Acute pulmonary oedema: preliminary results of a randomized trial of the intravenous phosphodiesterase inhibitor, enoximone, vs conventional therapy.

The purpose of this open study was to compare the effects of enoximone and conventional therapy in 44 patients with acute pulmonary oedema. In this preliminary report, 22 patients were randomly assigned to the enoximone group (1 mg/kg bolus, every 8 hours for 48 hours) and 22 patients to conventional therapy (frusemide, nitrates, dopamine-dobutamine). Patients were assessed clinically at 0, 1, 2, 24 and 48 hours by the change in their Killip-Kimball score, dyspnoea, pulmonary rales, blood pressure, diuresis, requirement for additional therapy and/or death. Patient characteristics were similar except for distribution of the sexes. Improvements of each clinical parameter seemed more marked in the enoximone group, except during the first hour (due to the diuretics). The general course of the disease was more favourable in the enoximone group (17 cases vs 11 in the conventional therapy group), in which enoximone used alone was sufficient to normalize the haemodynamic variables. On the other hand, in the conventional therapy group, it was necessary to institute enoximone therapy in 9 cases. With the dosage used, enoximone appeared to be at least as effective as conventional therapy in acute pulmonary oedema. Moreover, no side-effects or tachyphylaxis appeared during the hospital assessment.