RANDOMIZED, DOUBLE-BLIND, COMPARATIVE-STU DY OF THE EFFECTS OF CIBENZOLINE AND HYDROQUINIDINE IN THE PREVENTION OF ATRIAL-FIBRILLATION

The objective of this study was to compare the efficacy and safety of cibenzoline (130 mg twice a day) and sustained-release hydroquinidine (300 mg twice a day) in the prevention of recurrent atrial fibrillatio n (AF). This randomized double-blind study was conducted in 87 patient s, with a mean age of 62 years, presenting with a history of AF for 72 hours to a maximum of 3 years. After restoration of sinus rhythm, in order for the subjects to be included in the study, echocardiography h ad to reveal a left ventricular shortening fraction of more than 20 %. Patients were followed for one year by clinical examination, ECG and 24-hour Holter monitoring performed 7 days after inclusion, then after 3, 6, 9 and 12 months. The two groups, treated with either cibenzolin e (n=40) or hydroquinidine (n=44), were comparable. The AF recurrence rates with cibenzoline or hydroquinidine were 34.9 % had 36.4 % at 6 m onths, and 41.9 % and 43.2 % at 12 months, respectively (NS). Most rec urrences occurred during the first month. Adverse effects were reporte d in 10 patients (23.3 %) with cibenzoline and 12 patients (27.3 %) wi th hydroquinidine. They led to discontinuation of treatment in 6 patie nts (14 %) treated with cibenzoline and 5 patients (11.4 %) treated wi th hydroquinidine, Serious adverse events included one death from hypo glycaemic coma and one case of persistent ventricular tachycardia with hydroquinidine. In conclusion, oral cibenzoline demonstrated the same antiarrhythmic activity as hydroquinidine in the long-term prevention of recurrent atrial fibrillation, with a similar degree of safety. Th is drug can therefore constitute an alternative to conventional antiar rhythmics in this context.