Drug updated on 4/16/2024
| 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.
Summary
- 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 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 |