Ikuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
Datack, Inc., Tokyo, Japan.
Diabetes Obes Metab. 2024 May;26(5):1615-1623. doi: 10.1111/dom.15461. Epub 2024 Feb 27.
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.
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.
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).
Japanese people with T2D and G3 CKD initiating an SGLT2i had a lower risk of renal events than people initiating an oGLD.
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。
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)。
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。
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。