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The aim of the study was to evaluate the clinical and renal hemodynamic effects of cilazapril in 10 hypertensive patients with moderate-to-severe chronic renal failure (creatinine clearance 14-50 ml/min). After 2 weeks of placebo, cilazapril 0.5 mg/day was given, and the dose was increased up to 5 mg/day if sitting diastolic blood pressure (SDBP) was not normalized (less than or equal to 90 mm Hg). Once a normal SDBP value was achieved, the patients remained on the given dose regimen for 6 months. After this period SDBP decreased from 107 +/- 2 to 95 +/- 2 mm Hg (p less than 0.001). At the end of treatment, glomerular filtration rate (GFR) remained unchanged in five patients, improved in four patients, and slightly decreased in one patient, the slope from baseline being 0.137 and the variation of GFR per unit of GFR at baseline being between -0.20 and 0.47. Likewise, effective renal plasma flow increased not significantly, showing considerable variability. Urinary protein excretion was reduced significantly from 2.51 +/- 0.75 to 0.51 +/- 0.10 g/L (p less than 0.05), suggesting that converting enzyme inhibition may exert a renal protective effect. In conclusion, it appears that cilazapril does not induce functional damage in the kidney of predialysis hypertensives.

The antihypertensive activity of cilazapril, a new nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor was evaluated in 20 outpatients (13 women, 7 men; mean age, 49 +/- 2.4 years) with mild to moderate essential hypertension, by means of an open dose-finding study of 10 weeks' duration. Cilazapril, 0.5 mg/day, was given, and the dose increased up to 10 mg/day if sitting diastolic blood pressure (SDBP) was not normalized (less than or equal to 90 mm Hg). Blood pressure measurements were carried out every 2 weeks before and 2 h after dosing. Predose and 2-h postdose measurements of plasma renin activity (PRA), angiotensin II (AII), plasma aldosterone (PA), and enzyme converting activity (ECA) were performed on the 1st day of active treatment and after 2 weeks of therapy. The SDBP decreased from 107.6 +/- 2 to 97.2 +/- 3 mm Hg 2 h after the initial dose (p less than 0.01). At the same time, ECA was inhibited 84.2 +/- 5% (p less than 0.01), AII decreased from 21.2 +/- 3 to 13.6 +/- 2 pg/ml (p less than 0.05), and PA from 208 +/- 29 to 119 +/- 14 pg/ml (p less than 0.01). After 2 weeks of therapy, ECA remained markedly reduced, by 68 +/- 6%, 24 h after the preceding cilazapril dose (p less than 0.01). The mean SDBP decreased from baseline to the end of treatment by 14.6 +/- 3 mm Hg (p less than 0.01). Cilazapril seems to be an effective antihypertensive drug which exerts potent and long-lasting ACE inhibition.

The effect of cilazapril as monotherapy or in combination with hydrochlorothiazide was assessed in 30 severely hypertensive patients, 23 men and seven women, aged 38 to 68 years, with sitting diastolic blood pressure of more than 115 mmHg. Fifteen patients had left ventricular hypertrophy documented by two-dimensional echocardiography. Sitting systolic blood pressure was reduced from 175.8 ±2.0 to 143.3 ±3.0 mmHg within 25 days of therapy (p