Key result
Amlodipine/benazepril fixed-dose combination significantly improved BP control rates (83.8% for 2.5/10 mg and 80.2% for 5/10 mg) compared to benazepril monotherapy (64.9%; p<0.01).
Why the study?
Does amlodipine/benazepril fixed-dose combination improve blood pressure reduction in Chinese essential hypertensive patients not adequately controlled with benazepril monotherapy?
RCT (n=341)
double-blind, double-dummy
randomized
Yes
Does amlodipine/benazepril fixed-dose combination improve blood pressure reduction in Chinese essential hypertensive patients not adequately controlled with benazepril monotherapy?
Absolute Event Rate: 83.8% vs 64.9%
p-value: p=< 0.01
In Chinese patients with hypertension uncontrolled on benazepril monotherapy, adding amlodipine (2.5 or 5 mg) significantly improved blood pressure reduction and control rates.
Supports amlodipine/benazepril combination for BP control in Chinese patients uncontrolled on benazepril; extends evidence for CCB/ACEI fixed-dose therapy.
This double-blind, double-dummy clinical trial evaluated the efficacy and safety of two strengths of fixed-dose combination of amlodipine/benazepril in Chinese hypertensive patients not adequately controlled with benazepril. Of 442 patients who received treatment with benazepril 10 mg for 4 weeks, 341 patients failed to achieve to diastolic blood pressure (DBP) <90 mmHg. These non-responders were randomized to receive amlodipine/benazepril 2.5/10 mg, or amlodipine/benazepril 5/10 mg, or benazepril 10 mg for 8 weeks. BP reductions with amodipinel/benazepril 2.5/10 mg (15.2/11.8 mmHg) or amlodipine/benazepril 5/10 mg (15.4/12.4 mmHg) were significantly greater than that with benazepril 10 mg (9.88/9.46 mmHg) at study end (p < 0.01, combination versus benazepril). BP control rate was 83.8% with amlodipine/benazepril 2.5/10 mg, 80.2% with amlodipine/benazepril 5/10 mg, 64.9% with benazepril 10 mg at study end (p < 0.01, combination versus benazepril). Three groups were generally well tolerated. Our study indicated that amlodipine/benazepril fixed-dose combination offered significant additional BP reductions and BP control rate compared with the continuation of benazepril monotherapy. No significant differences were observed in both BP reductions and BP control rate between amlodipine/benazepril 2.5/10 mg and amlodipine/benazepril 5/10 mg.
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Yan et al. (2013) conducted an RCT in essential hypertension (n=341). amlodipine/benazepril vs. benazepril 10 mg was evaluated on BP control rate (p=< 0.01). Amlodipine/benazepril fixed-dose combination significantly improved BP control rates (83.8% for 2.5/10 mg and 80.2% for 5/10 mg) compared to benazepril monotherapy (64.9%; p<0.01).
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