Progress report on the first sub-Saharan Africa trial of newer versus older antihypertensive drugs in native black patients

<p>Abstract</p> <p>Background</p> <p>The epidemic surge in hypertension in sub-Saharan Africa is not matched by clinical trials of antihypertensive agents in Black patients recruited in this area of the world. We mounted the Newer versus Older Antihypertensive agents in...

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Main Authors: Odili Augustine N, Ezeala-Adikaibe Birinus, Ndiaye Mouhamadou B, Anisiuba Benedict C, Kamdem Marius M, Ijoma Chinwuba K, Kaptue Joseph, Boombhi Hilaire J, Kolo Philip M, Shu Elvis N, Thijs Lutgarde, Staessen Jan A, Omotoso Babatunde A, Kingue Samuel, Ba Serigne A, Lemogoum Daniel, M’Buyamba-Kabangu Jean-René, Ulasi Ifeoma I
Format: Article
Language:English
Published: BMC 2012-05-01
Series:Trials
Subjects:
Online Access:http://www.trialsjournal.com/content/13/1/59
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spelling doaj-d550263049b5466080dd871b930a8ae22020-11-25T00:26:20ZengBMCTrials1745-62152012-05-011315910.1186/1745-6215-13-59Progress report on the first sub-Saharan Africa trial of newer versus older antihypertensive drugs in native black patientsOdili Augustine NEzeala-Adikaibe BirinusNdiaye Mouhamadou BAnisiuba Benedict CKamdem Marius MIjoma Chinwuba KKaptue JosephBoombhi Hilaire JKolo Philip MShu Elvis NThijs LutgardeStaessen Jan AOmotoso Babatunde AKingue SamuelBa Serigne ALemogoum DanielM’Buyamba-Kabangu Jean-RenéUlasi Ifeoma I<p>Abstract</p> <p>Background</p> <p>The epidemic surge in hypertension in sub-Saharan Africa is not matched by clinical trials of antihypertensive agents in Black patients recruited in this area of the world. We mounted the Newer versus Older Antihypertensive agents in African Hypertensive patients (NOAAH) trial to compare, in native African patients, a single-pill combination of newer drugs, not involving a diuretic, with a combination of older drugs including a diuretic.</p> <p>Methods</p> <p>Patients aged 30 to 69 years with uncomplicated hypertension (140 to 179/90 to 109 mmHg) and ≤2 associated risk factors are eligible. After a four week run-in period off treatment, 180 patients have to be randomized to once daily bisoprolol/hydrochlorothiazide 5/6.25 mg (R) or amlodipine/valsartan 5/160 mg (E). To attain blood pressure <140/<90 mmHg during six months, the doses of bisoprolol and amlodipine should be increased to 10 mg/day with the possible addition of up to 2 g/day α-methyldopa.</p> <p>Results</p> <p>At the time of writing of this progress report, of 206 patients enrolled in the run-in period, 140 had been randomized. At randomization, the R and E groups were similar (<it>P</it> ≥ 0.11) with respect to mean age (50.7 years), body mass index (28.2 kg/m<sup>2</sup>), blood pressure (153.9/91.5 mmHg) and the proportions of women (53.6%) and treatment naïve patients (72.7%). After randomization, in the R and E groups combined, blood pressure dropped by 18.2/10.1 mmHg, 19.4/11.2 mmHg, 22.4/12.2 mmHg and 25.8/15.2 mmHg at weeks two (n = 122), four (n = 109), eight (n = 57), and 12 (n = 49), respectively. The control rate was >65% already at two weeks. At 12 weeks, 12 patients (24.5%) had progressed to the higher dose of R or E and/or had α-methyldopa added. Cohort analyses of 49 patients up to 12 weeks were confirmatory. Only two patients dropped out of the study.</p> <p>Conclusions</p> <p>NOAAH (NCT01030458) demonstrated that blood pressure control can be achieved fast in Black patients born and living in Africa with a simple regimen consisting of a single-pill combination of two antihypertensive agents. NOAAH proves that randomized clinical trials of cardiovascular drugs in the indigenous populations of sub-Saharan Africa are feasible.</p> http://www.trialsjournal.com/content/13/1/59Antihypertensive therapyHealth policy and outcome researchRandomized clinical trialSpecial populations
collection DOAJ
language English
format Article
sources DOAJ
author Odili Augustine N
Ezeala-Adikaibe Birinus
Ndiaye Mouhamadou B
Anisiuba Benedict C
Kamdem Marius M
Ijoma Chinwuba K
Kaptue Joseph
Boombhi Hilaire J
Kolo Philip M
Shu Elvis N
Thijs Lutgarde
Staessen Jan A
Omotoso Babatunde A
Kingue Samuel
Ba Serigne A
Lemogoum Daniel
M’Buyamba-Kabangu Jean-René
Ulasi Ifeoma I
spellingShingle Odili Augustine N
Ezeala-Adikaibe Birinus
Ndiaye Mouhamadou B
Anisiuba Benedict C
Kamdem Marius M
Ijoma Chinwuba K
Kaptue Joseph
Boombhi Hilaire J
Kolo Philip M
Shu Elvis N
Thijs Lutgarde
Staessen Jan A
Omotoso Babatunde A
Kingue Samuel
Ba Serigne A
Lemogoum Daniel
M’Buyamba-Kabangu Jean-René
Ulasi Ifeoma I
Progress report on the first sub-Saharan Africa trial of newer versus older antihypertensive drugs in native black patients
Trials
Antihypertensive therapy
Health policy and outcome research
Randomized clinical trial
Special populations
author_facet Odili Augustine N
Ezeala-Adikaibe Birinus
Ndiaye Mouhamadou B
Anisiuba Benedict C
Kamdem Marius M
Ijoma Chinwuba K
Kaptue Joseph
Boombhi Hilaire J
Kolo Philip M
Shu Elvis N
Thijs Lutgarde
Staessen Jan A
Omotoso Babatunde A
Kingue Samuel
Ba Serigne A
Lemogoum Daniel
M’Buyamba-Kabangu Jean-René
Ulasi Ifeoma I
author_sort Odili Augustine N
title Progress report on the first sub-Saharan Africa trial of newer versus older antihypertensive drugs in native black patients
title_short Progress report on the first sub-Saharan Africa trial of newer versus older antihypertensive drugs in native black patients
title_full Progress report on the first sub-Saharan Africa trial of newer versus older antihypertensive drugs in native black patients
title_fullStr Progress report on the first sub-Saharan Africa trial of newer versus older antihypertensive drugs in native black patients
title_full_unstemmed Progress report on the first sub-Saharan Africa trial of newer versus older antihypertensive drugs in native black patients
title_sort progress report on the first sub-saharan africa trial of newer versus older antihypertensive drugs in native black patients
publisher BMC
series Trials
issn 1745-6215
publishDate 2012-05-01
description <p>Abstract</p> <p>Background</p> <p>The epidemic surge in hypertension in sub-Saharan Africa is not matched by clinical trials of antihypertensive agents in Black patients recruited in this area of the world. We mounted the Newer versus Older Antihypertensive agents in African Hypertensive patients (NOAAH) trial to compare, in native African patients, a single-pill combination of newer drugs, not involving a diuretic, with a combination of older drugs including a diuretic.</p> <p>Methods</p> <p>Patients aged 30 to 69 years with uncomplicated hypertension (140 to 179/90 to 109 mmHg) and ≤2 associated risk factors are eligible. After a four week run-in period off treatment, 180 patients have to be randomized to once daily bisoprolol/hydrochlorothiazide 5/6.25 mg (R) or amlodipine/valsartan 5/160 mg (E). To attain blood pressure <140/<90 mmHg during six months, the doses of bisoprolol and amlodipine should be increased to 10 mg/day with the possible addition of up to 2 g/day α-methyldopa.</p> <p>Results</p> <p>At the time of writing of this progress report, of 206 patients enrolled in the run-in period, 140 had been randomized. At randomization, the R and E groups were similar (<it>P</it> ≥ 0.11) with respect to mean age (50.7 years), body mass index (28.2 kg/m<sup>2</sup>), blood pressure (153.9/91.5 mmHg) and the proportions of women (53.6%) and treatment naïve patients (72.7%). After randomization, in the R and E groups combined, blood pressure dropped by 18.2/10.1 mmHg, 19.4/11.2 mmHg, 22.4/12.2 mmHg and 25.8/15.2 mmHg at weeks two (n = 122), four (n = 109), eight (n = 57), and 12 (n = 49), respectively. The control rate was >65% already at two weeks. At 12 weeks, 12 patients (24.5%) had progressed to the higher dose of R or E and/or had α-methyldopa added. Cohort analyses of 49 patients up to 12 weeks were confirmatory. Only two patients dropped out of the study.</p> <p>Conclusions</p> <p>NOAAH (NCT01030458) demonstrated that blood pressure control can be achieved fast in Black patients born and living in Africa with a simple regimen consisting of a single-pill combination of two antihypertensive agents. NOAAH proves that randomized clinical trials of cardiovascular drugs in the indigenous populations of sub-Saharan Africa are feasible.</p>
topic Antihypertensive therapy
Health policy and outcome research
Randomized clinical trial
Special populations
url http://www.trialsjournal.com/content/13/1/59
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