Sotagliflozin in Patients with Diabetes and Chronic Kidney Disease
There exist less knowledge about the potency and safety of sodium–glucose cotransporter 2 inhibitors (SGLT2) such as sotagliflozin in preventing cardiovascular events in individuals with diabetes with chronic kidney disease (CKD) with or without albuminuria. The author Deepak L. Bhatt and colleagues conducted research titled “Sotagliflozin in Patients with Diabetes and Chronic Kidney Disease” published in the “New England Journal of Medicine”. The summary of the findings is below:
Objectives:
To examine whether sotagliflozin would decrease hospitalizations for heart failure, the total number of deaths from cardiovascular causes, and urgent visits for heart failure in patients with diabetes mellitus and CKD, regardless of the degree of albuminuria.
Method:
In this multicenter, double-blind trial, patients with chronic kidney disease (estimated glomerular filtration rate, 25 to 60 ml per minute per 1.73 m2 of body-surface area), type 2 diabetes mellitus (glycated hemoglobin level, ≥7%), and risks for cardiovascular disease were included. They were randomly assigned in a 1:1 ratio to receive sotagliflozin or placebo. After the changes, the primary outcome considered includes; hospitalizations for heart failure, the composite of the total number of deaths from cardiovascular causes, and urgent visits for heart failure. The trial terminated early due to the loss of funding.
Findings:
Findings suggest that there is a lower risk of hospitalizations for heart failure, a total number of deaths from cardiovascular causes, and urgent visits for heart failure with the SGLT1/2 inhibitor sotagliflozin than placebo. On the other hand, there was no difference found between deaths from cardiovascular causes and renal endpoints between the trial groups. Genital mycotic infections, diarrhea, diabetic ketoacidosis, and volume depletion occurred with sotagliflozin.
Limitations:
Investigators acknowledge early termination of the trial due to loss of funds that resulted in an inability to complete the intended duration of follow-up. Due to concerns about the potential for an inadequate number of events, the primary and secondary outcomes have been changed. This might result in biased findings towards the benefit of the trial drugs.
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