title: Placebo-controlled study of oral enoximone in congestive heart failure with initial and final intravenous hemodynamic evaluation.
abstract: Seventeen patients with stable congestive heart failure (class II and III New York Heart Association) received intravenous and oral enoximone in a 2-part study. Hemodynamic data were first obtained after intravenous administration of 0.75 mg/kg of enoximone; data were again obtained after 12 weeks of therapy with either oral enoximone (150 mg 3 times daily) or placebo. The efficacy and safety of oral enoximone were also studied in a 12-week, double-blind randomized format. In the intravenous study, enoximone was delivered over 5 minutes and hemodynamic data were measured for up to 12 hours after. Cardiac index increased 2.76 +/- 0.63 to 3.42 +/- 0.72 liters/min/m2), pulmonary wedge pressure decreased (19.5 +/- 8.8 to 14.6 +/- 8.0 mm Hg) as did mean arterial blood pressure (101 +/- 14.8 to 85 +/- 13.7 mm Hg) and systemic vascular resistance (1,880 +/- 573 to 1,254 +/- 383 dynes s cm-5). Heart rate increased slightly (82 +/- 17 to 86 +/- 14 beats/min). All these changes were maximal 1 to 2 hours after infusion and lasted 8 hours at least. Patients were then randomized double-blind to oral treatment. Baseline values showed that the 7 patients who received placebo had more severe CHF. Therefore, comparison might be biased. Patient overall assessment showed a continuous benefit in both groups. Ejection fraction improved from 30.1 +/- 6.8% to 33.9 +/- 9.9% in the enoximone group while it remained unchanged with placebo (23.4 +/- 6.5% to 23.4 +/- 1.5%).(ABSTRACT TRUNCATED AT 250 WORDS)
mesh_terms: D000284:Administration, Oral; D000328:Adult; D002316:Cardiotonic Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D017335:Enoximone; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000188:drug therapy / Q000503:physiopathology*; D006439:Hemodynamics / Q000187:drug effects*; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage* / Q000627:therapeutic use; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D011897:Random Allocation
chemical_list: D002316:Cardiotonic Agents; D007093:Imidazoles; D017335:Enoximone