An eight-week, multicenter, randomized, double-blind study to evaluate the efficacy and tolerability of fixed-dose amlodipine/benazepril combination in comparison with amlodipine as first-line therapy in Chinese patients with mild to moderate hypertension

作者：Ueng Kwo Chang; Lin Lung Chun; Voon Wen Chol; Lin Ming Cheng; Liu Yen Bin; Su Ho Ming; Chang Po Yuan; Lin Tsung Hsien; Chen Wei Liang; Wu Chau Chung; Lai Wen Ter; Lin Chung Sheng^*

来源：Blood Pressure, 2008, 17: 24-31.

DOI：10.1080/08037050802102660

• amlodipine besylate
• Asian population
• benazepril hydrochloride
• fixed-dose combination
• hypertension

Aims. This study sought to compare the antihypertensive efficacy and tolerability of a fixed-dose combination with amlodipine/benazepril with that of amlodipine monotherapy in Chinese hypertensive subjects. Results. This multicenter, double-blind, 8-week study randomized 111 patients to fixed-dose amlodipine besylate/benazepril HCl (2.5/5 mg/day titrated to 5/10 mg/day as needed at week 4 to reach goal blood pressure (BP) < 140/90 mmHg) or amlodipine besylate monotherapy (5 mg/day titrated to 10 mg/day as needed). At week 8, patients randomized to combination therapy compared with monotherapy had a comparable BP control rate (56.0% vs 46.2%; p=0.32). Fixed-dose combination resulted in similar reductions in sitting systolic (SBP) and diastolic BP (DBP) compared with monotherapy (SBP: - 19.3 +/- 12.5 vs -20.9 +/- 13.3 mmHg; DBP: -9.2 +/- 10.4 vs - 11.3 +/- 9.3 mmHg; both p=NS). Safety profiles did not differ between groups, but cough was more common in the combination group (11.0% vs 0%; p=0.013). Conclusions. In this group of patients, comparable antihypertensive effects were seen with the fixed-dose combination therapy, compared with amlodipine monotherapy. Both treatments appeared well tolerated in the studied population, but cough was more common in the fixed-dose combination group.

• 出版日期2008-6
• 单位河北医科大学