[Propafenone and sotalol: long-term efficacy and tolerability in the prevention of paroxysmal atrial fibrillation. A placebo-controlled double-blind study].
BACKGROUND
Atrial fibrillation is a relatively frequent atrial arrhythmias activated with increased morbidity and mortality.


METHODS
To assess the propafenone and sotalol efficacy in the prevention of paroxysmal atrial fibrillation (FA) we enrolled, in a double blind placebo controlled study over 1 year, 300 patients (168 males); mean age 52.3 +/- 17.2 years, randomized to receive orally, three times daily, either propafenone (mean daily dose of 13 +/- 1.5 mg/Kg; Group A: 102 patients) or sotalol (mean daily dose of 3 +/- 0.4 mg/Kg; Group B: 106 patients) or placebo (Group C: 92 patients). All subjects experienced in previous 12 months at least 4 FA episodes. During follow-up we considered atrial tachyarrhythmia (TAA) onset: FA recurrences and/or the onset of atrial flutter (FIA). Three patients (3%) of Group A and 5 (5%) of Group B interrupted therapy for side effects; 5 patients (5.5%) of Group C with supraventricular tachycardia interrupted the double blind therapy; 11 were lost to follow-up.


RESULTS
Of the remaining 276 patients, TAA were observed in 43 (44.8%) of 96 patients in Group A, 28 (29.5%) of 95 patients in Group B and 62 (72.9%) of 85 patients in Group C. TAA were significantly less in A and B groups than in Group C (p < 0.005); a significant TAA reduction was also observed in patients treated with sotalol compared with those treated with propafenone (p < 0.05). TAA were: FA-118 (88.7%) and FIA-15 (11.3%). The arrhythmia free time was significantly shorter in Group C.


CONCLUSIONS
Sotalol seems to be more effective than propafenone and therefore represents a valid alternative for FA prevention.
Bellandi
F
F
Ospedale di Prato, Università di Firenze.
Dabizzi
R P
RP
Niccoli
L
L
Cantini
F
F
Palchetti
R
R
D000328:Adult; D000368:Aged; D000889:Anti-Arrhythmia Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000503:physiopathology / Q000517:prevention & control*; D004311:Double-Blind Method; D004562:Electrocardiography; D005260:Female; D005500:Follow-Up Studies; D006439:Hemodynamics; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos; D011405:Propafenone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013015:Sotalol / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors
D000889:Anti-Arrhythmia Agents; D010919:Placebos; D011405:Propafenone; D013015:Sotalol
Propafenone e sotalolo: efficacia e tollerabilità a lungo termine nella prevenzione della fibrillazione atriale parossistica. Studio in doppio cieco controllato con placebo.