In a study published recently in the Journal of the American College of Cardiology: Heart Failure, researchers conducted a post hoc analysis of the SOLOIST-WHF (Effect of Sotagliflozin on Cardiovascular [CV] Events in Patients With Type 2 Diabetes Post-Worsening Heart Failure [WHF]) trial to assess the efficacy of sotagliflozin versus placebo to diminish mortality and heart failure–related events among patients who initiated study treatment on or before discharge from their index hospitalization.

The SOLOIST-WHF trial was a phase III, international, double-blind, randomized, placebo-controlled trial involving patients (aged 18-85 years) with type 2 diabetes (T2D) who were recently admitted for WHF, regardless of left ventricular ejection fraction (LVEF).

The primary endpoint of the post hoc analysis was cardiovascular death or HF-related event (HF hospitalization or urgent-care visit) occurring within 90 and 30 days after discharge for the index WHF hospitalization. Treatment comparisons were by proportional hazard models, generating HRs, 95% CIs, and P values.

For the post hoc analysis involving 1,222 patients from SOLOIST-WHF (mean age, 70 years; 35% women), the researchers compared the 596 who received sotagliflozin on or before their discharge date with the rest of the cohort. Participants were assigned randomly to once-daily sotagliflozin 200 mg (with a possible dose escalation to 400 mg) or placebo.

The results revealed that compared with the control group, the sotagliflozin on or before discharge group had reduced risk for CV death, HF hospitalization, or HF urgent care visit at 90 days (HR = 0.54; 95% CI, 0.35-0.82; P = .004) and at 30 days (HR = 0.49; 95% CI, 0.27-0.91; P = .023), as well as reduced risk for all-cause mortality at 90 days (HR = 0.39; 95% CI, 0.17-0.88; P = .024).

Treatment with sotagliflozin resulted in significant relative risk reductions of around 50% for readmission for nonfatal HF events and for the composite of CV death and readmission for HF at 30 or 90 days following hospital discharge versus placebo.

In subgroup analyses, sotagliflozin reduced the 90-day primary endpoint regardless of gender, age, estimated glomerular filtration rate, N-terminal pro-B-type natriuretic peptide, LVEF, or mineralocorticoid receptor antagonist use. Additionally, results revealed that the use of sotagliflozin was well-tolerated but with slightly greater rates of diarrhea and volume-depletion adverse events than placebo.

Based on their findings, the authors concluded that initiating sotagliflozin before discharge in patients with T2D hospitalized for WHF significantly decreased CV deaths and HF events through 30 and 90 days after discharge, emphasizing the importance of beginning sodium-glucose cotransporter (SGLT) inhibitor treatment before discharge.

The authors wrote, “This post hoc analysis of a subset of the SOLOIST-WHF trial population suggests that sotagliflozin, when administered before hospital discharge after an episode of hospitalization for WHF in patients with T2D, decreases the 30- and 90-day rates of cardiovascular mortality and HF-related events by >40%, as well as total mortality, by 90 days after discharge.”

Finally, the authors indicated that their findings are the first to demonstrate a reduction in mortality and HF events for an SGLT inhibitor treatment initiated during WHF hospitalization. Additionally, the findings emphasize the benefits of early initiation of evidence-based HF therapy, and the post hoc analysis results suggest that dual inhibition of SGLT1 and SGLT2 is safe and may provide additional benefit to patients with worsening HF.

Bertram Pitt, MD, FACC, professor of medicine emeritus at the University of Michigan, School of Medicine and the publication’s lead author, stated, “Our analysis concluded that starting sotagliflozin before discharge in patients hospitalized for worsening heart failure significantly decreased cardiovascular deaths and heart failure events. Hospital readmissions are burdensome, time-consuming, and costly. The results emphasize the importance of beginning SGLT inhibition before discharge.”

Craig Granowitz, MD, PhD, Lexicon’s senior VP and CMO stated, “We are grateful to the SOLOIST-WHF investigators for conducting this important analysis. It highlights Inpefa’s effect in reducing readmission rates for heart failure events, which may provide important clinical and financial benefits to patients, caregivers, and the healthcare system.”

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