SAFETY OF LONG-TERM FLECAINIDE AND PROPAFENONE IN THE MANAGEMENT OF PATIENTS WITH SYMPTOMATIC PAROXYSMAL ATRIAL-FIBRILLATION - REPORT FROM THE FLECAINIDE AND PROPAFENONE ITALIAN STUDY INVESTIGATORS

To compare the relative safety of flecainide acetate to propafenone HC l during long-term treatment (12 months), we conducted a randomized, o pen-label, comparative, parallel, multicenter trial in 200 patients wi th paroxysmal atrial fibrillation (AF) and no history of heart disease . Initial daily doses were flecainide 200 mg (n = 97) or propafenone 4 50 mg (n = 103). Dose escalations up to a maximum of flecainide 300 mg /day or propafenone 900 mg/day were permitted after greater than or eq ual to 2 attacks of paroxysmal AF. patients were assessed for safety a nd drug tolerance at designated intervals over the 12-month study unle ss discontinued for adverse experience or inadequate response. Ten pat ients on flecainide reported 14 cardiac adverse experiences; 4 discont inued the drug. Seven propafenone patients reported 8 cardiac adverse experiences; 5 discontinued the drug. Three proarrhythmic events occur red: 1 propafenone patient developed ventricular tachycardia and 2 fle cainide patients experienced AF with a rapid ventricular response. An intention-to-treat analysis showed that the probability of safe and ef fective treatment after 12 months was 77% for flecainide-treated patie nts and 75% for the propafenone-treated patients. There was an accepta ble risk-benefit profile in patients with paroxysmal AF and no evidenc e of clinically significant heart disease who were treated with flecai nide or propafenone for 12 months. Further, there was no statistically significant difference in safety or efficacy between flecainide and p ropafenone in this study.