Dutta Deep, Nagendra Lakshmi, Kumar Manoj, Kamrul-Hasan A B M, Bhattacharya Saptarshi
Department of Endocrinology, CEDAR Superspeciality Healthcare, Dwarka, New Delhi, India.
Department of Endocrinology, JSS Medical College, JSS Academy of Higher Education and Research, Mysore, India.
Endocr Pract. 2025 Apr;31(4):471-478. doi: 10.1016/j.eprac.2024.12.013. Epub 2024 Dec 20.
No meta-analysis has holistically analyzed and summarized the efficacy and safety of the novel once-weekly basal insulin efsitora alfa in managing type 1 diabetes (T1D) and type 2 diabetes (T2D).
Clinical trials involving subjects with T1D and T2D receiving once-weekly efsitora alfa in the intervention arm and once-daily basal insulins in the control arm were searched throughout the electronic databases. The primary outcome assessed was the change from baseline in glycated hemoglobin (HbA1c).
Data from 6 studies (2465 subjects) were analyzed (follow-up 26-54 weeks). Once-weekly efsitora alfa and once-daily degludec achieved comparable HbA1c reduction in study subjects with T2D (mean difference [MD] 0.02% [-0.11, 0.16]; P = .74) and T1D (MD 0.11% [-0.01, 0.22]; P = .08). Efsitora and degludec were similarly effective in reducing fasting plasma glucose and achieving HbA1c < 7% in subjects with T2D. Individuals with T2D and T1D in the 2 groups had comparable time in range, time above range, and time below range. Subjects with T2D receiving efsitora and once-daily basal insulin had comparable total adverse events, severe adverse events, injection-site reactions, hypersensitivity events, and overall and severe hypoglycemia; however, nocturnal hypoglycemia risk was lower with efsitora (risk ratio 0.85 [0.74, 0.98]; P = .03). However, in individuals with T1D, total adverse events, severe adverse events, and injection-site reactions were higher with efsitora, with comparable risks of hypersensitivity events and overall, severe and nocturnal hypoglycemia.
Once-weekly basal insulin efsitora alfa is well tolerated with glycemic efficacy similar to once-daily degludec.
尚无荟萃分析全面分析和总结新型每周一次基础胰岛素艾西托拉α治疗1型糖尿病（T1D）和2型糖尿病（T2D）的疗效和安全性。
在整个电子数据库中检索涉及T1D和T2D受试者的临床试验，干预组接受每周一次的艾西托拉α，对照组接受每日一次的基础胰岛素。评估的主要结局是糖化血红蛋白（HbA1c）相对于基线的变化。
分析了6项研究（2465名受试者）的数据（随访26 - 54周）。在T2D研究受试者中，每周一次的艾西托拉α和每日一次的德谷胰岛素降低HbA1c的效果相当（平均差异[MD] 0.02% [-0.11, 0.16]；P = 0.74），在T1D受试者中也是如此（MD 0.11% [-0.01, 0.22]；P = 0.08）。艾西托拉和德谷胰岛素在降低T2D受试者空腹血糖和使HbA1c < 7%方面同样有效。两组中的T2D和T1D个体在血糖范围内的时间、高于范围的时间和低于范围的时间相当。接受艾西托拉和每日一次基础胰岛素的T2D受试者在总不良事件、严重不良事件注射部位反应、过敏事件以及总体和严重低血糖方面相当；然而，艾西托拉的夜间低血糖风险较低（风险比0.85 [0.74, 0.98]；P = 0.03）。然而，在T1D个体中，艾西托拉的总不良事件、严重不良事件和注射部位反应较高，过敏事件以及总体、严重和夜间低血糖风险相当。
每周一次基础胰岛素艾西托拉α耐受性良好，血糖疗效与每日一次的德谷胰岛素相似。
