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Cibenzoline Versus Flecainide in the Prevention of Paroxysmal Atrial Arrhythmias: A Double‐Blind Randomized Study
Author(s) -
Babuty D.,
D'Hautefeuille B.,
Scheck F.,
Mycinsky C.,
Pruvost P.,
Peraudeau P.
Publication year - 1995
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1002/j.1552-4604.1995.tb04090.x
Subject(s) - flecainide , medicine , double blind , cardiology , paroxysmal atrial fibrillation , atrial fibrillation , anesthesia , placebo , alternative medicine , pathology
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 Sixteen patients were withdrawn (7 were lost to follow‐up, 7 had side effects, 2 had another medical event).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.