Abstract | BACKGROUND: METHODS: We studied 1518 patients with symptomatic congestive heart failure and severe left ventricular dysfunction at 34 Danish hospitals. We randomly assigned 762 patients to receive dofetilide, a novel class III antiarrhythmic agent, and 756 to receive placebo in a double-blind study. Treatment was initiated in the hospital and included three days of cardiac monitoring and dose adjustment. The primary end point was death from any cause. RESULTS: During a median follow-up of 18 months, 311 patients in the dofetilide group (41 percent) and 317 patients in the placebo group (42 percent) died (hazard ratio, 0.95; 95 percent confidence interval, 0.81 to 1.11). Treatment with dofetilide significantly reduced the risk of hospitalization for worsening congestive heart failure (risk ratio, 0.75; 95 percent confidence interval, 0.63 to 0.89). Dofetilide was effective in converting atrial fibrillation to sinus rhythm. After one month, 22 of 190 patients with atrial fibrillation at base line (12 percent) had sinus rhythm restored with dofetilide, as compared with only 3 of 201 patients (1 percent) given placebo. Once sinus rhythm was restored, dofetilide was significantly more effective than placebo in maintaining sinus rhythm (hazard ratio for the recurrence of atrial fibrillation, 0.35; 95 percent confidence interval, 0.22 to 0.57; P<0.001). There were 25 cases of torsade de pointes in the dofetilide group (3.3 percent) as compared with none in the placebo group. CONCLUSIONS:
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Authors | C Torp-Pedersen, M Møller, P E Bloch-Thomsen, L Køber, E Sandøe, K Egstrup, E Agner, J Carlsen, J Videbaek, B Marchant, A J Camm |
Journal | The New England journal of medicine
(N Engl J Med)
Vol. 341
Issue 12
Pg. 857-65
(Sep 16 1999)
ISSN: 0028-4793 [Print] United States |
PMID | 10486417
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anti-Arrhythmia Agents
- Phenethylamines
- Sulfonamides
- dofetilide
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Anti-Arrhythmia Agents
(adverse effects, therapeutic use)
- Atrial Fibrillation
(drug therapy, etiology, prevention & control)
- Double-Blind Method
- Electrocardiography
(drug effects)
- Female
- Heart Failure
(complications, drug therapy, mortality)
- Hospitalization
(statistics & numerical data)
- Humans
- Male
- Middle Aged
- Phenethylamines
(adverse effects, therapeutic use)
- Secondary Prevention
- Sulfonamides
(adverse effects, therapeutic use)
- Survival Analysis
- Torsades de Pointes
(chemically induced)
- Ventricular Dysfunction, Left
(etiology)
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