Document Detail

Dronedarone for the treatment of atrial fibrillation and atrial flutter: approval and efficacy.
MedLine Citation:
PMID:  20730068     Owner:  NLM     Status:  MEDLINE    
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.
Deborah Wolbrette; Mario Gonzalez; Soraya Samii; Javier Banchs; Erica Penny-Peterson; Gerald Naccarelli
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Publication Detail:
Type:  Journal Article; Review     Date:  2010-08-09
Journal Detail:
Title:  Vascular health and risk management     Volume:  6     ISSN:  1178-2048     ISO Abbreviation:  Vasc Health Risk Manag     Publication Date:  2010  
Date Detail:
Created Date:  2010-08-23     Completed Date:  2010-12-03     Revised Date:  2013-05-29    
Medline Journal Info:
Nlm Unique ID:  101273479     Medline TA:  Vasc Health Risk Manag     Country:  New Zealand    
Other Details:
Languages:  eng     Pagination:  517-23     Citation Subset:  IM    
Penn State Heart and Vascular Institute, Penn State Milton S Hershey Medical Center, Hershey, Pennsylvania 17033-0850, USA.
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MeSH Terms
Amiodarone / adverse effects,  analogs & derivatives*,  contraindications,  therapeutic use
Anti-Arrhythmia Agents / adverse effects,  contraindications,  therapeutic use*
Atrial Fibrillation / drug therapy*,  physiopathology
Atrial Flutter / drug therapy*,  physiopathology
Drug Approval
Product Surveillance, Postmarketing
Stroke Volume / drug effects,  physiology
Reg. No./Substance:
0/Anti-Arrhythmia Agents; 1951-25-3/Amiodarone; JQZ1L091Y2/dronedarone

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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