Friday, July 08, 2011


Dronedarone is a drug that was FDA approved in 2009. It was indicated for the treatment of non-permanent atrial fibrillation. Atrial fibrillation is the arrhythmia of the decade. In the ATHENA trial, dronedarone was shown to be efficacious in reducing the number of first hospitalisation from atrial fibrillation and also seem to reduced the number of cardiovascular deaths. That all sounded good, and Dronedarone was launshed at the beginning of this year, in Malaysia, with some Greek pomp.
Now, in a press release by Sanofi-Aventis, the maker of Dronedarone, the company has stopped an on-going dronedarone trial name PALLAS ( Permanent Atrial fibriLLation outcome Study using dronedarone on top of standard therapy). This study started in 2010, and was still enrolling patients. It is due for completion in 2013. It targeted 10,800 patients and to date, it had just completed enrollment of 3,149 patients. Its aim was to study to see if dronedarone therapy will improve the cardiovascular outcomes in patients with permanent atrial fibrillation.
The data safety monitoring committee that met recently, noticed an increase in the number of CV events in the dronedarone arm, so the trial has been halted. This obviously is of great concern to me as I do have some patients on dronedarone for non-permanent atrial fibrillation. Although the company advised that it is still safe for non-permanent atrial fibrialltion, I am concerned, and wonder if I should withdraw the drug.
It is true that the PALLAS population is sicker then the ATHENA population. In PALLAS, besides the presence of permanent atrial fibrillation, the patients also have one important cardiovascular risk factor including previous stroke or heart attack.
The company was not willing to tell us, which cardiovascular side effects seemed related to the drug. This is also of importance to us.
Dronedarone in Malaysia is marketed under the trade name of MULTAG.

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