ATHENA Clinical Results with Dronedarone (Multaq(R)) Highlighted at the World Cardiology Congress

Friday, May 23, 2008 General News
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BUENOS AIRES, Argentina, May 22 On May 21, 2008at the World Congress of Cardiology (WCC), the press conference entitled, "NewPerspectives in Atrial Fibrillation Management" chaired by John Camm,Professor of Clinical Cardiology, St George's University of London,highlighted the importance of the newly announced ATHENA clinical trialresults, on the potential management of atrial fibrillation, a common form ofcardiac arrhythmia.

"ATHENA is truly a landmark trial, that marks a paradigm change for themanagement of atrial fibrillation," said Prof Christopher Cannon, a SeniorInvestigator in the TIMI Study Group at Brigham and Women's Hospital, HarvardMedical School, who was not involved in the study. "Atrial fibrillation is avery common disease, and our prior treatment options have been focused only onsymptom relief and a hope to not do harm, which has been the problem withprior antiarrhythmic drugs. Now, with a highly significant reduction incardiovascular hospitalization or death, as well as a 45% reduction inarrhythmic death or 30% cardiovascular death, dronedarone may become anappropriate treatment option for atrial fibrillation".

The ATHENA study results were presented by Prof Stefan Hohnloser last week(15th May 08) at the Heart Rhythm Society's 29th Annual Scientific Sessions inSan Francisco, USA. The study results show that dronedarone significantlydecreased the risk of cardiovascular hospitalizations or death from any causeby 24% (p=0.00000002), meeting the study's primary endpoint. Results of theprimary endpoint were consistent across all the pre-specified clinicallyrelevant subgroups.

The most frequently reported adverse events of Multaq(R) vs. placebo inthe ATHENA trial were gastro-intestinal effects (26% vs. 22%), skin disorders(10% vs. 8%, mainly rash) and increased blood creatinine (4.7% vs. 1%). Themechanism of blood creatinine increase (inhibition of creatinine secretion atthe renal tubular level) was well defined, in a separate study of healthyvolunteers. Multaq(R) showed a rate of pro-arrhythmia similar to placebo andno excess of hospitalizations for congestive heart failure. There was asimilar rate of study drug discontinuation between the 2 study groups.

ATHENA, was the largest double blind randomized study in patients withatrial fibrillation, and conducted in more than 550 sites in 37 countries andenrolled a total of 4,628 patients. The landmark ATHENA trial is the firstmorbidity-mortality study as part of the Multaq(R) phase III clinicaldevelopment program, which also included five other multinational clinicalstudies: an initial study, ANDROMEDA, conducted in patients with severecongestive heart failure and a recent decompensation, and a total of 4international studies in atrial fibrillation: EURIDIS/ADONIS, ERATO, and theongoing DIONYSOS trial.

Atrial fibrillation is a major cause of hospitalization and mortality andaffects about 2.5 million people in the United States, as well as 4.5 millionpeople in the European Union and is emerging as a growing public healthconcern due to an aging population. Patients suffering from atrialfibrillation have twice the risk of death, an increased risk of stroke andcardiovascular complications, including congestive heart failure.

About Atrial Fibrillation / Flutter

Atrial fibrillation is a major cause of hospitalization and mortality andaffects about 2.5 million people in the USA and 4.5 million people in theEuropean Union. The Atrial Fibrillation Foundation expects the number ofpatients with AF to double in the next 20 years. Without appropriatemanagement, atrial fibrillation can lead to serious complications, such asstroke and congestive heart failure.

AF is a condition in which the upper chambers of the heart beat in anuncoordinated and disorganised fashion, resulting in an irregular and fastheart rhythm (i.e. an irregular heartbeat). Atrial flutter

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