DRONEDARONE HYDROCHLORIDE (MULTAQ(R), SR-33589)
- -Description: class III antiarrhythmic
- -Indication(s) Submitted for Approval: treatment of
atrial fibrillation
- -Drug Sponsor: Sanofi-Aventis
- -NDA Filed: 07-2008
- -User Fee Goal: 01-2009 (priority review)
- -NDA Status: pending; 03-18-2009, FDA Advisory
Study Summary/Authors conclusion :
1) Dronedarone is less effective than amiodarone for the maintenance of sinus rhythm, but has fewer adverse effects. For every 1,000 patients treated with dronedarone instead of amiodarone, we estimate approximately 228 more recurrences of AF in exchange for 9.6 fewer deaths and 62 fewer adverse events requiring discontinuation of drug.
Piccini JP, Hasselblad V, Peterson ED, et al. Comparative efficacy of dronedarone and amiodarone for the maintenance of sinus rhythms in patients with atrial fibrillation. J Am Coll Cardiol 2009; 54: 1089-95
2) "... antiarrhythmic drug trials that are available and demonstrated that mortality might be reduced by dronedarone, but might be adversely affected by amiodarone and sotalol. One the other hand, the advantageous affect on stroke seen with dronedarone, might also be paralleled by amiodarone and sotalol. ..." "......cardiovascular hospitalizations a great deal, specifically in relationship to the ATHENA trial where there was a dramatic effect of dronedarone on hospitalization of patients with AF and other CV risk factors. These hospitalizations were not trivial. They were not simply related to cardioversion. Many of them involved aggravation of heart failure. Many of them involved stays in the coronary care unit and the ITU [intensive treatment unit]. So, CV outcomes including hospitalization have now become a major endpoint.:"
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