Cardiome Reports Positive Heart Drug Data With Lower Dose Better Than Higher Dose

Cardiome Pharma Corp. said Wednesday that a mid-stage clinical trial showed its experimental drug normalized heartbeats in patients with the lower dose performing better than the higher dose.

The Phase IIa trial treated patients with atrial fibrillation, a type of irregular heart beat where the upper chambers of the heart quiver and do not pump blood effectively to the lower chambers. Patients were given either 300 milligrams or 600 milligrams of RSD1235 or a placebo intraveneously.

In the 300 milligrams group, 61 percent of patients had a normal heartbeat by the end of the study, compared with 43 percent taking placebo. This difference was statistically significant, the type of difference the Food and Drug Administration looks for in a drug application.

However, in the 600 milligram group, the difference was not statistically significant even though the percentages were the same, because fewer people participated in the higher-dose group.

When both dose groups were combined, the difference was statistically significant.

Cardiome Pharma shares fell $1.63, or 12.25 percent, to $11.68 in lat afternoon trading on the Nasdaq.