CIBENZOLINE VERSUS ORAL PROPAFENONE IN TH E PREVENTION OF RECURRENT ATRIAL ARRHYTHMIAS - MULTICENTER RANDOMIZED DOUBLE-BLIND-STUDY

This multicentre, randomized, double-blind study, conducted in paralle l groups, was designed to compare the efficacy and safety of cibenzoli ne (C) and oral propafenone (P) in the prevention of recurrent atrial arrhythmias (M) over a 6-month period. Patients of either sex with red uced atrial fibrillation or flutter and predominantly in sinus rhythm (>50%), with a left ventricular shortening fraction greater than or eq ual to 20% and not receiving any antiarrhythmic treatment were include d, Patients presenting severe conduction disorders, severe heart failu re (NYHA class III or IV), marked hypotension or recent myocardial inf arction were not included, Treatments were administered at the dosage of one tablet twice a day, i.e. 260 mg/day of cibenzoline or 600 mg/da y of propafenone, This dosage was reduced by one half in elderly patie nts (>70 years), Patients were seen on inclusion (D0), and at the thir d and sixth months or in the case of recurrence of symptoms. Recurrent arrhythmias were assessed by ECG and 24-hour Holter monitoring and ac cording to the symptoms experienced by the patients. Sixty-five patien ts, 36 men and 29 women, between the ages of 34 to 86 years and presen ting an atrial arrhythmia - atrial fibrillation (80%) or atrial flutte r (20%)- were included in the trial: 34 patients received cibenzoline and 31 received propafenone.