Author(s) |
The Atrial Fibrillation Investigation with Bidisomide (AFIB) Investigators
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Title(s) |
Treatment of atrial fibrillation and paroxysmal supraventricular tachycardia with bidisomide
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Reference(s) |
Circulation 1997;96:2625-32
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Disease |
Atrial fibrillation, supraventricular tachycardia
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Purpose |
To determine the efficacy of bidisomide in atrial fibrillation and supraventricular tachycardia, to establish the appropriate dose range, and to detect any adverse mortality effect in atrial fibrillation
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Study design |
Randomised, double-blind, placebo-controlled
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Follow-up |
Aim 52 weeks
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Patients |
1227 patients with atrial fibrillation (mean age 63 years), 187 patients with paroxysmal supraventricular tachycardia (mean age 57 years). Aim 1900 in total
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Treatment regimen |
Bidisomide, 200, 400, or 600 mg bid, or placebo
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Results |
In the atrial fibrillation patients, there was no significant difference in the time to first symptomatic recurrence between the placebo group and any of the 3 bidisomide dose groups. The hazard ratios (placebo:treatment) were 1.19, 1.03 and 1.14 for bidisomide, 200, 400 and 600 mg bid, respectively. Results in the supraventricular tachycardia patients were similar (hazard ratios 1.30, 1.93 and 1.55; p = ns). In the primary safety analysis, 3 of 493 patients taking placebo died, compared to 9 of 488 patients taking 1 of the 2 higher doses of bidisomide (p < 0.10). The hazard ratio (bidisomide:placebo) was 2.82
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Comments |
This trial was terminated early because the unfavourable trend in mortality among patients receiving bidisomide was not balanced by substantial evidence of efficacy
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