Dike B Ojji1, Bongani Mayosi1, Veronica Francis1, Motasim Badri1, Victoria Cornelius1, Wynand Smythe1, Nicky Kramer1, Felix Barasa1, Albertino Damasceno1, Anastase Dzudie1, Erika Jones1, Charles Mondo1, Okechukwu Ogah1, Elijah Ogola1, Mahmoud U Sani1, Gabriel L Shedul1, Grace Shedul1, Brian Rayner1, Ikechi G Okpechi1, Karen Sliwa1, Neil Poulter1. 1. From the Department of Medicine, Faculty of Clinical Sciences, University of Abuja, and University of Abuja Teaching Hospital (D.B.O.), and the Departments of Family Medicine (G.L.S.) and Pharmacy (G.S.), University of Abuja Teaching Hospital, Gwagwalada, Abuja, the Cardiology Unit, Department of Medicine, University College Hospital, Ibadan (O.O.), and the Department of Medicine, Bayero University, and Aminu Kano Teaching Hospital, Kano (M.U.S.) - all in Nigeria; the Department of Medicine (B.M.), the Division of Nephrology and Hypertension (E.J., B.R., I.G.O.), and the Clinical Research Center (V.F., W.S., N.K.), Faculty of Health Sciences, University of Cape Town, and the Hatter Institute of Cardiovascular Research in Africa (K.S.) - all in Cape Town, South Africa; the Department of Epidemiology and Biostatistics, College of Public Health and Health Informatics, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia (M.B.); the Imperial Clinical Trials Unit, School of Public Health, Imperial College London, London (V.C., N.P.); the Department of Cardiology, Moi Teaching and Referral Hospital, Eldoret (F.B.), and the Department of Clinical Medicine and Therapeutics, University of Nairobi, Nairobi (E.O.) - both in Kenya; Eduardo Mondlane University Hospital, Maputo, Mozambique (A. Damasceno); Douala General Hospital, Douala, Cameroon (A. Dzudie); and St. Francis Hospital, Nsambya, Kampala, Uganda (C.M.).
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 receivingamlodipine 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.).
RCT Entities:
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.).
Authors: Mahmoud Al Rifai; Xiaoming Jia; Mouaz H Al-Mallah; Michael D Miedema; Seth S Martin; Salim S Virani Journal: Curr Atheroscler Rep Date: 2019-05-24 Impact factor: 5.113
Authors: Pauline Cavagna; Méo Stéphane Ikama; Kouadio Euloge Kramoh; Jean Laurent Takombe; Ibrahima Bara Diop; Ibrahim Ali Toure; Dadhi M Balde; Anastase Dzudie; Beatriz Ferreira; Martin D Houenassi; Murielle Hounkponou; Adama Kane; Suzy G Kimbally-Kaki; Samuel Kingue; Charles Kouam Kouam; Emmanuel Limbole; Liliane Mfeukeu Kuate; Jean Bruno Mipinda; Roland N'guetta; Carol Nhavoto; Jean Marie Damorou; Abdallahi Sidy Ali; Bamba Gaye; Gabriel S Tajeu; Diane Macquart de Terline; Marie Cécile Perier; Michel Azizi; Xavier Jouven; Marie Antignac Journal: Eur J Prev Cardiol Date: 2021-09-20 Impact factor: 7.804
Authors: Jon C Van Tassell; Daichi Shimbo; Rachel Hess; Rick Kittles; James G Wilson; Lynn B Jorde; Man Li; Leslie A Lange; Ethan M Lange; Paul Muntner; Adam P Bress Journal: J Clin Hypertens (Greenwich) Date: 2020-02-12 Impact factor: 3.738