Sotagliflozin

(Inpefa®)

Sotagliflozin

Drug updated on 4/16/2024

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.

Latest News

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Summary
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  • Sotagliflozin (Inpefa) is indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure as well as those with type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors.
  • Seventeen studies provided insights into the safety and effectiveness of Sotagliflozin compared to other drugs within its class.
  • Compared to dapagliflozin, Sotagliflozin has been shown to significantly reduce cardiovascular mortality when initiated in cases of heart failure. It also exhibited enhanced mortality reduction associated with a greater initial symptom burden.
  • The pooled effects demonstrate that SGLT2 inhibitors like Sotagliflozin improve the quality of life in patients suffering from heart failure by positively impacting left ventricular dysfunction regardless of their diabetes status.
  • In head-to-head comparisons among different types of SGLT2 inhibitors, including Sotagliflozin, there was no significant difference found in major efficacy outcomes for established heart failures. However, it may be associated with the lowest risks related to composite outcomes such as cardiovascular deaths or hospitalizations due to heart failures.
  • Sotagliflozin can serve as foundational therapy among patients, improving their chances against cardiovascular deaths/hospitalizations regardless of diabetes status.
  • Significant attention was given to populations across the spectrum of ejection fractions, where benefits were observed even without baseline diabetes, expanding the therapeutic reach beyond T2DM patients.
  • The side effects include increased risks of genital mycotic infections and acidosis-related events, especially in T1D, but these adverse events are considered tolerable, highlighting a favorable safety profile.

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
Sotagliflozin reduces HF events in T2DM regardless of baseline characteristics, including HF, CKD and LVEF. 2021Cardiovascular Drugs and Therapy
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