MONTPELLIER, France, Sept. 1 /CNW/ - 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(less than)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(less than)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
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
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
For further information:
For further information: MEDIA CONTACT: Pr. Jean-Marc Davy,
+33-467-33-61-87, Fax: +33-467-336-186, Email: firstname.lastname@example.org