Background

In Japan, six types of sodium–glucose cotransporter inhibitors (SGLT2Is) are currently in use. Here, we evaluated differences in renal composite outcomes between SGLT2Is with or without evidence of cardio vascular outcome trials (CVOTs).

Methods

We retrospectively surveyed 536 Japanese patients with type 2 diabetes mellitus with chronic kidney disease who received SGLT2Is for more than 1 year. Patients were classified as having received empagliflozin, canagliflozin, or dapagliflozin (n = 270, Evidence (+) group) or as having received ipragliflozin, tofogliflozin, or luseogliflozin (n = 266, Evidence (−) group). The propensity score matching method was performed.

Result

On matched cohort model including 205 cases in each group, there were no significant differences in the incidence of renal composite outcomes (n = 28 [14%] in the Evidence (+) group, n = 21 [10%] in the Evidence (−) group for the matched model; p = 0.29) between groups. Cox hazard analyses in the matched cohort model showed that the risk ratio for renal composite outcomes in the Evidence (−) group was 0.73 (95% confidence interval: 0.40–1.32), which was greater than the noninferiority margin of 1.22.

Conclusion

Three SGLT2Is with no CVOT’s evidence did not show noninferiority compared with other SGLT2Is with evidences.

中文翻译：

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日本钠-葡萄糖协同转运蛋白抑制剂对肾脏复合结局的非劣效性评估

背景

在日本，目前正在使用六种钠-葡萄糖协同转运蛋白抑制剂 (SGLT2Is)。在这里，我们评估了有或没有心血管结局试验 (CVOTs) 证据的 SGLT2I 之间肾脏复合结局的差异。

方法

我们回顾性调查了 536 名接受 SGLT2Is 超过 1 年的慢性肾病日本 2 型糖尿病患者。患者被分类为接受过恩格列净、卡格列净或达格列净（n = 270，证据（+）组）或接受过伊格列净、托格列净或卢塞格列净（n = 266，证据（-）组）。进行了倾向得分匹配方法。

结果

在包括每组 205 例病例的匹配队列模型中，肾脏复合结局的发生率没有显着差异（证据 (+) 组 n = 28 [14%]，证据 (+) 组 n = 21 [10%]） −) 匹配模型的组；p = 0.29) 组间。匹配队列模型中的 Cox 风险分析显示，证据 (-) 组肾脏复合结局的风险比为 0.73（95% 置信区间：0.40-1.32），高于非劣效性界值 1.22。

结论

与其他有证据的 SGLT2I 相比，三个没有 CVOT 证据的 SGLT2I 没有显示出非劣效性。