Safety and utility of flecainide acetate in the routine care of patients with supraventricular tachyarrhythmias: results of a multicenter trial. The Flecainide Supraventricular Tachycardia Study Group.

Patients with supraventricular arrhythmias have been safely and effectively treated with flecainide. We conducted an open-label, 20-center trial to define further the safety and efficacy profile of oral flecainide in patients with supraventricular arrhythmias, including atrial tachycardias (ectopic or multifocal), atrial-ventricular tachycardias (reentrant), paroxysmal atrial fibrillation/flutter (PAF), and chronic atrial fibrillation (CAF). Our study population of 151 patients with documented supraventricular arrhythmias requiring treatment included 67 with paroxysmal supraventricular tachycardia (PSVT), 67 with PAF (symptoms < 15 days), and 17 with CAF (symptoms > of = 15 days)> The initial flecainide dose of 100 mg twice daily could be increased by 50 mg bid every 4 days to a maximum of 200 mg twice daily. Patients who were effectively treated could receive flecainide for 1 year. The study was terminated April 26, 1989, in response to interim results reported by the Cardiac Arrhythmia Suppression Trial (CAST). All patients were removed from the study by August 1989. At study termination 87% of PSVT, 73% of PAF, and 56% of CAF patients had improved symptomatically while on flecainide therapy. Eleven patients experienced cardiac adverse experiences: proarrhythmic events (3 patients), new or worsened congestive heart failure (7 patients), sinus pauses (1 patient). Cardiac side effects appeared to be more frequent in patients in the CAF group (5/17 patients), all of whom had structural heart disease. Overall, 45 (67%) PSVT, 43 (64%) PAF, and 9 (56%) CAF patients reported at least 1 noncardiac adverse experience; the most common were abnormal vision, dizziness, and headaches. One patient from the CAF group died; the death was considered to be unrelated to flecainide. Flecainide appears to be safe and effective treatment for patients with supraventricular arrhythmias of a variety of mechanisms and appears particularly effective for patients with PSVT. The efficacy is lowest and side effects most frequent in patients with CAF, as seen with other trials of antiarrhythmic medication in these patients. In the context of the CAST experience and other trials of antiarrhythmic drugs in patients with CAF, the balance of risk and benefit of therapy should be considered carefully before initiating treatment.