METHODS AND RESULTS: In this clinical trial, 1227 patients with
atrial fibrillation and 187 with
paroxysmal supraventricular tachycardia were randomly assigned to
bidisomide (200, 400, or 600 mg BID) or placebo; patient groups with each
arrhythmia were analyzed separately. Symptomatic recurrences of
atrial fibrillation and
paroxysmal supraventricular tachycardia were documented with the use of transtelephonic ECG monitoring. The time to the first symptomatic
arrhythmia recurrence was measured in each patient and compared among treatment groups. Among the
atrial fibrillation patients, there was no significant difference in the time to first symptomatic recurrence between the placebo group and any of the three
bidisomide treatment groups; the hazard ratios (placebo:treatment) were 1.19, 1.03, and 1.14 for
bidisomide 200, 400, and 600 mg BID, respectively. Among
paroxysmal supraventricular tachycardia patients, there was a similar lack of a significant treatment effect; the hazard ratios were 1.30, 1.93, and 1.59 for
bidisomide 200, 400, and 600 mg BID, respectively. In the primary safety analysis of mortality, 3 of 493 patients taking placebo died, compared with 9 of 488 patients taking one of the two higher doses of
bidisomide (P>.10).
CONCLUSIONS: