Healio
Healio
May 16, 2009
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Dronedarone effective for treatment of AF in different patient populations

Results from clinical trials evaluating dronedarone have been positive

Heart Rhythm Society's 30th Annual Scientific Sessions

Dronedarone is associated with a reduction in recurrent AF and may have other potential benefits.

According to Richard L. Page, MD, president of the Heart Rhythm Society and a professor of medicine and head of cardiology at the University of Washington School of Medicine in Seattle, results from studies of dronedarone in several patient populations published since 2007 have suggested that dronedarone can not only prolong the time to recurrence of AF, but may also yield benefits for other endpoints in different patient populations.

“A while back, the efficacy of dronedarone was shown in a dose-ranging study looking at placebo vs. several doses of dronedarone, and if you draw a line looking at the median time to occurrence, you can see that [the] 800 mg dose – or 400 mg twice daily – was more effective at prolonging the time to recurrence of AF than placebo or other doses,” Page said in his presentation. “That has been the dose that has subsequently been studied.”

Benefits, safety concerns

Page cited findings from several clinical trials evaluating dronedarone to show its potential benefits and drawbacks. He noted that the results from the EURIDIS and ADONIS trials, both published in 2007, suggested that dronedarone increased the time to recurrence of AF by 22% (EURIDIS) and 28% (ADONIS). The two trials were the first pivotal trials examining the drug.

However, results from the ANDROMEDA study suggested a potential safety signal, and the trial was terminated prematurely after a high mortality was reported in the dronedarone group vs. placebo (8.1% vs. 3.8%).

“Results from ANDROMEDA caused a fair amount of concern for safety, and any drug for approval in the United States needs to demonstrate both safety and efficacy,” Page said.

Page also shared data from the 504-patient DIONYSOS trial, which compared dronedarone with amioderone. The study results suggested that dronedarone was not as well tolerated as amioderone. The panel voted to recommend approval of dronedarone in March 2009.

Despite some safety concerns raised by ANDROMEDA and DIONYSOS, results from the ATHENA trial, a recently-published randomized trial enrolling 4,628 patients randomly assigned to placebo (n=2,327) or dronedarone 400 mg (n=2,301), suggested that dronedarone prolonged time to first hospitalization or death in moderate to high-risk patients with AF. In addition, results from several published substudies of the ATHENA population have suggested that dronedarone is associated with other potential benefits in patients.

“Dronedarone is an effective agent for the treatment of AF. It prolongs the time to occurrence, slows the rate in AF and reduces the combined endpoint of death and CV hospitalization,” Page concluded. “The clinical role for dronedarone will be determined with future study and clinical experience.” – by Eric Raible

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