The landmark ATHENA study is the only double-blind, antiarrhythmic study in patients with AF that assesses morbidity-mortality. The study was conducted at more than 550 sites in 37 countries and enrolled a total of 4,628 patients. The patients studied in ATHENA were either 75 years of age or older (with or without cardiovascular risk factors) or below 75 years of age with at least one additional cardiovascular risk factor (hypertension, diabetes, previous ischemic cerebrovascular event, left atrium size greater than 50 mm or left ventricular ejection fraction lower than 40 percent). Patients with recently decompensated heart failure or in New York Heart Association (NYHA) class IV were excluded. Patients were randomized to receive dronedarone 400 mg BID or placebo, with a mean follow-up of 21 months. The ATHENA study objectives were designed to show a potential benefit of dronedarone on the primary composite endpoint of all-cause mortality combined with cardiovascular hospitalization compared with placebo. The pre-specified secondary endpoints were death from any cause, cardiovascular death and hospitalization for cardiovascular reasons. The pre-specified safety endpoint was the incidence of treatment emergent adverse events (between first study drug intake and last study drug intake plus 10 days) including all adverse events, serious adverse events and adverse events leading to study drug discontinuation. About Atrial Fibrillation
AF is a common heart arrhythmia in which the upper chambers of the heart beat in an uncoordinated and disorganized fashion, which can cause palpitations, shortness of breath and fatigue. AF currently represents a major economic burden for society. Seventy percent of the annual cost of AF management in Europe is driven by in-patient care and interventional procedures. Hospitalizations for AF have increased dramatically (two-to-three-fold) in recent years. AF hospitalizations now represent a third of all hospitalizations for arrhythmia and mortality in the US and Europe. AF affects nearly 7 million people in the European Union and the United States. 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. About dronedarone (Multaq®)
Multaq® (dronedarone) is an investigational treatment and the only antiarrhythmic drug to have shown a significant reduction in cardiovascular hospitalization or death in patients with AF/AFL. Multaq®, discovered and developed by sanofi-aventis, has been studied in a clinical development program including more than 6,200 patients. Multaq® is one of the major therapeutic innovations in atrial fibrillation for the last twenty years. Multaq® has been granted a priority review by the U.S. Food and Drug Administration (FDA) and a registration dossier is also under regulatory review by the European Medicines Agency (EMEA). About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT : SAN) and in New York (NYSE : SNY). (1) Singh SN et al. J Am Coll Cardiol. 2006;48:721-730
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