New England Journal of Medicine Publishes Results From the Landmark ATHENA Trial with Multaq (dronedarone) in Atrial Fibrillation
PARIS, Feb. 11 /PRNewswire-FirstCall/ -- <!-- cpurl -->Sanofi-aventis <!-- /cpurl -->(Paris Bourse: EURONEXT: SAN; and New York: NYSE: SNY) announced today that the ATHENA trial was published in the New England Journal of Medicine. The trial showed that <!-- ppurl -->Multaq<!-- /ppurl -->(R) (dronedarone), in addition to standard therapy, significantly reduced the risk of first cardiovascular hospitalization or death by 24 percent (31.9% vs. 39.4%, p<0.001) in patients with atrial fibrillation (AF)/atrial flutter (AFL) or a recent history of these conditions.
Atrial fibrillation is the leading cause of hospitalization for arrhythmia in the US(1) and represents one-third of hospitalizations for arrhythmia in Europe(2). Hospitalization due to AF has increased dramatically (two-to-three fold) in recent years in the US(1). Atrial fibrillation is a complex disease that increases the risk of stroke up to five-fold(3), worsens the prognosis of patients with cardiovascular risk factors(4) and that doubles the risk of mortality(5).
The authors' findings, as reported in the New England Journal of Medicine, showed a significant decrease in the risk of cardiovascular death by 29 per cent (p=0.03) in patients with AF. Multaq significantly decreased the risk of arrhythmic death by 45 per cent (p=0.01) and there were numerically fewer deaths (16 per cent) from any cause in the dronedarone group compared to placebo (p=0.18). First cardiovascular hospitalization was reduced by 26 per cent (p<0.001) in the dronedarone group.
"The ATHENA trial is the first trial to show a reduction in the incidence of cardiovascular hospitalization or death in patients taking an anti-arrhythmic drug for atrial fibrillation" commented Dr. Stefan H. Hohnloser J.W., Goethe University's Division of Clinical Electrophysiology, Frankfurt, Germany, principal investigator of the ATHENA study.
Reported significant adverse events in the Multaq(R) arm vs. placebo arm included diarrhea (9.7% vs. 6.2%), nausea (5.3% vs. 3.1%), bradycardia (3.5% vs. 1.2%), QT-interval prolongation (1.7% vs. 0.6%); skin disorders (10.3% vs. 7.6%) consisting mainly of rash, and an increase in blood creatinine (4.7% vs. 1.3%)*. There was no difference in permanent study drug discontinuation between Multaq(R) and placebo (30.2% vs. 30.8%).
Dr. Stuart J. Connolly, Director of the division of cardiology at McMaster University, Ontario, Canada and co-principal investigator of the ATHENA trial said "The clinical benefits observed with dronedarone in ATHENA occurred without a significantly higher rate of thyroid or pulmonary disorders compared with placebo reported within the study period."
The condition is increasingly frequent with advancing age and is often caused by age-related changes in the heart or as a result of cardiovascular disease. AF increases the risk of stroke up to five-fold and heart failure two-to-three-fold. AF also doubles the risk of mortality.
Without appropriate management, AF can lead to serious complications such as stroke and congestive heart failure. In addition to preventing stroke and reducing the burden of the disease, successful management of AF should also aim at further reducing cardiovascular morbidity and mortality.
The goals of treatment for patients with AF are related to managing the arrhythmia itself and to the prevention of thromboembolism. AF may be treated with medications that either slow the heart rate or revert the heart rhythm back to normal sinus rhythm.