A clinical study on the anti-Hypertensive effect of cilazapril in patients with mild to moderate essential hypertension

ABSTRACT

BACKGROUND: In order to investigate the efficacy and safety of cilazapril, a recently developed angiotensin converting enzyme inhibitor, a clinical study was performed in the patients with mild to moderate essential hypertension. METHODS: The study subject consisted of 31 patients with diastolic blood pressure of 95mmHg~115mmHg (mean age 56.0+/-8.1 years, 16 males and 15 females). Cilazapril was administered orally in a daily dose of 2.5mg~5.0mg Q.D. for 8 weeks. During cilazapril medication, anti-hypertensive efficacy, side effects and laboratory changes were monitored. RESULTS: Cilazapril decreased blood pressure from baseline value of 162.2+/-4.7/98.4+/-2.8mmHg to 144.6+/-10.0/89.7+/-5.7mmHg after 4weeks of medication (p<0.05) and 138.2+/-4.5/87.8+/-4.0mmHg after 8 weeks of medication (p<0.05). Heart rate change was not significant (72.3+/-4.7/min vs 71.7+/-3.6/min). Body weight change was not significant (66.6+/-9.8 Kg vs 66.8+/-9.9 Kg). There were no significant change in blood chemistry and hematologic examination except mild elevation of alanine transaminase and serum creatinine values but these date were within normal ranges. The side effects were dry cough (4 case, 12.9%), headache (2 case, 6.4%), indigestion (1 case, 3.2%) and dry mouth (1 case, 3.2%). One patient dropped out due to severe dry cough but others were mostly mild in nature. CONCLUSIONS: Cliazapril 2.5mg~5.0mg once daily regimen was effective and well tolerated in patients with mild to moderate essential hypertension.