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."
Dronedarone increased rates of heart failure, stroke, and death from cardiovascular causes in patients with permanent atrial fibrillation who were at risk for major vascular events. Our data show that this drug should not be used in such patients.