Serum digoxin concentrations during ethmozine antiarrhythmic therapy

Am Heart J. 1986 Apr;111(4):667-72. doi: 10.1016/0002-8703(86)90096-7.

Abstract

The potential for pharmacokinetic drug interaction between ethmozine (moricizine HCl), a phenothiazine class I antiarrhythmic investigational drug, and digoxin was evaluated in 13 cardiac patients with normal renal function. Antiarrhythmic therapy was initiated in patients with potentially lethal (nonlife-threatening) ventricular arrhythmias (greater than 30 ventricular ectopic beats [VEB]/hr) who were receiving maintenance digoxin therapy for congestive heart failure and/or atrial fibrillation. Serum digoxin concentrations of patients were measured frequently by radioimmunoassay and plasma ethmozine concentrations by high-performance liquid chromatographic methods. Patients entered a short-term (4 weeks) single-blind, placebo controlled ethmozine protocol with an option to receive long-term (1 to 6 months) open-label maintenance ethmozine therapy. Ambulatory ECGs (48 hour) used to assess antiarrhythmic efficacy of ethmozine during each week of the short-term protocol showed that 77% of patients demonstrated greater than 90% mean hourly frequency suppression of all forms of ventricular ectopy. Serum digoxin concentrations during short-term ethmozine dosing showed a nonsignificant (p greater than 0.05) increase of 10% to 15% (mean 0.91 ng/ml to 1.13 ng/ml). The short-term protocol serum digoxin levels correlated closely with serum digoxin concentrations during placebo therapy (1st week, r = 0.90; 2nd week, r = 0.87). Serum digoxin concentrations were not significantly different (p greater than 0.05) from placebo values at the end of 1, 3, and 6 months of maintenance ethmozine therapy. Thus, we conclude that ethmozine administered in an antiarrhythmic efficacious dosage (10 mg/kg/day) showed no important clinical or statistically significant change in serum digoxin concentrations of cardiac patients with normal renal function.

Publication types

  • Clinical Trial
  • Controlled Clinical Trial

MeSH terms

  • Adult
  • Aged
  • Anti-Arrhythmia Agents / blood
  • Anti-Arrhythmia Agents / therapeutic use*
  • Arrhythmias, Cardiac / blood
  • Arrhythmias, Cardiac / complications
  • Arrhythmias, Cardiac / drug therapy*
  • Atrial Fibrillation / blood
  • Atrial Fibrillation / complications
  • Atrial Fibrillation / drug therapy
  • Cardiac Complexes, Premature / blood
  • Cardiac Complexes, Premature / complications
  • Cardiac Complexes, Premature / drug therapy
  • Clinical Trials as Topic
  • Digoxin / blood*
  • Digoxin / therapeutic use
  • Drug Interactions
  • Female
  • Heart Failure / blood
  • Heart Failure / complications
  • Heart Failure / drug therapy
  • Humans
  • Kinetics
  • Male
  • Middle Aged
  • Moricizine
  • Phenothiazines / blood
  • Phenothiazines / therapeutic use*

Substances

  • Anti-Arrhythmia Agents
  • Phenothiazines
  • Moricizine
  • Digoxin