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

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

"ERATO demonstrates that dronedarone is well tolerated and demonstrates sustained rate-control efficacy in addition to standard agents, in patients who are only eligible for this therapeutic strategy" said Professor Davy. "In the landmark ATHENA trial, dronedarone has significantly reduced CV hospitalisation and death and has been proven to be effective and

ERATO provides the additive piece to complement earlier dronedarone clinical trial result findings and now confirms its efficacy and safety across the entire spectrum of AF patients," he added.

In ERATO, the incidence of adverse events in the dronedarone arm was not statistically different although marginally higher compared to the placebo group. Gastrointestinal disturbances and mild increases in mean serum creatinine levels were observed more frequently in the dronedarone group, in accordance with previous studies. Creatinine increase occurred early after treatment initiation and reached a plateau after seven days. Values returned to baseline within one week after treatment discontinuation

ERATO (The Efficacy and safety of dRonedArone for the cOntrol of ventricular rate during atrial fibrillation), a randomised, double blind, placebo-controlled, parallel group study, was conducted in 174 adult patients with symptomatic, permanent AF of at least six months' duration, recruited from 38 centres in nine European countries.

ERATO is the first dronedarone study conducted in patients with permanent AF.

The pivotal EURIDIS-ADONIS trials in the maintenance of sinus rhythm (published in the NEJM in 2007) have already demonstrated that dronedarone significantly decreased ventricular rate during a first recurrence of atrial fibrillation in paroxysmal and persistent AF patients.

The well- proven rate-controlling effects of dronedarone observed in ERATO as well as the previously demonstrated rhythm-controlling effects seen in the EURIDIS-ADONIS trials are thought to have contributed to the significant reduction of CV hospitalisations or deaths observed in the landmark ATHENA trial.

SOURCE: CHU Montpellier

--Distributed by AsiaNet ( www.asianetnews.net )--

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