Sotagliflozin

(Inpefa®)

Inpefa®

Drug updated on 9/4/2024

Dosage FormTablet (oral: 200 mg, 400 mg)
Drug ClassSodium-glucose co-transporter 2 inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure.
  • Indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors.

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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.

Product Monograph / Prescribing Information

Document TitleYearSource
Inpefa (sotagliflozin) Prescribing Information. 2024Lexicon Pharmaceuticals, Inc., The Woodlands, TX

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Sotagliflozin vs dapagliflozin: a systematic review comparing cardiovascular mortality. 2023Cureus
Systematic review of sodium-glucose cotransporter 2 inhibitors: a hopeful prospect in tackling heart failure-related events. 2023ESC Heart Failure
Indirect comparison of SGLT2 inhibitors in patients with established heart failure: evidence based on Bayesian methods. 2023ESC Heart Failure
SGLT2 inhibitors and cardiovascular outcomes in heart failure with mildly reduced and preserved ejection fraction: a systematic review and meta-analysis. 2023Indian Heart Journal
SGLT-2 inhibitors in patients with heart failure: a comprehensive meta-analysis of five randomised controlled trials. 2022The Lancet
Comparison the effects of finerenone and SGLT2i on cardiovascular and renal outcomes in patients with type 2 diabetes mellitus: a network meta-analysis. 2022Frontiers in Endocrinology
Cardiovascular outcomes in patients treated with sodium-glucose transport protein 2 inhibitors, a network meta-analysis of randomized trials. 2022Frontiers in Cardiovascular Medicine
Cardiovascular and renal outcomes with sodium glucose co-transporter 2 inhibitors in patients with type 2 diabetes mellitus: a system review and network meta-analysis. 2022Frontiers in Pharmacology
The safety of sotagliflozin in the therapy of diabetes mellitus type 1 and type 2: a meta-analysis of randomized trials.2022Frontiers in Endocrinology
Sodium-glucose cotransporter 2 inhibitors in patients with heart failure: a systematic review and meta-analysis of randomized trials. 2022European Heart Journal - Quality of Care and Clinical Outcomes
Effects of sodium/glucose cotransporter 2 (SGLT2) inhibitors and combined SGLT1/2 inhibitors on cardiovascular, metabolic, renal, and safety outcomes in patients with diabetes: a network meta-analysis of 111 randomized controlled trials. 2022American Journal of Cardiovascular Drugs
Sacubitril/valsartan, sodium-glucose cotransporter 2 inhibitors and vericiguat for congestive heart failure therapy. 2022Basic & Clinical Pharmacology & Toxicology
Robustness of outcomes in trials evaluating sodium-glucose co-transporter 2 inhibitors for heart failure. 2022ESC Heart Failure
Influence of receptor selectivity on benefits from SGLT2 inhibitors in patients with heart failure: a systematic review and head-to-head comparative efficacy network meta-analysis. 2022Clinical Research in Cardiology
SGLT-2 inhibitors and cardiorenal outcomes in patients with or without type 2 diabetes: a meta-analysis of 11 CVOTs. 2021Cardiovascular Diabetology
Effects of sodium-glucose cotransporter 1 and 2 inhibitors on cardiovascular and kidney outcomes in type 2 diabetes: a meta-analysis update. 2021American Heart Journal
Sotagliflozin for patients with type 2 diabetes: a systematic review and meta-analysis.2021Diabetes, Obesity & Metabolism

Clinical Practice Guidelines