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1型糖尿病的基础胰岛素类似物 - 一种尺寸适合所有吗? 基于单个患者结局的HypoDeg试验的教训
S Hjejle1,2, R M Agesen1, B Thorsteinsson1
1Dept. of Endocrinology and Nephrology, North Zealand University Hospital Hillerød, Dyrehavevej 29, DK-3400, Hillerød, Denmark.
Heliyon
|December 3, 2024
概括
与insulin glargine U100 (IGlar) 相比,insulin degludec (IDeg) 在1型糖尿病患者中显著降低了夜间低血糖症. 个体患者数据显示IDeg对许多人来说优越,但强调了个性化基础胰岛素治疗的必要性.
科学领域:
- 内分泌学 在内分泌学.
- 代谢疾病 代谢疾病
- 药理学 药理学是指药理学的学科.
背景情况:
- 夜间严重的低血糖是1型糖尿病患者的一个重大问题.
- 基础胰岛素类似物,如胰岛素降级剂 (IDeg) 和胰岛素格拉U100 (IGlar),用于治疗1型糖尿病.
- 之前的试验表明,与IGlar相比,IDeg在降低低血糖事件中的有效性.
研究的目的:
- 为了对HypoDeg试验数据进行后期,单个患者级别的分析.
- 评估在夜间症状性低血糖症,全天重度低血糖症和HbA1c方面,IDeg与IGlar获得优异结果的参与者的比例.
- 评估一个整体复合终点,对个人参与者来说,偏好一种胰岛素而不是另一种胰岛素.
主要方法:
- 利用了来自HypoDeg随机交叉试验的133名参与者的单一患者数据.
- 分类结果为优于IDeg,优于IGlar,或类似的夜间症状低血糖症,全天严重的低血糖症和HbA1c.
- 计算了一个复合终点,以确定每个参与者的整体治疗优越性.
主要成果:
- 与IGlar (15%) 相比,显著更高的比例的参与者 (38%) 在夜间症状性低血糖症 (p < 0.001) 中表现出 IDeg 的优势.
- 对于全天严重低血糖或HbA1c的IDeg和IGlar之间没有发现显著差异.
- 在44%的参与者中,复合终点有利于IDeg,而有利于IGlar的比例为16% (p < 0.001).
结论:
- 胰岛素降糖 (IDeg) 在降低夜间低血糖症方面的优势在显著比例的参与者中在个体患者水平上得到证实.
- 一小部分患者经历了胰岛素glargine U100 (IGlar) 的优异结果,强调治疗的好处不是普遍的.
- 这些发现强调了在临床实践中为1型糖尿病管理选择个性化的基础胰岛素治疗的关键需求.
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