PMID: 2502464Apr 1, 1989Paper

Efficacy and safety of flecainide in patients with stable ventricular ectopic beats. Multicenter trial of the Italian Study Group on the Electrophysiology of Arrhythmias

Giornale italiano di cardiologia

Abstract

The aim of this multicentre study, carried out by the Italian Study Group on the Electrophysiology of Arrhythmias (GISEA) in 60 Italian Cardiology Centres on 260 patients, was to assess the efficacy and the safety of flecainide in the treatment of stable hyperkinetic ventricular arrhythmias (greater than 100 ventricular ectopic beats/hour per day). The stability of the arrhythmia was verified using 24 hour Holter recordings allowing for a spontaneous variability of less than 20%. All the patients belonged to class NYHA I or II. Flecainide was administered in 2 x 100 mg/day doses and if the efficacy criteria, checked by the Holter on the 6th day, were not met the dose was increased to 2 x 150 mg/day. After a further Holter recording on the 11th day, therapy continued until the 31st day when the final recordings were carried out. The study protocol was completed by 249/260 pts. (95.7%). Due to violation of the protocol which included lack of basal stability of the arrhythmia 69/249 pts. (28%) were excluded. The 69 excluded patients were not considered for the efficacy evaluation, but entered for safety considerations. Only 16/180 (8%) of the qualified pts. were drop-outs. In the remaining 164 patients considered in the final eval...Continue Reading

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