Double-blind placebo-controlled trial of aprindine and digoxin for the prevention of symptomatic atrial fibrillation.
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.
Atarashi
Hirotsugu
H
First Department of Internal Medicine, Nippon Medical School, Tama-City, Tokyo, Japan.
Inoue
Hiroshi
H
Fukunami
Masatake
M
Sugi
Kaoru
K
Hamada
Chikuma
C
Origasa
Hideki
H
D000368:Aged; D000889:Anti-Arrhythmia Agents / Q000627:therapeutic use*; D001073:Aprindine / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000517:prevention & control*; D003327:Coronary Disease / Q000150:complications; D003925:Diabetic Angiopathies / Q000150:complications; D004077:Digoxin / Q000627:therapeutic use*; D004311:Double-Blind Method; D004554:Electric Countershock; D005260:Female; D006349:Heart Valve Diseases / Q000150:complications; D006801:Humans; D006973:Hypertension / Q000150:complications; D008297:Male; D008875:Middle Aged; D010919:Placebos; D012449:Safety; D013997:Time Factors
D000889:Anti-Arrhythmia Agents; D010919:Placebos; D001073:Aprindine; D004077:Digoxin