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 HCl during long-term treatment (12 months), we conducted a randomized, open-label, comparative, parallel, multicenter trial in 200 patients with paroxysmal atrial fibrillation (AF) and no history of heart disease. Initial daily doses were flecainide 200 mg (n = 97) or propafenone 450 mg (n = 103). Dose escalations up to a maximum of flecainide 300 mg/day or propafenone 900 mg/day were permitted after > or = 2 attacks of paroxysmal AF. Patients were assessed for safety and drug tolerance at designated intervals over the 12-month study unless discontinued for adverse experience or inadequate response. Ten patients on flecainide reported 14 cardiac adverse experiences; 4 discontinued the drug. Seven propafenone patients reported 8 cardiac adverse experiences; 5 discontinued the drug. Three proarrhythmic events occurred: 1 propafenone patient developed ventricular tachycardia and 2 flecainide patients experienced AF with a rapid ventricular response. An intention-to-treat analysis showed that the probability of safe and effective treatment after 12 months was 77% for flecainide-treated patients and 75% for the propafenone-treated patients. There was an acceptable risk-benefit profile in patients with paroxysmal AF and no evidence of clinically significant heart disease who were treated with flecainide or propafenone for 12 months. Further, there was no statistically significant difference in safety or efficacy between flecainide and propafenone in this study.

RCT Entities:   Population Interventions Outcomes