Safety and efficacy of vadadustat for anemia in patients undergoing dialysis
New England Journal of Medicine May 04, 2021
Eckardt KU, Agarwal R, Aswad A, et al. - Among patients with anemia and incident or prevalent dialysis-dependent chronic kidney disease (DD-CKD) who were included in two randomized, open-label, noninferiority phase 3 trials, researchers compared vadadustat (an oral hypoxia-inducible factor prolyl hydroxylase inhibitor) vs darbepoetin alfa in terms of safety as well as efficacy as treatment options for these patients. They randomized (1:1) 3923 patients to receive vadadustat or darbepoetin alfa: 369 in the incident DD-CKD trial and 3554 in the prevalent DD-CKD trial. As revealed by the pooled analysis, the occurrence of a first major adverse cardiovascular event (a composite of death from any cause, a nonfatal myocardial infarction, or a nonfatal stroke) was seen in 355 patients (18.2%) in the vadadustat group and in 377 patients (19.3%) in the darbepoetin alfa group. Overall, findings demonstrated noninferiority of vadadustat to darbepoetin alfa, in terms of cardiovascular safety and correction and maintenance of hemoglobin levels, in patients with anemia and CKD who were receiving dialysis.
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