Sotagliflozin

(Inpefa®)

Inpefa®

Drug updated on 7/25/2024

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 visits in adults with heart failure or type 2 diabetes mellitus with chronic kidney disease and other cardiovascular risk factors.
  • The information is derived from a review of 17 systematic reviews/meta-analyses studies.
  • Comparative analysis shows sotagliflozin significantly improves cardiovascular mortality, hospitalizations, and urgent heart failure visits compared to dapagliflozin.
  • Benefits are consistent across patients with HFpEF (Heart Failure with Preserved Ejection Fraction) regardless of diabetes status.
  • In populations with type 2 diabetes and chronic kidney disease at high cardiovascular risk, sotagliflozin effectively reduces major adverse cardiovascular events (MACE), heart failure hospitalization (HHF), and cardiovascular death.
  • Increased risks were noted for genital mycotic infections, specific acidosis-related events, and diarrhea in both type 1 and type 2 diabetes patients on sotagliflozin.
  • Compared to other SGLT2 inhibitors like empagliflozin or dapagliflozin, sotagliflozin shows superior benefits in reducing heart failure hospitalizations but similar benefits regarding all-cause mortality and overall cardiovascular outcomes.
  • Dual inhibition mechanism via SGLT1/2 by sotagliflozin may offer additional glycemic control advantages potentially leading to better overall cardiovascular outcomes.

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

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