CARDIOME ANNOUNCES DATA FROM TRIAL IN ATRIAL FIBRILLATION
Cardiome Pharma has announced top-line results from both the 300- and 600-mg dosing groups for its recently completed Phase IIa pilot study of RSD1235 (oral). The study was initiated in December 2005, and an interim analysis of the 300-mg dosing group relative to the initial placebo group was announced in July 2006.
The double-blind, placebo-controlled, randomized, dose-ranging study was designed to explore safety and tolerability, pharmacokinetics and preliminary efficacy of RSD1235 over 28 days of dosing in patients at risk of recurrent atrial fibrillation. For the 300-mg group, 61 percent of patients receiving RSD1235 completed the study in normal heart rhythm compared with 43 percent of all patients receiving placebo. For the 600-mg dosing group, 61 percent of patients receiving RSD1235 completed the study in normal heart rhythm compared with 43 percent of all patients receiving placebo.
A Kaplan-Meier analysis of the results demonstrated a statistically significant efficacy difference between the 300-mg group and the placebo group. The difference between the 600-mg group and the placebo group trended toward but did not reach statistical significance. A combined analysis of all drug patients relative to the placebo group also demonstrated a statistically significant difference.
For the entire study, a total of 171 patients were successfully cardioverted after the initial 3 days of dosing and continued in the study, of which 159 reached an endpoint of the study (completion of dosing or relapse to atrial fibrillation). The rest of the patients were discontinued from the study for reasons unrelated to atrial fibrillation.
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