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钠-葡萄糖共转运蛋白 2 抑制剂在无心血管和肾脏疾病的日本 2 型糖尿病患者中的使用与较低的心衰和慢性肾脏疾病风险相关。

Lower heart failure and chronic kidney disease risks associated with sodium-glucose cotransporter-2 inhibitor use in Japanese type 2 diabetes patients without established cardiovascular and renal diseases.

机构信息

Department of Cardiovascular Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.

Toranomon Hospital, Tokyo, Japan.

出版信息

Diabetes Obes Metab. 2021 Apr;23 Suppl 2:19-27. doi: 10.1111/dom.14119.

Abstract

AIMS

To examine heart failure (HF) and chronic kidney disease (CKD) risks reduction associated with sodium-glucose cotransporter-2 inhibitors (SGLT-2i) compared to other glucose-lowering drugs (oGLD) in the early stage of type 2 diabetes patients without established cardiovascular or renal diseases (CVRD-free T2D).

MATERIALS AND METHODS

We performed an observational cohort study using a Japanese hospital claims registry, Medical Data Vision. CVRD-free T2D patients were identified between 1 April 2014 and 30 September 2018. SGLT-2i and oGLD new users (and dipeptidyl peptidase 4 inhibitors [DPP-4i] separately) were subjected to 1:1 propensity-score matching analysis. Hazard ratios (HRs) of cardiorenal disease (HF and/or CKD), HF, CKD, stroke, myocardial infarction (MI), and all-cause mortality, were estimated using unadjusted Cox regression.

RESULTS

A total of 108 362 CVRD-free patients including 54 181 SGLT-2i and 54 181 oGLD users were matched. Baseline characteristics were well balanced (mean age 59.1 years, 63% male, and follow-up 1.50 years [162 970 patient-years]). Compared to oGLD group, SGLT-2i group had lower risk of cardiorenal disease, HF, CKD, stroke, and all-cause mortality with HRs (95% confidence intervals) 0.55 (0.49-0.61), 0.73 (0.61-0.87), 0.45 (0.39-0.52), 0.69 (0.59-0.81), and 0.52 (0.46-0.58), respectively, while no difference in MI. These were consistent in 1:1 propensity-score matching analysis between SGLT-2i and DPP-4i users (n = 17 232 in each group).

CONCLUSIONS

In Japanese CVRD-free T2D patients, SGLT-2i initiation was associated with lower risk of cardiorenal diseases, stroke, and all-cause mortality compared to oGLD, suggesting preventive effect of SGLT-2i treatment in the early stage of T2D patients without CVRD manifestation.

摘要

目的

在没有心血管或肾脏疾病(CVRD)的 2 型糖尿病(T2D)患者的早期阶段,与其他降糖药物(oGLD)相比,评估钠-葡萄糖共转运蛋白-2 抑制剂(SGLT-2i)对心力衰竭(HF)和慢性肾脏病(CKD)风险的降低作用。

材料和方法

我们使用日本医院理赔登记处 Medical Data Vision 进行了一项观察性队列研究。在 2014 年 4 月 1 日至 2018 年 9 月 30 日期间,确定了无 CVRD 的 T2D 患者。SGLT-2i 和 oGLD 的新使用者(分别为二肽基肽酶 4 抑制剂 [DPP-4i])进行了 1:1 倾向评分匹配分析。使用未调整的 Cox 回归估计了心血管疾病(HF 和/或 CKD)、HF、CKD、中风、心肌梗死(MI)和全因死亡率的风险比(HR)。

结果

共纳入了 108362 名无 CVRD 的患者,包括 54181 名 SGLT-2i 和 54181 名 oGLD 使用者。基线特征得到很好的平衡(平均年龄 59.1 岁,63%为男性,随访时间为 1.50 年[162970 患者年])。与 oGLD 组相比,SGLT-2i 组的心血管疾病、HF、CKD、中风和全因死亡率的风险较低,HR(95%置信区间)分别为 0.55(0.49-0.61)、0.73(0.61-0.87)、0.45(0.39-0.52)、0.69(0.59-0.81)和 0.52(0.46-0.58),而 MI 无差异。在 SGLT-2i 和 DPP-4i 使用者(每组 17232 人)之间的 1:1 倾向评分匹配分析中,这些结果也一致。

结论

在没有 CVRD 表现的日本无 CVRD 的 T2D 患者中,与 oGLD 相比,SGLT-2i 的起始治疗与较低的心血管疾病、中风和全因死亡率风险相关,提示 SGLT-2i 治疗在 T2D 患者的早期阶段具有预防作用。

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