Antihypertensive effects of cilazapril, 2.5 and 5 mg, once daily versus placebo on ambulatory blood pressure following single- and repeat-dose administration

Abstract

Ambulatory blood pressure (ABP) monitoring was used to evaluate the 24-h antihypertensive efficacy of single- and repeat-dose administrations of the nonsulfhydryl-converting enzyme inhibitor cilazapril, 2.5 and 5 mg, versus placebo in patients with mild to moderate essential hypertension. After a 2-week placebo run-in period, patients were randomized to receive, in a double-blind procedure, either 2.5 mg cilazapril (n = 14), 5 mg cilazapril (n = 14), or placebo (n = 14) for 4 weeks. In calculating the systolic/diastolic blood pressure (BP) trough-to-peak (T/P) ratio after subtraction of the placebo effect, 5 mg cilazapril appeared to be more effective than 2.5 mg cilazapril following single- (59/54% vs. 21/48%) and repeat-dose administration (47/76% vs. 31/49%). There were significant differences in 24-h and awake ABP for both 2.5 and 5 mg cilazapril as compared to placebo after single- and repeat-dose administrations. However, there were no significant differences in 24-h and awake ABP reduction between 2.5 and 5 mg cilazapril after single- and repeat-dose administrations. Furthermore, the percentages of "BP load" were identical with both regimens after the first dose (46 vs. 43%) and at steady-state (37 vs. 29%). These data demonstrate that 2.5 and 5 mg doses of cilazapril have equivalent antihypertensive efficacy using ABP and that 24-h ABP monitoring should also be performed in dose-response studies.