The US Food and Drug Administration (FDA) has approved sotagliflozin with a broad heart-failure indication, even in the absence of trial data in patients without diabetes. No one knows what the benefits or risks of inhibiting SGLT1 in the heart might be.
References
Borges-Júnior, F. A. et al. J. Am. Soc. Nephrol. 32, 1616–1629 (2021).
Packer, M. Circulation 146, 1383–1405 (2022).
Chan, L. K. Y., Wang, Y., Ng, E. K. W. & Leung, P. S. Diabetes Obes. Metab. 20, 709–717 (2018).
Turk, E., Zabel, B., Mundlos, S., Dyer, J. & Wright, E. M. Nature 350, 354–356 (1991).
SCORED Investigators. N. Engl. J. Med. 384, 129–139 (2021).
SOLOIST-WHF Trial Investigators. N. Engl. J. Med. 384, 117–128 (2021).
US FDA. INPEFA (sotagliflozin) tablets, for oral use. https://go.nature.com/3CVjPBw (2023).
van Raalte, D. H. et al. Diabetes Care 42, 1921–1929 (2019).
Sayour, A. A. et al. Cardiovasc Diabetol. 19, 159 (2020).
Ramratnam, M. et al. J. Am. Heart Assoc. 3, e000899 (2014).
Connelly, K. A., Zhang, Y., Desjardins, J. F., Thai, K. & Gilbert, R. E. Cardiovasc. Diabetol. 17, 99 (2018).
Ferté, L. et al. Am. J. Physiol. Heart Circ. Physiol. 320, H838–H853 (2021).
Takebayashi, K. & Inukai, T. J. Clin. Med. Res. 9, 745–753 (2017).
Posch, M. G. et al. Diabetes Care 45, 2118–2126 (2022).
Sudo, M. et al. Atherosclerosis 265, 283–291 (2017).
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Competing interests
In the past three years, M.P. has been a consultant to 89bio, Abbvie, Altimmune, Amgen, Ardelyx, AstraZeneca, Boehringer Ingelheim, Caladrius, Casana, CSL Behring, Cytokinetics, Imara, Lilly, Moderna, Novartis, Pharmacosmos, Reata, Regeneron, Relypsa and Salamandra.
Rights and permissions
About this article
Cite this article
Packer, M. Dual SGLT1 and SGLT2 inhibitor sotagliflozin achieves FDA approval: landmark or landmine?. Nat Cardiovasc Res 2, 705–707 (2023). https://doi.org/10.1038/s44161-023-00306-x
Published:
Issue Date:
DOI: https://doi.org/10.1038/s44161-023-00306-x
- Springer Nature Limited