title: A randomized, controlled trial of RSD1235, a novel anti-arrhythmic agent, in the treatment of recent onset atrial fibrillation.
abstract: OBJECTIVE
  The purpose of this study was to determine the efficacy and safety of intravenous RSD1235 in terminating recent onset atrial fibrillation (AF).
  
  
  BACKGROUND
  Anti-arrhythmic drugs currently available to terminate AF have limited efficacy and safety. RSD1235 is a novel atrial selective anti-arrhythmic drug.
  
  
  METHODS
  This was a phase II, multi-centered, randomized, double-blinded, step-dose, placebo-controlled, parallel group study. Fifty-six patients from 15 U.S. and Canadian sites with AF of 3 to 72 h duration were randomized to one of two RSD1235 dose groups or to placebo. The two RSD1235 groups were RSD-1 (0.5 mg/kg followed by 1 mg/kg) or RSD-2 (2 mg/kg followed by 3 mg/kg), by intravenous infusion over 10 min; a second dose was given only if AF was present. The primary end point was termination of AF during infusion or within 30-min after the last infusion. Secondary end points included the number of patients in sinus rhythm at 0.5, 1, and 24 h post-last infusion and time to conversion to sinus rhythm.
  
  
  RESULTS
  The RSD-2 dose showed significant differences over placebo in: 1) termination of AF (61% vs. 5%, p < 0.0005); 2) patients in sinus rhythm at 30 min (56% vs. 5%, p < 0.001); 3) sinus rhythm at 1 h (53% vs. 5%, p = 0.0014); and 4) median time to conversion to SR (14 vs. 162 min, p = 0.016). There were no serious adverse events related to RSD1235.
  
  
  CONCLUSIONS
  RSD1235, a new atrial-selective anti-arrhythmic agent, appears to be efficacious and safe for converting recent onset AF to sinus rhythm.
authors.affiliation: Montreal Heart Institute, University of Montreal, 5000 Belanger Street, Montreal, Quebec, Canada H1T 1C8. d_roy@icm-mhi.com
authors.forename: Denis
authors.initials: D
authors.lastname: Roy
authors.forename: Brian H
authors.initials: BH
authors.lastname: Rowe
authors.forename: Ian G
authors.initials: IG
authors.lastname: Stiell
authors.forename: Benoit
authors.initials: B
authors.lastname: Coutu
authors.forename: John H
authors.initials: JH
authors.lastname: Ip
authors.forename: Denis
authors.initials: D
authors.lastname: Phaneuf
authors.forename: Jacques
authors.initials: J
authors.lastname: Lee
authors.forename: Humberto
authors.initials: H
authors.lastname: Vidaillet
authors.forename: Garth
authors.initials: G
authors.lastname: Dickinson
authors.forename: Sheila
authors.initials: S
authors.lastname: Grant
authors.forename: Alan M
authors.initials: AM
authors.lastname: Ezrin
authors.forename: Gregory N
authors.initials: GN
authors.lastname: Beatch
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000889:Anti-Arrhythmia Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004569:Electroencephalography; D005260:Female; D005500:Follow-Up Studies; D006339:Heart Rate / Q000187:drug effects; D006439:Hemodynamics / Q000187:drug effects; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D000889:Anti-Arrhythmia Agents