Sotagliflozin, an SGLT2/1 inhibitor, reduced cardiovascular deaths and hospitalizations in patients with type 2 diabetes and chronic kidney disease (CKD) in the SCORED trial presented Nov. 16 during AHA 2020 and simultaneously published in the New England Journal of Medicine. Similarly, the SOLOIST-WHF trial, also presented during AHA 2020 and simultaneously published in the New England Journal of Medicine, found sotagliflozin reduced deaths and hospitalizations in patients with type 2 diabetes and acute decompensated heart failure (HF).

In the multicenter, double-blind SCORED trial, researchers randomized 10,584 patients with type 2 diabetes and CKD to receive either sotagliflozin or placebo. The average participant age was 69; 45% were women; and 17% were non-white.

Results showed the cohort of patients receiving sotagliflozin had a 26% reduction in the number of cardiovascular deaths, hospitalizations for HF or urgent visits for HF. Additionally, a 23% decrease in myocardial infarction and stroke was observed, "likely due to the SGLT1 effect," said Deepak L. Bhatt, MD, MPH, FACC, et al.

In the multicenter, double-blind SOLOIST-WHF trial, 1,222 patients with type 2 diabetes who were recently hospitalized for worsening HF were randomized to receive either sotagliflozin or placebo. Results showed the rate of death from cardiovascular causes was 10.6 in the sotagliflozin cohort and 12.5 in the placebo cohort. The rate of death from any cause was 13.5 in the sotagliflozin cohort and 16.3 in the placebo cohort.

"In patients with acute decompensated HF, sotagliflozin significantly reduced the composite of total cardiovascular deaths, hospitalizations for HF and urgent HF visits by 33%," the researchers conclude. "With careful patient selection and close monitoring, early initiation of sotagliflozin was generally well tolerated and safe."

Both trials were stopped early because of the loss of funding during the onset of the COVID-19 pandemic. However, Bhatt and colleagues suggest that "with careful patient selection and monitoring, as a class, SGLT2 inhibitors should be strongly considered in the majority of patients with type 2 diabetes, including those admitted with acute decompensated HF; with HF with either reduced or preserved ejection fraction; and with CKD across the full range of proteinuria."

Clinical Topics: Diabetes and Cardiometabolic Disease, Dyslipidemia, Heart Failure and Cardiomyopathies, Acute Heart Failure

Keywords: AHA Annual Scientific Sessions, AHA20, Renal Insufficiency, Chronic, Renal Insufficiency, Heart Failure, Dyslipidemias, Diabetes Mellitus

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