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21359例2型糖尿病合并慢性肾脏病患者使用甘精胰岛素U300的患者特征及安全性分析:DPV注册研究

Analysis of patient characteristics and safety of insulin glargine U300 use in 21 359 patients with type-2 diabetes and chronic kidney disease: DPV registry study.

作者信息

Vijayan Anjaly, Lanzinger Stefanie, Forestier Nicole, Hess Gregor, Rottmann Marcus, Wosch Frank J, Seufert Jochen, Holl Reinhard W, Bramlage Peter

机构信息

Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany.

Institute of Epidemiology and Medical Biometry, ZIBMT, University of Ulm, Ulm, Germany.

出版信息

Diabetes Obes Metab. 2025 May;27(5):2485-2494. doi: 10.1111/dom.16245. Epub 2025 Feb 19.

Abstract

AIMS

Managing type-2 diabetes (T2D) in chronic kidney disease (CKD) patients requires consideration of kidney function, and many drugs have not been investigated thoroughly. Clinical studies have demonstrated Glargine U300 (Gla-300) supports achievement of adequate glycemic control at low hypoglycemia risk.

MATERIALS AND METHOD

This cross-sectional study analysed routine data of 21 359 T2D patients with CKD (1786 using Gla-300; 19 568 without any insulin) from the prospective Diabetes-Patienten-Verlaufsdokumentation (DPV) registry to evaluate patient characteristics and safety of Gla-300 use across different CKD stages.

RESULTS

Patients on Gla-300 had T2D onset at an earlier age (median age 55.1 vs. 62.3 years), longer diabetes duration (17.3 vs. 11.3 years), higher body weight (91.3 vs. 83.9 kg) and HbA1c levels (7.3% vs. 6.7%) than non-insulin patients (all p < 0.001). Gla-300 usage increased from CKD stage 1-4 (median dose 44 vs. 55 units) with higher baseline HbA1c levels (7.2% vs. 7.4%). Although severe hypoglycemia rates were low, a slight increase (0.01%/PY vs. 0.04%/PY) was observed with decreasing estimated glomerular filtration rate levels. Compared to others, stage 5 CKD patients had a distinct profile with lower HbA1c levels (6.9%), body weight (90 kg) and higher Gla-300 usage (50 units). Metformin, SGLT-2 inhibitors and GLP-1 RA were common concomitant drugs with diminished usage in advanced CKD stages, while Gla-300 was common at all stages.

CONCLUSION

Despite variations in patient profiles, Gla-300 is widely used across all CKD stages, particularly in advanced stages with a low rate of severe hypoglycemia, suggesting its safe administration in CKD patients.

摘要

目的

管理慢性肾脏病(CKD)患者的2型糖尿病(T2D)需要考虑肾功能,且许多药物尚未得到充分研究。临床研究表明,甘精胰岛素U300(Gla-300)有助于在低血糖风险较低的情况下实现充分的血糖控制。

材料与方法

这项横断面研究分析了来自前瞻性糖尿病患者病程记录(DPV)登记处的21359例CKD合并T2D患者的常规数据(1786例使用Gla-300;19568例未使用任何胰岛素),以评估不同CKD阶段患者的特征以及使用Gla-300的安全性。

结果

与未使用胰岛素的患者相比,使用Gla-300的患者T2D发病年龄更早(中位年龄55.1岁对62.3岁),糖尿病病程更长(17.3年对11.3年),体重更高(91.3千克对83.9千克),糖化血红蛋白(HbA1c)水平更高(7.3%对6.7%)(所有p<0.001)。从CKD 1-4期,Gla-300的使用量增加(中位剂量44单位对55单位),基线HbA1c水平更高(7.2%对7.4%)。虽然严重低血糖发生率较低,但随着估计肾小球滤过率水平降低,观察到轻微增加(0.01%/人年对0.04%/人年)。与其他患者相比,5期CKD患者有不同的特征,HbA1c水平较低(6.9%),体重(90千克),Gla-300使用量较高(50单位)。二甲双胍、钠-葡萄糖协同转运蛋白2(SGLT-2)抑制剂和胰高糖素样肽-1受体激动剂(GLP-1 RA)是常见的伴随用药,在晚期CKD阶段使用量减少,而Gla-300在所有阶段都很常见。

结论

尽管患者情况存在差异,但Gla-300在所有CKD阶段都广泛使用,尤其是在严重低血糖发生率较低的晚期阶段,表明其在CKD患者中给药安全。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c35e/11965019/ee59bee62a17/DOM-27-2485-g002.jpg

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