Drug updated on 4/17/2024
| Dosage Form | Tablet (oral: 1 mg, 2 mg, 4 mg, 6 mg, 8 mg) |
| Drug Class | Hypoxia-inducible factor prolyl hydroxylase 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.
Summary
- Daprodustat (Jesduvroq) is recommended for the treatment of anemia due to chronic kidney disease in adults undergoing dialysis for at least four months. It demonstrates similar efficacy to recombinant human erythropoietin (rhEPO) and other erythropoiesis-stimulating agents (ESAs) in managing anemia, with no significant differences in hemoglobin level changes observed between nondialysis-dependent and dialysis-dependent patient subgroups.
- Twelve studies were reviewed, providing insights into Jesduvroq's effectiveness compared to ESAs and hypoxia-inducible factor-prolyl hydroxylase domain inhibitors (HIF-PHIs).
- Compared to ESAs, Jesduvroq was associated with slightly improved hemoglobin levels and significantly reduced incidence of major adverse cardiovascular events (MACE) and myocardial infarction, particularly within the dialysis-dependent subgroup, positioning it as a safer alternative.
- Jesduvroq demonstrated significant increases in transferrin saturation, total iron-binding capacity, and total iron compared with rhEPO, suggesting potential advantages in optimizing iron metabolism, especially within patients dependent on dialysis.
- The safety profile for daprodustat appears favorable when compared against both ESAs and placebo. There was no increase in serious adverse events overall; however, minor side effects such as diarrhea were reported more frequently than in those taking ESAs.
- When comparing daprodustat's effectiveness in managing hemoglobin levels against other HIF-PHIs like roxadustat, although somewhat less effective, it showed lower risks related to hypertension or thrombosis complications, making it a potentially safer option among this drug class.
- Among nondialyzed CKD patients, Jesduvroq significantly reduced hepcidin levels – crucial for proper iron metabolism – showing promise as an effective treatment alternative over darbepoetin alfa.
- In terms of subgroup considerations, Jesduvroq's effects closely matched overall trends observed for other HIF-PHIs. However, it showed specific improvements in cardiovascular outcomes and iron metabolism parameters within certain CKD patient subgroups, making it a potentially more beneficial treatment option.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Jesduvroq (daprodustat) Prescribing Information. | 2023 | GlaxoSmithKline., Durham, NC |