Odili Augustine N, Richart Tom, Thijs Lutgarde, Kingue Samuel, Boombhi Hilaire J, Lemogoum Daniel, Kaptue Joseph, Kamdem Marius K, Mipinda Jean-Bruno, Omotoso Babatunde A, Kolo Philip M, Aderibigbe Ademola, Ulasi Ifeoma I, Anisiuba Benedict C, Ijoma Chinwuba K, Ba Serigne A, Ndiaye Mouhamadou B, Staessen Jan A, M'buyamba-Kabangu Jean-René
Studies Coordinating Centre, Division of Hypertension and Cardiovascular Rehabilitation, Department of Cardiovascular Diseases, University of Leuven, Leuven, Belgium.
Blood Press. 2011 Oct;20(5):256-66. doi: 10.3109/08037051.2011.572614. Epub 2011 Apr 15.
Sub-Saharan Africa experiences an epidemic surge in hypertension. Studies in African Americans led to the recommendation to initiate antihypertensive treatment in Blacks with a diuretic or a low-dose fixed combination including a diuretic. We mounted the Newer versus Older Antihypertensive Agents in African Hypertensive Patients (NOAAH) trial to compare in native African patients a fixed combination of newer drugs, not involving a diuretic, with a combination of older drugs including a diuretic.
Patients aged 30-69 years with uncomplicated hypertension (140-179/90-109 mmHg) and two or fewer associated risk factors are eligible. After a 4-week run-in period off treatment, 180 patients will be randomized to once daily bisoprolol/hydrochlorothiazide 5/6.25 mg or amlodipine/valsartan 5/160 mg. To attain and maintain blood pressure below 140/90 mmHg during 6 months of follow-up, the doses of bisoprolol and amlodipine in the combination tablets will be increased to 10 mg/day with the possible addition of α-methyldopa or hydralazine. NOAAH is powered to demonstrate a 5-mmHg between-group difference in sitting systolic pressure with a two-sided p-value of 0.01 and 90% power. NOAAH is investigator-led and complies with the Helsinki declaration.
Six centers in four sub-Saharan countries started patient recruitment on September 1, 2010. On December 1, 195 patients were screened, 171 were enrolled, and 51 were randomized and followed up. The trial will be completed in the third quarter of 2011.
NOAAH (NCT01030458) is the first randomized multicenter trial of antihypertensive medications in hypertensive patients born and living in sub-Saharan Africa.
撒哈拉以南非洲地区高血压发病率呈流行趋势。针对非裔美国人的研究建议，对黑人高血压患者采用利尿剂或含利尿剂的低剂量固定复方制剂开始抗高血压治疗。我们开展了非洲高血压患者新型与传统抗高血压药物对比试验（NOAAH），以比较在非洲本土患者中，不含利尿剂的新型药物固定复方制剂与含利尿剂的传统药物复方制剂的疗效。
年龄在30 - 69岁、患有单纯性高血压（收缩压140 - 179 mmHg，舒张压90 - 109 mmHg）且伴有两个或更少相关危险因素的患者符合入选标准。在为期4周的停药导入期后，180名患者将被随机分为每日一次服用比索洛尔/氢氯噻嗪5/6.25 mg组或氨氯地平/缬沙坦5/160 mg组。为使随访6个月期间血压维持在140/90 mmHg以下，复方片剂中比索洛尔和氨氯地平的剂量将增至10 mg/天，并可能加用α-甲基多巴或肼屈嗪。NOAAH旨在显示组间坐位收缩压有5 mmHg的差异，双侧p值为0.01，检验效能为90%。NOAAH由研究者主导，遵循赫尔辛基宣言。
撒哈拉以南四个国家的六个中心于201年9月1日开始招募患者。2010年12月1日，195名患者接受筛查，171名患者入选，51名患者被随机分组并进行随访。该试验将于2011年第三季度完成。
NOAAH（NCT01030458）是首个针对出生并生活在撒哈拉以南非洲地区的高血压患者进行的抗高血压药物随机多中心试验。
