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Propafenone Treatment of Symptomatic Paroxysmal
Atrial Fibrillation. A Randomized, Placebo-Controlled Trial in Patients With Oral Therapy.
Pozzer Domingo Luis; Fernandez Eva; Farias
Department of Arrhytmias Institute of Cardiology, Juana F.
Introduction: The maintenance of sinus rhythm in patients
with recurrent paroxysmal atrial fibrilation (RPAF) is frequently hard, this situation is
generated by the low effectiveness of antiarrythmic drugs.
Objectives: To evaluate if propafenone administered orally is effective
and safe in prevent recurrent atrial fibrillation we conduct a randomized double blind
Methods: Patients with history of paroxystic atrial fibrillation
successfully treated and actually with normal sinus rhythm without any other
antiarrhythmic drug and left ventricular shortening fraction over 30 % were assigned to
receive or placebo or 300 mg twice daily of propafenone, over a six month period.
Exclusion criteria were recent myocardial infarction, severe heart failure, New York Heart
functional class over III, severe conduction disorders in the EKG, systolic blood pressure
less than 90 mm Hg.
Results: Thirty-six patients, 16 men and 20 women, (range of ages: 33 to
80 years) were included. The two groups were comparable with respect to baseline
characteristics. Its etiology was related to hypertensive heart disease (39%), valvular
heart disease (5%), or idiopathic (55.5%). The arrhythmia was symptomatic in all patients
At the end of follow up only 1 patients of the oral propafenone group (6.25 % CI 95 %
0.130%) and 4 of the placebo group (25% CI 95 % 7.252.4 %) suffered arrhythmic
recurrence (p= 0.33). During the same period 1 patients in the placebo group dead of
Discussion: The number of patients included in this study do not permit
takes definitively conclusions, but there were less number of recurrences in the
propafenone group, but this difference not reach statistically significance (6.25 % vs. 25
% p=0.3). The tolerance of the drug was good. The main limitation of this study was the
low number of patients included, however propafenone seem to be effective and safe to
Conclusions: Oral propafenone seems to be effective and safe in reducing
symptomatic paroxysmal atrial fibrillation.
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