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钠-葡萄糖共转运蛋白 2 抑制剂在患有 3 期慢性肾脏病和 2 型糖尿病的日本人群中的肾脏结局:医疗管理数据库分析。

Renal outcomes with sodium-glucose cotransporter 2 inhibitors in Japanese people with grade 3 chronic kidney disease and type 2 diabetes: Analysis of medical administrative databases.

机构信息

Ikuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.

Datack, Inc., Tokyo, Japan.

出版信息

Diabetes Obes Metab. 2024 May;26(5):1615-1623. doi: 10.1111/dom.15461. Epub 2024 Feb 27.

Abstract

AIM

To evaluate whether sodium-glucose cotransporter 2 inhibitor (SGLT2i) therapy is associated with a reduction of renal events compared with other glucose-lowering drugs (oGLDs) among Japanese people with type 2 diabetes (T2D) and grade 3 (G3) chronic kidney disease (CKD) in a real-world clinical practice setting.

MATERIALS AND METHODS

People with T2D who were newly prescribed an SGLT2i or an oGLD from April 2014 to November 2021 (without prior use of index drugs for ≥ 1 year prior to index date) and G3 CKD (estimated glomerular filtration rate [eGFR] ≥ 30 to < 60 mL/min/1.73 m) were selected from the Medical Data Vision database (MDV-DB) and the Real-World Data database (RWD-DB). SGLT2i and oGLD users were matched (1:1) using propensity score on patient background characteristics. The primary endpoint was a composite of the development of end-stage kidney disease or a sustained decline in eGFR of 50% or more. Hazard ratios (HRs) were estimated using the Cox proportional hazards model.

RESULTS

Overall, 3190 (1595 per group) patients in the MDV-DB and 2572 (1286 per group) patients in the RWD-DB were included in the analyses. The composite outcome was significantly lower in the SGLT2i group than in the oGLD group in the MDV-DB (HR 0.49, 95% confidence interval [CI] 0.33 to 0.74, P < 0.001) and in the RWD-DB (HR 0.57, 95% CI 0.37 to 0.88, P = 0.011).

CONCLUSIONS

Japanese people with T2D and G3 CKD initiating an SGLT2i had a lower risk of renal events than people initiating an oGLD.

摘要

目的

在真实临床实践环境中,评估与其他降糖药物(oGLD)相比,钠-葡萄糖共转运蛋白 2 抑制剂(SGLT2i)治疗是否与 2 型糖尿病(T2D)和 3 级(G3)慢性肾脏病(CKD)的日本患者的肾脏事件减少相关。

材料和方法

从 2014 年 4 月至 2021 年 11 月,从 Medical Data Vision 数据库(MDV-DB)和真实世界数据数据库(RWD-DB)中选择新处方 SGLT2i 或 oGLD(在索引日期前≥1 年未使用索引药物)且 G3 CKD(估算肾小球滤过率[eGFR]≥30 至 <60 mL/min/1.73 m2)的 T2D 患者。根据患者背景特征的倾向评分对 SGLT2i 和 oGLD 使用者进行 1:1 匹配。主要终点是终末期肾病的发展或 eGFR 持续下降 50%或更多的复合终点。使用 Cox 比例风险模型估计风险比(HR)。

结果

总体而言,MDV-DB 中有 3190 名(每组 1595 名)患者,RWD-DB 中有 2572 名(每组 1286 名)患者纳入分析。在 MDV-DB 中(HR 0.49,95%置信区间[CI]0.33 至 0.74,P<0.001)和 RWD-DB 中(HR 0.57,95%CI 0.37 至 0.88,P=0.011),SGLT2i 组的复合结局显著低于 oGLD 组。

结论

起始 SGLT2i 的 T2D 合并 G3 CKD 的日本患者发生肾脏事件的风险低于起始 oGLD 的患者。

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