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Abstract: FR-OR45

Sotagliflozin and Kidney and Cardiorenal Outcomes in SCORED

Session Information

Category: CKD (Non-Dialysis)

  • 2302 CKD (Non-Dialysis): Clinical, Outcomes, and Trials


  • Cherney, David, University of Toronto, Toronto, Ontario, Canada
  • Bhatt, Deepak L., Mount Sinai Heart, New York, New York, United States
  • Szarek, Michael, University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States
  • Davies, Michael J., Lexicon Pharmaceuticals Inc, The Woodlands, Texas, United States
  • Banks, Phillip, Lexicon Pharmaceuticals Inc, The Woodlands, Texas, United States
  • Pitt, Bertram, University of Michigan, Ann Arbor, Michigan, United States
  • Steg, Philippe Gabriel, Universite Paris Cite, Paris, Île-de-France, France

SGLT2 inhibitors reduce kidney and cardiovascular (CV) outcomes in patients with and without type 2 diabetes (T2D). The aim of this exploratory analysis was to evaluate the effect of sotagliflozin (SOTA), a dual SGLT1 and 2 inhibitor, on kidney and cardiorenal outcomes in patients with T2D and chronic kidney disease (CKD).


SCORED, a Phase 3, double-blind, placebo-controlled study, randomized 10,584 patients with T2D, CKD, and CV risk factors to SOTA or placebo (1:1). Kidney criteria for inclusion were an eGFR 25 to 60 mL/min/1.73m2 regardless of UACR. The outcomes in this analysis included kidney and cardiorenal composites derived using laboratory values, with treatment comparisons by proportional hazards models.


At baseline, median eGFR was 45 mL/min/1.73m2 and 35, 34, and 31% of patients were categorized as having normo-, micro-, and macroalbuminuria, respectively. Over a median follow up of 16 months, SOTA reduced the primary CV endpoint by 26% (p<0.001). SOTA reduced the risk of the composite of first event of 50% decline in eGFR, eGFR<15 mL/min/1.73m2, chronic dialysis, renal transplant, or renal or CV death (p=0.0023, Figure 1). Results were generally consistent when using different eGFR decline thresholds and/or only renal death (all p<0.01, Figure 2).


SOTA reduced the risk of kidney and cardiorenal endpoints in patients with T2D and CKD.

Figure 1. First event within cardiorenal composite

Figure 2. Forest plot of various cardiorenal composites


  • Commercial Support – Lexicon Pharmaceuticals, Inc.