Comparison of dual therapies for lowering blood pressure in black Africans
File(s)
Published version
Author(s)
Type
Journal Article
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 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.).
Date Issued
2019-03-18
Date Acceptance
2019-03-01
Citation
New England Journal of Medicine, 2019, 380 (25), pp.2429-2439
ISSN
0028-4793
Publisher
Massachusetts Medical Society
Start Page
2429
End Page
2439
Journal / Book Title
New England Journal of Medicine
Volume
380
Issue
25
Copyright Statement
© 2019 Massachusetts Medical Society. All rights reserved.
Identifier
https://www.ncbi.nlm.nih.gov/pubmed/30883050
Subjects
Science & Technology
Life Sciences & Biomedicine
Medicine, General & Internal
General & Internal Medicine
ARTERIAL-HYPERTENSION
CARDIOVASCULAR EVENTS
EUROPEAN-SOCIETY
MANAGEMENT
TRIALS
HYDROCHLOROTHIAZIDE
AMLODIPINE
RATIONALE
EFFICACY
OUTCOMES
Adult
Africa South of the Sahara
African Continental Ancestry Group
Aged
Amlodipine
Antihypertensive Agents
Blood Pressure
Drug Combinations
Drug Therapy, Combination
Female
Humans
Hydrochlorothiazide
Hypertension
Logistic Models
Male
Middle Aged
Perindopril
Single-Blind Method
CREOLE Study Investigators
Humans
Hypertension
Amlodipine
Hydrochlorothiazide
Perindopril
Antihypertensive Agents
Drug Combinations
Drug Therapy, Combination
Logistic Models
Single-Blind Method
Blood Pressure
Adult
Aged
Middle Aged
African Continental Ancestry Group
Africa South of the Sahara
Female
Male
11 Medical and Health Sciences
General & Internal Medicine
Publication Status
Published
Coverage Spatial
United States
Date Publish Online
2019-03-18