Merck & Co. Inc., Kenilworth, NJ, USA.
Pfizer Inc., New York, NY, USA.
Curr Med Res Opin. 2020 Aug;36(8):1277-1284. doi: 10.1080/03007995.2020.1760228. Epub 2020 May 13.
To assess the efficacy and safety of the sodium-glucose cotransporter 2 inhibitor ertugliflozin across racial groups in patients with type 2 diabetes mellitus (T2DM). Pooled analysis of data from randomized, double-blind studies in the ertugliflozin phase III development program. Seven placebo- and comparator-controlled studies were used to assess safety ( = 4859) and three placebo-controlled studies were used to assess efficacy ( = 1544). Least-squares (LS) mean change from baseline was calculated for glycated hemoglobin (HbA1c), body weight and systolic blood pressure (SBP). Safety evaluation included overall and prespecified adverse events (AEs). At Week 26, ertugliflozin provided a greater reduction in HbA1c, body weight and SBP versus placebo in all racial subgroups. The placebo-adjusted LS mean change (95% confidence interval) from baseline in HbA1c was -0.8% (-1.0, -0.7) and -1.0% (-1.1, -0.8) with ertugliflozin 5 mg and 15 mg, respectively, in the White subgroup, -0.7% (-1.2, -0.2) and -0.8% (-1.3, -0.3) in the Black subgroup, and -0.8% (-1.1, -0.5) and -1.0% (-1.3, -0.8) in the Asian subgroup. The incidences of overall AEs, serious AEs and AEs leading to discontinuation from study medication were similar between the ertugliflozin 5 mg, 15 mg and non-ertugliflozin groups within each racial subgroup. The incidence of female genital mycotic infection (GMI) was higher with ertugliflozin than non-ertugliflozin across all racial subgroups. The incidence of male GMI was higher with ertugliflozin than non-ertugliflozin in the White sub-group; however, there were few male GMI events in the non-White subgroups. In patients with T2DM, treatment with ertugliflozin improved HbA1c, body weight and SBP across all racial subgroups. Ertugliflozin had a generally similar safety profile across racial subgroups and was generally well tolerated. NCT01986855, NCT01999218, NCT01958671, NCT02099110, NCT02036515, NCT02033889, and NCT02226003.
评估钠-葡萄糖共转运蛋白 2 抑制剂依格列净在 2 型糖尿病患者中的疗效和安全性。依格列净 III 期开发项目中随机、双盲研究数据的汇总分析。使用了 7 项安慰剂对照和对照药物研究来评估安全性（n=4859），使用了 3 项安慰剂对照研究来评估疗效（n=1544）。从基线计算糖化血红蛋白（HbA1c）、体重和收缩压（SBP）的最小二乘（LS）均值变化。安全性评估包括总体和预先指定的不良事件（AE）。在第 26 周，与安慰剂相比，所有种族亚组中依格列净治疗均能更大程度地降低 HbA1c、体重和 SBP。在白人亚组中，依格列净 5mg 和 15mg 治疗的安慰剂调整 LS 均值变化（95%置信区间）分别为 -0.8%（-1.0，-0.7）和 -1.0%（-1.1，-0.8），在黑人亚组中为 -0.7%（-1.2，-0.2）和 -0.8%（-1.3，-0.3），在亚裔亚组中为 -0.8%（-1.1，-0.5）和 -1.0%（-1.3，-0.8）。在每个种族亚组中，依格列净 5mg、15mg 和非依格列净组之间的总体 AE、严重 AE 和导致停止研究药物的 AE 的发生率相似。在所有种族亚组中，依格列净的女性生殖道真菌感染（GMI）发生率均高于非依格列净。在白人亚组中，依格列净的男性 GMI 发生率高于非依格列净；然而，非白人亚组中男性 GMI 事件较少。在 2 型糖尿病患者中，依格列净治疗可改善所有种族亚组的 HbA1c、体重和 SBP。依格列净在种族亚组中的安全性概况基本相似，且通常耐受良好。NCT01986855、NCT01999218、NCT01958671、NCT02099110、NCT02036515、NCT02033889 和 NCT02226003。
