title: Antiarrhythmic efficacy of azimilide in patients with atrial fibrillation. Maintenance of sinus rhythm after conversion to sinus rhythm.
abstract: BACKGROUND
  Azimilide dihydrochloride (azimilide) is an investigational antiarrhythmic drug that has been tested in patients with a variety of arrhythmias. In patients with atrial fibrillation, it has shown excellent efficacy in some previous trials and minimal efficacy in others.
  
  
  METHODS
  Patients who had symptomatic atrial fibrillation for > 48 hours but < 6 months were eligible for this multicenter, randomized, placebo-controlled clinical trial. Patients were admitted to a hospital and randomly assigned to receive either azimilide 125 mg or a matched placebo twice daily for 3 days and then once daily. Patients who were in sinus rhythm spontaneously or had sinus rhythm restored by electric cardioversion on day 4 were discharged from the hospital. Recurrence of atrial fibrillation was documented by electrocardiogram. In the primary efficacy analysis, time to recurrence in the 2 treatment groups was compared with the log-rank test in the subgroup of patients with structural heart disease. Safety was assessed as deaths, adverse events, and serious adverse events.
  
  
  RESULTS
  A total of 446 patients were randomized in the study; 314 were in the subgroup with structural heart disease. The median time to arrhythmia recurrence in both treatment groups with structural heart disease was 13 days, and the difference between treatments was not significant (P = .4596, n = 314). The relative risk for recurrence (placebo:azimilide) was 1.104 (95% CI 0.849-1.436). There was 1 death in the placebo group and 3 in the azimilide group.
  
  
  CONCLUSIONS
  Azimilide did not demonstrate clinically important or statistically significant efficacy in reducing the risk for arrhythmia recurrence in patients with structural heart disease who were in atrial fibrillation and converted to sinus rhythm.
authors.affiliation: Duke University Medical Center, Durham, NC, USA. ed.pritchett@edwardpritchett.com
authors.forename: Edward L C
authors.initials: EL
authors.lastname: Pritchett
authors.forename: Peter
authors.initials: P
authors.lastname: Kowey
authors.forename: Stuart
authors.initials: S
authors.lastname: Connolly
authors.forename: Richard L
authors.initials: RL
authors.lastname: Page
authors.forename: Charles
authors.initials: C
authors.lastname: Kerr
authors.forename: William E
authors.initials: WE
authors.lastname: Wilkinson
mesh_terms: D000368:Aged; D000889:Anti-Arrhythmia Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001145:Arrhythmias, Cardiac / Q000401:mortality; D001281:Atrial Fibrillation / Q000188:drug therapy* / Q000503:physiopathology*; D005260:Female; D006339:Heart Rate / Q000187:drug effects*; D006801:Humans; D006827:Hydantoins; D048289:Imidazolidines / Q000009:adverse effects / Q000627:therapeutic use*; D008133:Long QT Syndrome / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D013575:Syncope / Q000139:chemically induced; D016171:Torsades de Pointes / Q000139:chemically induced; D016896:Treatment Outcome
chemical_list: D000889:Anti-Arrhythmia Agents; D006827:Hydantoins; D048289:Imidazolidines; D010879:Piperazines; C086123:azimilide