Montpellier, France (ots/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,
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
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
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.
ots Originaltext: CHU Montpellier
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MEDIA CONTACT: Pr. Jean-Marc Davy, +33-467-33-61-87, Fax:
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