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Landmark ATHENA Study Findings With Multaq(R) (dronedarone) Shows 24% Reduction In Cardiovascular Hospitalization or Death in Patients With Atrial Fibrillation
Date:5/15/2008

f hospitalization and mortality and affects about 2.5 million people in the United States, as well as 4.5 million people in the European Union and is emerging as a growing public health concern because of the aging of the population. Patients suffering from atrial fibrillation have twice the risk of death, an increased risk of stroke and cardiovascular complications, including congestive heart failure. Furthermore atrial fibrillation considerably impairs patients' lives, mainly because of their inability to perform normal daily activities due to complaints of palpitations, chest pain, dyspnoea, fatigue or light-headedness, without consideration of the cumbersome and sometime serious constraints imposed by current therapies of atrial fibrillation.

"In atrial fibrillation where treatment morbidity-mortality benefit still needed to be demonstrated, ATHENA is a unique trial using clinically relevant outcomes such as cardiovascular hospitalization or death as the primary endpoint. In this regard, the trial has clearly achieved these safety and efficacy endpoints," said Dr Stefan H. Hohnloser, J.W. from the Goethe University, Division of Clinical Electrophysiology, Frankfurt, Germany, who served as co-principal investigator of the ATHENA study. "As a consequence, dronedarone is the first potential treatment for atrial fibrillation, which was demonstrated in the ATHENA trial to reduce cardiovascular hospitalization or mortality in patients with AF," he added.

The most frequently reported adverse events of Multaq(R) vs. placebo induced gastro-intestinal effect (26% vs. 22%), skin disorder (10% vs. 8%, mainly rash) and increased blood creatinine (4.7% vs. 1%). The mechanism of blood creatinine increase (inhibition of creatinine secretion at the renal tubular level) was well defined, in a separate study of healthy volunteers. Multaq(R) showed a rate of pro-arrhythmia similar to placebo and no excess of hospitalizations for congestive heart failure. There was a s
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