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American Heart Journals Publishes Results From ERATO Trial Showing Dronedarone (Multaq(R)) Improves Ventricular Rate Control in Patients With Permanent Atrial Fibrillation
Date:8/31/2008

MONTPELLIER, France, September 1 /PRNewswire/ -- The ERATO study published today in the American Heart Journal demonstrated, for the first time in patients with permanent atrial fibrillation, that dronedarone (Multaq(R)) significantly reduces mean 24 hour ventricular rate, on top of other rate control agents. The mean heart rate reduction was 11.7 beats per minute (p< 0, 0001) with dronedarone compared to placebo, which is clinically relevant and highly statistically significant. This rate-controlling effect of dronedarone was sustained throughout the six-month trial and was additive to the effect of other rate control therapies. Dronedarone also significantly reduced maximal exercise heart rate by 24.5 beats per minute (p<0,0001) without impairing exercise capacity. Dronedarone was well tolerated with no evidence of organ toxicity or proarrhythmia over six months.

"Effective control of ventricular rate in patients with permanent AF is associated with significant improvements in both symptom control and clinical outcomes," explained principal investigator Jean-Marc Davy of Departement de Cardiologie, CHU Montpellier, France.

AF is the most frequent cardiac rhythm disorder and can be classified into three types: paroxysmal (self-limiting), persistent (responsive to cardioversion) or permanent (continuous atrial fibrillation with cardioversion proven or deemed ineffective). In patients with permanent AF (a substantial subset of the AF population), the only available therapeutic option is to control the ventricular response rate to prevent deterioration of the ventricular function and to minimise the symptoms (rate control strategy). Existing rate control agents (beta blockers, calcium channel blockers and cardiac glycosides) do not always achieve targeted heart rate, mainly due to the poor tolerability of high doses. In that regard, adequate rate control was only achieved in 64% of patients in the AFFIRM trial. Therefore additional therapeutic opt
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SOURCE CHU Montpellier
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