Oral
dronedarone is a non-iodinated benzofurane derivative structurally related to
amiodarone. Although it is considered a class III antiarrhythmic agent like
amiodarone, it demonstrates multi-class electrophysiological activity. Data from the ATHENA study demonstrated that patients receiving oral
dronedarone 400 mg twice daily for 12-30 months had a significantly lower risk of experiencing first hospitalization due to a cardiovascular event or death from any cause than those receiving placebo.
Dronedarone exhibited rate- and rhythm-controlling properties in patients with atrial fibrilation (AF) or
atrial flutter, significantly reducing the risk of a first recurrence of AF versus placebo following 12 months'
therapy in the ADONIS and EURIDIS studies. In the ERATO study,
dronedarone was also significantly more effective than placebo in terms of ventricular rate control. Furthermore, the beneficial effects of oral
dronedarone on ventricular rate control were maintained during exercise and sustained with continued
therapy. Oral
dronedarone was generally well tolerated in the treatment of adult patients with AF and/or
atrial flutter in clinical studies. The incidence of diarrhoea,
nausea,
bradycardia,
rash and QT-interval prolongation was significantly higher with oral
dronedarone than placebo in the large ATHENA study; however, serious cardiac-related adverse events were observed in <1% of oral
dronedarone recipients.