Sanofi-aventis has announced that findings from the Athena study show that Multaq (dronedarone), a potential therapy for the treatment of patients with atrial fibrillation or atrial flutter, decreases the risk of cardiovascular hospitalizations or death by 24% (p=0.00000002), meeting the study’s primary endpoint.
For the first time in 20 years of clinical drug trials in atrial fibrillation, an investigational medicine, Multaq demonstrates 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.
It also significantly decreases the risk of arrhythmic death by 45% (p=0.01), and there are fewer deaths (16%) from any cause in the dronedarone group compared to placebo (p=0.17). First cardiovascular hospitalization is reduced by 25% (p=0.000000009) in the dronedarone group.
The Athena results were presented at the Heart Rhythm 2008, the Heart Rhythm Society's 29th Annual Scientific Sessions in San Francisco, USA, in May.
Atrial fibrillation is a major cause of hospitalization and mortality and affects about 2.5 million people in the US, as well as 4.5 million people in the European Union, and is emerging as a growing public health concern due to an aging population.
