Oral loading with propafenone: a placebo-controlled study in elderly and nonelderly patients with recent onset atrial fibrillation.
The efficacy and safety of propafenone as an oral loading dose (600-mg single oral dose) in converting recent-onset atrial fibrillation (< or = 7 days duration) to sinus rhythm were evaluated in a single-blind, placebo-controlled study according to patients' age. Overall, 240 hospitalized patients, NYHA Class < or = 2 without signs or symptoms of heart failure were enrolled: among patients aged < or = 60 years, 55 were allocated to propafenone treatment and 59 to placebo, respectively, and among patients aged > 60 years, 64 were allocated to propafenone treatment and 62 to placebo, respectively.


RESULTS
In each age group, the likelihood of conversion to sinus rhythm was significantly greater after propafenone compared with placebo at 3 and 8 hours. For patients aged < or = 60 years, corresponding odd ratios were 3.78 (95% CI = 1.80-7.92, P = 0.04) at 3 hours and 4.74 (95% CI = 2.12-10.54, P = 0.02) at 8 hours; for patients aged > 60 years odd ratios were 5.03 (95% CI = 2.08-12.12, P = 0.02) at 3 hours and 6.75 (95% CI = 3.28-73.86, P = 0.01) at 8 hours, respectively. Logistic regression analysis showed that conversion to sinus rhythm within 3 hours was predicted by age < or = 60 years (P = 0.0064) and by propafenone treatment (P < 0.0001), and conversion to sinus rhythm within 8 hours was predicted by age < or = 60 years (P = 0.0467) and by propafenone treatment (P < 0.0001). The occurrence of adverse effects was observed in 14%-16% of propafenone treated patients and in 8% of placebo treated patients without significant differences according to age. In conclusion, in patients with recent-onset atrial fibrillation without signs of heart failure, propafenone as a single oral loading dose is effective. It is also effective in selected elderly subjects with a favorable safety profile. Moreover, spontaneous conversion to sinus rhythm appears to occur less frequently in elderly patients.
Boriani
G
G
Institute of Cardiology, University of Bologna, Italy. cardio1@almadns.unibo.it
Biffi
M
M
Capucci
A
A
Botto
G L
GL
Broffoni
T
T
Rubino
I
I
Della Casa
S
S
Sanguinetti
M
M
Branzi
A
A
Magnani
B
B
D000284:Administration, Oral; D000367:Age Factors; D000368:Aged; D000889:Anti-Arrhythmia Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D001281:Atrial Fibrillation / Q000175:diagnosis / Q000188:drug therapy*; D015716:Electrocardiography, Ambulatory; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011405:Propafenone / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D016037:Single-Blind Method
D000889:Anti-Arrhythmia Agents; D011405:Propafenone