Abstract

Anemia frequently occurs in chronic kidney disease (CKD), is associated with poor quality of life and cardiovascular outcomes, and its treatment represents a considerable economic burden to the healthcare system. Although effective, the current standard of care for the treatment of anemia in chronic kidney disease patients with erythropoiesis-stimulating agents requires chronic/ongoing injections, making the treatment less accessible or desirable to patients not treated by in-center maintenance hemodialysis. Furthermore, safety concerns, including an increased risk of cardiovascular events and mortality, have emerged from their use in studies targeting hemoglobin concentrations in the normal or near-normal range. The orally active hypoxia-inducible factor prolyl hydroxylase inhibitor vadadustat may offer advantages over erythropoiesis-stimulating agents by correcting anemia via pathways activating endogenous erythropoietin production, with fewer excursions of hemoglobin concentrations above the target range.To comprehensively analyze the safety profile of vadadustat in patients with CKD-related anemia, we pooled the safety populations from each of the four trials in the phase 3 clinical program (n=7373) and compared the risk of treatment-emergent adverse events (TEAEs) for each treatment arm.In patients randomized to vadadustat vs darbepoetin alfa, rates of TEAEs (88.9% vs 89.3%), treatment-emergent serious adverse events (58.0% vs. 59.3%), and TEAEs leading to death (16.1% vs 16.2%) were similar, as were rates of adverse events of special interest, including cardiovascular-, hepatic-, and neoplasm-related adverse events.Among patients with CKD-related anemia treated with vadadustat, we observed similar rates of adverse events relative to those treated with darbepoetin alfa.

View details for DOI 10.1159/000528443

View details for Web of Science ID 000892801700001

View details for PubMedID 36450264