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Dronedarone (Multaq(R)) Reduced the Incidence and Duration of Hospitalization in Patients with Atrial Fibrillation
Date:11/11/2008

in lower risk populations studied in the EURIDIS(1), ADONIS and ERATO(2) trials. This analysis showed that dronedarone reduced the incidence of first AF recurrence by 25 percent in patients in sinus rhythm at study initiation (p<0.001), and the incidence of first electrical cardioversion by 31 percent (p<0.001), compared with placebo.

Dronedarone also decreased mean heart rate during atrial fibrillation to 78 beats per minute, compared with 87 for placebo (p<0.001). Fewer patients developed permanent atrial fibrillation during the study in the dronedarone group - 178 patients (7.7%) compared with 295 patients (12.7%) in the placebo arm (p<0.001). In these patients, the non-significant reduction of CV hospitalization or death was 26% lower for those receiving dronedarone (p=0.096). These results are consistent with the overall study results.

"This study demonstrates both significant rhythm and rate controlling properties of dronedarone in the ATHENA population, which consisted of higher-risk patients with atrial fibrillation," added Dr. Richard Page, Professor and Head of the Division of Cardiology at the University of Washington School of Medicine, Seattle, USA and a member of the steering committee of the ATHENA study. "It is intriguing that there was a trend toward reduction of the primary endpoint of cardiovascular hospitalization or death even in patients with permanent AF, suggesting that the benefit of dronedarone may not only be linked to arrhythmia control."

The most frequently reported adverse events of dronedarone vs. placebo in the ATHENA trial were gastrointestinal effects (26% vs. 22%), skin disorders (10% vs. 8%, mainly rash) and mild increase in blood creatinine (4.7% vs. 1%) due to inhibition of tubular secretion of creatinine in the kidneys. The mechanism of blood creatinine increase was well defined in a separate study of healthy volunteers and is not indicative of renal toxicity. In the ATHENA trial, compared to placebo, drone
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