Articles tagged ‘PALLAS’

Dronedarone increases rates of serious vascular events in patients with permanent atrial fibrillation (AF) and additional cardiovascular risk factors, according to the PALLAS (Permanent Atrial Fibrillation Outcome Study Using Dronedarone on Top of Standard Therapy) trial¹ published recently in the New England Journal of Medicine.

The European Medicines Agency (EMA) is reviewing the cardiovascular (CV) risk associated with the anti-arrhythmic drug, dronedarone¹ (Multaq®, Sanofi-Aventis), following the company’s recent discontinuation of the phase IIIb PALLAS (Permanent Atrial fibriLLAtion outcome Study using Dronedarone on top of standard therapy) trial after it found increased CV events in those randomised to the drug.

The initiation of 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, was announced during the Heart Rhythm Society’s 31st Annual Scientific Sessions.