Randomized, crossover, controlled comparison of oral loading versus intravenous infusion of propafenone in recent-onset atrial fibrillation.
A population of 123 patients with recent-onset (< 72 hours) atrial fibrillation (AF) without heart failure was randomly treated with propafenone (PFN) intravenously (i.v.) (2 mg/kg bolus followed by 0.0078 mg/kg/min infusion) or in a single oral dose (o.s.) (600 mg), or with placebo (PLA) (phase 1). If AF persisted 8 hours later, patients on active drugs received the alternative formulation (crossover), and patients receiving PLA remained on PLA (phase 2). A 24-hour Holter monitoring was performed and conversion to sinus rhythm (SR) at 1, 4, and 8 hours of each phase was used as the criterion of efficacy. Conversion to SR occurred within 1 hour in 48% of patients with i.v.-PFN, 15% with o.s.-PFN, and in 17% with PLA (both P < 0.05 vs i.v.-PFN). Oral PFN was superior to PLA at 4 hours (71% vs 33%, P = 0.001) and 8 hours (78% vs 48%, P < 0.01), and 1 at 8 hours also superior to i.v.-PFN (53%, P < 0.03). The mean conversion time within 4 hours was shorter with i.v.-PFN (25 +/- 15') than with o.s.-PFN (167 +/- 166', P < 0.001) or with PLA (156 +/- 107', P < 0.001). The rates of conversion to SR with i.v.-PFN after o.s.-PFN failure were comparable to PLA at any observation time, whereas nonresponders to i.v.-PFN who received o.s.-PFN had significantly higher conversion rates than with placebo at both 4 hours (65% vs 19%) and 8 hours (76% vs 24%; both P < 0.045). Neither serious adverse effects nor episodes of regular tachycardia with 1:1 AV conduction were noted. PFN administered intravenously or in a single oral loading dose was safe and efficacious in converting recent-onset AF to SR. The rates of conversion were different with different routes of administration: i.v.-PFN was superior to o.s.-PFN over a short observation period, while the overall efficacy of o.s.-PFN was superior at 8 hours.
Botto
G L
GL
Division of Cardiology, St. Anna Hospital, Como, Italy.
Bonini
W
W
Broffoni
T
T
Espureo
M
M
Cappelletti
G
G
Lombardi
R
R
Molteni
S
S
Pedraglio
E
E
Ferrari
G
G
D000284:Administration, Oral; D000889:Anti-Arrhythmia Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D001281:Atrial Fibrillation / Q000188:drug therapy*; D018592:Cross-Over Studies; D015716:Electrocardiography, Ambulatory; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D011405:Propafenone / Q000008:administration & dosage* / Q000627:therapeutic use; D013997:Time Factors
D000889:Anti-Arrhythmia Agents; D011405:Propafenone