�The results of a post-hoc analysis of the data from the ATHENA study were presented today at the clinical trial update session of the European Society of Cardiology congress 2008, in Munich, Germany. Previous results from the landmark ATHENA study have shown that the investigational medicament dronedarone on top of standard therapy decreased the combined primary endpoint of the peril of cardiovascular hospitalisations or death from any cause by a statistically significant 24% (p=0.00000002) as compared to placebo.
The ATHENA cam stroke post-hoc analysis on non-pre-specified secondary endpoints showed that dronedarone decreased the risk of exposure of stroke (ischemic or haemorrhagic) compared to placebo by 34% (46/2301 vs 70/2327 stroke events respectively; p=0.027) in atrial fibrillation / atrial flutter patients adequately treated by standard therapy including antithrombotics.
The significant reduction in stroke risk with dronedarone was incremental to background anti-thrombotic therapy like oral anticoagulants and / or anti-platelet agents.
"ATHENA is a landmark trial, as it is the first base time that an antiarrhythmic medication drug has shown a significant impingement on cardiovascular outcomes. As stroke is one of the prima complications of atrial fibrillation, and a major movement of death and long-run disability, these new results demonstrate the unique profile of dronedarone beyond its pure rhythm method and rate-controlling effects," aforesaid Professor Stuart Connolly, Mc Master University, Department of Cardiology, Hamilton Canada, co-principal investigator of the ATHENA study.
The most oft reported contrary events of dronedarone vs. placebo in the ATHENA trial as seen in the pre-specified safety analysis, were gI effects (26% vs. 22%), skin disorders (10% vs. 8%, in the main rash) and mild increase in blood creatinine (4.7% vs. 1%) due to inhibition of tubelike secretion of creatinine in the kidneys. The mechanism of parentage creatinine increase was well defined in a split up study of healthy volunteers. In the ATHENA trial, compared to placebo, dronedarone showed a low peril of pro-arrhythmia and no excess of hospitalisations for congestive heart failure. There was a similar rate of study drug discontinuance between the 2 study groups.
About Atrial Fibrillation / Flutter and Stroke
Atrial Fibrillation (AF) is the most unwashed cardiac arrhythmia in clinical practice and is one of the most important independent risk of infection factors for stroke. Stroke is a major public health problem because this acute outcome often causes permanent neurological disabilities and death. Atrial fibrillation increases the peril of stroke by up to 5 times. It also is responsible for 15-20% of all strokes, which if caused by AF, are 2.2 times more likely to leave patients bedridden.
Atrial fibrillation is a major cause of hospitalisation and mortality and affects around 2.5 million multitude in the USA and 4.5 million mass in the European Union. The Atrial Fibrillation Foundation expects the number of patients with AF to double in the side by side 20 years. Without set aside management, atrial fibrillation can buoy lead to serious complications, such as stroke and congestive heart failure.
About the ATHENA Study
The turning point ATHENA, sketch is the only double blind, anti-arrhythmic, morbidity-mortality study in patients with atrial fibrillation. It was conducted in 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 years or old (with or without cardiovascular risk factor) or supra 70 eld of age with at least ane additional cardiovascular risk factor (hypertension, diabetes, previous cerebrovascular event, left atrium size greater than 50 mm or left ventricular expulsion fraction depress than 40%). Patients were randomized to receive dronedarone 400 mg BID or placebo, with a uttermost follow-up of 30 months.
The ATHENA study objectives were to show a potential benefit of dronedarone on the primary composite endpoint of all-cause mortality combined with cardiovascular hospitalization as compared to placebo. The pre-specified secondary endpoints were destruction from whatever cause, cardiovascular death and hospitalisation for cardiovascular reasons. The pre-specified safety end point was the incidence of treatment emergent adverse events (between first study dose intake and last study drug inlet plus 10 days) including: all inauspicious events, grave adverse events, adverse events leading to study drug discontinuation.
The ATHENA stroke post-hoc analysis on a non-pre-specified secondary endpoint was conducted in order to confirm the consistent benefit of dronedarone in atrial fibrillation or atrial waver patients in reducing major cardiovascular complications like stroke, which is a leading cause of cardiovascular hospitalization or death in this patient population.
About Multaq� (dronedarone)
Dronedarone is an investigational treatment and the only anti-arrhythmic dose (AAD) to have shown, as seen in ATHENA, a meaning reduction in morbidity and mortality in atrial fibrillation /atrial flicker patients compared with baseline treatment. In the like study dronedarone also demonstrated a lucky safety profile as evidenced by a low incidence of pro-arrhythmia (including torsades de pointes) and extra-cardiac organ perniciousness. Dronedarone, ascertained and developed by sanofi-aventis, has been studied in a clinical development programme including more than than 7,000 patients. Dronedarone is one of the major therapeutic innovations for atrial fibrillation in the last twenty age.
Dronedarone has been given a antecedency review by the U.S. Food and Drug Administration (FDA) and a registration dossier is also under regulatory inspection by the European Medicines Agency (EMEA). Dronedarone is not expected to be available for use in the NHS before September 2009.
About sanofi-aventis
Sanofi-aventis, a leading worldwide pharmaceutical company, contributes to improving life by providing a all-inclusive offering of medicines, vaccines, and integrated healthcare solutions adapted to local necessarily and means. http://en.sanofi-aventis.com
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