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Vadadustat in non-dialysis dependent CKD

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eMediNexus    22 May 2021

Vadadustat has been found to be noninferior to darbepoetin alfain terms of cardiovascular safety and correction and maintenance of haemoglobin concentrations. Vadadustat is an oral hypoxia-inducible factor hydroxylase inhibitor and belongs to a class of compounds that stimulate endogenous erythropoietin production. 

Two randomized, open-label, non-inferiority phase 3 trials evaluated the safety and efficacy of vadadustat compared with darbepoetin alfa, in patients with anaemia and incident or prevalent dialysis-dependent chronic kidney disease (DD-CKD). The results of these trials showed that in the vadadustat group, a first major adverse cardiovascular event (MACE) occurred in 355 patients (18.2%) and in 377 patients (19.3%) in the darbepoetin alfa group (hazard ratio, 0.96; 95% confidence interval [CI], 0.83 to 1.11). The occurrence of serious adverse events in the vadadustat group was 49.7% in the incident DD-CKD trial and 55.0% in the prevalent DD-CKD trial, and the incidences in the darbepoetin alfa group were 56.5% and 58.3%, respectively. 

Reference

  1. Eckardt KU, Agarwal R, Aswad A, Awad A, Block GA, Bacci MR, et al. Safety and efficacy of vadadustat for anaemia in patients undergoing dialysis. N Engl J Med. 2021; 384: 1601-1612. 

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