Drug updated on 7/25/2024
Dosage Form | Tablet (oral: 200 mg, 400 mg) |
Drug Class | Sodium-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
- 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 Title | Year | Source |
---|---|---|
Inpefa (sotagliflozin) Prescribing Information. | 2024 | Lexicon Pharmaceuticals, Inc., The Woodlands, TX |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Practical guidance for the use of SGLT2 inhibitors in heart failure. | 2023 | American Journal of Cardiovascular Drugs |
Sodium-glucose co-transporter 2 inhibitors in heart failure: an updated evidence-based practical guidance for clinicians. | 2023 | European Heart Journal Supplements |
Sodium-glucose co-transporter 2 inhibitors in acute heart failure: a review of the available evidence and practical guidance on clinical use. | 2022 | Reviews in Cardiovascular Medicine |
2022 AHA/ACC/HFSA guideline for the management of heart failure: a report of the American College of Cardiology/American Heart Association joint committee on clinical practice guidelines. | 2022 | Journal of the American College of Cardiology |
Sodium-glucose co-transporter 2 inhibitors as an early, first-line therapy in patients with heart failure and reduced ejection fraction. | 2022 | European Journal of Heart Failure |