Sanofi-aventis Initiates 10,000 Patient Study with Multaq® in Permanent AF

   Sanofi-aventis announced the initiation of a multi-national, randomized, double-blind Phase IIIb trial, PALLAS, to assess the potential clinical benefit of Multaq^® (dronedarone) in over 10,000 patients with permanent atrial fibrillation (AF) to reduce major adverse cardio- vascular events. The announcement was made during Heart Rhythm 2010.    Permanent AF afflicts 50% of patients suffering from AF and these patients are at high risk of major adverse cardiovascular events. The trial rationale was based on post-hoc findings from the landmark ATHENA trial, in which a trend towards reduction of CV hospitalization and death was seen in patients classified as “permanent” (i.e., with AF/AFL at each ECG recording).     “This is a trial of major significance since no antiarrhythmic drug has ever been shown to reduce major morbidity and mortality in permanent AF patients in a large-scale clinical trial,” said Stuart Connolly, MD, Division of Cardiology, McMaster University, Hamilton, Canada, one of the trial’s principal investigators. “We designed the PALLAS trial to further assess the role of Multaq^® to reduce cardiovascular outcomes in patients with AF.”    The primary objective of the PALLAS trial is to demonstrate a reduction in either or both of two composite outcomes which are 1) major cardiovascular events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death) or 2) cardiovascular hospitalization or death from any cause among patients with permanent AF and additional risk factors. The secondary objectives are to evaluate the efficacy of Multaq^® in preventing cardiovascular death and whether the drug is well-tolerated in this patient population.     “We are looking forward to first patient enrollment of PALLAS in the third-quarter 2010,” said Marc Cluzel, MD, Executive Vice President, Research and Development, sanofi-aventis.