New Data on Renal Protective Benefits of Sotagliflozin Will be Presented at Kidney Week 2024

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A new post hoc analysis of the SCORED phase 3 clinical trial shows that treatment with sotagliflozin (Inpefa, Lexicon Pharmaceuticals) confers kidney protection across a spectrum of baseline kidney function and glycemic control in adults with diabetes and chronic kidney disease (CKD).¹

The data will be presented at Kidney Week 2024, the annual meeting of the American Society of Nephrology, being held October 23-26, 2024, in San Diego, California, according to a press release today from Lexicon.¹

The SCORED clinical trial included 10 584 (mean age, 69 years; 45% women) adults with type 2 diabetes (T2D) and CKD, with or without albuminuria, who were randomized to either sotagliflozin 400 mg daily or placebo for a median of 16 months. Treatment with sotagliflozin, a dual sodium glucose cotransporter (SGLT)-1 and SGLT-2 inhibitor, resulted in a lower risk of the composite of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure compared to placebo.²

In the initial study, reconciliation of eGFR laboratory data and case report forms had not been completed due to early trial termination and suspension of adjudication. For this reason, a secondary analysis was conducted using the complete laboratory dataset, and results showed that sotagliflozin reduced the risk of kidney and cardiorenal composite endpoints.³

In the post hoc analysis of the SCORED study, researchers compared the effects of sotagliflozin to placebo on eGFR slope, and the impact of baseline kidney function and glycemia. Among the entire cohort, they observed a placebo-adjusted acute decline in eGFR of -2.59 ml/min/1.73m²/year (95% CI -2.88 to -2.30; P < .001). The total placebo-adjusted slope was -0.08ml/min/1.73m²/year (95% CI -0.43 to 0.27; P =.67). Compared to placebo, sotagliflozin had a greater benefit on chronic slope with increasing baseline albuminuria (P_interaction = .023).¹

Sotagliflozin is an inhibitor of sodium glucose cotransporters 2 and 1, which are responsible for glucose regulation in the kidney and gastrointestinal tract, respectively. In May 2023, sotagliflozin was approved by the FDA as Inpefa as a once-daily oral tablet that reduces the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure or T2D, CKD, and other cardiovascular risk factors.

The study abstract titled “Effect of sotagliflozin on eGFR slope by baseline kidney function and glycemic control” will be presented on October 25, 2024, during the poster session Diabetic Kidney Disease: Clinical Modeling, Diagnosis, Education, and More between 10am PDT and 12pm PDT.

References

1. New analysis of phase 3 data demonstrating renal protective benefits of sotagliflozin to be presented at ASN Kidney Week 2024. News release. Lexicon Pharmaceuticals. October 23, 2024. Accessed October 23, 2024. https://www.lexpharma.com/media-center/news/2024-10-23-new-analysis-of-phase-3-data-demonstrating-renal-protective-benefits-of-sotagliflozin-to-be-presented-at-asn-kidney-week-2024

2. Bhatt DL, Szarek M, Pitt B, et al. Sotagliflozin in patients with diabetes and chronic kidney disease. N Engl J Med. 2021;384:129-139.

3. Sridhar VS, Bhatt DL, Odutayo A, et al. Sotagliflozin and kidney outcomes, kidney function, and albuminuria in type 2 diabetes and CKD: A secondary analysis of the SCORED trial. Clin J Am Soc Nephrol. 2024;19:557-564.