Sanofi-aventis commences multinational Phase IIIb PALLAS trial of Multaq in permanent AF patients

May 12 2010

- New Outcomes Trial to Expand Evidence for Dronedarone in a Different AF Population

Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today the initiation of a multinational, randomized double-blind Phase IIIb trial, PALLAS, to assess the potential clinical benefit of Multaq(R) (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.

In the U.S., Multaq(R) is indicated to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors (i.e., age >70, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter ≥50 mm or left ventricular ejection fraction [LVEF] <40%), who are in sinus rhythm or who will be cardioverted. Multaq(R) is contraindicated in patients with NYHA Class IV heart failure, or NYHA Class II-III heart failure with a recent decompensation requiring hospitalization or referral to a specialized heart failure clinic.

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 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, 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(R) 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 atrial fibrillation and additional risk factors. The secondary objectives are to evaluate the efficacy of Multaq(R) in preventing cardiovascular death and whether the drug is well-tolerated in this patient population.

"The initiation of the PALLAS trial signals our strong belief in Multaq(R) and our commitment to improve AF patient well-being and overall cardiovascular health," said Marc Cluzel, MD, Executive Vice President, Research and Development, sanofi-aventis. "We are looking forward to first patient enrolment of PALLAS in Q3 2010."