The interim analysis demonstrated a clear positive trend toward efficacy, with 61% (33 of 54) of patients receiving RSD1235 completing the study with normal heart rhythm, as compared to 37% (10 of 27) of patients receiving placebo. The drug also appeared to be well tolerated at the 300mg dosage tested.
“We are very pleased with these results and are enthusiastic about the prospects of RSD1235 (oral) as a therapy for the prevention of recurrence of atrial fibrillation,” said Dr Charles Fisher, chief medical officer of Cardiome. “The 300mg dose is well below the maximum tolerated dose indicated by our phase I studies, and to see a positive safety profile coupled with a clear trend toward efficacy at these levels is very encouraging.”
Cardiome initiated the phase IIa pilot study of RSD1235 (oral) in December 2005. The study is being conducted across 72 centers in Canada, US and Europe.