The US Food and Drug Administration (FDA) is reviewing data from a clinical trial that evaluated the effects of the antiarrhythmic drug Multaq (dronedarone) in patients with permanent atrial fibrillation.
The study was stopped early after the data monitoring committee found a two-fold increase in death, as well as two-fold increases in stroke and hospitalisation for heart failure in patients receiving Multaq compared to patients taking a placebo.
FDA is evaluating whether and how the preliminary results of the PALLAS study apply to patients taking Multaq for paroxysmal or persistent atrial fibrillation or atrial flutter. The PALLAS study results are considered preliminary at this stage because the data have not undergone quality assurance procedures and have not been completely adjudicated.
Multaq is approved for use to reduce the risk of cardiovascular hospitalisation 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, who are in sinus rhythm or who will be cardioverted.