Cibenzoline versus flecainide in the prevention of paroxysmal atrial arrhythmias: a double-blind randomized study.

Abstract

In a randomized, double-blind, parallel clinical trial, the authors tested and compared flecainide and cibenzoline, a new antiarrhythmic drug, on atrial arrhythmias. Sixty-eight patients (36 men, 32 women, mean age 62.5 +/- 1.6 years) with documented symptomatic paroxysmal atrial arrhythmias (fibrillation in 56, flutter in 12) were recruited and received either cibenzoline 260 mg/day (n = 33) or flecainide 200 mg/day (n = 35). Patients were assessed with physical examination, resting ECG, 24-hour ambulatory ECG recording, two-dimensional echocardiography, and standard biologic titrations before the inclusion day, and 3 months and 6 months after the randomization day. Sixteen patients were withdrawn (7 were lost to follow-up, 7 had side effects, 2 had another medical event). Seventeen patients had documented recurrence of atrial arrhythmia (9 in the cibenzoline group, 8 in the flecainide group) during the study. The efficacy of cibenzoline and flecainide for preventing recurrence of atrial arrhythmias was not significantly different (62.5% versus 71.4%). Eleven patients complained of one or more side effects (cibenzoline, n = 6; flecainide, n = 5), justifying leaving the trial in 6 cases (cibenzoline, n = 3; flecainide, n = 3). Two ventricular proarrhythmic effects were observed. No atrial proarrhythmic effects were reported. The efficacy of cibenzoline and flecainide for preventing atrial arrhythmia is good and similar during a follow-up period of 6 months. In view of these results, cibenzoline may be administered first to prevent atrial arrhythmia.

• Authors: D Babuty, B D'Hautefeuille, F Scheck, C Mycinsky, P Pruvost, P Peraudeau
• Journal: Journal of clinical pharmacology (J Clin Pharmacol) Vol. 35 Issue 5 Pg. 471-7 (May 1995) ISSN: 0091-2700 [Print] England
• PMID: 7657846 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial)

Chemical References

• Anti-Arrhythmia Agents
• Imidazoles
• Flecainide
• cifenline

Topics

• Aged
• Anti-Arrhythmia Agents (adverse effects, therapeutic use)
• Atrial Fibrillation (prevention & control)
• Atrial Flutter (prevention & control)
• Double-Blind Method
• Drug Tolerance
• Echocardiography
• Electrocardiography (methods)
• Electrocardiography, Ambulatory
• Female
• Flecainide (adverse effects, therapeutic use)
• Follow-Up Studies
• Humans
• Imidazoles (adverse effects, therapeutic use)
• Male
• Middle Aged
• Physical Examination
• Recurrence