Articles tagged ‘dronedarone’

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.

“Hypertension is the most prevalent risk factor leading to the development of atrial fibrillation (AF), the most common arrhythmia” according to Dr I Grundvold, University of Oslo.

Sanofi-aventis has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has adopted a positive opinion recommending to grant a marketing authorization in the European Union for Multaq® (dronedarone – 400mg Tablets).

Use of the antiarrhythmic drug dronedarone significantly reduced the risk of hospitalisation due to cardiovascular events or death in patients with paroxysmal or persistent atrial fibrillation or flutter in the ATHENA trial. New data are now available on trial patients with heart failure.