고혈압 환자에 대한 이베사탄의 혈압강하효과 및 안전성을 평가하기 위한 양측 눈가림, 무작위 배정, 에날라프릴과의 비열등성 4상 임상시험
A Randomized, Double-Blind, Non-Inferiority Clinical Trial for Safety and Efficacy of Irbesartan Compared with Enalapril in Patients with Essential Hypertension
임상약리학회지 2003년 11권 2호 p.101 ~ p.110
김광일(Kim Kwang-Il) - 서울대학교 의과대학 내과학교실
강현재(Kang Hyun-Jae) - 서울대학교 의과대학 내과학교실
김효수(Kim Hyo-Soo) - 서울대학교 의과대학 내과학교실
손대원(Sohn Dae-Won) - 서울대학교 의과대학 내과학교실
오병희(Oh Byung-Hee) - 서울대학교 의과대학 내과학교실
박영배(Park Young-Bae) - 서울대학교 의과대학 내과학교실
최윤식(Choi Yun-Shik) - 서울대학교 의과대학 내과학교실
조주희(Zo Joo-Hee) - 서울대학교 의과대학 내과학교실
김상현(Kim Sang-Hyun) - 서울대학교 의과대학 내과학교실
김명아(Kim Myung-A) - 서울대학교 의과대학 내과학교실
채인호(Chai In-Ho) - 서울대학교 의과대학 내과학교실
이명묵(Lee Myoung-Mook) - 서울대학교 의과대학 내과학교실
박병주(Park Byung-Joo) - 서울대학교 의과대학 예방의학교실
배장환(Bae Jang-Hwan) - 서울대학교 의과대학 내과학교실
서선예(Suh Sun-Ye) - 서울대학교 의과대학 내과학교실
오세일(Oh Se-Il) - 서울대학교 의과대학 내과학교실
Abstract
Background:Irbersartan, an orally active antihypertensive agent, effectively reduces blood pressure by blocking angiotensin II receptors without any significant adverse effects. The purpose of this study is to compare the antihypertensive efficacy, safety and tolerability of irbesartan and enalapril in hypertensive patients.
Methods:In this two centers, double-blind, randomized, non-inferiority study, the efficacy, safety and tolerability of once-daily irbesartan(150mg) versus once-daily enalapril(10mg) were evaluated over 8 weeks in 67 patients who had diastolic pressure between 95mmHg and 114mmHg on two measurements. If trough sitting diastolic blood pressure was equal to or greater than 90mmHg after a 4-week treatment period, the dosage for both study drugs was doubled until the end of the study. Baseline pressures, antihypertensive effect, side effects, laboratory findings were compared before and after treatment.
Results: Data from 57 of 67 patients were eligible for intention to treat analysis. After the 8 weeks treatment with dose titration, mean reductions in peak sitting diastolic blood pressure were 11.9mmHg(95% confidence interval 7.61 -16.13) with irbesartan and 10.9mmHg(95%;confidence\;interval;7.05{sim}14.70) with enalapril. There was no significant difference between the two treatments in the percentage of patients achieving an effective blood pressure reduction or in the degree of change in mean systolic and/or diastolic blood pressure. Safety profiles were also similar between treatments.
Conclusions: The antihypertensive efficacy of once-daily administration of irbesartan is non-inferior to that of enalapril in hypertensive patients. Both irbesartan and enalapril are well tolerated with similar safety profiles.
키워드
Angiotensin receptor blocker, Hypertension, Irbesartan
KMID :
0391020030110020101
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유효성결과(Recomendation)
The antihypertensive efficacy of once-daily administration of irbesartan is non-inferior to that of enalapril in hypertensive patients. Both irbesartan and enalapril are well tolerated with similar safety profiles.