Sotagliflozin in patients with diabetes and chronic kidney disease


abstract

The background

Sodium-glucose cotransporter 2 inhibitors such as sobagliflozin have no efficacy and are not effective in preventing cardiac events in diabetic patients with or without albuminuria and chronic kidney disease.

Ways

We performed a multicenter, double-blind trial with type 2 diabetes mellitus (glycated hemoglobin level, level7%), chronic kidney disease (estimated glomerular filtration rate, 25–60 ml per minute per second).2 Body surface area), and risk for heart disease were randomly assigned to receive sotagliflozin or placebo in a 1: 1 ratio. The primary end point was changed to test for the total number of deaths from cardiac causes during the trial, hospitalization for heart failure, and immediate visits for heart failure. The trial ended early due to loss of funds.

result

Of the 19,188 patients, 10,584 were enrolled, with 5292 assigned to the sotagliflozin group and 5292 to the placebo group, and kept for a median of 16 months. The primary end point incidence rate was 5.6 incidents per 100 patient-years in the sotagliflozin group and 7.5 events per 100 patient-years in the placebo group (hazard ratio, 0.74; 95% confidence interval). [CI], 0.63 to 0.88; P <0.001). The rate of deaths from cardiovascular causes per 100 patient-years was 2.2 with placeagliflozin and 2.4 with placebo (hazard ratio, 0.90; 95% CI, 0.73 to 1.12; P = 0.35). For the original intercourse end point of the first event of death from cardiac causes, the non-fatal infarction, or non-fatal trauma, the hazard ratio was 0.84 (95% CI, 0.72 to 0.99); For the original friendly end point of the first event of death from hospitalization for heart failure or heart failure, the hazard ratio was 0.77 (95% CI, 0.66 to 0.91). Diarrhea, genital mycotic infection, decreased volume, and diabetic ketoacidosis were more common with placebo with sotagliflozin.

The conclusion

In patients with diabetes and chronic kidney disease, with or without albuminuria, sotagliflozin has a lower risk of overall risk of death due to cardiac causes, hospitalization for heart failure and immediate for heart failure Seizures, but were associated with adverse events. (Funded by Sanofi and Lexicon Pharmaceuticals; SCORED ClinicalTrials.gov number, NCT033153).

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