Rahul Aggarwal, MD: Sotagliflozin Benefit Grows with Increasing Diabetes Duration

An analysis of the SCORED trial from the European Society of Cardiology (ESC) Congress 2024 highlights the effect of the SGLT1/2 inhibitor sotagliflozin (Inpefa) on heart failure outcomes based on diabetes duration.

Results of the analysis, which were presented by Rahul Aggarwal, MD, of Brigham and Women’s Hospital, indicate use of the agent was associated with consistent benefit on the primary endpoint regardless of diabetes duration, with the magnitude of benefit increased as diabetes duration increased.¹

SCORED, along with the SOLOIST-WHF trial, was used as the basis of the US Food and Drug Administration approval for sotagliflozin in heart failure. A phase 3, double-blind, randomized, placebo-controlled trial, SCORED enrolled a patient population with type 2 diabetes, chronic kidney disease, and risk for cardiovascular disease.²

As a result of loss of funding during the COVID-19 pandemic, the trial was stopped early and the primary endpoint was changed from the first occurrence of major adverse cardiovascular events (MACE) to a composite endpoint of cardiovascular death or worsening heart failure events. Of note, the MACE endpoint included cardiovascular death, myocardial infarction, and stroke.²

Results of the 10,584-patient trial indicated the rate of primary endpoint events was significantly reduced among those receiving sotagliflozin relative to their counterparts receiving placebo therapy (5.6 vs 7.5 events per 100 patient-years; HR, 0.74 [95% CI, 0.63-0.88]; P = .0004).¹

At ESC Congress 2024, Aggarwal’s analysis stratified patients according to diabetes duration. Of the 10,584 included in the original trial, 10,579 had completed data on diabetes duration. Among these, 22.8%, 41.8%, and 25.9% had a diabetes duration of less than 10, 10 to 19, and 20 or more years, respectively.¹

Results of the analysis presented by Aggarwal offered evidence of increasing benefit on the primary outcomes relative to placebo therapy as diabetes duration increased, with 5.6 vs 5.8 events per 100 person-years, 6.1 vs 7.4 events per 100 person-years, and 4.6 vs 8.5 events per 100 person-years for diabetes durations of less than 10, 10 to 19, and 20 or more years, respectively. For more on the study, check out our interview with Aggarwal from the floor of ESC Congress 2024.¹

Aggarwal has no relevant disclosures to report.

References:

1. R Aggarwal, DL Bhatt, M Szarek, et al. Efficacy of sotagliflozin by diabetes duration: a secondary analysis of SCORED. Presented at: European Society of Cardiology Congress 2024. August 30 - September 2, 2024. London, UK.
2. Campbell P. FDA approves Sotagliflozin for treatment of heart failure. HCP Live. May 26, 2023. Accessed August 31, 2024. https://www.hcplive.com/view/fda-approves-sotagliflozin-for-treatment-of-heart-failure.