March 18, 2019Open Access
View Full PaperComparison of Dual Therapies for Lowering Blood Pressure in Black Africans
Key Result
Amlodipine plus hydrochlorothiazide or perindopril reduced 24-hour systolic blood pressure more than perindopril plus hydrochlorothiazide (difference -3.14 mm Hg, P=0.03; and -3.00 mm Hg, P=0.04).
Study Design
Type
RCT (n=728)
Blinding
Single-blind
Randomization
randomly assigned
Multicenter
Yes
Structured PICO
Does amlodipine combined with either hydrochlorothiazide or perindopril improve blood pressure reduction compared to perindopril plus hydrochlorothiazide in black African patients with uncontrolled hypertension?
P
Population
728 black patients in sub-Saharan Africa with uncontrolled hypertension, followed for 6 months.
I
Intervention
Amlodipine 5 mg plus hydrochlorothiazide 12.5 mg OR amlodipine 5 mg plus perindopril 4 mg daily for 2 months, with doses doubled (10/25 mg and 10/8 mg, respectively) for an additional 4 months.
C
Comparator
Perindopril 4 mg plus hydrochlorothiazide 12.5 mg daily for 2 months, with doses doubled (8/25 mg) for an additional 4 months.
O
Outcome
Change in the 24-hour ambulatory systolic blood pressure between baseline and 6 months.surrogate
In black African patients with uncontrolled hypertension, amlodipine-based dual therapy (with either hydrochlorothiazide or perindopril) is more effective at lowering ambulatory systolic blood pressure than perindopril plus hydrochlorothiazide.
Main Result
Mean Difference: -3.14 (95% CI -5.9–-0.38)
p-value: p=0.03
Abstract
BACKGROUND: The prevalence of hypertension among black African patients is high, and these patients usually need two or more medications for blood-pressure control. However, the most effective two-drug combination that is currently available for blood-pressure control in these patients has not been established. METHODS: In this randomized, single-blind, three-group trial conducted in six countries in sub-Saharan Africa, we randomly assigned 728 black patients with uncontrolled hypertension (≥140/90 mm Hg while the patient was not being treated or was taking only one antihypertensive drug) to receive a daily regimen of 5 mg of amlodipine plus 12.5 mg of hydrochlorothiazide, 5 mg of amlodipine plus 4 mg of perindopril, or 4 mg of perindopril plus 12.5 mg of hydrochlorothiazide for 2 months. Doses were then doubled (10 and 25 mg, 10 and 8 mg, and 8 and 25 mg, respectively) for an additional 4 months. The primary end point was the change in the 24-hour ambulatory systolic blood pressure between baseline and 6 months. RESULTS: The mean age of the patients was 51 years, and 63% were women. Among the 621 patients who underwent 24-hour blood-pressure monitoring at baseline and at 6 months, those receiving amlodipine plus hydrochlorothiazide and those receiving amlodipine plus perindopril had a lower 24-hour ambulatory systolic blood pressure than those receiving perindopril plus hydrochlorothiazide (between-group difference in the change from baseline, -3.14 mm Hg; 95% confidence interval CI, -5.90 to -0.38; P = 0.03; and -3.00 mm Hg; 95% CI, -5.8 to -0.20; P = 0.04, respectively). The difference between the group receiving amlodipine plus hydrochlorothiazide and the group receiving amlodipine plus perindopril was -0.14 mm Hg (95% CI, -2.90 to 2.61; P=0.92). Similar differential effects on office and ambulatory diastolic blood pressures, along with blood-pressure control and response rates, were apparent among the three groups. CONCLUSIONS: These findings suggest that in black patients in sub-Saharan Africa, amlodipine plus either hydrochlorothiazide or perindopril was more effective than perindopril plus hydrochlorothiazide at lowering blood pressure at 6 months. (Funded by GlaxoSmithKline Africa Noncommunicable Disease Open Lab; CREOLE ClinicalTrials.gov number, NCT02742467.).