Safety of a controlled-release flecainide acetate formulation in the prevention of paroxysmal atrial fibrillation in outpatients.

OBJECTIVES

The cardiac safety of a once-a-day 200 mg controlled-release formulation of flecainide acetate in the prevention of paroxysmal atrial fibrillation (PAF) was assessed in outpatients.

MATERIAL AND METHODS

The drug was administered for 24 weeks to 227 patients diagnosed with recurrent Paf episodes. Cardiac safety was assessed primarily by the maximum change from baseline in QRS duration. Changes in left ventricular function at echocardiography, incidence of proarrhythmic effects determined from ECG and Holter recordings and cardiovascular adverse events were also taken into account to assess cardiac safety. Efficacy was documented by actuarial methods.

RESULTS

Mean maximum QRS increase from baseline was 11.4% (n = 181); QRS increase was < 15% in 71.8% of the patients and > or = 25% in 18.8%. Only 4 patients had maximum QRS value > 100 ms under treatment. Left ventricular ejection fraction remained within +/- 20% of baseline for 90% of the patients, increased above 20% for 8.6% and decrease below 30% for 1.4% (n = 139). Bradycardia (13.2%; n = 129) and ventricular extrasystoles (10.6%; n = 104) were the most frequently identified proarrhythmic effects. Atrio-ventricular block (4.0%), supra-ventricular tachycardia (2.2%), bundle branch block (1.8%) and atrial fibrillation (1.3%) were the most frequent drug-related cardiac adverse events. Estimated treatment success rate was 74% (95% CI: [68%; 80%]) and the incidence of Paf episodes decreased from baseline 28.6% to 11.0% (P < 0.0001).

CONCLUSIONS

We provided evidence for a good cardiac safety profile of the controlled-release formulation of flecainide acetate and confirmed the effectiveness of the drug in the prevention of PAF recurrences.