AIM Post-hoc analysis of the efficacy and safety of ertugliflozin in East/Southeast (E/SE) Asian patients with type 2 diabetes mellitus (T2DM). MATERIALS AND METHODS Efficacy evaluations used data from randomized, double-blind, phase 3 studies: a pool of two 26-week placebo-controlled studies and one 52-week active-comparator (glimepiride) study. Least squares mean change from baseline was calculated for HbA1c, fasting plasma glucose (FPG), body weight (BW) and systolic blood pressure (SBP). Safety evaluation included overall and prespecified adverse events based on pooled data (broad pool) from seven phase 3 studies (including studies in the efficacy analysis). RESULTS Among 161 E/SE Asian patients in the placebo pool (ertugliflozin, n = 106), ertugliflozin reduced HbA1c, FPG, BW and SBP from baseline at week 26. The placebo-adjusted changes from baseline for ertugliflozin 5 and 15 mg were: HbA1c, -0.9% and -1.0%; BW, -2.1 and -1.9 kg; and SBP, -3.3 and -3.5 mmHg, respectively. Among 174 E/SE Asian patients in the active-comparator study (ertugliflozin, n = 118), HbA1c changes from baseline at week 52 were -0.6%, -0.6% and -0.7% for ertugliflozin 5 mg, 15 mg and glimepiride, respectively. Ertugliflozin 5 and 15 mg reduced BW from baseline by -4.3 and -4.1 kg, respectively, and SBP by -7.4 and -9.3 mmHg, respectively, compared with glimepiride. Safety findings were generally consistent with overall ertugliflozin safety data published to date. CONCLUSIONS Treatment with ertugliflozin was associated with reductions in HbA1c, FPG, BW and SBP, and was generally well tolerated in E/SE Asian patients with T2DM. ClinicalTrials.gov identifier: NCT01986855, NCT01999218, NCT01958671, NCT02099110, NCT02036515, NCT02033889, NCT02226003.

中文翻译：

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ertugliflozin 在东亚/东南亚 2 型糖尿病患者中的疗效和安全性。

目的 对 ertugliflozin 在东亚/东南亚 (E/SE) 亚洲 2 型糖尿病 (T2DM) 患者中的疗效和安全性进行事后分析。材料和方法 疗效评估使用来自随机、双盲、3 期研究的数据：两项 26 周安慰剂对照研究和一项 52 周活性比较剂（格列美脲）研究的集合。计算 HbA1c、空腹血糖 (FPG)、体重 (BW) 和收缩压 (SBP) 与基线的最小二乘平均变化。安全性评估包括基于来自七项 3 期研究（包括疗效分析研究）的汇总数据（广泛池）的总体和预先指定的不良事件。结果 在安慰剂组中的 161 名 E/SE 亚洲患者（ertugliflozin，n = 106）中，ertugliflozin 在第 26 周时降低了 HbA1c、FPG、BW 和 SBP。ertugliflozin 5 和 15 mg 与基线相比的安慰剂调整变化为：HbA1c，-0.9% 和 -1.0%；体重，-2.1 和 -1.9 公斤；和 SBP，分别为 -3.3 和 -3.5 mmHg。在积极比较研究（ertugliflozin，n = 118）中的 174 名 E/SE 亚洲患者中，在第 52 周，ertugliflozin 5 mg、15 mg 和格列美脲的 HbA1c 相对于基线的变化分别为 -0.6%、-0.6% 和 -0.7%，分别。与格列美脲相比，Ertugliflozin 5 和 15 mg 分别使 BW 从基线降低 -4.3 和 -4.1 kg，SBP 分别降低 -7.4 和 -9.3 mmHg。安全性调查结果与迄今为止公布的总体 ertugliflozin 安全性数据基本一致。结论 ertugliflozin 治疗与 HbA1c、FPG、BW 和 SBP 的降低相关，并且在 E/SE 亚洲 T2DM 患者中普遍耐受良好。ClinicalTrials.gov 标识符：NCT01986855，