[Cibenzoline versus propafenone by the oral route for preventing recurrence of atrial arrhythmia: multicenter, randomized, double-blind study]. / Cibenzoline versus propafénone par voie orale dans la prévention de la récidive des arythmies auriculaires: étude multicentrique randomisée réalisée en double aveugle.

This multicentre, randomized, double-blind study, conducted in parallel groups, was designed to compare the efficacy and safety of cibenzoline (C) and oral propafenone (P) in the prevention of recurrent atrial arrhythmias (M) over a 6-month period. Patients of either sex with reduced atrial fibrillation or flutter and predominantly in sinus rhythm (> 50%), with a left ventricular shortening fraction greater than or equal to 20% and not receiving any antiarrhythmic treatment were included. Patients presenting severe conduction disorders, severe heart failure (NYHA class III or IV), marked hypotension or recent myocardial infarction 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/day of propafenone. This dosage was reduced by one half in elderly patients (> 70 years). Patients were seen on inclusion (Dzero), and at the third and sixth months or in the case of recurrence of symptoms. Recurrent arrhythmias were assessed by ECG and 24-hour Holter monitoring and according to the symptoms experienced by the patients. Sixty-five patients, 36 men and 29 women, between the ages of 34 to 86 years and presenting an atrial arrhythmia-atrial fibrillation (80%) or atrial flutter (20%)-were included in the trial: 34 patients received cibenzoline and 31 received propafenone. The arrhythmia had already been treated in 78% of cases. Its aetiology was related to hypertensive heart disease (32%), valvular heart disease (8%), other (17%) or idiopathic (43%). The arrhythmia was symptomatic in 91% of patients on inclusion. The ultrasonographic left ventricular shortening fraction was 32.8 +/- 8.1% in group C and 32.6 +/- 6.4% in group P. The two groups were comparable before treatment. The efficacy of the two treatments was comparable: no significant difference in the number of recurrences was demonstrated: 11 patients treated with C and 12 patients treated with P; cumulative percentages of patients without recurrence with good tolerance of treatment (Kaplan-Meier acturial curves) at 6 months were 55.9% with C and 48.4% with P(NS); probability of no recurrence at 6 months (0.63 +/- 0.09 in group C and 0.57 +/- 0.09 in group P); mean time to recurrence (53.4 +/- 44.3 days in group C and 61.6 +/- 35.3 days in group P). Adverse events leading to discontinuation of treatment occurred in 4 patients from each group, and one proarrhythmic effect at 6 months in a patient in group P. The treatments were well tolerated in the majority of cases: there was no significant difference in the number of patients presenting at least one adverse event: 9(26.5%) in group C, 11(35.5%) in group P. Most events were considered to be mild or moderate. The effects of the two treatments on the course of blood pressure, heart rate, PR interval and QT interval calculated at 3 and 6 months compared to DO were not statistically different. The QRS interval increased to a significantly greater extent in group C that in group P (p = 0.02 at 3 months; p = 0.0005 at 6 months). No significant difference was observed between the two groups for the course of laboratory parameters at 3 and 6 months compared to DO in the patients present at these three visits. Cibenzoline can therefore constitute a good alternative to propafenone in the prevention of symptomatic recurrences of atrial tachyarrhythmias. The preferential use of one or other treatment can be guided by individual factors, including tolerance.

[Comparative study of the efficacy and tolerability of 2 modalities of intravenous cibenzoline administration in the reduction of recent spontaneous atrial arrhythmia]. / Etude comparative de l'efficacité et de la tolérance de deux modalités d'administration de la cibenzoline intraveineuse dans la réduction des arythmies auriculaires spontanées et récentes.

This multicentre, single blind, parallel group study compared the efficacy and clinical and electrocardiographic tolerance of a 2 minute intravenous administration of cibenzoline at a dose of 1.2 mg.kg-1 with that of a 10 minute 1.75 mg.kg-1 infusion in patients presenting with spontaneous atrial fibrillation (AF) for less than 6 weeks. Sixty-two patients (40 men and 22 women) with an average age of 62 years and presenting with sustained AF for at least 30 minutes with a ventricular rate greater than or equal to 80 bpm were randomly assigned to groups and received via the intravenous route either one of the two treatments. Efficacy (return to sinus rhythm) was assessed by an ECG recording every 5 minutes and at 45 and 60 minutes thereafter. Sixty-one of the 62 randomised patients were assessed for efficacy. Cibenzoline, administered in the form of a bolus or infusion, proved effective within one hour in 4 patients in each group (13%) and arrhythmia persisted with ventricular rate of less than 80 bpm in 10 (33%) and 5 (16%) of the patients respectively. In patients in whom sinus rhythm was not restored, ventricular rate was significantly reduced by cibenzoline. The patients in whom normal rhythm was restored under one of these treatment regimens were significantly younger. Patients in whom rhythm returned to normal following the administration of the bolus had AF of significantly more recent onset than that of the patients in whom abnormal rhythm persisted, whilst the history of the AF did not differ significantly between these two types of response after the infusion.(ABSTRACT TRUNCATED AT 250 WORDS)

[Value of cibenzoline in the preventive treatment of recurrent atrial arrhythmia]. / Intérêt de la cibenzoline dans le traitement préventif des arythmies auriculaires récidivantes.

Cibenzoline is a Vaughan-Williams class I anti-arrhythmic with properties intermediate between subclasses IA and IC which limit the incidence of proarrhythmic effects. These specific properties of the drug facilitate the prescription of cibenzoline in cardiology, particularly for the prevention of recurrent atrial arrhythmia: fibrillation, flutter, atrial tachycardia. This study demonstrates that cibenzoline is effective in these indications, since only 23% of the patients had relapsed after 6 months. This efficacy, combined with the good tolerance of the treatment, makes it possible to recommend the prescription of cibenzoline as a first-line treatment for the prevention of atrial arrhythmia. It represents an effective and safe option.