Sanofi-aventis phase IIIb AF trial

Sanofi-aventis (S-A) has announced the initiation of a phase IIIb trial to assess the clinical benefit of Multaq (dronedarone) in atrial fibrillation (AF) patients. The multinational, randomised, double-blind trial, known as PALLAS (Permanent Atrial fibriLLAtion outcome Study), will investigate the potential of Multaq in over 10,000 patients with permanent AF.

Permanent AF afflicts half of patients suffering from AF and these patients are at high risk of major adverse cardiovascular events. It follows on from the ATHENA trial, which showed a trend towards reduced CV hospitalisation and death in permanent AF patients.

"This is a trial of major significance, since no anti-arrhythmic drug has ever been shown to reduce major morbidity and mortality in permanent AF patients in a large-scale clinical trial," said Dr Stuart Connolly of the Division of Cardiology, McMaster University, Hamilton, Canada, one of the trial's principal investigators.

The primary objective is to demonstrate a reduction in major cardiovascular events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death) and/or cardiovascular hospitalisation or death from any cause among patients with permanent atrial fibrillation and additional risk factors.

"The initiation of the PALLAS trial confirms our strong belief in Multaq and our commitment to improve AF patient w¬¬¬ell-being and overall cardiovascular health," said Dr Marc Cluzel, executive vice president, Research and Development, S-A.

There will be 10,800 patients enrolled in 43 countries at 700 sites. The first patient enrolment is scheduled for the third quarter of 2010. AF affects about 4.5 million people in Europe and represents a third of hospitalisations for arrhythmia in the European Union.

Multaq is currently available in the US, Canada, Switzerland, Germany, Denmark, Ireland, Norway, Finland and the UK and is being launched in most European countries in 2010.