July 9th, 2011
Will You Still Use Multaq (Dronedarone)? A CardioExchange Panel
With the news that the PALLAS study of dronedarone (Multaq) for permanent AF has been stopped early, CardioExchange convened a panel to address a simple question:
What use—if any—do you see for dronedarone given both the cessation of this trial and the recent data on liver toxicity associated with this agent?
Sorry, there are no polls available at the moment.
Stuart Connolly, MD (PI for the PALLAS study)
There is a big difference between the ATHENA and PALLAS trials—with only intermittent AF in the former and only permanent AF in the latter. The results of PALLAS do not negate ATHENA. Because ATHENA had more patients and much longer follow up compared with PALLAS, it had much more statistical power as well. It is still unclear if there is a causal link between dronedarone and liver toxicity. So there still appears to be a good rationale to use dronedarone in intermittent AF.
A basic tenet of treating AF is to avoid making the treatment worse than the disease. Multaq is not only ineffective in controlling AF episodes and often associated with side effects, but now, recent reports suggest it confers an increased risk of cardiovascular and hepatic toxicity. Therefore, I see no role for Multaq in the treatment of AF.
I read the brief announcement on the trial that was stopped, but with no additional data yet available, I plan to continue using dronedarone as I have been for suppressing atrial fibrillation episodes in appropriate symptomatic AF patients. I am routinely adding occasional liver-function tests as part of the follow-up of patients taking dronedarone.
The premature stopping of the PALLAS trial due to unacceptable safety concerns strengthens our previous caveat against off-label, indiscriminate use of dronedarone and narrows the therapeutic window of dronedarone to “low-risk” patients with non-permanent atrial fibrillation/flutter who are unable to tolerate other antiarrhythmic agents including amiodarone. Given its modest antiarrhythmic efficacy, lack of well-established safety advantage over amiodarone, huge cost disadvantage, and potential hepatic toxicity, I see this agent as having a limited role that is far from making dronedarone a “game changer” or an “important milestone” in management of atrial fibrillation.
Finally, this should strike a cautionary note for the guidelines to refrain from making strong recommendations that are not driven by high-quality evidence.
For those of you on the front lines of AF treatment, who among these panelists do you agree with—if anyone?