Use of sotagliflozin in patients with both diabetes and heart failure (HF) "robustly and significantly" reduced the composite of total cardiovascular deaths, hospitalizations for HF, and urgent visits for HF across the full range of ejection fraction, including HF with preserved ejection fraction (HFpEF), according to researchers presenting findings from the SCORED and SOLOIST-WHF trials May 17 during ACC.21.

Researchers pooled patient data (n=11,784) from the SCORED and SOLOIST-WHF trials (the results from which were previously published in the New England Journal of Medicine in 2020) and examined the effectiveness of sotagliflozin treatment according to differences in patients' ejection fraction at study entry. They also analyzed data from a subgroup of 4,500 patients with a history of HF.

Compared with placebo, overall results found sotagliflozin resulted in significant reductions over a median period of nine to 16 months in the risk of death due to cardiovascular causes and hospitalization or an urgent visit for HF, irrespective of ejection fraction at study entry, across both patient groups. Among those patients with an ejection fraction of 40% or less, sotagliflozin treatment reduced risk by 22% in both the entire cohort and in the HF group. For patients with an ejection fraction of 40% to 50%, sotagliflozin reduced risk in the entire cohort by 39% and in the HF group by 43%. For patients with HFpEF, the medication reduced risk by 30% in the entire cohort and by 33% in the HF group. All results were statistically significant and were similar for men and women.

"We saw a significant reduction in the primary endpoint irrespective of patients' ejection fraction at study entry," said Deepak L. Bhatt, MD, MPH, FACC, principal investigator for the study. "The benefit for patients with HFpEF is striking – this is the first trial to find a significant benefit in this population. We believe that these results merit a recommendation that patients who have both diabetes and HFpEF should be treated with sotagliflozin or another medication in its class."

Bhatt noted that a limitation of the study is that the results apply only to patients with HF who also have diabetes. The researchers had intended to also analyze the effect of sotagliflozin in patients with HF who did not have diabetes; however, this analysis was not performed because both the SCORED and SOLOIST-WHF trials were terminated early due to loss of funding at the onset of the COVID-19 pandemic.

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

Keywords: ACC Annual Scientific Session, ACC21, Dyslipidemias, Heart Failure, Stroke Volume

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