启动胰高血糖素样肽-1受体激动剂治疗的2型糖尿病合并慢性肾脏病患者的临床特征及治疗模式：一项多国队列研究
Clinical Profile and Treatment Patterns in Individuals with Type 2 Diabetes and Chronic Kidney Disease Who Initiate a GLP-1 Receptor Agonist: A Multinational Cohort Study.
作者信息
Pladevall-Vila Manel, Ziemiecki Ryan, Johannes Catherine B, Khan Anam M, Mines Daniel, Ebert Natalie, Kovesdy Csaba P, Thomsen Reimar W, Baak Brenda N, García-Sempere Aníbal, Kanegae Hiroshi, Coleman Craig I, Walsh Michael, Andersen Ina Trolle, Bernal Clara Rodríguez, Cabaniñas Celia Robles, 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, Beest Fernie J A Penning-van, Yamashita Satoshi, Yano Yuichiro, Layton J Bradley, Vizcaya David, Oberprieler Nikolaus G
机构信息
RTI Health Solutions, Barcelona, Spain.
The Center for Health Policy and Health Services Research, Henry Ford Health System, Detroit, MI, USA.
出版信息
Diabetes Ther. 2025 May;16(5):931-954. doi: 10.1007/s13300-025-01717-8. Epub 2025 Mar 19.
INTRODUCTION
Novel therapies are emerging for the prevention of chronic kidney disease (CKD) progression in patients with type 2 diabetes (T2D). Within the FOUNTAIN platform (NCT05526157; EUPAS48148), this real-world study aimed to characterize cohorts of adults with CKD and T2D starting therapy with a glucagon-like peptide-1 receptor agonist (GLP-1 RA) in Europe, Japan, and the United States (US) during 2012-2021.
METHODS
This multinational, multicohort study was conducted in five data sources: the Danish National Health Registers (DNHR) (Denmark), PHARMO Data Network (PHARMO) (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 T2D (defined by data source-specific algorithms) and CKD (based on diagnosis codes, estimated glomerular filtration rate values, and/or urine albumin-to-creatinine ratio) and initiated an GLP-1 RA during 2012-2021. Baseline demographic, lifestyle, and clinical characteristics were analyzed, and treatment patterns were described.
RESULTS
Study cohorts included 18,929 GLP-1 RA initiators in DNHR; 476 in PHARMO; 11,798 in VID; 329 in J-CKD-DB-Ex; and 70,158 in CDM. Across cohorts, mean age ranged from 66.1 years in J-CKD-DB-Ex to 67.9 years in CDM, and between 46.6% (PHARMO) and 59.6% (J-CKD-DB-Ex) of patients were men. There was a steady increase in GLP-1 RA initiators from 2012 (when 1.6-4.8% of GLP-1 RA initiators started therapy) to 2019 (when 19.8-31.5% started therapy). The median duration of initial treatment with a GLP-1 RA ranged from 2.3 months (PHARMO) to 12.4 months (VID). At 1-year follow-up, between 52% (CDM) and 78% (DNHR) of patients were receiving treatment. Findings suggested that GLP-1 RA use was independent of CKD severity.
CONCLUSIONS
During 2012-2021, GLP-1 RA use steadily increased across multinational cohorts of patients with T2D and CKD, and persistence with treatment was high. GLP-1 use was independent of CKD severity.
简介
预防2型糖尿病（T2D）患者慢性肾脏病（CKD）进展的新型疗法不断涌现。在FOUNTAIN平台（NCT05526157；EUPAS48148）内，这项真实世界研究旨在描述2012年至2021年期间在欧洲、日本和美国开始使用胰高血糖素样肽-1受体激动剂（GLP-1 RA）治疗的CKD合并T2D成年患者队列的特征。
方法
这项多国多队列研究在五个数据源中进行：丹麦国家卫生登记册（DNHR）（丹麦）、PHARMO数据网络（PHARMO）（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）以及Optum的去识别化临床信息学®数据集市数据库（CDM）（美国）。符合条件的患者患有T2D（由特定数据源算法定义）和CKD（基于诊断代码、估计肾小球滤过率值和/或尿白蛋白与肌酐比值），并在2012年至2021年期间开始使用GLP-1 RA。分析了基线人口统计学、生活方式和临床特征，并描述了治疗模式。
结果
研究队列包括DNHR中的18929名GLP-1 RA起始使用者；PHARMO中的476名；VID中的11798名；J-CKD-DB-Ex中的329名；以及CDM中的70158名。在各个队列中，平均年龄范围从J-CKD-DB-Ex中的66.1岁到CDM中的67.9岁，男性患者比例在46.6%（PHARMO）至59.6%（J-CKD-DB-Ex）之间。从2012年（当时1.6 - 4.8%的GLP-1 RA起始使用者开始治疗）到2019年（当时19.8 - 31.5%开始治疗），GLP-1 RA起始使用者稳步增加。GLP-1 RA初始治疗的中位持续时间范围从2.3个月（PHARMO）到12.4个月（VID）。在1年随访时，52%（CDM）至78%（DNHR）的患者仍在接受治疗。研究结果表明，GLP-1 RA的使用与CKD严重程度无关。
结论
在2012年至2021年期间，多国T2D合并CKD患者队列中GLP-1 RA的使用稳步增加，且治疗持续性较高。GLP-1的使用与CKD严重程度无关。
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