恩格列净联合二甲双胍治疗的疗效与安全性：来自亚洲的2型糖尿病合并超重或肥胖患者的汇总人群研究
Efficacy and Safety of Ertugliflozin Added to Metformin: A Pooled Population from Asia with Type 2 Diabetes and Overweight or Obesity.
作者信息
Ji Linong, Liu Jie, Xu Zhi Jin, Wei Zhiqi, Zhang Ruya, Malkani Seema, Cater Nilo B, Frederich Robert
机构信息
Endocrinology and Metabolism, Peking University People's Hospital, Beijing, China.
Global Clinical Development, MRL, Merck & Co., Inc., Rahway, NJ, USA.
出版信息
Diabetes Ther. 2023 Feb;14(2):319-334. doi: 10.1007/s13300-022-01345-6. Epub 2023 Feb 3.
INTRODUCTION
The efficacy and safety of ertugliflozin have not been well characterized in Asian populations with type 2 diabetes (T2D) and overweight or obesity as defined by the Chinese Diabetes Society [body mass index (BMI) ≥ 24 kg/m].
METHODS
These post hoc analyses of pooled data from two randomized, double-blind, 26-week studies assessed the efficacy and safety of ertugliflozin (5 mg or 15 mg) compared with placebo in participants from Asia with T2D and baseline BMI ≥ 24 kg/m, with inadequate glycemic control on metformin. Longitudinal analyses were used to calculate least squares (LS) mean [95% confidence interval (CI)] change from baseline in glycemic indices and body weight. The proportions of participants achieving efficacy targets and experiencing adverse events (AEs) were assessed.
RESULTS
The 445 participants had a mean age of 55.5 years, T2D duration 6.6 years, glycated hemoglobin (HbA1c) 8.1%, and BMI 27.6 kg/m. At week 26, placebo-adjusted LS mean (95% CI) changes from baseline for ertugliflozin 5 mg and 15 mg, respectively, were - 0.78% (- 0.95% to - 0.61%) and - 0.80% (- 0.98% to - 0.63%) for HbA1c, and - 1.74 kg (- 2.29 kg to - 1.19 kg) and - 2.04 kg (- 2.60 kg to - 1.48 kg) for body weight. A greater proportion of participants receiving ertugliflozin 5 mg and 15 mg versus placebo, respectively, achieved HbA1c < 7.0% (42.1% and 46.3% vs. 13.9%), body weight reduction ≥ 5% (35.5% and 38.3% vs. 11.1%), and systolic blood pressure < 130 mmHg (42.4% and 34.5% vs. 21.7%). The proportion of participants with AEs was 52.6% (ertugliflozin 5 mg), 52.3% (ertugliflozin 15 mg), and 55.6% (placebo).
CONCLUSIONS
In participants from Asia with T2D inadequately controlled by metformin monotherapy, and BMI ≥24 kg/m, ertugliflozin (5 mg or 15 mg) resulted in greater glycemic and body weight reductions compared with placebo and was generally well tolerated.
TRIAL REGISTRATION
Clinicaltrials.gov identifiers NCT02033889, NCT02630706.
引言
对于中国糖尿病学会定义的超重或肥胖（体重指数[BMI]≥24kg/m²）的亚洲2型糖尿病（T2D）患者，恩格列净的疗效和安全性尚未得到充分描述。
方法
这些对两项随机、双盲、为期26周研究的汇总数据进行的事后分析，评估了恩格列净（5mg或15mg）与安慰剂相比，在亚洲T2D且基线BMI≥24kg/m²、二甲双胍治疗血糖控制不佳的参与者中的疗效和安全性。采用纵向分析计算血糖指标和体重相对于基线的最小二乘（LS）均值[95%置信区间（CI）]变化。评估了达到疗效目标和发生不良事件（AE）的参与者比例。
结果
445名参与者的平均年龄为55.5岁，T2D病程6.6年，糖化血红蛋白（HbA1c）为8.1%，BMI为27.6kg/m²。在第26周时，与安慰剂相比，恩格列净5mg和15mg相对于基线的安慰剂调整后LS均值（95%CI）变化，HbA1c分别为-0.78%（-0.95%至-0.61%）和-0.80%（-0.98%至-0.63%），体重分别为-1.74kg（-2.29kg至-1.19kg）和-2.04kg（-2.60kg至-1.48kg）。与安慰剂相比，接受恩格列净5mg和15mg的参与者中，分别有更高比例达到HbA1c＜7.0%（42.1%和46.3% vs. 13.9%）、体重减轻≥5%（35.5%和38.3% vs. 11.1%）以及收缩压＜130mmHg（42.4%和34.5% vs. 21.7%）。发生AE的参与者比例分别为52.6%（恩格列净5mg）、52.3%（恩格列净15mg）和55.6%（安慰剂）。
结论
在亚洲接受二甲双胍单药治疗血糖控制不佳且BMI≥24kg/m²的T2D患者中，恩格列净（5mg或15mg）与安慰剂相比，能更大程度地降低血糖和体重，且总体耐受性良好。
试验注册
Clinicaltrials.gov标识符NCT02033889、NCT02630706。
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