Summary

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• Inpefa (sotagliflozin) is indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure. It also aims to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors.
• This summary is based on the review of 17 systematic review(s)/meta-analysis(es). ^[1-17]
• Cardiovascular Mortality and Hospitalizations: Sotagliflozin significantly reduced cardiovascular mortality, hospitalizations, and urgent heart failure (HF) visits in patients with HF compared to dapagliflozin, particularly in those with higher initial symptom burden. SGLT2 inhibitors, including sotagliflozin, also significantly improved cardiovascular outcomes, with no significant differences observed among dapagliflozin, empagliflozin, and sotagliflozin in composite outcomes of cardiovascular death or hospitalization for HF.
• Composite Cardiovascular Outcomes: Sotagliflozin significantly improved the composite outcome of cardiovascular death or hospitalization for HF. Additionally, canagliflozin, dapagliflozin, empagliflozin, and sotagliflozin significantly reduced major adverse cardiovascular events (MACE) and hospitalization for HF.
• Quality of Life: Sotagliflozin increased the number of days alive and out of the hospital (DAOH) in HF patients, enhancing patient-centered outcomes. SGLT2 inhibitors, including sotagliflozin, were also associated with improved quality of life in HF patients.
• Renal Composite Outcomes: Sotagliflozin, along with other SGLT2 inhibitors like dapagliflozin and empagliflozin, significantly reduced the risk of renal composite outcomes.
• Sotagliflozin significantly increased the risk of genital mycotic infections in patients with both T1DM and T2DM, as well as the risk of acidosis-related adverse events, including diabetic ketoacidosis (DKA), particularly in T1DM patients.
• Sotagliflozin was associated with an increased risk of diarrhea, volume depletion, and severe hypoglycemia, with the latter being more pronounced compared to pure SGLT2 inhibitors.
• Comparative safety analysis showed no major differences in safety outcomes between sotagliflozin and empagliflozin, canagliflozin, or dapagliflozin, although dapagliflozin may have a lower risk of severe hypoglycemia.
• The evidence shows that SGLT2 inhibitors, including sotagliflozin, were studied in specific populations such as those with heart failure (HF), including HF with preserved ejection fraction (HFpEF) and mildly reduced ejection fraction (HFmrEF), as well as patients with type 1 and type 2 diabetes mellitus (T1DM and T2DM), and those with cardiovascular and renal conditions. Key findings include a significant reduction in cardiovascular death, hospitalization for HF, and improved quality of life in HF patients, improved cardiovascular and renal outcomes in T2DM patients, and an increased risk of acidosis-related events and hypoglycemia in T1DM patients.