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启动钠-葡萄糖协同转运蛋白2(SGLT2)抑制剂治疗的2型糖尿病合并慢性肾脏病患者的临床特征及治疗依从性:一项多队列研究

Clinical Profile and Treatment Adherence in Patients with Type 2 Diabetes and Chronic Kidney Disease Who Initiate an SGLT2 Inhibitor: A Multi-cohort Study.

作者信息

Johannes Catherine B, Ziemiecki Ryan, Pladevall-Vila Manel, Ebert Natalie, Kovesdy Csaba P, Thomsen Reimar W, Baak Brenda N, García-Sempere Aníbal, Kanegae Hiroshi, Coleman Craig I, Walsh Michael, Andersen Ina Trolle, Rodríguez Bernal Clara, Robles Cabaniñas Celia, Christiansen Christian Fynbo, Farjat Alfredo E, Gay Alain, Gee Patrick, Herings Ron M C, Hurtado Isabel, Kashihara Naoki, Kristensen Frederik Pagh Bredahl, Liu Fangfang, Okami Suguru, Overbeek Jetty A, Penning-van Beest Fernie J A, Yamashita Satoshi, Yano Yuichiro, Layton J Bradley, Vizcaya David, Oberprieler Nikolaus G

机构信息

RTI Health Solutions, Waltham, MA, USA.

RTI Health Solutions, Research Triangle Park, NC, USA.

出版信息

Diabetes Ther. 2025 Feb;16(2):205-226. doi: 10.1007/s13300-024-01671-x. Epub 2024 Dec 17.

Abstract

INTRODUCTION

The clinical landscape for the treatment of patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) is rapidly evolving. As part of the FOUNTAIN platform (NCT05526157; EUPAS48148), we described and compared cohorts of adult patients with CKD and T2D initiating a sodium-glucose cotransporter 2 inhibitor (SGLT2i) before the launch of finerenone in Europe, Japan, and the United States (US).

METHODS

This was a multinational, multi-cohort study of patients with T2D in five data sources: the Danish National Health Registers (DNHR) (Denmark), PHARMO Data Network (The Netherlands), Valencia Health System Integrated Database (VID) (Spain), Japan Chronic Kidney Disease Database Extension (J-CKD-DB-Ex) (Japan), and Optum's de-identified Clinformatics Data Mart Database (CDM) (US). Eligible patients had CKD (based on either diagnosis codes, eGFR values, and/or urine ACR) and initiated an SGLT2i between 2012 and 2021. Baseline demographic, lifestyle, and clinical characteristics were analyzed, and drug utilization patterns were described.

RESULTS

The final cohorts included 21,739 patients in DNHR, 381 in PHARMO, 31,785 in VID, 1157 in J-CKD-DB-Ex, and 56,219 in CDM. Across data sources, approximately 41-70% had CKD stage 1 or 2 at baseline; severe CKD (stage 4) was uncommon (1.6-6.7%). The median duration of SGLT2i therapy ranged from 7.5 months in PHARMO to 17.0 months in VID. At least 50% of patients were currently receiving SGLT2i treatment at 1 year after initiation.

CONCLUSIONS

At a 1-year follow-up, at least half of the patients with CKD and T2D were receiving SGLT2i treatment across the data sources. In patients initiating SGLT2i, treatment options for T2D and CKD were heterogeneous and dynamic within and among data sources.

摘要

引言

慢性肾脏病(CKD)合并2型糖尿病(T2D)患者的临床治疗格局正在迅速演变。作为FOUNTAIN平台(NCT05526157;EUPAS48148)的一部分,我们描述并比较了在欧洲、日本和美国(US)非奈利酮推出之前开始使用钠-葡萄糖协同转运蛋白2抑制剂(SGLT2i)的成年CKD合并T2D患者队列。

方法

这是一项对来自五个数据源的T2D患者进行的多国、多队列研究:丹麦国家卫生登记册(DNHR)(丹麦)、PHARMO数据网络(荷兰)、巴伦西亚卫生系统综合数据库(VID)(西班牙)、日本慢性肾脏病数据库扩展版(J-CKD-DB-Ex)(日本)和Optum的去识别化临床信息数据集市数据库(CDM)(美国)。符合条件的患者患有CKD(基于诊断代码、估算肾小球滤过率(eGFR)值和/或尿白蛋白肌酐比值(ACR)),并在2012年至2021年期间开始使用SGLT2i。分析了基线人口统计学、生活方式和临床特征,并描述了药物使用模式。

结果

最终队列包括DNHR中的21739名患者、PHARMO中的381名患者、VID中的31785名患者、J-CKD-DB-Ex中的1157名患者和CDM中的56219名患者。在所有数据源中,约4l%-70%的患者在基线时处于CKD 1期或2期;重度CKD(4期)并不常见(1.6%-6.7%)。SGLT2i治疗的中位持续时间从PHARMO中的7.5个月到VID中的17.0个月不等。至少50%的患者在开始治疗1年后仍在接受SGLT2i治疗。

结论

在1年的随访中,所有数据源中至少一半的CKD合并T2D患者正在接受SGLT2i治疗。在开始使用SGLT2i的患者中,T2D和CKD的治疗选择在数据源内部和之间是异质性的且动态变化的。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fc98/11794911/b5a3fa626c3c/13300_2024_1671_Fig1_HTML.jpg

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