Key result
In a review of trials including the 4,600-patient ATHENA study, dronedarone significantly reduced cardiovascular hospitalizations and death in patients with atrial fibrillation compared to placebo.
Why the study?
Does dronedarone improve clinical outcomes in patients with atrial fibrillation?
Does dronedarone improve clinical outcomes in patients with atrial fibrillation?
Dronedarone is an effective antiarrhythmic for nonpermanent atrial fibrillation that reduces cardiovascular hospitalizations, though it is contraindicated in unstable heart failure.
Supports dronedarone in nonpermanent AF with CV benefit; leaves open optimal selection and long-term safety beyond reviewed trials.
PURPOSE OF REVIEW: To describe the electrophysiological profile and the clinical portfolio of dronedarone, a new multichannel-blocking antiarrhythmic drug developed for the treatment of atrial fibrillation. RECENT FINDINGS: Dronedarone is a derivative of amiodarone that is free of iodine and less lipophilic. The drug has - as its predecessor - multichannel-blocking efficacy and in addition vasodilating effects. It reduces the incidence of ventricular fibrillation in several experimental models. Dronedarone has undergone thorough clinical evaluation in various patient populations. In two large trials, the drug was shown to postpone the recurrence of atrial fibrillation after cardioversion relative to placebo. In a trial in unstable heart failure patients, there was excess mortality in the dronedarone arm. This trial was stopped prematurely and prompted the conduct of a large outcome study. The ATHENA trial demonstrated a significant reduction in cardiovascular hospitalizations and death in atrial fibrillation patients randomly assigned to receive dronedarone or placebo. This large trial in more than 4600 patients revealed no signs of excess mortality or morbidity in patients receiving dronedarone. SUMMARY: On the basis of the results of five international, multicenter, randomized clinical trials involving nearly 6300 patients, dronedarone was approved by the FDA for treatment of nonpermanent atrial fibrillation to reduce the risk of cardiovascular hospitalization.
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Duray et al. (2009) conducted a review in atrial fibrillation (n=6,300). Dronedarone vs. placebo was evaluated on cardiovascular hospitalizations and death. In a review of trials including the 4,600-patient ATHENA study, dronedarone significantly reduced cardiovascular hospitalizations and death in patients with atrial fibrillation compared to placebo.
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