmacokinetics of edoxaban, an oral factor Xa inhibitor. Am J Cardiovasc Drugs 2013;13(5):331-42
   PubMed Web of Science ®Google Scholar
• Gautier P, Marion A, Bertrand J, et al. Electrophysiological characteristics of dronedarone (SR 33589), a new amiodarone-like agent, in cardiac ventricular myocytes. Eur Heart J 1997;18(Suppl):269
   Google Scholar
• Manning A, Thisse V, Hodeige D, et al. SR 33589, a new amiodarone-like antiarrhytmic agent: electrophysiological effects in anesthetized dogs. J Cardiovasc Pharmacol 1995;25:252-61
   PubMed Web of Science ®Google Scholar
• Heijman J, Voigt N, Dobrev D. New directions in antiarrhythmic drug therapy for atrial fibrillation. Future Cardiol 2013;9(1):71-88
   PubMedGoogle Scholar
• Wakili R, Voigt N, Kaab S, et al. Recent advances in the molecular pathophysiology of atrial fibrillation. J Clin Invest 2011;121(8):2955-68
   PubMed Web of Science ®Google Scholar
• Dobrev D, Friedrich A, Voigt N, et al. The G protein-gated potassium current IK. ACh is constitutively active in patients with chronic atrial fibrillation. Circulation 2005;112(24):3697-706
   PubMed Web of Science ®Google Scholar
• Pandit SV, Berenfeld O, Anumonwo JM, et al. Ionic determinants of functional reentry in a 2-D model of human atrial cells during simulated chronic atrial fibrillation. Biophys J 2005;88(6):3806-21
   PubMed Web of Science ®Google Scholar
• Wolbrette D, Gonzales M, Samii S, et al. Dronedarone for the treatment of atrial fibrillation and atrial flutter: approval and efficacy. Vasc Health Risk Manag 2010;6:517-23
   PubMedGoogle Scholar
• Schmidt C, Wiedmann F, Schweizer PA, et al. Novel electrophysiological properties of dronedarone: inhibition of human cardiac two-pore-domain potassium channels. Naunyn Schmiedebergs Arch Pharmacol 2012;385(10):1003-16
   PubMed Web of Science ®Google Scholar
• Echt DS, Liebson PR, Mitchell LB, et al. The CAST Investigators. Mortality and morbidity in patients receiving encainide, flecainide, or placebo. The Cardiac Arrhythmia Suppression Trial. N Engl J Med 1991;324:781-8
   PubMed Web of Science ®Google Scholar
• Dobrev D, Carlsson L, Nattel S. Novel molecular targets for atrial fibrillation therapy. Nat Rev Drug Discov 2012;11(4):275-91
   PubMed Web of Science ®Google Scholar
• van Opstal JM, Schoenmakers M, Verduyn SC, et al. Chronic amiodarone evokes no torsade de pointes arrhythmias despite QT lengthening in an animal model of acquired long-QT syndrome. Circulation 2001;104(22):2722-7
   PubMed Web of Science ®Google Scholar
• Bauman JL. Torsade de pointes due to dronedarone: deja vu? Pharmacotherapy 2012;32(8):764-6
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Mason PK, DiMarco JP. New pharmacological agents for arrhythmias. Circ Arrhythm Electrophysiol 2009;2(5):588-97
   PubMed Web of Science ®Google Scholar
• Sobrado LF, Varone BB, Machado AD, et al. Dronedarone’s inhibition of if current is the primary mechanism responsible for its bradycardic effect. J Cardiovasc Electrophysiol 2013;24(8):914-18
   PubMed Web of Science ®Google Scholar
• Verrier RL, Sobrado MF, Pagotto VP, et al. Inhibition of I(f) in the atrioventricular node as a mechanism for dronedarone’s reduction in ventricular rate during atrial fibrillation. Heart Rhythm 2013;10(11):1692-7
   PubMed Web of Science ®Google Scholar
• Mason P, Jacob RF, Kubant R, et al. Dronedarone enhances rat aortic and glomerular endothelial nitric oxide release in a dose dependent manner. J Am Coll Cardiol 2011;57E:431
   Google Scholar
• Kathofer S, Thomas D, Karle CA. The novel drug dronedarone: comparison with amiodarone. Cardiovasc Drug Rev 2005;23:217-30
   PubMed Web of Science ®Google Scholar
• Pisters R, Hohnloser SH, Connolly SJ, et al. Effect of dronedarone on clinical end points in patients with atrial fibrillation and coronary heart disease: insight from the ATHENA trial. Europace 2014;16(2):174-81
   PubMed Web of Science ®Google Scholar
• Benaim G, Paniz Mondolfi AE. The emerging role of amiodarone and dronedarone in Chagas disease. Nat Rev Cardiol 2012;9(10):605-9
   PubMed Web of Science ®Google Scholar
• Benaim G, Hernandez-Rodriguez V, Mujica-Gonzalez S, et al. In vitro anti-Trypanosoma cruzi activity of dronedarone, a novel amiodarone derivative with an improved safety profile. Antimicrob Agents Chemother 2012;56(7):3720-5
   PubMed Web of Science ®Google Scholar
• Parvez B, Vaglio J, Rowan S, et al. Symptomatic response to antiarrythmic drug theraphy is modulated by a common single nucleotide polymorphism in atrial fibrillation. J Am Coll Cardiol 2012;60(6):539-45
   PubMed Web of Science ®Google Scholar
• Jamshidi Y, Nolte IM, Dalageorgou C, et al. Common variation in the NOSIAP gene is associated with drug-induced QT prolungation and ventricular arrhythmia. J Am Coll Cardiol 2012;60(9):841-50
   PubMed Web of Science ®Google Scholar
• Singh BN, Connolly SJ, Crijns HJ, et al. Dronedarone for maintenance of sinus rhythm in atrial fibrillation or flutter. N Engl J Med 2007;357(10):987-99
   PubMed Web of Science ®Google Scholar
• Hohnloser SH, Crijns HJ, van Eickels M, et al. for the ATHENA Investigators. Effect of dronedarone on cardiovascular events in atrial fibrillation. N Engl J Med 2009;360(7):668-78
   PubMed Web of Science ®Google Scholar
• Kober L, Torp-Pedersen C, McMurray JJ, et al. for the Dronedarone Study Group. Increased mortality after dronedarone therapy for severe heart failure. N Engl J Med 2008;358(25):2678-87
   PubMed Web of Science ®Google Scholar
• Tschuppert Y, Buclin T, Rothizen LE, et al. Effect of dronedarone on renal function in healthy subjects. Br J Clin Pharmacol 2007;64:785-91
   PubMed Web of Science ®Google Scholar
• Bongard V, Marc D, Philippe V, et al. Incidence rate of adverse drug reactions during long- term follow-up of patients newly treated with amiodarone. Am J Ther 2006;13:315-19
   PubMedGoogle Scholar
• Connolly SJ, Crijns JHGM, Torp-Pedersen C, et al. 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
   PubMed Web of Science ®Google Scholar
• Reynolds MR, Nilsson J, Akeborg O, et al. Cost-effectiveness of dronedarone and standard of care compared with standard of care alone: US results of an Athena lifetime model. Clinicoecon Outcomes Res 2013;5:19-28
   Google Scholar
• Le Heuzey JY, De Ferrari GM, Radzik D, et al. 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(6):597-604
   PubMed Web of Science ®Google Scholar
• Naccarelli GV. Appropriate and inappropriate use of dronedarone in 2013. Curr Treat Options Cardiovasc Med 2013;15:467-75
   PubMedGoogle Scholar
• Davy JM, Herold M, Hoglund K, 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.e1-9
   PubMedGoogle Scholar
• Connolly SJ, Camm AJ, Halperin JL, et al. Dronedarone in high-risk permanent atrial fibrillation. N Engl J Med 2011;365:2268-76
   PubMed Web of Science ®Google Scholar
• Anderson JL, Halperin JL, Albert NM, et al. Management of patients with atrial fibrillation (compilation of 2006 ACCF/AHA/ESC and 2011 ACCF/AHA/HRS guideline recommendations: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 2013;61:1935-44
   PubMed Web of Science ®Google Scholar
• Camm AJ, Lip GY, De Caterina R, et al. ESC Committee for Practice Guidelines (CPG). 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation. Eur Heart J 2012;32(21):2719-47
   Google Scholar
• U.S. Food and drug administration Multaq (dronedarone): Drug safety communication-Increased risk of death or serious cardiovascular events. Available from: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm264204.htm. [Accessed 24 September 2013]
   Google Scholar
• Ezekowitz M, Di Marco J, Kaszala K, et al. HESTIA, the effects of dronedarone on atrial fibrillation burden in subjects with permanent pacemaker. Circulation 2012;126:A15020
   Google Scholar
• Burashnikov A, Belardinelli L, Antzelevitch C. Acute dronedarone is inferior to amiodarone in terminating and preventing atrial fibrillation in canine atria. Heart Rhythm 2010;7(9):1273-9
   PubMed Web of Science ®Google Scholar
• Burashnikov A, Sicouri S, Di Diego JM, et al. Synergistic effect of the combination of ranolazine and dronedarone to suppress atrial fibrillation. J Am Coll Cardiol 2010;56:1216-24
   PubMed Web of Science ®Google Scholar
• Akeborg O, Nilsson J, Bascle S, et al. Cost-effectiveness of dronedarone in atrial fibrillation: results for Canada, Italy, Sweden, and Switzerland. Clin Ther 2012;34(8):1788-802
   PubMed Web of Science ®Google Scholar
• Newman CM, Price A, Davies DW, et al. Amiodarone and the thyroid: a practical guide to the management of thyroid dysfunction induced by amiodarone therapy. Heart 1998;79:121-7
   PubMed Web of Science ®Google Scholar
• Papiris SA, Triantafillidous C, Kolilekas L, et al. Amiodarone: review of pulmonary effects and toxicity. Drug Saf 2010;33(7):539-58
   PubMed Web of Science ®Google Scholar
• Babatin M, Lee SS, Pollak PT. Amiodarone hepatotoxicity. Curr Vasc Pharmacol 2008;6(23):228-36
   PubMedGoogle Scholar
• Dusman RE, Stanton MS, Miles WM, et al. Clinical features of amiodarone-induced pulmonary toxicity. Circulation 1990;82:51-9
   PubMed Web of Science ®Google Scholar
• Joghtaei N, Weirich G, Huber W, et al. Acute liver failure associated with dronedarone. Circ Arrhythm Electrophysiol 2011;4:592-3
   PubMed Web of Science ®Google Scholar
• Camm AJ, Lip GY, De Caterina R, et al. 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation—developed with the special contribution of the European Heart Rhythm Association. Europace 2012;14(10):1385-413
   PubMed Web of Science ®Google Scholar
• Huang JH, Lin Y-K, Hsieh M-H, et al. Non-standard dose dronedarone in treating atrial fibrillation patients. Int J Cardiol 2014;172:e214-16
   PubMed Web of Science ®Google Scholar
• Iannone P, Haupt E, Flego G, et al. Dronedarone for atrial fibrillation. The limited reliability of clinical pracctice guidelines. JAMA 2024;174(4):625-9
   Google Scholar
• Verrier RL, Pagotto VP, Kanas AF, et al. Low doses of ranolazine and dronedarone in combination exert potent protection against atrial fibrillation and vulnerability to ventricular arrhythmias during acute ischemia. Heart Rhythm 2013;10:121-7
   PubMed Web of Science ®Google Scholar
• Briefing Document. Advisory Committee Meeting of the Cardiovascular and Renal Drugs Division of the US Food and Drug Administration. 2009. Available from: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/CardiovascularandRenalDrugsAdvisoryCommittee/UCM134981
   Google Scholar