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Abstract: SA-PO474

Effects of Sotagliflozin on Anemia in Patients with Type 2 Diabetes (T2D) and Stages 3 and 4 CKD

Session Information

Category: Diabetic Kidney Disease

  • 702 Diabetic Kidney Disease: Clinical

Authors

  • Sridhar, Vikas, University Health Network, Toronto, Ontario, Canada
  • Davies, Michael J., Lexicon Pharmaceuticals Inc, The Woodlands, Texas, United States
  • Banks, Phillip, Lexicon Pharmaceuticals Inc, The Woodlands, Texas, United States
  • Girard, Manon, Lexicon Pharmaceuticals Inc, The Woodlands, Texas, United States
  • Carroll, Amy K., Lexicon Pharmaceuticals Inc, The Woodlands, Texas, United States
  • Cherney, David, University Health Network, Toronto, Ontario, Canada
Background

Anemia is frequent in advanced diabetic kidney disease. Sodium-glucose cotransporter inhibitors (SGLTi) consistently increase hemoglobin (Hb) through multiple mechanisms. We examined the effects of sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, on Hb in patients with type 2 diabetes (T2D) and chronic kidney disease (CKD) stage 3 and 4, with and without anemia.

Methods

This was a pooled patient-level data analysis from two studies evaluating the efficacy and safety of sotagliflozin (200 and 400 mg) vs. placebo in patients with T2D and CKD 3 or 4 over 26 weeks. The effect of sotagliflozin on Hb, hematocrit, serum albumin, systolic blood pressure (SBP), body weight and estimated glomerular filtration rate (eGFR) was assessed in patients with anemia (defined as baseline Hb <13 mg/dL for men and <12 mg/dL for women) and without anemia.

Results

In the entire cohort, baseline mean Hb was 12.7 g/dL and sotagliflozin increased Hb from baseline to week 26 by 0.39 g/dL (200 mg; 95% CI 0.21-0.56) and 0.41 g/dL (400 mg; 95% CI 0.24-0.59) vs. placebo (p<0.0001). Of the 1064 patients randomized, 493 (46.3%) patients had anemia at baseline. The effect on Hb with sotagliflozin relative to placebo was more pronounced in patients without anemia over 26 weeks (Figure [doses pooled]). Sotagliflozin (doses pooled) increased odds of anemia resolving (odds ratio 1.95, p=0.017), with a trend towards decreased odds of anemia developing (odds ratio 0.75, p=0.41) over 26 weeks. The effect of sotagliflozin on serum albumin, SBP, body weight, and eGFR was generally consistent between patients with and without anemia. Sotagliflozin was generally well tolerated with similar safety profiles between anemia subgroups.

Conclusion

Sotagliflozin increased Hb in a rapid and sustained manner in patients with T2D and moderate-severe CKD over 26 weeks, and reversed anemia in a population at high risk of anemia.

Figure. Mean change in hemoglobin from baseline over 26 weeks by anemia subgroup

Funding

  • Commercial Support – Lexicon Pharmaceuticals, Inc., The Woodlands, TX