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Experts await more data on dronedarone
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Boston AF Symposium
BOSTON — Varying clinical trial results and recent FDA labeling changes to warn of the risks for serious CV events have left many cardiologists questioning when and how to use dronedarone.
During a presentation at the 17th Annual Boston Atrial Fibrillation Symposium, Peter Kowey, MD, chief of the division of CVD at Main Line Health and professor of medicine at Jefferson Medical School, Philadelphia, examined data from previous key clinical trials that studied dronedarone (Multaq, Sanofi-Aventis), such as EURIDIS/ADONIS, which found that dronedarone significantly prolonged time to first atrial fibrillation recurrence; ANDROMEDA, which was terminated early because of a twofold increase in mortality in patients taking dronedarone; and ATHENA, which showed reduced CV hospitalizations and mortality in a composite endpoint. Kowey said the results of the prematurely terminated PALLAS study should apply to patients using dronedarone for permanent AF and who have the clinical profile of patients enrolled in that trial.
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Despite unanswered questions, researchers have not given up on dronedarone, choosing to continue investigation for efficacy and safety endpoints. Kowey announced the launch of HARMONY, a randomized, double blind, placebo-controlled, parallel-arm, pacemaker-based trial that will examine the efficacy and safety of a dronedarone/ranolazine (Ranexa, Gilead Sciences) combination on AF burden. Researchers for the trial anticipate enrolling 150 patients with an AF burden of 3% to 50% at 45 sites in North America and Europe. HARMONY will investigate lower dronedarone and ranolazine doses than approved.
“The combination of dronedarone and ranolazine looks to be extremely effective in preclinical models,” Kowey, also a Cardiology Today Editorial Board member, said during his presentation. “There is still a lot of work to be done to provide clinical safety and efficacy.”
Until data from HARMONY and other trials are available, Kowey said dronedarone should not be used in patients with HF or permanent AF. Those patients who do use the drug should be monitored regularly by cardiologists and electrophysiologists to ensure that they remain within the approved indication and do not progress to permanent AF or new or worsening HF.
“Don’t give up on dronedarone,” Kowey said. “If you do use it, understand that it requires as much surveillance as any other antiarrhythmic drug.” – by Casey Murphy
For more information:
- Kowey P. Antiarrhythmic use in clinical practice: focus on clinical trials of dronedarone. Presented at: The 17th Annual International Boston AF Symposium; Jan. 12-14, 2012; Boston.
Disclosure: Dr. Kowey has provided consultation and has been a speaker for Sanofi-Aventis.
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A new antiarrhythmic drug that is highly effective and carries no safety baggage would be widely used in patients with symptomatic AF. The hope was that engineering the toxicity out of amiodarone while leaving its efficacy intact would accomplish that. However, we still don't know why amiodarone is as (apparently) effective as it is, and dronedarone has now accumulated a lot of safety baggage that makes it hard to use in practice. There are preclinical data that support the combined use of dronedarone and ranolazine, but, as with many other ideas, the trials have to be done before this approach is adopted clinically. It will be interesting to see what the combination does in patients with HF or those who progress to permanent AF, and how regulatory agencies will view whatever result emerges.
– Dan Roden, MD
Cardiology Today Editorial Board member
Disclosure:Dr. Roden reports consulting for Astellas, Novartis, Sanofi and Warner Chilcott.
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