Circulation, Vol 80, 1557-1570, Copyright © 1989 by American Heart Association
JL Anderson, EM Gilbert, BL Alpert, RW Henthorn, AL Waldo, AK Bhandari, RW Hawkinson and EL Pritchett
Paroxysmal atrial fibrillation (PAF) is a problematic clinical arrhythmia
that is usually symptomatic. Unfortunately, few adequate trials and trial
methods are available for assessment of the value of therapy, and
traditional treatment has often been ineffective or associated with
unacceptable side effects. Transtelephonic monitoring is a new method that
allows evaluation of paroxysmal arrhythmias and arrhythmia-related symptoms
in outpatients. We used a patient-initiated transtelephonic monitor system
to evaluate the potential of flecainide, a class 1C antiarrhythmic, in
prevention of symptomatic recurrences of PAF. Sixty-four patients qualified
for the study (two or more PAF attacks documented within a 4-week baseline
period) and entered a dose- finding phase to determine drug tolerance. Dose
was incremented at weekly intervals from 200-300 and finally to 400 mg/day.
The largest dose that was well tolerated was selected for the 4-month,
double- blind, randomized, crossover comparison with placebo. Fifty-five
patients entered and 53 received both treatments in the double-blind phase;
48 of these patients without protocol violations were evaluable for
efficacy comparisons. Evaluable patients had undergone an average of 3.8
previous drug trials (range, 1-8); 30 were men, 18 had hypertension, and 14
had ischemic heart disease. The study demonstrated a highly significant
correlation (p less than 0.0001) between perceived symptoms and documented
PAF by transtelephonic monitoring. The rate of symptoms and PAF attacks was
also significantly reduced by therapy (median dose, 300 mg/day). The first
PAF attack occurred after a median of 3 days on placebo versus 14.5 days on
flecainide (p less than 0.001) therapy. Similarly, the time interval
between attacks was lengthened, from a median of 6.2 days on placebo to
27.0 days on flecainide (p less than 0.001) therapy. PAF was prevented in
15 patients (31%) during flecainide and four (9%) during placebo therapy (p
= 0.013). However, during the study, 13 patients dropped out, seven because
of adverse effects (five cardiac), five for other reasons, and one because
of cardiac arrest/death. Adverse cardiac events occurred in a total of
seven patients (11%) during flecainide therapy. Thus, transtelephonic
monitoring is a useful method for documentation of the occurrence of
paroxysmal arrhythmias such as PAF and its related symptoms during daily
living and for assessment of new therapies in an outpatient setting.
ARTICLES
Prevention of symptomatic recurrences of paroxysmal atrial fibrillation in patients initially tolerating antiarrhythmic therapy. A multicenter, double-blind, crossover study of flecainide and placebo with transtelephonic monitoring. Flecainide Supraventricular Tachycardia Study Group
University of Utah, Salt Lake City.
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