At the World Congress of Cardiology (WCC), the press conference entitled “New Perspectives 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 trial results, as the way forward in the future management of Atrial fibrillation, the most common form of cardiac arrhythmia.

“ATHENA is truly a landmark trial, that marks a paradigm change for the management of atrial fibrillation,” said Prof Christopher Cannon, a Senior Investigator in the TIMI Study Group at Brigham and Women’s Hospital, Harvard Medical School, who was not involved in the study. “Atrial fibrillation is a very common disease, and our prior treatment options have been focused only on symptom relief and a hope to not do harm, which has been the problem with prior antiarrhythmic drugs. Now, with a highly significant reduction in cardiovascular hospitalisation or death, as well as a 45% reduction in arrhythmic death or 30% cardiovascular death, dronedarone may become a first line treatment of 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 in San Francisco, USA. The study results show that dronedarone significantly decreased the risk of cardiovascular hospitalisations or death from any cause by 24% (p=0.00000002), meeting the study’s primary endpoint. Results of the primary endpoint were consistent across all the pre-specified clinically relevant subgroups.

The most frequently reported adverse events of Multaq(R) vs. placebo in the ATHENA trial were gastro-intestinal effects (26% vs. 22%), skin disorders (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) is well defined. Compared to placebo, Multaq(R) showed a low risk of pro-arrhythmia and no excess of hospitalisations for congestive heart failure. There was a similar rate of study drug discontinuation between the 2 study groups.

Atrial fibrillation is a major cause of hospitalisation 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 due to an aging population. Patients suffering from atrial fibrillation have twice the risk of death, an increased risk of stroke and cardiovascular complications, including congestive heart failure.

ATHENA, was the largest double blind randomised study in patients with atrial fibrillation, and conducted in more than 550 sites in 37 countries and enrolled a total of 4,628 patients. The landmark ATHENA trial is the first morbidity-mortality study as part of the Multaq(R) phase III clinical development program, which also included five other multinational clinical studies: an initial study, ANDROMEDA, conducted in patients with severe congestive heart failure and a recent decompensation, and a total of 4 international studies in atrial fibrillation: EURIDIS/ADONIS, ERATO, and the ongoing DIONYSOS trial.