A randomized, controlled trial of RSD1235, a novel anti-arrhythmic agent, in the treatment of recent onset atrial fibrillation
Denis Roy, MD, FACC*,*,
Brian H. Rowe, MD, MSc ,
Ian G. Stiell, MD, MSc ,
Benoit Coutu, MD ,
John H. Ip, MD||,
Denis Phaneuf, MD¶,
Jacques Lee, MD, MSc#,
Humberto Vidaillet, MD, FACC**,
Garth Dickinson, MD,
Sheila Grant, MBA,
Alan M. Ezrin, PhD,
Gregory N. Beatch, PhD for the CRAFT Investigators
* Montreal Heart Institute, University of Montreal, Montreal, Quebec, Canada
University of Alberta, Edmonton, Alberta, Canada
University of Ottawa, Ottawa, Ontario, Canada
CHUM-Notre Dame, Montreal, Quebec, Canada
|| Cardiovascular Institute, Lansing, Michigan
¶ CHUM-Hotel-Dieu, Montreal, Quebec, Canada
# University of Toronto, Toronto, Ontario, Canada
** Marshfield Clinic, Marshfield, Wisconsin
Cardiome Pharma, Vancouver, British Colombia, Canada
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Figure 1 Cumulative percentage of patients terminating atrial fibrillation (AF) after infusions of placebo, 0.5 and 1.0 mg/kg RSD1235, or 2.0 and 3.0 mg/kg RSD1235 in patients with recent onset AF. Efficacy was significantly higher after 2 + 3 mg/kg RSD1235 than after placebo (p = 0.0003) and was significantly different between the two RSD1235 (p = 0.002) dosing regimens. The median time for termination of AF was 11 min from the start of the first infusion in the RSD1235 treatment groups.
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Figure 2 Plasma concentrations of RSD1235 after infusion in patients dosed at 2 mg/kg intravenously (inverted triangles) and those additionally dosed at 3 mg/kg intravenously (circles). The RSD1235 doses were infused over 10 min, as indicated in the text. Initially, a 2-mg/kg infusion was given, and, if required, an additional 3 mg/kg was infused 30 min later in the RSD-2 group. Time is shown relative to the end of the first infusion (T1).
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