ATHENA Clinical Results for Dronedarone (Multaq(R)) Highlighted at the World Cardiolog...(cardiovasculardeath and hospitalisation ...),Health

Date:5/20/2008

cardiovascular death and hospitalisation for cardiovascular reasons. Furthermore from the study secondary endpoints, Multaq(R), showed a significant decrease in the risk of cardiovascular death by 30% (p=0.03) on top of standard therapy, including rate control and antithrombotic drugs, in patients with atrial fibrillation or atrial flutter. Multaq(R) also significantly decreased the risk of arrhythmic death by 45% (p=0.01) and there were numerically fewer deaths (16%) from any cause in the dronedarone group compared to placebo (p=0.17). First cardiovascular hospitalisation was reduced by 25% (p=0.000000009) in the dronedarone group. 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 patients studied were either 75 years of age or over (with or without cardiovascular risk factor) or were below 75 years of age with at least one additional cardiovascular risk factor (hypertension, diabetes, previous cerebrovascular event, left atrium size greater than 50 mm or left ventricular ejection fraction lower than 40 percent). Patients suffering from decompensated heart failure were excluded from the study. Patients were randomised 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
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