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Heart failure is a clinical syndrome of structural damage and dysfunction of heart tissue, leading to a decreased ability of the ventricles to circulate blood throughout the body. The disease is classified by symptom severity using assessment tools such as the New York Heart Association (NYHA) Functional Classification. The American College of Cardiology Foundation/American Heart Association (ACC/AHA) provides additional stage information regarding the development of heart failure.

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Heart failure affects an estimated 64 million people worldwide, and the AHA estimates that 6.2 million of them are in the United States.1 The main goals of treatment for those diagnosed include managing symptoms, slowing or reversing the decline in myocardial function, and reducing mortality.2 So far, the mainstays of treatment include beta-blockers, renin-angiotensin system inhibitors, diuretics, mineralocorticoid receptor antagonists, and more recently sodium-glucose cotransporter (SGLT) 2 inhibitors. I am. One of the newest FDA-approved heart failure treatments is sotagliflozin (Inpefa; Lexicon), a dual inhibitor of SGLT2 and SGLT1.

table.3 Sotagliflozin Overview

Although newly approved, there is some debate about the benefits and for whom sotagliflozin is most effective. It is approved by the FDA in two major patient populations, including patients with heart failure and patients with type 2 diabetes who have chronic kidney disease and additional cardiovascular risk factors. However, the two major trials evaluating sotagliflozin included only patients with type 2 diabetes, so despite its approval, its efficacy in patients without diabetes is still unclear.Four

Another aspect of the debate is the role of SGLT1 inhibition in the clinical efficacy of sotagliflozin. Concentrations of this drug are not expected to be high enough to inhibit SGLT1 in the renal tubules, but it may play a role in the myocardium. SGLT1 is upregulated in heart failure and can lead to ventricular hypertrophy and dysfunction, but the clinical effects of myocardial SGLT1 inhibition are not fully understood.Four

Although these questions remain, the two major trials evaluating sotagliflozin, SOLOIST-WHF and SCORED, have shown promising results. The SOLOIST-WHF trial found that combined cardiovascular death and hospitalization were reduced in patients with type 2 diabetes admitted to the hospital due to worsening heart failure.Five The SCORED trial evaluated patients with type 2 diabetes, chronic kidney disease, and additional cardiovascular risk factors to reduce total cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, as well as cardiovascular A reduction in total deaths and non-fatal strokes was found. Hospitalized for heart failure.6 Diarrhea was found to be the most commonly occurring adverse event in both trials, although statistical significance was not observed.

In the future, sotagliflozin may be a good alternative to SGLT2 inhibitors for patients with heart failure, especially those with type 2 diabetes. It is hoped that further data will be discovered regarding SGLT1 inhibitors in reducing myocardial infarction and stroke, which was lacking with SGLT2 inhibitors.

References

1. GBD 2017 Disease and Injury Incidence and Prevalence Collaborator. Global, regional and national incidence, prevalence and years lived with disability of 354 diseases and injuries in 195 countries and territories from 1990 to 2017: Global Burden of Disease Study 2017 systematic analysis. lancet. 2018;392(10159):1789. Epub 2018 November 8th.

2. Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, et al. 2022 AHA/ACC/HFSA Heart Failure Management Guidelines: Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. circle 2022;145:e895-e1032. doi:10.1161/CIR.0000000000001063

3. Sotagliflozin [package insert]. Lexicon Pharmaceuticals, Inc., The Woodlands, Texas, 2023. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a46614e-05f6-421a-b6f4-d6f8760d643a

4. Packer M. Dual SGLT1 and SGLT2 inhibitor sotagliflozin wins FDA approval: landmark or landmine? national cardiovascular examination 2705–707 (2023)

5. Butt DL, Sharek M, Steg PG, Cannon CP, Reiter LA, McGuire DK, Lewis JB, Riddle MC, Voels AA, Metra M, Lund LH, Komagida M, Testani JM, Wilcox CS, Ponikowski P, Lopez. RD, Verma S, Lapuerta P, Pitt B; SOLOIST-WHF Trial Investigator. Sotagliflozin in patients with diabetes and recently worsened heart failure. N English J Medicine. 2021 1 14;384(2):117-128.

6. Butt DL, Zarek M, Pitt B, Cannon CP, Reiter LA, McGuire DK, Lewis JB, Riddle MC, Inzucchi SE, Kociborod MN, Charney DZI, Dwyer JP, Sirica BM, Bailey CJ, Diaz R, Ray KK, Udell JA, Lopez RD, Gates P, Steg PG; Featured Investigators. Sotagliflozin in patients with diabetes and chronic kidney disease. N English J Medicine. 2021 1 14;384(2):129-139.

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