July 15, 2008
Cardiome Reports Positive Results From Phase II Atrial Fibrillation Study
Cardiome Pharma has announced positive clinical results from its 90-day Phase IIb study of vernakalant. The final analysis demonstrated statistically significant efficacy for the patient group receiving 500mg bid of vernakalant as compared to placebo.
The safety data from the final analysis also shows that vernakalant (oral) was well-tolerated in the atrial fibrillation population studied. The final results demonstrated that the 500mg dosing group significantly reduced the rate of atrial fibrillation relapse as compared to placebo (two-sided log rank, p=0.0221).The median time to recurrence of atrial fibrillation was greater than 90 days for the 500mg dosing group, compared to 27 days for the placebo group, an even stronger signal of sinus rhythm maintenance than what was seen in the interim analysis.
Approximately 51% of patients in the 500mg dosing group (n=150) completed the study in normal heart rhythm compared to 37% of patients receiving placebo (n=160). Both the 150mg (n=147) and 300mg (n=148) dosing groups also reduced the rate of atrial fibrillation relapse, but were not statistically significant when compared with placebo.
These results provide evidence of a clear dose response, with 500mg bid proving to be the effective dose to prevent the recurrence of atrial fibrillation in this trial.
Bob Rieder, chairman and CEO of Cardiome, said: "We are delighted to report clearly positive clinical results from our vernakalant (oral) program, which continue to support our belief in the exciting potential of vernakalant as a therapy for atrial fibrillation."