Abstract | BACKGROUND: 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:
|
Authors | Edward L C Pritchett, Peter Kowey, Stuart Connolly, Richard L Page, Charles Kerr, William E Wilkinson, A-COMET-I Investigators |
Journal | American heart journal
(Am Heart J)
Vol. 151
Issue 5
Pg. 1043-9
(May 2006)
ISSN: 1097-6744 [Electronic] United States |
PMID | 16644334
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
|
Chemical References |
- Anti-Arrhythmia Agents
- Hydantoins
- Imidazolidines
- Piperazines
- azimilide
|
Topics |
- Aged
- Anti-Arrhythmia Agents
(adverse effects, therapeutic use)
- Arrhythmias, Cardiac
(mortality)
- Atrial Fibrillation
(drug therapy, physiopathology)
- Female
- Heart Rate
(drug effects)
- Humans
- Hydantoins
- Imidazolidines
(adverse effects, therapeutic use)
- Long QT Syndrome
(chemically induced)
- Male
- Middle Aged
- Piperazines
(adverse effects, therapeutic use)
- Syncope
(chemically induced)
- Torsades de Pointes
(chemically induced)
- Treatment Outcome
|