Findings from the Phase III Effect of Sotagliflozin on Cardiovascular and Renal Events in Patients with Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk (SCORED) trial were presented at the recent American Society of Nephrology’s Kidney Week (ASN). The trial revealed that use of the dual sodium-glucose cotransporter (SGLT) 1 and 2 inhibitor sotagliflozin enhances kidney and cardiorenal outcomes in patients with T2DM and CKD. SGLT

The phase III SCORED trial is a double-blind, placebo-controlled study that randomized 10,584 patients with T2DM, CKD, and cardiovascular factors to receive sotagliflozin or placebo.

The goal of this exploratory analysis was to evaluate the effect of sotagliflozin (SOTA), a dual SGLT1 and SGLT2 inhibitor, on kidney and cardiorenal outcomes in patients with T2DM and CKD. Kidney criteria for inclusion were an estimated glomerular filtration rate (eGFR) of 25 to 60 mL/min/1.73 m2, regardless of urine albumin creatine ratio.

The outcomes in this analysis included kidney and cardiorenal composites derived utilizing laboratory values, with treatment comparisons by proportional hazards models. At baseline, median eGFR was 45 mL/min/1.73 m2, and 35%, 34%, and 31% of patients were categorized as having normal-, micro-, and macroalbuminuria, respectively.

The results revealed that over an average follow-up of 16 months, 223 events were identified, and sotagliflozin reduced the risk of the composite of sustained ≥50% decline in eGFR, eGFR <15 mL/min/1.73 m2, dialysis, or kidney transplant by 38%. Sotagliflozin also reduced the risk of a cardiorenal composite outcome (the above composite plus cardiovascular- or kidney-related death) by 23%.

The presenters concluded that SOTA reduced the risk of kidney and cardiorenal endpoints in patients with T2DM and CKD.

In an interview on the ASN website, David Cherney, MD CM, PhD, FRCP(C), of the University of Toronto, stated, “These effects are consistent with what has been reported with other SGLT inhibitors in people with type 2 diabetes at high cardiorenal risk and add to the already reported benefits of sotagliflozin in reducing both heart failure and ischemic events such as myocardial infarction or stroke. Sotagliflozin is now FDA-approved under the name ‘Inpefa’ to reduce the risk of cardiovascular death and heart failure events with a broad label that includes patients with heart failure or chronic kidney disease, so the drug is now an option for nephrologists and cardiologists, as well as primary care physicians, to prescribe.”

In an interview on the Renal & Urology News website, Deepak L. Bhatt, MD, MPH, chair of the SCORED trial and director of Mount Sinai Heart in Manhattan, New York, stated, “This analysis of the SCORED trial shows that sotagliflozin is at least as effective on kidney outcomes as other SGLT2 inhibitors. This is in addition to its known benefits on heart failure, but also to its benefits on heart attacks and strokes, which has not been evident with other SGLT2 inhibitors. Head-to-head randomized clinical trials would be useful to evaluate further the possible incremental benefits of SGLT1 inhibition [in the gastrointestinal tract], over and above SGLT2 inhibition [in the kidney].”

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