신질환이 있는 경증 미치 중등도의 고혈압 환자에서 Irbesartan의 항고혈압효과 및 안전성을 평가하기 위한 제 4상 임상 시험

Abstract

Irbesartan is a new selective angiotensin II subtype 1 receptor antagonist. We evaluated the efficacy and tolerability of irbesartan in patients with mild to moderate hypertension and renal disease. On 24 hypertensive patients, oral irbesartan 150mg a day was administered. In cases whose seated diastolic blood pressure did not decrease to 85mmHg after treatment for 4 weeks, the dose of irbesartan was increased to 300mg per day. Every 4 weeks, blood pressure, heart rates, and adverse effects were monitored. And we assessed WBC counts, hemoglobin, hematocrits, platelets, creatinine, BUN, total protein, albumin, fasting blood sugar, total cholesterol, AST, ALT, alkaline phosphatase, total bilirubin, sodium, potassium, calcium, uric acid and urine protein/creatinine ratio to evaluate the change of renal and hepatic function and other adverse effects. Seated systolic blood pressure was decreased from 157.1±3.1mmHg to 135.5±3.7mmHg, and seated diastolic blood pressure was also decreased frorn 99.2±1.7mmHg to 84.3±2.5mmHg. Irbesartan was effective in lowering blood pressure in 20 among 24 patients, and the effective rate of this drug was 83.3%. After treatment, a non clinically significant increase of heart rates and statistically significant decrease of total cholesterol level were noted. There was no dose-related adverse effect. We conclude that irbesartan is a safe and effective angiotensin II subtype 1 receptor antagonist for lowering blood pressure in patients with mild to moderate hyrtension and renal disease.