An article in the Journal of the American College of Cardiology has suggested that the use of French drug major Sanofi-Aventis' Multaq (dronedarone) should be limited to second- or third-line therapy for atrial fibrillation (AF) in cases where amiodarone is effective but not tolerated. The authors stated that data from several studies, including the Phase III ANDROMEDA trial, showed that Multaq was about half as efficacious as amiodarone but may offer slightly better safety in certain patient populations. The authors conclude that more studies of Multaq and amiodarone with longer follow-up are needed.
"We believe that dronedarone should only be used as a second-line or third-line agent in individuals that are not able to tolerate amiodarone or other first-line agents recommended by the guidelines," Sanjay Kaul of Division of Cardiology at the Cedars-Sinai Heart Institute in Los Angeles, USA, who led the study published in the JACC, said in a statement.
Summarizing the findings, Dr Kaul noted that dronedarone is a new antiarrhythmic agent that was recently approved for the prevention of cardiovascular hospitalization driven by atrial fibrillation/flutter. Its approval was based largely on the results of the ATHENA (A Placebo-Controlled, Double-Blind, Parallel Arm Trial to Assess the Efficacy of Dronedarone 400mg bid for the Prevention of Cardiovascular Hospitalization or Death From Any Cause in Patients With Atrial Fibrillation/Atrial Flutter) trial, which demonstrated a significant 24% reduction in the combined end
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Chairman, Sanofi Aventis UK
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