Efficacy and safety of cilazapril in hypertensive patients with moderate to severe renal impairment.

This open uncontrolled trial was undertaken to evaluate the safety and the efficacy of a new angiotensin-converting enzyme inhibitor cilazapril in patients with both hypertension and renal impairment defined as endogenous creatinine clearance below 50 ml/minute. Twenty-five patients with a diastolic blood pressure from 95 to 115 mm Hg completed the trial. Blood pressure was measured pre-dose sitting and standing every week during placebo and every second week during active therapy, as well as two hours post-dose after placebo and at the end of active therapy. The dose of cilazapril was from 0.5 to 5.0 mg daily. After eight weeks of active therapy, a reduction in both pre-dose systolic and diastolic blood pressure was seen. No orthostatic effect on blood pressure was observed. The systolic blood pressure was better controlled as measured two hours post-dose compared with pre-dose, whereas no difference was found in diastolic blood pressure. No deterioration in kidney function occurred. Some cases of moderately increased serum-potassium were observed, especially in acidotic patients. No serious adverse reactions were observed.