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Desidustat in anaemia in patients with chronic kidney disease: a profile of its use

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Abstract

Desidustat (Oxemia), a hypoxia-inducible factor prolyl hydroxylase inhibitor, is a promising new oral alternative to injectable erythropoiesis-stimulating agents (ESAs) for the treatment of anaemia in patients with chronic kidney disease (CKD). Desidustat is approved in India for adults with CKD who are either not on dialysis or on dialysis. It is administered orally three times a week and dosage should be individualised based on the haemoglobin response of the patient. In clinical trials in patients with non-dialysis-dependent and dialysis-dependent CKD, desidustat was non-inferior to darbepoetin alfa and epoetin alfa, respectively, in increasing haemoglobin levels. Desidustat was generally well tolerated in clinical trials of up to 24 weeks and had a broadly similar tolerability and safety profile to darbepoetin alfa and epoetin alfa. The most common adverse events with desidustat were peripheral oedema in patients with non-dialysis-dependent CKD, and pyrexia, increased blood potassium, nausea and chills in patients with dialysis-dependent CKD.

Plain Language Summary

The current standard of care for the treatment of anaemia in patients with chronic kidney disease (CKD) is an injectable erythropoiesis-stimulating agent (ESA) and iron supplementation. However, some patients are hypo-responsive (resistant) to ESAs and there are concerns around their cardiovascular safety at high doses. This has led to the development of hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs), which correct anaemia by modulating the expression of genes that control red blood cell production. Desidustat (Oxemia™), an oral HIF-PHI administered three times a week, is approved in India for the treatment of anaemia in adults with CKD who are either not on dialysis or on dialysis. In clinical trials, desidustat was non-inferior to ESAs in increasing haemoglobin levels in patients with non-dialysis-dependent and dialysis-dependent CKD. Desidustat was generally well tolerated in clinical trials of up to 24 weeks, with similar incidences of adverse events compared with ESAs. Thus, desidustat is a promising new oral alternative to injectable ESAs for the treatment of anaemia in patients with CKD.

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Acknowledgements

The manuscript was reviewed by: A. Gundroo, Division of Nephrology, Department of Internal Medicine, The Ohio State University Wexner Medical Center, Columbus, OH, USA; F. Locatelli, Department of Nephrology, Dialysis & Renal Transplant, Alessandro Manzoni Hospital, Lecco, Italy; J. B. Wish, Division of Nephrology, Indiana University Health, Indianapolis, IN, USA. During the peer review process, Zydus Lifesciences Ltd, the marketing authorization holder of desidustat, was also offered an opportunity to provide a scientific accuracy review of their data. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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Correspondence to Tina Nie.

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Tina Nie and Yahiya Syed are salaried employees of Adis International Ltd/Springer Nature and declare no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

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Nie, T., Syed, Y.Y. Desidustat in anaemia in patients with chronic kidney disease: a profile of its use. Drugs Ther Perspect 39, 279–286 (2023). https://doi.org/10.1007/s40267-023-01012-1

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