Key result
Fixed-dose amlodipine/benazepril combination therapy resulted in a comparable blood pressure control rate to amlodipine monotherapy (56.0% vs. 46.2%; p=0.32) at 8 weeks.
Why the study?
Does fixed-dose amlodipine/benazepril combination improve blood pressure control compared to amlodipine monotherapy in Chinese patients with mild to moderate hypertension?
RCT (n=111)
Double-blind
randomized
Yes
Does fixed-dose amlodipine/benazepril combination improve blood pressure control compared to amlodipine monotherapy in Chinese patients with mild to moderate hypertension?
Absolute Event Rate: 56% vs 46.2%
p-value: p=0.32
Fixed-dose amlodipine/benazepril combination therapy provides comparable blood pressure control to amlodipine monotherapy in Chinese patients with mild to moderate hypertension, though with a higher incidence of cough.
No BP control advantage with combination over monotherapy; challenges superiority assumptions for fixed-dose amlodipine/benazepril in mild-moderate 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.
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Ueng et al. (2008) conducted an RCT in mild to moderate hypertension (n=111). fixed-dose amlodipine besylate/benazepril HCl vs. amlodipine besylate monotherapy (5 mg/day titrated to 10 mg/day as needed) was evaluated on blood pressure control rate (<140/90 mmHg) (p=0.32). Fixed-dose amlodipine/benazepril combination therapy resulted in a comparable blood pressure control rate to amlodipine monotherapy (56.0% vs. 46.2%; p=0.32) at 8 weeks.
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