Merck & Co., Inc, Kenilworth, NJ, USA.
Pfizer Inc., New York, NY, USA.
Curr Med Res Opin. 2020 Jul;36(7):1097-1106. doi: 10.1080/03007995.2020.1760227. Epub 2020 May 13.
To assess the efficacy and safety of ertugliflozin in Hispanic/Latino patients with type 2 diabetes (T2DM). Analysis of data from Hispanic/Latino patients who participated in randomized, double-blind phase III studies. Ertugliflozin efficacy was evaluated when initiated as a single agent (as monotherapy or add-on therapy) and when initiated in combination with sitagliptin. Least-squares mean change from baseline was calculated for glycated hemoglobin (HbA1c), body weight (BW), and systolic blood pressure (SBP). Safety evaluation included overall and prespecified adverse events (AEs). Analyses included 1178 Hispanic/Latino patients. In a pooled analysis of three placebo-controlled studies where ertugliflozin was initiated as a single agent, the placebo-corrected change from baseline in HbA1c at week 26 for ertugliflozin 5 and 15 mg was -0.8 and -1.0%, respectively. In an active-comparator study, when initiated as a single agent, the change from baseline in HbA1c at week 52 was -0.5, -0.7, and -0.5% for ertugliflozin 5 mg, ertugliflozin 15 mg, and glimepiride, respectively. In a placebo-controlled study, when initiated in combination with sitagliptin, the placebo-corrected change from baseline in HbA1c at week 26 for ertugliflozin 5 mg/sitagliptin and ertugliflozin 15 mg/sitagliptin was -1.3 and -1.6%, respectively. In an active-comparator study, when initiated in combination with sitagliptin, the change from baseline in HbA1c at week 26 was -1.4, -1.6, and -0.9 for ertugliflozin 5 mg/sitagliptin, ertugliflozin 15 mg/sitagliptin, and sitagliptin alone, respectively. Reductions in BW and SBP were observed with ertugliflozin as a single agent or combined with sitagliptin. The incidences of overall and prespecified AEs in Hispanic/Latino patients were generally consistent with the known safety profile of ertugliflozin. Ertugliflozin, administered as a single agent or as a combination with sitagliptin, improved HbA1c, BW, and SBP. Ertugliflozin was generally well-tolerated in Hispanic/Latino patients with T2DM. NCT01986855, NCT01999218, NCT01958671, NCT02099110, NCT02036515, NCT02033889, and NCT02226003.
评估依格列净在 2 型糖尿病（T2DM）西班牙裔/拉丁裔患者中的疗效和安全性。分析参与随机、双盲 III 期研究的西班牙裔/拉丁裔患者的数据。评估依格列净起始单药治疗（作为单药治疗或联合治疗）以及与西格列汀联合治疗时的疗效。计算糖化血红蛋白（HbA1c）、体重（BW）和收缩压（SBP）从基线的最小二乘均值变化。安全性评估包括总体和预先指定的不良事件（AE）。分析包括 1178 例西班牙裔/拉丁裔患者。在三项安慰剂对照研究的汇总分析中，依格列净起始单药治疗，依格列净 5mg 和 15mg 治疗 26 周时与安慰剂相比，HbA1c 的校正基线变化分别为-0.8%和-1.0%。在活性对照研究中，依格列净起始单药治疗，52 周时与基线相比，HbA1c 的变化分别为-0.5%、-0.7%和-0.5%，分别为依格列净 5mg、依格列净 15mg 和格列美脲。在一项安慰剂对照研究中，依格列净与西格列汀联合起始治疗，依格列净 5mg/西格列汀和依格列净 15mg/西格列汀治疗 26 周时与安慰剂相比，HbA1c 的校正基线变化分别为-1.3%和-1.6%。在活性对照研究中，依格列净与西格列汀联合起始治疗，26 周时与基线相比，HbA1c 的变化分别为-1.4%、-1.6%和-0.9%，分别为依格列净 5mg/西格列汀、依格列净 15mg/西格列汀和西格列汀单药治疗。依格列净单药或联合西格列汀治疗可降低体重和收缩压。西班牙裔/拉丁裔患者的总体和预先指定 AE 发生率与依格列净已知的安全性概况基本一致。依格列净作为单药或与西格列汀联合治疗可改善 HbA1c、BW 和 SBP。依格列净在西班牙裔/拉丁裔 T2DM 患者中总体耐受性良好。NCT01986855、NCT01999218、NCT01958671、NCT02099110、NCT02036515、NCT02033889 和 NCT02226003。
