Ranolazine: Phase II data

The double-blind, international Phase II HARMONY trial in 134 patients with paroxysmal AF showed that twice-daily 750 mg oral ranolazine plus 150 and 225 mg dronedarone each led to greater reductions in AF burden from baseline to week 12, the primary endpoint, vs. placebo. Specifically, ranolazine plus 150 mg dronedarone reduced AF burden by 45% and ranolazine plus 225 mg dronedarone reduced AF burden by 59% from baseline to week 12 compared to placebo (p=0.072 and p=0.008, respectively). In patients who received ranolazine plus 225 mg dronedarone (n=27), 45% achieved AF burden reductions from baseline of >=70% over 12 weeks. Neither 750 mg ranolazine alone (p=0.49) nor 225 mg dronedarone alone (p=0.78) led to significant reductions in AF burden from baseline to week 12 vs. placebo. Data were presented at the Heart Rhythm Society meeting in San Francisco. Gilead said it plans to start Phase III testing with a fixed-dose combination of ranolazine and low-dose dronedarone for paroxysmal/persistent AF, but did not disclose a time frame. ...