Daprodustat

(Jesduvroq®)

Daprodustat

Drug updated on 12/11/2024

Dosage FormTablet (oral: 1 mg, 2 mg, 4 mg, 6 mg, 8 mg)
Drug ClassHypoxia-inducible factor prolyl hydroxylase (HIF PH) inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least four months.

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Summary
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  • This summary is based on the review of nine systematic review(s)/meta-analysis(es). [1-11]
  • Daprodustat significantly increased hemoglobin levels in chronic kidney disease (CKD) patients compared to placebo, with a mean difference (MD) of 1.86 (95% confidence interval (CI), 1.20 to 2.52) and demonstrated no significant difference in hemoglobin changes compared to recombinant human erythropoietin (RHEPO) in both dialysis-dependent (DD) and non-dialysis-dependent (NDD) CKD patients.
  • Daprodustat improved iron metabolism markers such as ferritin and total iron binding capacity (TIBC), showing a reduction in serum ferritin (MD = -180.84, 95% CI [-264.47; -97.20]) and an increase in TIBC (MD = 11.03, 95% CI [3.15; 18.92]).
  • Comparative effectiveness showed that daprodustat's ability to elevate hemoglobin levels was similar to that of rhEPO and other hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs), with roxadustat demonstrating slightly higher efficacy in hemoglobin correction among HIF-PHIs.
  • Daprodustat did not show an increased risk of adverse events (AES) or serious adverse events (SAES) compared to erythropoiesis-stimulating agents (ESA) or placebo in both dialysis-dependent and non-dialysis-dependent chronic kidney disease (CKD) patients. The incidence of thromboembolic and retinal events was comparable between daprodustat and ESA.
  • Gastrointestinal disorders, such as diarrhea and vomiting, were more common with daprodustat compared to ESA. Additionally, there was an increased risk of thrombosis and headache associated with hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs), including daprodustat.
  • The studies included both dialysis-dependent (DD) and non-dialysis-dependent (NDD) CKD patients, with daprodustat showing no significant difference in hemoglobin changes between these two groups. In DD-CKD patients, daprodustat improved iron metabolism more effectively than recombinant human erythropoietin (RHEPO). Adverse events were more common in NDD-CKD patients treated with daprodustat compared to rhEPO, but trial sequential analysis (TSA) corrected this finding. Additionally, daprodustat showed lower vascular-access complications compared to ESA.

Product Monograph / Prescribing Information

Document TitleYearSource
Jesduvroq (daprodustat) Prescribing Information.2023GlaxoSmithKline., Durham, NC

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Hypoxia-inducible factor-prolyl hydroxylase inhibitors for treatment of anemia in chronic kidney disease: a systematic review and network meta-analysis2024Frontiers in Pharmacology
Efficacy of daprodustat for patients on dialysis with anemia: systematic review and network meta-analysis2024Pan African Medical Journal
Safety and Efficacy of Hypoxia-Inducible Factor-Prolyl Hydroxylase Inhibitors vs. Erythropoietin-Stimulating Agents in Treating Anemia in Renal Patients (With or Without Dialysis): A Meta-Analysis and Systematic Review2023Cureus
Safety of HIF prolyl hydroxylase inhibitors for anemia in dialysis patients: a systematic review and network meta-analysis2023Frontiers in Pharmacology
A network meta-analysis of the efficacy of hypoxia-inducible factor prolyl-hydroxylase inhibitors in dialysis chronic kidney disease2023Aging
Efficacy and Safety of Daprodustat Vs rhEPO for Anemia in Patients With Chronic Kidney Disease: A Meta-Analysis and Trial Sequential Analysis2022Frontiers in Pharmacology
Safety of daprodustat in patients with anemia of chronic kidney disease: A pooled analysis of phase 3 studies in Japan2022Therapeutic Apheresis and Dialysis
Hypoxia‐inducible factor stabilisers for the anaemia of chronic kidney disease2022The Cochrane Database of Systematic Reviews
Long-term efficacy and safety of hypoxia-inducible factor prolyl hydroxylase inhibitors in anaemia of chronic kidney disease: A meta-analysis including 13,146 patients2021Journal of Clinical Pharmacy and Therapeutics
Efficacy and Safety of Daprodustat for Anemia Therapy in Chronic Kidney Disease Patients: A Systematic Review and Meta-Analysis2020Frontiers in Pharmacology
Effect of hypoxia-inducible factor-prolyl hydroxylase inhibitors on anemia in patients with CKD: a meta-analysis of randomized controlled trials including 2804 patients2020Renal Failure