1. The evaluation of noninferiority for renal composite outcomes between sodium–glucose cotransporter inhibitors in Japan
- Author
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Kazuo Kobayashi, Kouichi Tamura, Akira Kanamori, Nobuo Hatori, Masao Toyoda, Kazuyoshi Sato, and Masaaki Miyakawa
- Subjects
medicine.medical_specialty ,Endocrinology, Diabetes and Metabolism ,Urology ,chemistry.chemical_compound ,Japan ,Internal Medicine ,Empagliflozin ,medicine ,Humans ,Hypoglycemic Agents ,Dapagliflozin ,Sodium-Glucose Transporter 2 Inhibitors ,Retrospective Studies ,Canagliflozin ,Nutrition and Dietetics ,business.industry ,Sodium ,medicine.disease ,Confidence interval ,Glucose ,Ipragliflozin ,Diabetes Mellitus, Type 2 ,chemistry ,Relative risk ,Family Practice ,Tofogliflozin ,business ,medicine.drug ,Kidney disease - 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.
- Published
- 2021
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