July 7th, 2011
Dronedarone (Multaq) Study for Permanent AF Stopped Early
The PALLAS trial of dronedarone (Multaq) for permanent AF has been stopped early, according to a press release issued by Sanofi. PALLAS (Permanent Atrial fibriLLAtion outcome Study using Dronedarone on top of standard therapy) was a double-blind, placebo-controlled, phase IIIb trial of dronedarone in patients with permanent AF.
The company said the discontinuation of the trial resulted from recommendations from the study’s Operations Committee and the Data Monitoring Committee (DMC) following “a significant increase in cardiovascular events in the dronedarone arm.” The company said the study termination “was not related to any hepatic adverse event.” (Earlier this year the FDA warned about liver injury associated with dronedarone.) The company has informed regulatory authorities and has instructed PALLAS clinical investigators to tell patients enrolled in the study to stop taking the study medication. The company said that it remained “committed to Multaq as an essential treatment option for non-permanent AF patients.” (Dronedarone is currently approved for use only in patients with non-permanent AF.)
The trial had two composite co-primary endpoints: major cardiovascular events and cardiovascular hospitalization or death from any cause. According to ClinicalTrials.Gov, the study was started in July 2010 and scheduled to be completed in August 2013 with a planned enrollment of 10,800 patients.
The co-principal investigator of PALLAS, Stuart Connolly, said in the press release that “the PALLAS Operations Committee is very disappointed to discover that the hypothesis that dronedarone would improve major outcomes for this high risk patient population has been refuted.”
Sanofi said that 400,000 patients worldwide have now been treated with dronedarone.
Click here for previous coverage of dronedarone on CardioExchange.