Kidney Week

Abstract: FR-OR45

Sotagliflozin and Kidney and Cardiorenal Outcomes in SCORED

Session Information

• Interventions to Reduce CKD Progression
  November 03, 2023 | Location: Room 119, Pennsylvania Convention Center
  Abstract Time: 05:06 PM - 05:15 PM

Category: CKD (Non-Dialysis)

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

Authors

• Cherney, David, University of Toronto, Toronto, Ontario, Canada

David Cherney, MD, PhD

• Bhatt, Deepak L., Mount Sinai Heart, New York, New York, United States

Deepak L. Bhatt,

• Szarek, Michael, University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States

Michael Szarek,

• Davies, Michael J., Lexicon Pharmaceuticals Inc, The Woodlands, Texas, United States

Michael J. Davies,

• Banks, Phillip, Lexicon Pharmaceuticals Inc, The Woodlands, Texas, United States

Phillip Banks,

• Pitt, Bertram, University of Michigan, Ann Arbor, Michigan, United States

Bertram Pitt,

• Steg, Philippe Gabriel, Universite Paris Cite, Paris, Île-de-France, France

Philippe Gabriel Steg,

Background

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).

Methods

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.

Results

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).

Conclusion

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

Funding

• Commercial Support – Lexicon Pharmaceuticals, Inc.