CIBENZOLINE VERSUS FLECAINIDE IN THE PREVENTION OF PAROXYSMAL ATRIAL ARRHYTHMIAS - A DOUBLE-BLIND RANDOMIZED STUDY

In a randomized, double-blind, parallel clinical trial, the authors te sted and compared flecainide and cibenzoline, a new antiarrhythmic dru g, 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 re ceived 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 month s and 6 months after the randomization day. Sixteen patients were with drawn (7 were lost to follow-up, 7 had side effects, 2 had another med ical event). Seventeen patients had documented recurrence of atrial ar rhythmia (9 in the cibenzoline group, 8 in the flecainide group) durin g 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 effec ts (cibenzoline, n = 6; flecainide, n = 5), justifying leaving the tri al 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 preventi ng atrial arrhythmia is good and similar during a follow-up period of 6 months. In view of these results, cibenzoline may be administered fi rst to prevent atrial arrhythmia.