Recently, Lexicon Pharmaceutics, Inc., announced that findings from a post hoc analysis of clinical data from the SCORED trial demonstrated clinical benefit from the use of Inpefa (sotagliflozin) in HF, and major adverse cardiovascular events (MACE)–related outcomes were observed as early as 3 months in patients at high risk for cardiovascular events. The data were presented by Rahul Aggarwal, MD, Brigham and Women’s Hospital, Boston, Massachusetts, at the American Heart Association Scientific Sessions 2023 in Philadelphia.
The goal of the analysis was to assess the time to clinical benefit for HF and MACE-related outcomes in patients at high risk for cardiovascular events who were treated with sotagliflozin.
For total cardiovascular deaths, hospitalizations for HF, or urgent visits for HF, the primary end point of the trial, the relative risk reduction observed in patients treated with sotagliflozin versus placebo was 26% (HR = 0.74; 95% CI, 0.63, 0.88; P <0.001).
A statistically significant persistent decrease in the primary end point was observed 95 days after randomization (HR = 0.70; 95% CI: 0.50, 0.98). With regard to MACE, a predefined secondary end point of the trial, the relative risk reduction observed in patients treated with sotagliflozin versus placebo was 23% (HR = 0.77; 95% CI, 0.65, 0.91; P <0.001), and a statistically significant sustained decrease in MACE was observed at 94 days after randomization (HR = 0.69; 95% CI: 0.47, 0.99).
During the scientific sessions, researchers also presented data from Lexicon-supported studies relating to Inpefa’s mechanism of action, pharmacoeconomic analyses of Inpefa use, and real-world evidence for patients hospitalized with HF.
Craig Granowitz, MD, PhD, Lexicon’s senior vice president and chief medical officer, stated, “We are pleased to support research in areas important to heart failure clinicians and payors, and we are confident that the early clinical benefit of INPEFA observed in the SCORED post hoc analysis will play a role in care decisions made by these stakeholders. Avoiding a stroke or myocardial infarction can have great benefit to both patients and the healthcare system, and we believe that the observed reductions in MACE as early as approximately three months are additional points of differentiation for Inpefa.”
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