"Our findings demonstrating no increased risk of pulmonary toxicity, thyroid or liver dysfunction are important because there are few treatment options for patients with AF and AFL that are not associated with serious side effects," Dr Singh said. "The low incidence of adverse events in the study was encouraging. It is also important to note that there were no cases of torsades de pointes."
About Atrial Fibrillation/Flutter
AF is the most common arrhythmia requiring hospitalization and is associated with increased morbidity and mortality. AF can cause palpitations, shortness of breath and fatigue.
AFL is an abnormal fast heart rhythm that occurs in the atria of the heart. This rhythm occurs most often in individuals with other heart conditions (e.g., pericarditis, coronary artery disease, and cardiomyopathy). AFL frequently degenerates to atrial fibrillation. However, it may persist for months to years.
Restoring sinus rhythm in AF is often associated with improvement in exercise capacity and quality of life, making sinus rhythm restoration and maintenance one of the therapeutic goals in AF.
EURIDIS and ADONIS were two identical placebo-controlled, multi-center, double-blind, parallel-group trials. EURIDIS was conducted in 12 European countries and ADONIS was conducted in the United States, Canada, Australia, South Africa, and Argentina. The studies were conducted in an out-patient population. 612 patients were randomized in EURIDIS and 625 in ADONIS. A total of 1,237 patients have been included in the two studies.
Enrollment criteria were at least one arrhythmic episode during the
previous three months and sinus rhythm for at least one hour before
randomization to dronedarone 400 mg twice-daily or placebo. Rhythm was
monitored on days 2, 3, 5; at 3, 5, 7, and 10 months; during symptomatic
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