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MONTPELLIER, France, September 1MONTPELLIER, 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 options to achieve appropriate ventricular rate are needed.
"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 safe in paroxysmal and persistent AF patients.
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 with no impact on renal function. No evidence of thyroid or pulmonary fibrosis was observed with dronedarone and no Torsade de Pointes was reported during the six-month follow-up.
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.
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