title: Progress report on the first sub-Saharan Africa trial of newer versus older antihypertensive drugs in native black patients.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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 (P ≥ 0.11) with respect to mean age (50.7 years), body mass index (28.2 kg/m(2)), 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Studies Coordinating Centre, Division of Hypertension and Cardiovascular Rehabilitation, Department of Cardiovascular Diseases, University of Leuven Campus Sint Rafaël, Kapucijnenvoer 35, Block D, Box 7001, Leuven BE-3000, Belgium.
authors.forename: Augustine N
authors.initials: AN
authors.lastname: Odili
authors.forename: Birinus
authors.initials: B
authors.lastname: Ezeala-Adikaibe
authors.forename: Mouhamadou B
authors.initials: MB
authors.lastname: Ndiaye
authors.forename: Benedict C
authors.initials: BC
authors.lastname: Anisiuba
authors.forename: Marius M
authors.initials: MM
authors.lastname: Kamdem
authors.forename: Chinwuba K
authors.initials: CK
authors.lastname: Ijoma
authors.forename: Joseph
authors.initials: J
authors.lastname: Kaptue
authors.forename: Hilaire J
authors.initials: HJ
authors.lastname: Boombhi
authors.forename: Philip M
authors.initials: PM
authors.lastname: Kolo
authors.forename: Elvis N
authors.initials: EN
authors.lastname: Shu
authors.forename: Lutgarde
authors.initials: L
authors.lastname: Thijs
authors.forename: Jan A
authors.initials: JA
authors.lastname: Staessen
authors.forename: Babatunde A
authors.initials: BA
authors.lastname: Omotoso
authors.forename: Samuel
authors.initials: S
authors.lastname: Kingue
authors.forename: Serigne A
authors.initials: SA
authors.lastname: Ba
authors.forename: Daniel
authors.initials: D
authors.lastname: Lemogoum
authors.forename: Jean-René
authors.initials: JR
authors.lastname: M'Buyamba-Kabangu
authors.forename: Ifeoma I
authors.initials: II
authors.lastname: Ulasi
mesh_terms: D000284:Administration, Oral; D000328:Adult; D017954:Africa South of the Sahara / Q000453:epidemiology; D000368:Aged; D017311:Amlodipine / Q000008:administration & dosage / Q000627:therapeutic use*; D000068838:Amlodipine, Valsartan Drug Combination; D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D017298:Bisoprolol / Q000008:administration & dosage / Q000627:therapeutic use*; D044383:Black People; D001794:Blood Pressure / Q000187:drug effects*; D004232:Diuretics / Q000627:therapeutic use; D004338:Drug Combinations; D005260:Female; D006801:Humans; D006852:Hydrochlorothiazide / Q000008:administration & dosage / Q000627:therapeutic use*; D006973:Hypertension / Q000188:drug therapy* / Q000208:ethnology / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D010352:Patient Dropouts; D018579:Patient Selection; D012307:Risk Factors; D013607:Tablets; D013777:Tetrazoles / Q000008:administration & dosage / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000068838:Amlodipine, Valsartan Drug Combination; D000959:Antihypertensive Agents; D004232:Diuretics; D004338:Drug Combinations; D013607:Tablets; D013777:Tetrazoles; C086062:bisoprolol, hydrochlorothiazide drug combination; D006852:Hydrochlorothiazide; D017311:Amlodipine; D017298:Bisoprolol