RESUMO
The aim of this study was to evaluate the long-term efficacy of cibenzoline in preventing recurrence of atrial fibrillation compared to a reference drug: quinidine arabo-galactane sulfate (QAGS). The two products were administered orally in a double blind multicentre trial to two different groups of patients (96 patients in all) in whom atrial fibrillation had been previously converted to sinus rhythm after having been present for at least 15 days and less than 18 months. The patients were either given four 65 mg gelules of cibenzoline (group I) or four 206 mg gelules of Longacor (group II) and were reviewed systematically after 3 days of treatment, in order to retain only those who had not relapsed during the first 72 hours (89 patients: 42 in group I; 47 in group II). As Holter monitoring was not available in all centres, follow-up was assessed by conventional ECG during clinical examination after 2 weeks, 6 weeks, 3 months and 6 months. The results seem to indicate that cibenzoline was more effective at the 6th month (20% recurrence rate in group I compared to 43.2% in group II). This difference was significant especially at the end of the 2nd week of treatment (p less than 0.04); the number of recurrences did not differ significantly between the two groups thereafter. In general the clinical tolerance was good. Biochemical tests showed a greater increase in serum transaminases (SGOT) in the cibenzoline than in the QAGS group but this difference did not attain statistical significance. We conclude that at 6 months cibenzoline is more effective than QAGS in preventing recurrent atrial fibrillation.