The evaluation of noninferiority for renal composite outcomes between sodium–glucose cotransporter inhibitors in Japan

Published:September 04, 2021DOI:https://doi.org/10.1016/j.pcd.2021.08.012

      Highlights

      • The renal composite outcome was evaluated among the types of SGLT2 inhibitors with or without evidences.
      • The propensity score matched analysis was performed in this study.
      • The inferiority margin for the renal outcome was calculated as 1.22 from the result of meta-analysis.
      • The risk ratio for renal composite outcome in the Evidence (-) group was0.73 (95% CI: 0.40–1.32).
      • SGLT2 inhibitors without evidence by CVOTs could not show the non-inferiority for the renal composite outcome.

      Abstract

      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.

      Keywords

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