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奈必洛尔对撒哈拉以南非洲黑人诊室血压的影响(一项试点研究)。

The Effect of Nebivolol on Office Blood Pressure of Blacks Residing in Sub-Saharan Africa (A Pilot Study).

作者信息

Ojji Dike, Ale Boni Maxime, Shedul Lamkur, Umuerri Ejiroghene, Ejim Emmanuel, Alikor Chizindu, Agunyenwa Charles, Njideofor Uche, Eze Helen, Ansa Victor

机构信息

Department of Internal Medicine, Faculty of Clinical Sciences, College of Health Sciences, University of Abuja and University of Abuja Teaching Hospital, Gwagwalada, Nigeria.

Cardiovacular Research Unit, Department of Internal Medicine, University of Abuja and University of Abuja Teaching Hospital, Gwagwalada, Nigeria.

出版信息

Front Cardiovasc Med. 2021 Jan 11;7:613917. doi: 10.3389/fcvm.2020.613917. eCollection 2020.

Abstract

There is substantial clinical evidence that monotherapy with beta-blockers are less effective in reducing blood pressure among hypertensive Black patients compared to Whites. The highly selective beta-1 agents like nebivolol and bisoprolol have, however, been reported to be effective in reducing blood pressure in African Americans. However, results in African Americans cannot be extrapolated to native Africans because of genetic admixture and gene-environment interaction. There is, therefore, the need for us to generate data that are applicable to Africans residing in sub-Saharan Africa. We therefore decided to evaluate the efficacy and tolerability of highly selective beta-1 agent nebivolol in hypertensive Black patients residing in sub-Saharan Africa. The nebivolol study was a multicenter, prospective, observational program among hypertensive patients with 4- and 8-week follow up which was conducted in 5 cities in Nigeria of Abuja, Calabar, Enugu, Oghara, and Port Harcourt. Dosages of nebivolol used in keeping with local prescribing information were 5 and 10 mg once daily each. The effectiveness of treatment was assessed by change from baseline in mean office systolic and diastolic blood pressures, and the proportion of patients achieving the therapeutic goal of <140/90 mmHg. Safety and tolerability of this medication were also assessed. We report the results of the 140 patients studied. The mean age and body mass index were 46.9 ± 7.3 years and 22.3 ± 5.8 kg/m, respectively, and 57.1% were female. Nebivolol reduced SBP and DBP by 7.6 and 6.6 mmHg, respectively, in 4 weeks, and by 11.1 and 8.0 mm Hg, respectively, in 8 weeks. Blood pressure control was achieved in 54.8% of the patients in 4 weeks and increased to 60.4% in 8 weeks. There was no change in metabolic profile between randomization and at 8 weeks, and erectile dysfunction occurred in 1.3% of the study population. Nebivolol 5 and 10 mg appear efficacious in Nigerian Africans with no negative metabolic effect and minimal side effect profile. www.ClinicalTrials.gov, Study Identification: NCT03598673.

摘要

有大量临床证据表明,与白人相比,β受体阻滞剂单药治疗在降低高血压黑人患者血压方面效果较差。然而,据报道,像奈必洛尔和比索洛尔这样的高选择性β1受体阻滞剂在降低非裔美国人血压方面是有效的。然而,由于基因混合和基因 - 环境相互作用,非裔美国人的研究结果不能外推到非洲本土人。因此,我们需要生成适用于居住在撒哈拉以南非洲的非洲人的数据。因此,我们决定评估高选择性β1受体阻滞剂奈必洛尔对居住在撒哈拉以南非洲的高血压黑人患者的疗效和耐受性。奈必洛尔研究是一项针对高血压患者的多中心、前瞻性观察项目,随访4周和8周,该研究在尼日利亚的5个城市进行,分别是阿布贾、卡拉巴尔、埃努古、奥加拉和哈科特港。根据当地处方信息使用的奈必洛尔剂量为每日一次,5毫克和10毫克。通过平均诊室收缩压和舒张压相对于基线的变化以及达到<140/90 mmHg治疗目标的患者比例来评估治疗效果。还评估了该药物的安全性和耐受性。我们报告了140名研究患者的结果。平均年龄和体重指数分别为46.9±7.3岁和22.3±5.8 kg/m²,57.1%为女性。奈必洛尔在4周内分别使收缩压和舒张压降低7.6 mmHg和6.6 mmHg,在8周内分别降低11.1 mmHg和8.0 mmHg。4周时54.8%的患者实现了血压控制,8周时增至60.4%。随机分组时和8周时代谢指标无变化,1.3%的研究人群出现勃起功能障碍。5毫克和10毫克的奈必洛尔对尼日利亚非洲人似乎有效,没有负面代谢影响且副作用最小。ClinicalTrials.gov,研究识别号:NCT03598673。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3019/7829216/a92cc4fa8d4c/fcvm-07-613917-g0001.jpg

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