The researchers also indicated that patients with HF who had longer durations of diabetes exhibited more significant benefit from using sotagliflozin, even controlling for comparable baseline HbA1c, yet all patients, regardless of diabetes duration, benefited from the therapy.
The objective of this analysis of the SCORED trial, one of two pivotal studies that led to FDA approval of sotagliflozin for heart failure in May 2023, was to evaluate if diabetes duration alters the efficacy of sotagliflozin.
The primary endpoint of the trial was a composite of CV death, HF hospitalization, and urgent heart failure visit events, and secondary endpoints included MACE: cardiovascular death, nonfatal heart attack, and nonfatal stroke.
The study results demonstrated that treatment with sotagliflozin decreased the risk of MACE and HF events overall, plus an added benefit for HF event reduction for patients with longer diabetes duration. Moreover, results revealed that in the study cohort of the SCORED trial, 10,579 (99.9%) of 10,584 patients had complete data on diabetes duration, with 2,412 (22.8%), 4,424 (41.8%), 3,743 (25.9%) having diabetes duration of <10, 10-19, and ≥20 years, respectively. Results also revealed that the median (Q1, Q3) diabetes duration was 16.4 years (10.4, 22.4 years), while average hemoglobin A1c was 8.6%, 8.7%, and 8.7%, respectively, by diabetes duration.
The rate of the primary endpoint was lower in the sotagliflozin group (5.6 events per 100 patient-years [p-y]) compared with the placebo group (7.5 events per 100 p-y) (HR: 0.74; 95% CI: 0.63, 0.88). Event rates among diabetes duration subgroups showed that rates in both the placebo group and relative treatment benefit augmented with increasing diabetes duration, with 5.6 versus 5.8 events per 100 p-y, 6.1 versus 7.4 events per 100 p-y, and 4.6 versus 8.5 events per 100 p-y for diabetes duration <10, 10-19, and ≥20 years, respectively. Spline analysis showed increasing treatment benefits with increasing duration when modeled continuously.
Comparable findings were observed for the secondary HF outcome of hospitalization for HF or urgent visits for HF, with increased treatment benefits with increasing diabetes duration. Total MACE was lower in the sotagliflozin group (4.8 events per 100 patient-years) than in the placebo group (6.3 events per 100 patient-years) (HR: 0.77; 95% CI: 0.65, 0.91), without significant variance in relative treatment benefit by diabetes duration.
Craig Granowitz, MD, PhD, Lexicon’s senior vice president and chief medical officer, stated, “This analysis reinforces clinical data previously shared with the medical community showing that treatment with Inpefa resulted in risk reductions for both heart failure and MACE events in heart failure patients. These benefits are critically important for patients, clinicians, and payers, and they are key differentiators within the class of SGLT2 inhibitors.”
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