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

Abstract

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.

• Amlodipine besylate
• Asian population
• benazepril hydrochloride
• fixed‐dose combination
• hypertension