Circulation Journal
Online ISSN : 1347-4820
Print ISSN : 1346-9843
ISSN-L : 1346-9843
Clinical Investigation
Double-Blind Placebo-Controlled Trial of Aprindine and Digoxin for the Prevention of Symptomatic Atrial Fibrillation
Hirotsugu AtarashiHiroshi InoueMasatake FukunamiKaoru SugiChikuma HamadaHideki Origasafor the Sinus Rhythm Maintenance in Atrial Fibrillation Randomized Trial (SMART) Investigators
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2002 Volume 66 Issue 6 Pages 553-556

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Abstract

A multicenter, placebo-controlled, randomized, double-blind trial compared the preventive effect of aprindine and digoxin on the recurrence of atrial fibrillation (AF) with placebo, and also compare the effectiveness of these 2 drugs in the prevention of AF. Patients with symptomatic paroxysmal or persistent AF who had converted to sinus rhythm (SR) were randomly assigned aprindine (40 mg/day), digoxin (0.25 mg/day) or placebo and followed up on an outpatient basis every 2 weeks for 6 months. Of the 141 patients from 36 participating centers, 47 were given aprindine, 47 digoxin, and 47 were on placebo. After the 6-month follow-up, the Kaplan-Meier estimates of the percentage of patients remaining free of recurrent symptomatic AF on aprindine, digoxin and placebo were 33.3%, 29.2% and 21.5%, respectively. In patients remaining in SR for 15 days after from the start of follow-up, freedom from recurrence was significantly more prevalent in the aprindine group than in the placebo group (p=0.0414), but there was no significant difference between the digoxin and placebo groups. The rate of adverse events was similar in the 3 groups. In conclusion, neither aprindine nor digoxin had a significant effect on preventing relapse of symptomatic AF; however, recurrence of AF occurred later with aprindine than with placebo or digoxin. (Circ J 2002; 66: 553 - 556)

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© 2002 THE JAPANESE CIRCULATION SOCIETY
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