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RxTrials Institute Drug Pipeline Alert
Feb. 8, 2005 | Vol. 3 No. 27
Cardiome Reports Additional ACT 1 Clinical Results
Cardiome Pharma and its co-development partner Fujisawa Healthcare has announced additional results from their recently completed 416-patient atrial arrhythmia (AF) clinical study, called ACT 1.
Top-line results for ACT 1 showed the drug converted 52 percent of recent-onset patients to normal heart rhythm, while causing no side-effect arrhythmias. The additional data covered three aspects of the clinical data that were not previously available: the time to conversion, the rate of relapse to AF, and the conversion rate in the atrial flutter subgroup.
In the recent-onset AF patients dosed with intravenous RSD1235 who converted to normal heart rhythm, the median time to conversion was 11 minutes from the initiation of dosing. This study result correlates very closely with the data from Cardiome's CRAFT Phase II study where the mean time to conversion was 11 minutes from the initiation of dosing.
Of those recent-onset AF patients dosed with RSD1235 who converted to normal heart rhythm within 90 minutes of the initiation of dosing, 1 of 75 patients relapsed to atrial arrhythmia within 24 hours. This relapse rate also compares well with the earlier data from the CRAFT Phase 2 study, where 0 of 11 RSD1235-dosed patients who met the primary endpoint reverted back to atrial fibrillation within 24 hours.
RSD1235 appears to be ineffective in converting atrial flutter patients to normal heart rhythm. Only 1 of 39 patients dosed with RSD1235 converted to normal heart rhythm, while 0 of 15 placebo patients converted to normal heart rhythm. In the 30 day interval following treatment administration, serious adverse events occurred in 27 percent of placebo patients and 18 percent of drug group patients. Potentially drug-related serious adverse events occurred in 0 placebo patients and in two patients receiving RSD1235. Patients with atrial flutter account for approximately 8 percent of the 2.4 million patients with atrial arrhythmia.
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