Pennington Biomedical Research Center, LSU System, Baton Rouge, Louisiana, USA.
Merck & Co., Inc., Kenilworth, New Jersey, USA.
Obesity (Silver Spring). 2020 Apr;28(4):724-732. doi: 10.1002/oby.22748.
This study aimed to evaluate ertugliflozin in patients with overweight and obesity with type 2 diabetes mellitus.
Data from three placebo-controlled, randomized, Phase 3 studies were pooled. Patients with baseline BMI ≥ 25 (1,377/1,544; 89%) were assessed with a stratification by BMI subgroup.
At week 26, reductions from baseline in glycated hemoglobin A1c (HbA1c), fasting plasma glucose, body weight (BW), and systolic blood pressure (SBP) were greater with ertugliflozin versus placebo. For placebo, ertugliflozin 5 mg, and ertugliflozin 15 mg, respectively, least squares mean change was 0.1%, -0.8%, and -0.9% for HbA1c and -1.2 kg, -3.1 kg, and -3.2 kg for BW. HbA1c reductions were consistent across BMI subgroups. For ertugliflozin 5 mg and 15 mg, least squares mean change (placebo adjusted) in absolute BW was -1.4 kg and -1.2 kg for BMI 25 to < 30, -1.8 kg and -1.9 kg for BMI 30 to < 35, and -2.5 kg and -2.9 kg for BMI ≥ 35. Percent BW changes were similar across BMI subgroups. Incidence of adverse events was 52.5%, 44.6%, and 50.1% with placebo, ertugliflozin 5 mg, and ertugliflozin 15 mg, respectively.
Meaningful reductions in HbA1c, fasting plasma glucose, BW, and SBP were observed with ertugliflozin in patients with overweight and obesity with type 2 diabetes mellitus. Ertugliflozin improved HbA1c and SBP and reduced BW across BMI subgroups. Ertugliflozin was generally well tolerated.
本研究旨在评估恩格列净在超重和肥胖的 2 型糖尿病患者中的疗效。
对三项安慰剂对照、随机、3 期研究的数据进行了汇总。对基线 BMI≥25（1377/1544；89%）的患者进行了 BMI 亚组分层评估。
在 26 周时，与安慰剂相比，恩格列净治疗可使糖化血红蛋白（HbA1c）、空腹血糖、体重（BW）和收缩压（SBP）较基线水平显著降低。安慰剂、恩格列净 5 mg 和恩格列净 15 mg 治疗后，HbA1c 分别降低 0.1%、-0.8%和-0.9%，BW 分别降低 1.2 kg、-3.1 kg 和-3.2 kg。HbA1c 降低在各 BMI 亚组中是一致的。对于恩格列净 5 mg 和 15 mg，与安慰剂相比，BW 的绝对变化（校正后）分别为 BMI 25-<30 时为-1.4 kg 和-1.2 kg，BMI 30-<35 时为-1.8 kg 和-1.9 kg，BMI≥35 时为-2.5 kg 和-2.9 kg。各 BMI 亚组中 BW 的变化百分比相似。安慰剂、恩格列净 5 mg 和恩格列净 15 mg 治疗的不良事件发生率分别为 52.5%、44.6%和 50.1%。
恩格列净可使超重和肥胖的 2 型糖尿病患者的 HbA1c、空腹血糖、BW 和 SBP 显著降低。恩格列净改善了 HbA1c 和 SBP，降低了 BMI 亚组的 BW。恩格列净总体上具有良好的耐受性。
