American Heart Journals Publishes Results From ERATO Trial Showing Dronedarone (Multaq(R)) Improves Ventricular Rate Control in Patients With Permanent Atrial Fi...(ions to achieve appropriate ventricularr...),Health
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ions 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
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| SOURCE CHU Montpellier Copyright©2008 PR Newswire. All rights reserved |
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