Key result
A fixed-dose combination of perindopril 5 mg/amlodipine 5 mg significantly lowered systolic blood pressure at 8 weeks compared to amlodipine 5 mg (p=0.0095) or perindopril 4 mg (p<0.0001).
Why the study?
Does a fixed-dose combination of perindopril and amlodipine reduce systolic blood pressure in Chinese patients with mild-to-moderate essential hypertension not adequately controlled with monotherapy?
RCT
Double-blind
Does a fixed-dose combination of perindopril and amlodipine reduce systolic blood pressure in Chinese patients with mild-to-moderate essential hypertension not adequately controlled with monotherapy?
p-value: p=0.0095 vs Amlo 5 mg; <0.0001 vs Per 4 mg
A fixed-dose combination of perindopril and amlodipine significantly reduces systolic blood pressure in patients with mild-to-moderate hypertension uncontrolled by monotherapy.
Supports perindopril/amlodipine combination in Chinese patients uncontrolled on monotherapy; reinforces fixed-dose combination benefits over monotherapy in mild-to-moderate hypertension.
OBJECTIVES: To assess the blood pressure-lowering efficacy and tolerability of perindopril/amlodipine fixed-dose combinations in Chinese patients with mild-to-moderate essential hypertension not adequately controlled with monotherapy alone. METHODS: In 2 separate double-blind studies, patients received a 4-week run-in monotherapy of amlodipine 5 mg or perindopril 4 mg, respectively. Those whose blood pressure was uncontrolled were then randomized to receive the fixed-dose combination of perindopril 5 mg/amlodipine 5 mg (Per/Amlo group) or remain on the monotherapy for 8 weeks. Patients who were uncontrolled at the week 8 (W8) visit were up-titrated for the Per/Amlo combination, or received additional treatment if on monotherapy, for a further 4 weeks. The main efficacy assessment was at 8 weeks. RESULTS: After 8 weeks, systolic blood pressure (SBP; primary criterion) was statistically significantly lower in the Per/Amlo group (vs. Amlo 5 mg, p = 0.0095; vs. Per 4 mg, p < 0.0001). Uncontrolled patients at W8 who received an up-titration of the Per/Amlo combination showed a further SBP reduction. These changes were mirrored by reassuring reductions in diastolic blood pressure. The fixed-dose combinations were well tolerated. CONCLUSIONS: Single-pill combinations of perindopril and amlodipine provide hypertensive patients with a convenient and effective method of reducing blood pressure.
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Hu et al. (2016) conducted an RCT in mild-to-moderate essential hypertension. Perindopril/Amlodipine fixed-dose combination vs. amlodipine 5 mg or perindopril 4 mg monotherapy was evaluated on systolic blood pressure (SBP) (p=0.0095 vs Amlo 5 mg; <0.0001 vs Per 4 mg). A fixed-dose combination of perindopril 5 mg/amlodipine 5 mg significantly lowered systolic blood pressure at 8 weeks compared to amlodipine 5 mg (p=0.0095) or perindopril 4 mg (p<0.0001).
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