Dronedarone for the treatment of atrial fibrillation and atrial flutter: Approval and efficacy

Deborah Wolbrette, Mario Gonzalez, Soraya Samii, Javier Banchs, Erica Penny-Peterson, Gerald Naccarelli

Research output: Contribution to journalReview article

16 Citations (Scopus)

Abstract

Dronedarone, a new Class III antiarrhythmic agent, has now been approved by the US Food and Drug Administration for use in patients with atrial fibrillation or atrial flutter. Approval came in March 2009 due to the positive results of the ATHENA trial showing significant reductions in all-cause mortality and cardiovascular hospitalization with dronedarone use. A post hoc analysis of the ATHENA data also suggested a decrease in stroke risk with this agent. However, due to safety concerns in the heart failure population in the earlier ANDROMEDA trial, dronedarone is not recommended for patients with an ejection fraction,35% and recent decompensated heart failure. Dronedarone is an amiodarone analog with multichannel blocking electrophysiologic properties similar to those of amiodarone, but several structural differences. Dronedarone's lack of the iodine moiety reduces its potential for thyroid and pulmonary toxicity. Preliminary data from the DIONYSOS trial, and an indirect meta-analysis comparing amiodarone with dronedarone, showed amiodarone to be more effective in maintaining sinus rhythm, while dronedarone was associated with fewer adverse effects resulting in early termination of the drug. Dronedarone is the first antiarrhythmic drug for the treatment of atrial fibrillation and atrial flutter shown to reduce cardiovascular hospitalizations. In patients with structural heart disease who have an ejection fraction.35% and no recent decompensated heart failure, dronedarone should be considered earlier than amiodarone in the treatment algorithm.

Original languageEnglish (US)
Pages (from-to)517-523
Number of pages7
JournalVascular Health and Risk Management
Volume6
Issue number1
StatePublished - Dec 1 2010

Fingerprint

Atrial Flutter
Atrial Fibrillation
Amiodarone
Therapeutics
Heart Failure
Hospitalization
dronedarone
Anti-Arrhythmia Agents
United States Food and Drug Administration
Iodine
Meta-Analysis
Heart Diseases
Thyroid Gland
Stroke
Safety
Lung
Mortality

All Science Journal Classification (ASJC) codes

  • Endocrinology, Diabetes and Metabolism
  • Hematology
  • Public Health, Environmental and Occupational Health
  • Cardiology and Cardiovascular Medicine
  • Pharmacology (medical)

Cite this

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abstract = "Dronedarone, a new Class III antiarrhythmic agent, has now been approved by the US Food and Drug Administration for use in patients with atrial fibrillation or atrial flutter. Approval came in March 2009 due to the positive results of the ATHENA trial showing significant reductions in all-cause mortality and cardiovascular hospitalization with dronedarone use. A post hoc analysis of the ATHENA data also suggested a decrease in stroke risk with this agent. However, due to safety concerns in the heart failure population in the earlier ANDROMEDA trial, dronedarone is not recommended for patients with an ejection fraction,35{\%} and recent decompensated heart failure. Dronedarone is an amiodarone analog with multichannel blocking electrophysiologic properties similar to those of amiodarone, but several structural differences. Dronedarone's lack of the iodine moiety reduces its potential for thyroid and pulmonary toxicity. Preliminary data from the DIONYSOS trial, and an indirect meta-analysis comparing amiodarone with dronedarone, showed amiodarone to be more effective in maintaining sinus rhythm, while dronedarone was associated with fewer adverse effects resulting in early termination of the drug. Dronedarone is the first antiarrhythmic drug for the treatment of atrial fibrillation and atrial flutter shown to reduce cardiovascular hospitalizations. In patients with structural heart disease who have an ejection fraction.35{\%} and no recent decompensated heart failure, dronedarone should be considered earlier than amiodarone in the treatment algorithm.",
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Dronedarone for the treatment of atrial fibrillation and atrial flutter : Approval and efficacy. / Wolbrette, Deborah; Gonzalez, Mario; Samii, Soraya; Banchs, Javier; Penny-Peterson, Erica; Naccarelli, Gerald.

In: Vascular Health and Risk Management, Vol. 6, No. 1, 01.12.2010, p. 517-523.

Research output: Contribution to journalReview article

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AU - Wolbrette, Deborah

AU - Gonzalez, Mario

AU - Samii, Soraya

AU - Banchs, Javier

AU - Penny-Peterson, Erica

AU - Naccarelli, Gerald

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