title: Efficacy of azimilide for the maintenance of sinus rhythm in patients with paroxysmal atrial fibrillation in the presence and absence of structural heart disease.
abstract: Azimilide hydrochloride (azimilide), an investigational antiarrhythmic drug, has shown variable efficacy in preventing atrial fibrillation (AF). This study was designed to assess its efficacy in maintaining sinus rhythm in patients with paroxysmal AF and heart disease. Patients with symptomatic paroxysmal AF were screened for 1 month by transtelephonic monitoring. After recording 1 episode of AF in the screening period, they were randomized to receive azimilide 125 mg or placebo once daily. Patients were stratified by the presence or absence of congestive heart failure or coronary heart disease (CHF/CHD). A maximum of 220 patients without CHF/CHD were randomized, with the remainder having CHF/CHD. Patients with CHF/CHD were monitored for 3 days during loading. The primary efficacy analysis was the time to the first symptomatic recurrence of AF in the CHF/CHD group. Secondary analyses were the time to the first recurrence in the entire population and the time to the first recurrence in those with significant structural heart disease. The median time to recurrence of AF in the CHF/CHD group was 10 days in the 2 treatment arms. Nonsignificant trends were seen toward efficacy of azimilide in the CHF/CHD group (hazard ratio 1.28, 95% confidence interval 0.97 to 1.70, p=0.087), structural heart disease group (hazard ratio 1.22, 95% confidence interval 0.96 to 1.56, p=0.11), and overall group (hazard ratio 1.22, 95% confidence interval 1.00 to 1.49, p=0.053). No patient died. In conclusion, azimilide showed a nonsignificant trend toward efficacy in maintaining sinus rhythm in patients with AF.
authors.affiliation: St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada. ckerr@providencehealth.bc.ca
authors.forename: Charles R
authors.initials: CR
authors.lastname: Kerr
authors.forename: Stuart J
authors.initials: SJ
authors.lastname: Connolly
authors.forename: Peter
authors.initials: P
authors.lastname: Kowey
authors.forename: Richard L
authors.initials: RL
authors.lastname: Page
authors.forename: Edward L C
authors.initials: EL
authors.lastname: Pritchett
authors.forename: Mikhail Y
authors.initials: MY
authors.lastname: Ruda
authors.forename: Witold
authors.initials: W
authors.lastname: Ruzyllo
authors.forename: William E
authors.initials: WE
authors.lastname: Wilkinson
mesh_terms: D000889:Anti-Arrhythmia Agents / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D016001:Confidence Intervals; D003327:Coronary Disease / Q000150:complications* / Q000503:physiopathology; D004562:Electrocardiography; D005260:Female; D006333:Heart Failure / Q000150:complications* / Q000503:physiopathology; D006339:Heart Rate / Q000187:drug effects* / Q000502:physiology; D006801:Humans; D006827:Hydantoins; D048289:Imidazolidines / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010879:Piperazines / Q000627:therapeutic use*; D013614:Tachycardia, Paroxysmal / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D016896:Treatment Outcome
chemical_list: D000889:Anti-Arrhythmia Agents; D006827:Hydantoins; D048289:Imidazolidines; D010879:Piperazines; C086123:azimilide