Cardiome data show RSD1235 effective in lower dose

By Elaine Rigoli

Tampa, Fla., Sept. 13 - Cardiome Pharma Corp. released results from both the 300 mg and 600 mg dosing groups for its recently completed phase 2a pilot study of RSD1235 (oral).

For the 300 mg dosing group, 61% (33 of 54) of patients receiving RSD1235 (oral) completed the study in normal heart rhythm, as compared to 43% (24 of 56) of all patients receiving a placebo. For the 600 mg dosing group, 61% (30 of 49) of patients receiving RSD1235 (oral) completed the study in normal heart rhythm, as compared to 43% of all patients receiving a placebo.

A Kaplan-Meier analysis of the results demonstrated a statistically significant efficacy difference between the 300 mg dosing group and the placebo group.

However, the difference between the 600 mg dosing group and the placebo group trended toward but did not reach statistical significance.

The Vancouver, B.C., cardiovascular drug development company said a combined analysis of all drug group patients relative to the placebo group also demonstrated a statistically significant difference.

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