Abstract 2756: Time Dependent Efficacy of Budiodarone, an Analog of Amiodarone, in Patients With Paroxysmal AF and Implantable Pacemaker Capable of Monitoring Rhythm
Budiodarone (B) has similar electrophysiological properties to but a better pharmacokinetic profile than amiodarone (shorter half-life, esterase metabolism, limited CYP metabolism). Our goal is to study the time dependent efficacy of B for the three doses tested in the phase 2 PASCAL study in reducing AF burden (AFB) each month during the three month treatment phase.
Methods: Following 4 weeks of baseline (BL) observation, patients (pts) with AFB between 3–70% were randomized to placebo (P), 200, 400 and 600mg BID of B for 12 weeks followed by a 4 week washout period. Pacemaker (PM) recorded AFB was downloaded every month. PM downloads were adjudicated by an independent, blinded core lab. The efficacy of B was recorded as % change in AFB on treatment compared to baseline. Significance was tested by Wilcoxon single rank test.
Results: A total of 110 pts were enrolled. At the end of BL period, 72 pts met randomization criteria and 61 pts completed the study. Pts were 71 yrs old, 54% male, 71% symptomatic and 60% with CHF (43% NYHA I &17% NYHA II). Median BL AFB was 11.7, 18.3, 21.0, 18.2% for P, 200, 400, 600 mg BID respectively (NS). There was a significant reduction in median % change from BL for the 400, 600 mg groups by the first month of treatment (fig⇓)
Conclusions: Budiodarone demonstrated efficacy at least by four weeks after initiation in the 400 mg and 600 mg BID dose arms and a trend for efficacy in the 200 mg BID dose arm.