PASCAL: Budiodarone reduces AF burden in patients with pacemakers

A dose-dependent reduction in AF burden was observed in the study.

Heart Rhythm Society's 30th Annual Scientific Sessions

A chemical analog of amiodarone with a shorter half-life and reduced dependence on CYP450 for clearance can reduce AF burden in patients with paroxysmal AF, according to study results presented at Heart Rhythm 2009 in Boston.

Researchers for the PASCAL trial enrolled 110 patients with paroxysmal AF and dual-chamber pacemakers and randomly assigned them to receive either 200 mg, 400 mg or 600 mg of ATI-2042 (budiodarone, Aryx) or placebo for 12 weeks, followed by a four-week washout period. The primary endpoint was the percent change in AF burden from baseline at 12 weeks.

According to the study results, there was a 54.4% reduction in AF burden (P=.015) in the 400 mg group and a reduction of 75.5% in the 600 mg group (P=.006) vs. placebo. A dose response was also observed (P=.0001). No drug-related serious adverse events were reported. There was no difference in AF burden between baseline and the washout period. The researchers also reported a reduction in the secondary endpoints of the number and duration of atrial tachyarrhythmia/AF episodes.

“Budiodarone significantly reduced AF burden by 75% over a 12-week period in the highest dose group, and there was a dose-dependent reduction in AF burden,” said Michael Ezekowitz, MD, vice president of clinical research at the Lankenau Institute for Medical Research in Wynnewood, Penn., during his presentation. “The drug is safe and well-tolerated, and interestingly, the dual-chamber pacemakers were used successfully to monitor AF burden in this double-blind trial. The data will obviously need to be confirmed in a definitive trial.” – by Eric Raible

For more information:

Ezekowitz M. LBCT II. Presented at: Heart Rhythm 2009; May 13-16, 2009; Boston.

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