司美格鲁肽每周一次与钠-葡萄糖协同转运蛋白2抑制剂对比：对2型糖尿病患者体重、糖化血红蛋白及医疗资源利用的真实世界影响（PAUSE研究）
Once-Weekly Semaglutide Versus Sodium-Glucose Co-transporter 2 Inhibitors: Real-World Impact on Weight, HbA1c, and Healthcare Resource Utilization in Type 2 Diabetes (PAUSE).
作者信息
Amamoo James, Doshi Riddhi, Noone Joshua, Xie Lin, Gamble Cory, Guevarra Mico, Divino Victoria, Chen Justin, King Aaron
机构信息
Novo Nordisk Inc., Plainsboro, NJ, USA.
IQVIA, Falls Church, VA, USA.
出版信息
Diabetes Ther. 2025 May;16(5):1033-1048. doi: 10.1007/s13300-025-01721-y. Epub 2025 Mar 27.
INTRODUCTION
Clinical trials have demonstrated greater glycemic control and weight loss with once-weekly (OW) semaglutide versus other anti-diabetes medications, including sodium-glucose co-transporter 2 inhibitors (SGLT2is) in adults with type 2 diabetes (T2D), yet real-world evidence is limited.
METHODS
This observational study of adults with uncontrolled T2D (HbA1c ≥ 7.0%) initiating semaglutide OW or SGLT2is (January 2018-February 2022; first prescription = index) utilized linked data from IQVIA PharMetrics® Plus adjudicated claims and Ambulatory Electronic Medical Records databases. Among the all semaglutide OW cohort and subgroups (1: persistent [≤ 60-day gap in semaglutide OW supply]; 2: receiving maximum dose ≥ 1 mg; and 3: persistent and ≥ 1 mg dose), changes in weight, body mass index (BMI), and glycated hemoglobin (HbA1c) outcomes from baseline to 1 year post index were descriptively compared. For the main analysis, changes in weight, BMI, HbA1c, and all-cause healthcare resource utilization (HCRU) after 1 year were compared among adjusted semaglutide OW and comparator SGLT2i cohorts, following inverse probability of treatment weighting (IPTW).
RESULTS
The all semaglutide OW cohort included 772 patients, and IPTW adjusted cohorts included 416 semaglutide OW patients and 1093 SGLT2i patients. Significant (P < 0.0001) mean changes from baseline were observed in the all semaglutide OW cohort and all subgroups, in weight (kg [all: - 4.4; 1: - 5.0; 2: - 4.9; 3: - 5.2]), BMI (kg/m [all: - 1.5; 1: - 1.8; 2: - 1.8; 3: - 1.9]), and HbA1c (% [all: - 1.5; 1: - 1.7; 2: - 1.5; 3: - 1.6]). Post-IPTW adjustment, the semaglutide OW cohort had significantly greater mean reductions versus the SGLT2i cohort in weight (- 4.4 versus - 3.4 kg, P = 0.0061), BMI (- 1.5 versus - 1.1 kg/m, P = 0.0013), and HbA1c (- 1.6 versus - 1.2%, P < 0.0001), with similar all-cause HCRU.
CONCLUSION
Adults with T2D initiating semaglutide OW in the real-world had significant decreases in weight, BMI, and HbA1c after 1 year, with greater improvements versus SGLT2i, and similar HCRU.
引言
临床试验表明，与其他抗糖尿病药物相比，每周一次（OW）注射司美格鲁肽在2型糖尿病（T2D）成人患者中能实现更好的血糖控制和体重减轻，包括钠-葡萄糖协同转运蛋白2抑制剂（SGLT2i），但真实世界证据有限。
方法
这项针对未控制的T2D（糖化血红蛋白[HbA1c]≥7.0%）成人患者的观察性研究，纳入了开始使用OW司美格鲁肽或SGLT2i的患者（2018年1月至2022年2月；首次处方=索引），利用了来自IQVIA PharMetrics® Plus裁决索赔和门诊电子病历数据库的关联数据。在所有司美格鲁肽OW队列及其亚组（1：持续用药[司美格鲁肽OW供应间隔≤60天]；2：接受最大剂量≥1mg；3：持续用药且剂量≥1mg）中，描述性比较了从基线到索引后1年体重、体重指数（BMI）和糖化血红蛋白（HbA1c）结果的变化。在主要分析中，采用治疗逆概率加权法（IPTW）后，比较了调整后的司美格鲁肽OW队列和对照SGLT2i队列在1年后体重、BMI、HbA1c和全因医疗资源利用（HCRU）的变化。
结果
所有司美格鲁肽OW队列包括772例患者，IPTW调整后的队列包括416例司美格鲁肽OW患者和1093例SGLT2i患者。在所有司美格鲁肽OW队列及其所有亚组中，观察到体重（kg[所有：-4.4；1：-5.0；2：-4.9；3：-5.2]）、BMI（kg/m[所有：-1.5；1：-1.8；2：-1.8；3：-1.9]）和HbA1c（%[所有：-1.5；1：-1.7；2：-1.5；3：-1.6]）与基线相比有显著（P<0.0001）的平均变化。IPTW调整后，司美格鲁肽OW队列在体重（-4.4 vs -3.4kg，P=0.0061）、BMI（-1.5 vs -1.1kg/m，P=0.0013）和HbA1c（-1.6 vs -1.2%，P<0.0001）方面的平均降幅显著大于SGLT2i队列，全因HCRU相似。
结论
在真实世界中，开始使用OW司美格鲁肽的T2D成人患者在1年后体重、BMI和HbA1c显著下降，与SGLT2i相比改善更大，且HCRU相似。
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