Efficacy of oral and intravenous indecainide in ventricular arrhythmias.
To evaluate the efficacy of oral and intravenous indecainide, a new class IC antiarrhythmic agent, 3 separate protocols were performed in patients with benign or potentially lethal ventricular arrhythmias. An open-label intravenous trail in 10 patients was conducted using a dose of 1.7 mg/kg/min under constant monitoring. An oral short-term in-hospital trial in 20 patients (8 patients entered directly from the intravenous short-term trial) was conducted using a single-blind placebo dose titration protocol in which 50 mg of indecainide every 8 hours was increased at 3-day intervals to 75 mg, and then 100 mg every 8 hours depending on the observed change in ventricular arrhythmia frequency by Holter monitoring. Finally, an outpatient long-term oral trial was conducted in 17 of the 20 patients who completed the inpatient oral short-term trail. Two of the 10 patients from the inpatient intravenous trail did not enter the oral trial, because a proarrhythmic response developed in 1 and because of a lack of efficacy in the other. During the inpatient oral trial, 17 of 20 patients (85%) responded to indecainide and entered the long-term phase. Two of these patients were removed from the trial because of lack of efficacy at 3 and 10 months, respectively. In the oral therapy protocols, minor side effects of the central nervous system occurred in 4 of 17 patients (24%). Six of 20 patients (30%) each had more than a 25% increase in PR and QRS duration that was not associated with higher degrees of block.(ABSTRACT TRUNCATED AT 250 WORDS)
Nestico
P F
PF
Morganroth
J
J
Horowitz
L N
LN
Mulhern
C
C
D000284:Administration, Oral; D000368:Aged; D001145:Arrhythmias, Cardiac / Q000188:drug therapy* / Q000503:physiopathology; D002986:Clinical Trials as Topic; D004334:Drug Administration Schedule; D004562:Electrocardiography; D005260:Female; D005449:Fluorenes / Q000008:administration & dosage* / Q000009:adverse effects / Q000378:metabolism / Q000627:therapeutic use; D005500:Follow-Up Studies; D006352:Heart Ventricles; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D013997:Time Factors
D005449:Fluorenes; C042398:indecainide