Sotagliflozin Can Reduce Risk of Death, Readmission at 90 Days in People with Heart Failure

Data from a posthoc analysis of the SOLOIST-WHF trial suggests use of sotagliflozin (Inpefa) was associated with an early and durable benefit on hospital readmissions risk among people with heart failure.

An analysis of 30- and 90-day readmission rates among patients included in the trial, results of the study suggested use of sotagliflozin was associated with a 46% reduction in 90-day risk of cardiovascular mortality or hospital readmission relative to placebo therapy, with further analysis suggested use was associated with a 51% and 61% reduction in risk of the primary endpoint at 30 days and all-cause mortality at 90 days, respectively.¹

“Our analysis concluded that starting sotagliflozin before discharge in patients hospitalized for worsening heart failure significantly decreased cardiovascular deaths and heart failure events,” said lead investigator Bertram Pitt, MD, professor of medicine emeritus at the University of Michigan, School of Medicine.² “Hospital readmissions are burdensome, time-consuming, and costly. The results emphasize the importance of beginning SGLT inhibition before discharge.”

The first dual SGLT1/2 inhibitor to receive approval from the US Food and Drug Administration, sotagliflozin made headlines in late May 2023 when it received an indication for reducing the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure or type 2 diabetes, chronic kidney disease, and other cardiovascular risk factors based on data from the SOLOIST-WHF and SCORED trials.³

Designed as a phase 3, double-blind, randomized, placebo-controlled trial, SOLOIST-WHF randomized 1222 patients with type 2 diabetes recently hospitalized for worsening heart failure in a 1:1 ratio to sotagliflozin or placebo therapy. Stopped early due to a loss of funding during the COVID-19 pandemic, results of the study indicated the rate of primary endpoint events was significantly reduced among those receiving sotagliflozin relative to their counterparts receiving placebo therapy during a median follow-up of 9.0 months (51.0 vs 76.3 events per 100 patient-years; Hazard ratio [HR], 0.67 [95% confidence interval [CI], 0.52-0.85]; P < .001). Further analysis data from the trial indicated sotagliflozin was associated with reductions in risk of cardiovascular mortality (HR, 0.84 [95% CI, 0.58-1.22]) as well as all-cause mortality relative to placebo therapy.¹

In the current study, Pitt and a team of investigators sought to examine the effect of sotagliflozin use on or before discharge from hospital relative to placebo on risk of cardiovascular death or heart failure-related events, which was defined as a heart failure hospitalization or urgent care visit after discharge. Investigators also expressed an interest in assessing pointed out comparisons were conducted using proportional hazards models.¹

Of the 1222 included in the trial, 596 received sotagliflozin on or before the date of their hospital discharge. Upon analysis, results indicated use was associated with a reduction in the primary endpoint of interest at 90 days post-discharge (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) and all-cause mortality at 90 days (HR, 0.39; 95% CI, 0.17-0.88; P = .024). Further analysis indicated these results were consistent for the 90-day primary endpoint across subgroups defined by sex, age, eGFR, NTpro-BNP, left ventricular ejection fraction, and mineralocorticoid receptor agonist use.¹

“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,” said Craig Granowitz, MD, PhD, senior vice president and chief medical officer of Lexicon.²

References:

1. Pitt B, Bhatt DL, Szarek M, et al. Effect of Sotagliflozin on Early Mortality and Heart Failure-Related Events: A Post Hoc Analysis of SOLOIST-WHF. JACC Heart Fail. 2023;11(8 Pt 1):879-889. doi:10.1016/j.jchf.2023.05.026
2. Lexicon Pharmaceuticals. PUBLISHED ANALYSIS OF SOTAGLIFLOZIN (INPEFATM) CLINICAL DATA DEMONSTRATES SIGNIFICANT REDUCTIONS IN THE RISK OF HOSPITAL READMISSIONS FOR HEART FAILURE. Lexicon Pharmaceuticals. August 8, 2023. Accessed August 11, 2023. https://www.lexpharma.com/media-center/news/2023-08-08-published-analysis-of-sotagliflozin-inpefa-clinical-data-demonstrates-significant-reductions-in-the-risk-of-hospital-readmissions-for-heart-failure.
3. Campbell P. FDA approves Sotagliflozin for treatment of heart failure. HCP Live. May 26, 2023. Accessed May 27, 2023. https://www.hcplive.com/view/fda-approves-sotagliflozin-for-treatment-of-heart-failure.