COMPARISON OF THE SAFETY AND EFFICACY OF DELAPRIL WITH ENALAPRIL IN PATIENTS WITH CONGESTIVE-HEART-FAILURE

To evaluate safety and efficacy of delapril versus enalapril in patien ts with congestive heart failure (CHF), New York Heart Association (NY HA) class II and III, 198 patients were enrolled in a study in 13 cent ers involving a double-blind parallel group design. After completing a 2-week run-in period on placebo, patients were randomized to receive delapril 7.5 mg twice daily or enalapril 2.5 mg twice daily for 2 week s. The dose was then doubled for the remaining 6 weeks. In this phase, 1 patient in each group experienced orthostatic hypotension; the dose was then reduced to the initial dose for study completion. A total of 195 patients received active treatment (96 delapril, 99 enalapril). A fter 8 weeks' treatment, bicycle ergometry demonstrated a significant increase in exercise duration (p < 0.01) and workload (p < 0.01). Echo Doppler investigations showed a significant reduction (p < 0.01) in l eft ventricular end-systolic volume associated with a significant incr ease (p < 0.01) in ejection fraction and cardiac output. No clinically significant changes in blood pressure, heart rate, electrocardiogram, or biochemical and hematologic tests were found. There were no signif icant differences between treatment groups. Three patients in each gro up experienced adverse reactions requiring withdrawal of 1 patient in each group. Delapril 15 mg twice daily, like enalapril 5 mg twice dail y, was effective in improving signs and symptoms of CHF and was well t olerated.