Landmark ATHENA Study Findings With Multaq(R) (dronedarone) Shows 24% Reduction In Cardiovascular Hospitalization or Death in Patients With Atrial Fi...(ndpoint of all-cause mortality combinedw...),Health

Date:5/15/2008

ndpoint of all-cause mortality combined with cardiovascular hospitalization as compared to 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 (time of observation for treatment emergent adverse events) including: all adverse events, serious adverse events, adverse events leading to study drug discontinuation.

The atrial fibrillation or atrial flutter patient population studied were either greater than or equal to 75 years (with or without cardiovascular risk factor) or were <75 years with at least one additional cardiovascular risk factor (hypertension, diabetes, previous cerebrovascular event, left atrium size >50 mm or left ventricular ejection fraction <40 percent). Patients suffering from decompensated heart failure were excluded from the study. Patients were randomized to receive Multaq(R) 400 mg BID or placebo, with a maximum follow-up of 30 months.

The countries which enrolled patients included: Argentina, Australia, Austria, Belgium, Canada, Chile, China, Czech Republic, Finland, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Malaysia, Mexico, Morocco, New Zealand, Norway, Philippines, Poland, Portugal, Russia, South Africa, Singapore, South Korea, Spain, Sweden, Taiwan, Thailand, The Netherlands, Tunisia, Turkey, the UK, the US.

About Multaq(R) (dronedarone)

Dronedarone (brand name Multaq(R)) is an investigational new treatment for patients with atrial fibrillation, which has been discovered and developed by sanofi-aventis for the prevention and treatment of patients with atrial fibrillation or atrial flutter. Dronedarone is a multi-channel blocker that affects calcium, potassium and sodium channels and has anti-adrenergic properties. Dronedarone does not contain the iodine radical and did not show any evidence of thyroid or pulmonary toxic
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