Sanofi-Aventis Begins Study Of Heart Drug Multaq In 10,000 Patients For Expanded Use

Pharmaceutical company Sanofi-Aventis Wednesday said it has initiated a Phase IIIb trial of Multaq in over 10 thousand patients with permanent atrial fibrillation or abnormal heart rhythm. The Paris, France-based company’s study is focused on assessing the potential clinical benefit of the drug in reducing major adverse cardiovascular events, and it expects first patient enrollment to begin in the third quarter of 2010.

Multaq, or dronedarone, an antiarrhythmic drug, has completed clinical trials in more than 7,000 patients and has met the primary endpoint by reducing cardiovascular hospitalization or death by 24%. The company added that the incidence of atrial fibrillation is growing worldwide in relation to aging populations, increasing the risk of stroke up to five-fold, worsening the prognosis of patients with cardiovascular risk factors and doubling the risk of mortality.

The Phase IIIb study, dubbed PALLAS, is conducted primarily to demonstrate a reduction in major cardiovascular events like stroke, systemic arterial embolism, myocardial infarction or cardiovascular death. In addition, the study aims to lessen cardiovascular hospitalization or death from any cause among patients with permanent atrial fibrillation and additional risk factors.

The company said the secondary objectives are to evaluate the efficacy of Multaq in preventing cardiovascular death and to check whether the drug is well-tolerated in this patient population.

Stuart Connolly, MD, Division of Cardiology, McMaster University, Hamilton, Canada, one of the trial’s principal investigators commented, “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. We designed the PALLAS trial to further assess the role of Multaq(R) to reduce cardiovascular outcomes in patients with AF.”

Sanofi-Aventis elaborated that PALLAS is a multinational, randomized, double-blind, parallel-group, placebo-controlled, multicenter trial comparing the efficacy of Multaq 400mg twice-daily with placebo in permanent atrial fibrillation patients. The study of Multaq is expected to be conducted on 10,800 patients enrolled in 43 countries at 700 sites.

Multaq, discovered and developed by sanofi-aventis, was granted marketing authorization by the European Commission in November last year to treat adult clinically stable patients with a history of, or current non-permanent atrial fibrillation to prevent recurrence of atrial fibrillation or to lower ventricular rate.

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