STUDY OF THE EFFICACY AND SAFETY OF ORAL CIBENZOLINE IN THE PREVENTION OF RECURRENCES OF SYMPTOMATIC ATRIAL-FIBRILLATION

The efficacy and safety of oral cibenzoline were evaluated in 42 patie nts aged 67 +/- 7 (55-80) and with recurrent symptomatic atrial fibril lation for at least a year and for which at least one previous anti-ar rhythmic agent had been stopped for inefficacy or intolerance. Cibenzo line was administered for 6 months at the dose of 260 to 390 mg per da y in patients aged under 70, with the possibility of reducing this dos e in those aged over 70. Clinical, electrocardiographic and 24-hour Ho lter evaluation took place at inclusion and after 3 and 6 months' trea tment or at the time of trial termination for documented recurrence (a trial 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 c ases. 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 %), f eelings 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 cib enzoline, with the disappearance of palpitations in 83 % of cases. Onl y two patients had adverse reactions, in the form of epigastric discom fort, and none required a dose decrease nor the interruption of treatm ent. Heart rate increased significantly with cibenzoline (67 +/- 11 bp m to 75.5 bpm, p<0.001). There was a slight increase in the length of QRS (+ 6 %) without any significant increase in PR nor QT. No patient developped cardiac decompensation nor any pro-arrhythmic effect at atr ial or ventricular level. In conclusion, cibenzoline appears to be eff ective and safe in the preventive treatment of paroxysmal atrial fibri llation.