Ferdinand Keith C, Seman Leo, Salsali Afshin
a Tulane University School of Medicine , New Orleans , LA , USA.
b Boehringer Ingelheim Pharmaceuticals, Inc. , Ridgefield , CT , USA.
Curr Med Res Opin. 2018 Feb;34(2):361-367. doi: 10.1080/03007995.2017.1405800. Epub 2017 Nov 29.
Black/African American individuals have a higher prevalence of type 2 diabetes mellitus (T2DM), diabetes-related complications and hypertension, but they are often underrepresented in clinical trials. The sodium-glucose co-transporter 2 inhibitor, empagliflozin, was associated with significant improvements in glucose control (via hemoglobin [Hb] A) and reductions in blood pressure (BP; via office and ambulatory BP monitoring) in a primarily white population with T2DM and hypertension. The aim of this ongoing study is to assess the safety and efficacy of empagliflozin in terms of glucose- and BP-lowering in a self-identified black/African American population with T2DM and hypertension.
This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 3b study carried out at 85 centers in the USA. It was designed to assess the safety and efficacy of empagliflozin (10 or 25 mg/day) versus placebo in black/African American patients with uncontrolled T2DM and hypertension. Patients receiving stable glucose-lowering therapy prestudy continued at the same dose during the trial; BP-lowering medication was also held stable. The primary endpoint was the change from baseline in HbA at Week 24. Key secondary endpoints were change from baseline in: mean 24-hour ambulatory systolic BP (SBP) at Week 12, mean trough ambulatory SBP at Week 12, body weight at Week 24 and trough seated SBP at Week 12.
The study will report final data in 2018.
Results of this study will add to our understanding of the efficacy and safety of empagliflozin in self-identified black/African American patients with T2DM and hypertension. (ClinicalTrials.gov identifier: NCT02182830.).
黑人/非裔美国人患2型糖尿病（T2DM）、糖尿病相关并发症和高血压的患病率较高，但他们在临床试验中的代表性往往不足。钠-葡萄糖协同转运蛋白2抑制剂恩格列净，在主要为白人的T2DM和高血压患者群体中，与血糖控制（通过糖化血红蛋白[Hb]A）的显著改善及血压降低（通过诊室血压和动态血压监测）相关。这项正在进行的研究的目的是评估恩格列净在自我认定为黑人/非裔美国人的T2DM和高血压患者群体中降低血糖和血压方面的安全性和有效性。
这是一项在美国85个中心进行的多中心、随机、双盲、安慰剂对照、平行组3b期研究。其旨在评估恩格列净（10或25毫克/天）与安慰剂相比，在未得到控制的T2DM和高血压黑人/非裔美国患者中的安全性和有效性。研究前接受稳定降糖治疗的患者在试验期间继续使用相同剂量；降压药物也保持稳定。主要终点是第24周时HbA相对于基线的变化。关键次要终点是相对于基线的变化：第12周时24小时动态收缩压（SBP）均值、第12周时动态SBP谷值、第24周时体重以及第12周时坐位SBP谷值。
该研究将于2018年报告最终数据。
这项研究的结果将增进我们对恩格列净在自我认定为黑人/非裔美国人的T2DM和高血压患者中的疗效和安全性问题的理解。（ClinicalTrials.gov标识符：NCT02182830.）
