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Abstract: SA-PO264

Effect of Sotagliflozin (SOTA) on Albuminuria in Patients With Type 2 Diabetes (T2D) and CKD

Session Information

Category: Diabetic Kidney Disease

  • 602 Diabetic Kidney Disease: Clinical

Authors

  • Cherney, David, Toronto General Hospital, Toronto, Ontario, Canada
  • Bhatt, Deepak L., Brigham and Women's Hospital, Boston, Massachusetts, United States
  • Szarek, Michael, University of Colorado Anschutz, Aurora, Colorado, United States
  • Sun, Franklin W., Lexicon Pharmaceuticals Inc, The Woodlands, Texas, United States
  • Davies, Michael J., Lexicon Pharmaceuticals Inc, The Woodlands, Texas, United States
  • Pitt, Bertram, University of Michigan, Ann Arbor, Michigan, United States
  • Steg, Philippe Gabriel, Hôpital Bichat, Assistance Publique - Hôpitaux de Paris, Paris, France

Group or Team Name

  • the SCORED Investigators
Background

Albuminuria in patients with/without diabetes presents a higher risk for adverse renal and cardiovascular (CV) outcomes. SGLT inhibitors demonstrate improved albuminuria. The study observed the impact of the SGLT1/SGLT2 inhibitor SOTA on urine albumin-to-creatinine ratio (UACR).

Methods

SCORED—a Phase 3, multicenter, double-blind, placebo-controlled, parallel-group study—randomized 10,584 patients with T2D, CKD, and other CV risk factors to SOTA or placebo. Kidney inclusion criteria were eGFR 25-60mL/min/1.73m2 and any UACR. Percentage treatment difference was estimated by geometric mean ratio for the overall cohort and by eGFR and UACR subgroups. Progression/regression of UACR were assessed. Hazard ratios, 95% confidence intervals (CI), and p-values were estimated by Cox proportional hazards model.

Results

Median baseline eGFR was 44.5mL/min/1.73m2, with 8% at <30mL/min/1.73m2. At baseline, median UACR was 82mg/g, and 1/3 of patients had normoalbuminuria, 1/3 had micro, and 1/3 had macro. Median follow up was 16 months. The UACR difference for SOTA vs placebo was -21.3% (95% CI -23.4, -19.1; p<0.0001). Reductions were similar across eGFRs. In UACR 30-299mg/g and ≥300mg/g, reductions were significant in SOTA (p<0.0001;Fig 1). Progression risk was lower and regression risk higher in SOTA vs placebo (p<0.0001;Fig 2).

Conclusion

SOTA significantly reduced UACR and had favorable effects on UACR progression and regression.

Funding

  • Commercial Support