Department of Cardiovascular Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Toranomon Hospital, Tokyo, Japan.
Diabetes Obes Metab. 2021 Apr;23 Suppl 2:19-27. doi: 10.1111/dom.14119.
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).
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.
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).
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.
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。
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)。
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。
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。