Sotagliflozin Cuts MACE Rate in Patients With T2DM, CKD, CVD Risk Factors

MONDAY, March 3, 2025 (HealthDay News) — For patients with type 2 diabetes, chronic kidney disease, and additional cardiovascular risk factors, the dual sodium-glucose co-transporter (SGLT)-1/2 inhibitor sotagliflozin is associated with a significantly reduced rate of major adverse cardiovascular events (MACE), with independent reductions in myocardial infarction and stroke, according to a study published online Feb. 14 in The Lancet Diabetes & Endocrinology.

Rahul Aggarwal, M.D., from Harvard Medical School in Boston, and colleagues conducted a prespecified secondary analysis of the SCORED trial, a double-blind, randomized trial enrolling adult patients with type 2 diabetes, chronic kidney disease, and additional cardiovascular risk factors. A total of 10,584 patients from 750 sites in 44 countries were randomly assigned to receive oral sotagliflozin or placebo (5,292 to each group) between Dec. 8, 2017, and Jan. 20, 2020.

The researchers found that the rate of total MACE was significantly lower in the sotagliflozin group versus placebo group (4.8 versus 6.3 events per 100 person-years; hazard ratio [HR], 0.77). Among stratified subgroups, there was a consistent effect for sotagliflozin on total MACE, with no evidence of heterogeneity. Compared with placebo, sotagliflozin also significantly reduced the rate of myocardial infarction (1.8 versus 2.7 events per 100 person-years; HR, 0.68) and stroke (1.2 versus 1.8 events per 100 person-years; HR, 0.66).

“This ischemic benefit of sotagliflozin on both stroke and myocardial infarction has not been observed in trials of selective SGLT-2 inhibitors, warranting further investigation of SGLT-1 inhibition as a potential mechanism for these effects,” the authors write.

Several authors disclosed ties to pharmaceutical companies, including Lexicon Pharmaceuticals, which manufactures sotagliflozin and funded the study.

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