Drug updated on 12/11/2024
Dosage Form | Tablet (oral: 1 mg, 2 mg, 4 mg, 6 mg, 8 mg) |
Drug Class | Hypoxia-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.
Latest News
Summary
- 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 Title | Year | Source |
---|---|---|
Jesduvroq (daprodustat) Prescribing Information. | 2023 | GlaxoSmithKline., Durham, NC |