[A randomized double-blind trial comparing cibenzoline and disopyramide in the prevention of recurrences of atrial tachyarrhythmia]. / Etude randomisée en double aveugle comparant la cibenzoline et le disopyramide dans la prévention de récidives de tachyarythmies atriales.

The aim of this multicenter, randomised, double-blind trial was to compare the efficacy and tolerance of oral disopyramide (D: 250 mg slow release twice daily) compared with cibenzoline (C: 130 mg twice daily) in the prevention of recurrences of atrial arrhythmias over a 6 month period. Sixty patients (mean age: 62 +/- 14 years; 37 men, 23 women; cardiac disease in 60% of cases) were randomised to two groups: C (N = 31) and D (N = 29). The commonest arrhythmia was atrial fibrillation (83%). The arrhythmia was recent (< 3 months) in 41% of patients and present for more than one year in 38% of patients. Sixteen patients of Group C (52%) and 11 of Group D (38%) had recurrences after an average of 79 +/- 58 days for Group C and 58 +/- 40 days for Group D (p = NS). The probability of absence of recurrence at 6 months was 36 +/- 11% in Group C and 55 +/- 10% in Group D (p = NS). Four patients in Group C (13%) and 13 patients in Group D (45%) had at least one unwanted side-effect (p = 0.009). Treatment was stopped because of side-effects in 2 patients in group C (6%) and 6 patients in Group D (21%). These results show that cibenzoline has a comparable efficacy for the prevention of recurrence of atrial tachyarrhythmia and is significantly better tolerated than disopyramide. This differences is mainly related to the marked anticholinergic effects of disopyramide.

[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.

[Study of the efficacy and tolerability of oral administration of cibenzoline in the prevention of recurrence of symptomatic atrial fibrillation]. / Etude de l'efficacité et de la tolérance de la cibenzoline administrée par voie orale dans la prévention des récidives de fibrillation auriculaire symptomatique.

The efficacy and safety of oral cibenzoline were evaluated in 42 patients aged 67 +/- 7 (55-80) and with recurrent symptomatic atrial fibrillation for at least a year and for which at least one previous anti-arrhythmic agent had been stopped for inefficacy or intolerance. Cibenzoline was administered for 6 months at the dose of 260 to 390 mg per day in patients aged under 70, with the possibility of reducing this dose in those aged over 70. Clinical, electrocardiographic and 24-hour Holter evaluation took place at inclusion and after 3 and 6 months' treatment or at the time of trial termination for documented recurrence (atrial arrhythmia persisting for 60 seconds or more). The mean duration of atrial fibrillation was 5.6 +/- 5 years (1-26). It was related to ischemic (22%), valvular (17%), hypertensive (17%), hypertrophic (7%) or dilated (7%) heart disease. No etiology was found in 45% of cases. All patients had taken at least one anti-arrhythmic agent in the past (mean of 2 drugs, range 1 to 6). All patients were symptomatic, the commonest symptoms being palpitations (82%), chest pain (28%), feelings of vertigo (11%) or episodes of acute dyspnea (9%). Thirteen patients (31%) had a documented recurrence (> 60 seconds) during the six months of the trial. Recurrence occurred during the first months of treatment in the majority of patients (11 out of 13). The number of symptomatic patients decreased considerably during treatment with cibenzoline, with the disappearance of palpitations in 83% of cases.(ABSTRACT TRUNCATED AT 250 WORDS)

[Combination of oral administration of cibenzoline and digoxin in patients with supraventricular arrhythmia]. / Association de la cibenzoline et de la digoxine administrées par voie orale chez des patients ayant une arythmie supraventriculaire.

Chronic co-administration of digoxin and several antiarrhythmic drugs increases digoxin plasma levels. To determine the effects of the administration of oral cibenzoline on digoxin plasma levels and its effects on clinical and electrocardiographic parameters, we conducted a prospective multicenter study in 22 cardiac patients with a mean age of 66 +/- 12 years (39-85), who were on long term digoxin therapy (0.25 mg once daily for at least 2 weeks) and who required oral cibenzoline therapy in the prevention of recurrence of symptomatic atrial tachyarrhythmias. Cibenzoline was given for 4 weeks at a dose of 130 mg twice daily in patients aged less than 70 years (group I, n = 15) and this dosage was reduced by half in patients over 70 years of age (group II, n = 7). Evaluation of the effects of this combination on clinical and electrocardiographic tolerability as well as the drawing of blood samples for assay of cibenzoline and digoxin took place before and after 4 weeks treatment with cibenzoline. The digoxin plasma levels were (mean +/- sem) 0.96 +/- 0.1 ng.ml-1 before cibenzoline administration and remained unchanged after 4 weeks of combination therapy (1.0 +/- 0.1 ng.ml-1), p > 0.05. Digoxin plasma levels in group I varied from respectively 0.8 +/- 0.1 ng.ml-1 (0.5-1.7) to 0.8 +/- 0.1 ng.ml-1 (0.4-1.5) and in group II from 1.2 +/- 0.2 ng.ml-1 (0.6-2) to 1.4 +/- 0.3 ng.ml-1 (0.7-2.5). This therapy was well tolerated in 16 patients out of 21 evaluable patients (76%) and there was no significant change in vital signs during the study.(ABSTRACT TRUNCATED AT 250 WORDS)

[Comparison of the efficacy/tolerability ratio of cibenzoline and propafenone in the treatment of ventricular arrhythmia]. / Comparaison du rapport efficacité/tolérance de la cibenzoline et de la propafénone dans le traitement des arythmies ventriculaires.

Cibenzoline (C) was compared with propafenone (P) in 18 adult patients (7 women and 11 men) aged 50 +/- 7 in double-blind, placebo-controlled crossover trial. After a therapeutic wash-out period corresponding to 5 times the half-life of previous anti-arrhythmic drugs, patients with more than 100 premature ventricular contractions (PVC) per hour in two 24 hour Holter records obtained at an interval of 7 days were treated in succession and after randomised by C (390 mg/day in 3 divided doses) and P (900 mg/day in 3 divided doses) for a period of two weeks, each active sequence being followed by a two week wash-out period. Efficacy (based upon the decrease in PVC/hour in a 24 hour Holter) and tolerability were evaluated at the end of each sequence, with samples drawn at the same times for assay of the study drugs. Three patients dropped out of the trial, 1 with each active drug (for epigastric pain) and 1 with dummy. No significant difference was seen between the two drugs regarding the decrease in the total number of PVC/hour in the 15 patients completing the cross-over protocol. A reduction in PVC/hour of more than 70 per cent was seen in 7 patients with C and in 9 patients with P. C was better tolerated than P on the basis of both clinical and electrocardiographic parameters. One patient developed troublesome adverse reactions with C as compared with 4 patients in the case of P. A more than 20 per cent increase in QRS was seen in 7 patients with C and in 10 patients with P, the figures for PR being 2 and 6 patients respectively. One patient showed a proarrhythmic effect with P. Plasma levels of C were significantly higher in responders (328 +/- 149 ng/ml) than in non-responders (137 +/- 41 ng/ml, p less than 0.05). No significant difference was found concerning plasma levels of P (578 +/- 477 ng/ml compared with 646 +/- 457 ng/ml, p greater than 0.05). In conclusion, the efficacy/tolerability ratio in this population with a low risk of serious rhythm events appeared to be better with C than with P.