Sotagliflozin

(Inpefa®)

Inpefa®

Drug updated on 12/11/2024

Dosage FormTablet (oral: 200 mg, 400 mg)
Drug ClassSodium-glucose co-transporter 2 (SGLT2) 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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  • This summary is based on the review of 27 systematic review(s)/meta-analysis(es). [1-28]
  • Sotagliflozin significantly reduced hospitalizations for heart failure (HF) and cardiovascular (CV) death compared to empagliflozin (relative risk (RR) = 0.88, 95% confidence interval (CI), 0.79 to 0.97) and dapagliflozin (RR = 0.86, 95% CI, 0.77 to 0.96), demonstrating greater effectiveness in improving HF outcomes.
  • In patients with chronic kidney disease, sotagliflozin demonstrated notable reductions in cardiovascular-related deaths and hospitalizations for HF, irrespective of the presence of albuminuria.
  • Sotagliflozin also significantly lowered the risk of all types of stroke (RR = 0.74, 95% CI 0.56-0.97), highlighting its broader cardiovascular benefits beyond heart failure outcomes.
  • Improvements in quality of life and cardiac function, such as better Kansas City Cardiomyopathy Questionnaire (KCCQ) scores, left atrial volume index (LAVI), and left ventricular ejection fraction (LVEF), were observed with sotagliflozin, further supporting its beneficial effects in heart failure patients.
  • Sotagliflozin increased the risk of genital mycotic infections in patients with type 1 diabetes (T1D) and type 2 diabetes (T2D), with risk ratios of 3.49 and 2.83, respectively.
  • Sotagliflozin was associated with a higher risk of diarrhea and volume depletion in both T1D and T2D populations.
  • Sotagliflozin increased the risk of acidosis-related events, including diabetic ketoacidosis (DKA), particularly in patients with T1D.
  • Sotagliflozin demonstrated cardiovascular benefits in type 2 diabetes mellitus (T2DM) patients with heart failure (HF) or cardiovascular risk factors, particularly reducing cardiovascular-related deaths and hospitalizations for heart failure. Additionally, sotagliflozin showed beneficial effects in patients with chronic kidney disease (CKD), with or without albuminuria.

Product Monograph / Prescribing Information

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

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Effects of different sodium-glucose cotransporter 2 inhibitors in heart failure with reduced or preserved ejection fraction: a network meta-analysis2024Frontiers in Cardiovascular Medicine
Sodium-Glucose Cotransporter-2 Inhibitors and Cardiovascular Protection Among Patients With Type 2 Diabetes Mellitus: A Systematic Review2024Journal of Diabetes Research
The effect of sodium-glucose transporter 2 inhibitors on stroke in patients with type 2 diabetes: A meta-analysis2024Journal of Stroke and Cerebrovascular Diseases
Sodium-glucose co-transporter-2 inhibitors for the prevention of atrial fibrillation: a systemic review and meta-analysis2024European Journal of Preventive Cardiology
Comparative cardiovascular benefits of individual SGLT2 inhibitors in type 2 diabetes and heart failure: a systematic review and network meta-analysis of randomized controlled trials2023Frontiers in Endocrinology
Cardiovascular benefits and safety of sotagliflozin in type 2 diabetes mellitus patients with heart failure or cardiovascular risk factors: a bayesian network meta-analysis2023Frontiers in Pharmacology
Impact of SGLT2 inhibitors on patient outcomes: a network meta-analysis2023Cardiovascular Diabetology
Sotagliflozin vs Dapagliflozin: A Systematic Review Comparing Cardiovascular Mortality2023Cureus
Comparative safety of different sodium-glucose transporter 2 inhibitors in patients with type 2 diabetes: a systematic review and network meta-analysis of randomized controlled trials2023Frontiers in Endocrinology
Systematic review of sodium-glucose cotransporter 2 inhibitors: a hopeful prospect in tackling heart failure-related events2023ESC Heart Failure
SGLT2 inhibitors and cardiovascular outcomes in heart failure with mildly reduced and preserved ejection fraction: A systematic review and meta-analysis2023Indian Heart Journal
Indirect comparison of SGLT2 inhibitors in patients with established heart failure: evidence based on Bayesian methods2023ESC Heart Failure
Comparison the effects of finerenone and SGLT2i on cardiovascular and renal outcomes in patients with type 2 diabetes mellitus: A network meta-analysis2022Frontiers in Endocrinology
Cardiovascular outcomes in patients treated with sodium-glucose transport protein 2 inhibitors, a network meta-analysis of randomized trials2022Frontiers 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-analysis2022Frontiers in Pharmacology
Efficacy of Sodium-Glucose Cotransporter 2 Inhibitors in Heart Failure with a Preserved Ejection Fraction: A Meta-Analysis of Randomized Controlled Trials2022Reviews in Cardiovascular Medicine
The safety of sotagliflozin in the therapy of diabetes mellitus type 1 and type 2: A meta-analysis of randomized trials2022Frontiers in Endocrinology
Sacubitril/valsartan, sodium-glucose cotransporter 2 inhibitors and vericiguat for congestive heart failure therapy2022Basic & Clinical Pharmacology & Toxicology
Sodium-glucose cotransporter 2 inhibitors in patients with heart failure: a systematic review and meta-analysis of randomized trials2022European Heart Journal - Quality of Care and Clinical Outcomes
Sotagliflozin for patients with type 2 diabetes: A systematic review and meta-analysis2022Diabetes Obesity & Metabolism
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-analysis2022Clinical Research in Cardiology
SGLT-2 inhibitors and cardiorenal outcomes in patients with or without type 2 diabetes: a meta-analysis of 11 CVOTs2021Cardiovascular Diabetology
Gliflozins for the prevention of stroke in diabetes and cardiorenal diseases: A meta-analysis of cardiovascular outcome trials2021Medicine
Sodium-Glucose Cotransporter 2 Inhibitors, All-Cause Mortality, and Cardiovascular Outcomes in Adults with Type 2 Diabetes: A Bayesian Meta-Analysis and Meta-Regression2021Journal of the American Heart Association
Sotagliflozin Reduces HF Events in T2DM Regardless of Baseline Characteristics, Including HF, CKD and LVEF2021Cardiovascular Drugs and Therapy
Effects of sodium-glucose cotransporter type 2 inhibitors on cardiovascular, renal, and safety outcomes in patients with cardiovascular disease: a meta-analysis of randomized controlled trials2021Cardiovascular Diabetology
Sodium-glucose co-transporter-2 inhibitors for the prevention of cardiorenal outcomes in type 2 diabetes: An updated meta-analysis2021Diabetes Obesity & Metabolism
Effects of sodium-glucose cotransporter 1 and 2 inhibitors on cardiovascular and kidney outcomes in type 2 diabetes: A meta-analysis update2021American Heart Journal

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