Document Detail

Proarrhythmic potential of dronedarone: emerging evidence from spontaneous adverse event reporting.
MedLine Citation:
PMID:  22744806     Owner:  NLM     Status:  MEDLINE    
STUDY OBJECTIVE: To characterize the frequency and type of cardiac events, including torsade de pointes, associated with dronedarone and its structural analog, amiodarone, outside of the clinical trial setting.
DESIGN: Retrospective analysis.
DATA SOURCE: Spontaneous reports in the United States Food and Drug Administration (FDA) Adverse Event Reporting System (AERS) database generated between July 1, 2009, and June 30, 2011.
MEASUREMENTS AND MAIN RESULTS: All reports of adverse events during the study period were reviewed to identify cardiac events associated with any approved drug in the United States. The type and number of cardiac events associated with dronedarone and amiodarone were determined. Active ingredients were identified using the Drugs@FDA database, and the Medical Dictionary for Regulatory Activities (MedDRA) was used to aggregate related adverse events. To avoid redundant reporting, all statistics were generated in reference to unique case identifiers. Dronedarone was associated with more adverse cardiovascular event reports than amiodarone (810 vs 493 reports) during the study period. Dronedarone was also associated with the most reports of torsade de pointes of any approved drug in the United States (37 reports), followed by amiodarone (29 reports). Reports of ventricular arrhythmias and cardiac arrest (138 vs 113 reports) as well as heart failure (179 vs 126 reports) were more common with dronedarone than amiodarone.
CONCLUSION: Dronedarone was associated with reports of ventricular arrhythmia, cardiac arrest, and torsade de pointes in clinical practice. Whether this observation accounts for the increased risk of fatal arrhythmia observed in a recent prospective trial requires further investigation.
David P Kao; William R Hiatt; Mori J Krantz
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Publication Detail:
Type:  Comparative Study; Journal Article; Research Support, N.I.H., Extramural     Date:  2012-06-28
Journal Detail:
Title:  Pharmacotherapy     Volume:  32     ISSN:  1875-9114     ISO Abbreviation:  Pharmacotherapy     Publication Date:  2012 Aug 
Date Detail:
Created Date:  2013-01-11     Completed Date:  2013-06-20     Revised Date:  2013-10-11    
Medline Journal Info:
Nlm Unique ID:  8111305     Medline TA:  Pharmacotherapy     Country:  United States    
Other Details:
Languages:  eng     Pagination:  767-71     Citation Subset:  IM    
Copyright Information:
© 2012 Pharmacotherapy Publications, Inc. All rights reserved.
Division of Cardiology, University of Colorado School of Medicine, Aurora, Colorado, USA.
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MeSH Terms
Adverse Drug Reaction Reporting Systems / statistics & numerical data
Amiodarone / adverse effects,  analogs & derivatives*
Anti-Arrhythmia Agents / adverse effects*
Arrhythmias, Cardiac / chemically induced*,  epidemiology,  physiopathology
Heart Arrest / chemically induced,  epidemiology
Retrospective Studies
Torsades de Pointes / chemically induced,  epidemiology
United States
United States Food and Drug Administration
Grant Support
2 T32HL007822-12/HL/NHLBI NIH HHS; L30 HL110124/HL/NHLBI NIH HHS; T32 HL007822/HL/NHLBI NIH HHS; T32 HL007822-12/HL/NHLBI NIH HHS
Reg. No./Substance:
0/Anti-Arrhythmia Agents; 1951-25-3/Amiodarone; JQZ1L091Y2/dronedarone
Comment In:
Pharmacotherapy. 2012 Aug;32(8):764-6   [PMID:  23307524 ]

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

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