Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure
Sodium-glucose cotransporter 2 (SGLT2) inhibitors reduce the risk of hospital admission for heart failure or death from cardiovascular complaints among patients with stable heart failure. However, the safety and potency of SGLT2 inhibitors when initiated immediately after an episode of decompensated heart failure are not known. D.L. Bhatt and colleagues published a study in The New England Journal of Medicine under the title “Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure”. The summary of this study is given below:
To investigate whether sotagliflozin would reduce the risks of death from cardiovascular causes, hospitalization for heart failure, and an emergency visit for heart failure among diabetic patients
To evaluate whether administration of sotagliflozin soon after an episode of decompensated heart failure helps in reducing recent worsening of heart failure with either reduced or preserved ejection fraction.
It was a multicenter, double-blind trial that included patients with type 2 diabetes mellitus who were recently hospitalized for worsening heart failure. The subjects were randomly assigned to receive sotagliflozin or a placebo. The primary outcome was the total number of deaths from cardiovascular causes, emergency visits for heart failure, and hospitalization. The trial ended before the planned study duration because of the loss of funding from the sponsor.
The study reports that the total number of cardiovascular deaths and hospitalizations and emergency visits for heart failure was significantly less with the SGLT2 and SGLT1 inhibitor sotagliflozin as compared to placebo. Additionally, introducing SGLT2 inhibitor before or shortly after discharge in patients who were hospitalized for worsening heart failure was found to be beneficial. While a similar percentage of patients experienced hypotension in both groups, severe hypoglycemia was more common in the sotagliflozin group. Unlike other trials, it is not clear in this study whether the inhibition of SGLT1 with sotagliflozin therapy led to any other clinical benefits.
Trial got terminated early due to loss of funding through sponsors. This limited the statistical power to assess the secondary end points.
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