Sanofi-aventis has initiated a multinational, 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 cardiovascular events. The announcement was made during Heart Rhythm 2010, the Heart Rhythm Society’s 31st Annual Scientific Sessions.

Permanent AF afflicts 50 per cent 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.

“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 Stuart Connolly, 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 major cardiovascular events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death) or cardiovascular hospitalization or death from any cause among patients with permanent atrial fibrillation 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.

“The initiation of the Pallas trial confirms our strong belief in Multaq and our commitment to improve AF patient well-being and overall cardiovascular health,” said Marc Cluzel, executive vice president, Research and Development, sanofi-aventis. “We are looking forward to first patient enrolment of Pallas in the third-quarter 2010.”

Pallas is a multinational, randomized, double-blind, parallel-group, placebo-controlled, multicenter phase-IIIb trial comparing the efficacy of Multaq 400mg twice-daily with placebo in permanent AF patients.

Multaq, discovered and developed by sanofi-aventis, has been studied in a clinical development programme, including seven international, multicenter, randomized clinical trials involving more than 7000 patients with almost 4000 patients receiving Multaq.