Kamrul-Hasan A B M, Selim Shahjada, Afsana Faria, Nagendra Lakshmi, Ahmed Rezwana, Dutta Deep
Department of Endocrinology, Mymensingh Medical College, Mymensingh, Bangladesh.
Department of Endocrinology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh.
Endocr Pract. 2025 Mar;31(3):315-325. doi: 10.1016/j.eprac.2024.12.005. Epub 2024 Dec 11.
No meta-analysis has been published comparing the efficacy and safety of tirzepatide vs once-daily basal insulins in subjects with type 2 diabetes (T2D) inadequately controlled with oral anti-hyperglycemic drugs. This meta-analysis was conducted to address this knowledge gap.
Randomized controlled trials involving subjects with T2D inadequately controlled with oral anti-hyperglycemic drugs and receiving tirzepatide in intervention arm and basal insulins in control arm as add-on therapy were searched throughout the electronic databases. The primary outcome assessed was the change from baseline in hemoglobin A1c (HbA1c).
Three randomized controlled trials involving 4339 subjects met the inclusion criteria. Compared to basal insulins, tirzepatide arms achieved greater reductions from the baseline in HbA1c (tirzepatide 5 mg: mean difference (MD) -0.89% [95% CI: -1.23, -0.54]; tirzepatide 10 mg: MD -1.11% [95% CI: -1.42, -0.79]; and tirzepatide 15 mg: MD -1.23% [95% CI: -1.48, -0.97]; P < .00001 for all). Additionally, the proportions of patients achieving HbA1c levels below 7.0%, 6.5%, and 5.7% were significantly greater in the tirzepatide groups than in the basal insulin group. Greater body weight and blood pressure reductions were observed with tirzepatide than with basal insulins. Moreover, tirzepatide had a more favorable impact on lipid profile. Hypoglycemia was less frequent with tirzepatide. Gastrointestinal adverse events (AEs) were more frequent with tirzepatide (all doses) than basal insulin, although serious AEs were comparable between the 2 groups.
Tirzepatide outperformed basal insulins in controlling blood glucose, body weight, blood pressure, and lipids in subjects with T2D and is generally well-tolerated except for its higher gastrointestinal AEs.
尚无荟萃分析比较替尔泊肽与每日一次基础胰岛素在口服降糖药物控制不佳的2型糖尿病(T2D)患者中的疗效和安全性。本荟萃分析旨在填补这一知识空白。
通过电子数据库检索随机对照试验,这些试验纳入口服降糖药物控制不佳的T2D患者,干预组接受替尔泊肽,对照组接受基础胰岛素作为附加治疗。评估的主要结局是糖化血红蛋白(HbA1c)较基线的变化。
三项涉及4339名受试者的随机对照试验符合纳入标准。与基础胰岛素相比,替尔泊肽组的HbA1c较基线降低幅度更大(替尔泊肽5mg:平均差值(MD)-0.89%[95%CI:-1.23,-0.54];替尔泊肽10mg:MD -1.11%[95%CI:-1.42,-0.79];替尔泊肽15mg:MD -1.23%[95%CI:-1.48,-0.97];所有P<0.00001)。此外,替尔泊肽组达到HbA1c水平低于7.0%、6.5%和5.7%的患者比例显著高于基础胰岛素组。与基础胰岛素相比,替尔泊肽使体重和血压降低幅度更大。此外,替尔泊肽对血脂谱有更有利的影响。替尔泊肽导致低血糖的频率更低。替尔泊肽(所有剂量)引起的胃肠道不良事件(AE)比基础胰岛素更频繁,尽管两组严重AE的发生率相当。
在控制T2D患者的血糖、体重、血压和血脂方面,替尔泊肽优于基础胰岛素,除胃肠道AE较高外,总体耐受性良好。