| Proarrhythmic Potential of Dronedarone: Emerging Evidence from Spontaneous Adverse Event Reporting. | |
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MedLine Citation:
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PMID: 22744806 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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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. |
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Authors:
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David P Kao; William R Hiatt; Mori J Krantz |
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Publication Detail:
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Type: JOURNAL ARTICLE Date: 2012-6-28 |
Journal Detail:
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Title: Pharmacotherapy Volume: - ISSN: 1875-9114 ISO Abbreviation: - Publication Date: 2012 Jun |
Date Detail:
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Created Date: 2012-6-29 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 8111305 Medline TA: Pharmacotherapy Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Copyright Information:
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© 2012 Pharmacotherapy Publications, Inc. |
Affiliation:
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Division of Cardiology, University of Colorado School of Medicine, Aurora, Colorado. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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