Sotagliflozin, a recently approved drug by the Food and Drug Administration for treating type 2 diabetes and kidney disease in patients with additional cardiovascular risk factors, has been shown to reduce the risk of heart attack and stroke significantly.
The study, published in The Lancet Diabetes & Endocrinology, confirms the unique cardiovascular benefits of an SGLT inhibitor. The randomized, multicenter trial, known as SCORED, assessed the drug’s effectiveness in reducing life-threatening cardiovascular events. Researchers enrolled 10,584 patients with chronic kidney disease, type 2 diabetes, and cardiovascular risk factors, assigning them either sotagliflozin or a placebo and following them for an average of 16 months. Results showed a 23% reduction in heart attacks, strokes, and cardiovascular-related deaths in the sotagliflozin group compared to the placebo group.
The researchers emphasized that these findings highlight a distinct mechanism of action. The combined blockade of SGLT1 and SGLT2 receptors contributes to a significant reduction in cardiovascular risk, setting sotagliflozin apart from other widely used SGLT2 inhibitors.
As a sodium-glucose cotransporter (SGLT) inhibitor, sotagliflozin blocks the function of both SGLT1 and SGLT2 proteins, which regulate glucose and sodium transport across cell membranes. Unlike other SGLT2 inhibitors, sotagliflozin provides a more significant blockade of SGLT1, which is found in the kidney, gut, heart, and brain. This dual inhibition results in reduced intestinal glucose absorption and enhanced glucosuria, improving both glycemic control and cardiovascular outcomes.
In addition to its role in managing type 2 diabetes, sotagliflozin has demonstrated benefits in patients with heart failure, regardless of diabetes status. It helps reduce hospitalizations and cardiovascular deaths by improving cardiac efficiency and reducing fluid overload through its diuretic effects. Clinical trials such as SOLOIST-WHF have reinforced its efficacy in heart failure patients with preserved and reduced ejection fraction.
Similar studies by Li et al. and Deepak et al. have also demonstrated moderate cardiovascular benefits and acceptable safety, supporting the evidence-based use of sotagliflozin for patients with type 2 diabetes, heart failure, or cardiovascular risk factors. These findings suggest that sotagliflozin could become a preferred treatment option for reducing the risk of cardiovascular events in high-risk patients.
Sotagliflozin now presents an additional advantage in lowering heart attack and stroke risk, potentially leading to more widespread clinical use. Its integration into standard treatment protocols for diabetes and cardiovascular risk management, particularly in populations at high risk for adverse cardiovascular events, may help improve patient outcomes and reduce the associated burden.
References
- Aggarwal R, Bhatt DL, Szarek M, Cannon CP, Leiter LA, Inzucchi SE, et al. Effect of sotagliflozin on major adverse cardiovascular events: a prespecified secondary analysis of the SCORED randomised trial. The Lancet Diabetes & Endocrinology [Internet]. 2025 Feb 14 [cited 2025 Feb 17];0(0). Available from: https://www.thelancet.com/journals/landia/article/PIIS2213-8587(24)00362-0/abstract
- Li J, Zhu C, Liang J, Hu J, Liu H, Wang Z, et al. Cardiovascular benefits and safety of sotagliflozin in type 2 diabetes mellitus patients with heart failure or cardiovascular risk factors: a bayesian network meta-analysis. Front Pharmacol. 2023 Nov 17;14:1303694.
- Bhatt DL, Szarek M, Pitt B, Cannon CP, Leiter LA, McGuire DK, et al. Sotagliflozin in Patients with Diabetes and Chronic Kidney Disease. New England Journal of Medicine. 2021 Jan 13;384(2):129–39.