COMPARATIVE-STUDY OF ORAL TREATMENT WITH CIBENZOLINE AND FLECAINIDE IN THE SECONDARY PREVENTION OF PAROXYSMAL ATRIAL TACHYARRHYTHMIAS

Although paroxysmal atrial arrhythmias are the commonest form of arrhy thmia, their therapeutic management still remains controversial. Seven ty one patients-were included in a multicentre, randomized double-blin d, double-placebo study, in parallel groups (37 in group C and 34 in g roup F) to compare the efficacy of cibenzoline (C) and flecainide (F), administered orally, in the prevention of recurrent atrial arrhythmia . The arrhythmia usually consisted of atrial fibrillation (n = 65), wh ile 6 patients presented with paroxysmal atrial flutter. The mean dail y dosages were 221 +/- 60 mg (C) and 165 +/- 49 mg (F). The mean age w as 63 +/- 12 years in group C and 63 +/- 16 years in group F. In this trial, atrial arrhythmia was idiopathic in almost two-thirds of cases. The duration of follow-up of this study was 6 months, during which re currences of arrhythmia were evaluated in terms of the symptoms experi enced and in terms of ECG and Holter examinations repeated at the 3rd and 6th months. Supplementary ECG and Holter examinations were also pe rformed in the presence of a clinical suspicion of recurrent symptoms. Comparison of the percentages of patients not developing a documented recurrence and who tolerated treatment, by Kaplan-Meier curves, showe d a significant difference between cibenzoline (58%) and flecainide (5 6%), In the not-responders, the mean time to recurrence was 75 +/- 48 days in group C and 75 +/- 62 days in group F (NS). Six patients dropp ed out of the trial because of adverse events, including 3 cardiac adv erse events (2 case of ventricular proarrhythmic activity). Four extra cardiac adverse events led to discontinuation of treatment in group C. In conclusion, the efficacy of cibenzoline and flecainide in the seco ndary prevention of atrial arrhythmia was found to be comparable, with 58% and 56% of patients in sinus rhythm, respectively, with a follow- up of 6 months.