Daprodustat for the Treatment of Anemia in Patients Undergoing Dialysis

Singh, Ajay K.; Carroll, Kevin; Perkovic, Vlado; Solomon, Scott; Jha, Vivekanand; Johansen, Kirsten L.; Lopes, Renato D.; Macdougall, Iain C.; Obrador, Gregorio; Waikar, Sushrut S.; Wanner, Christoph; Wheeler, David C.; Wiecek, Andrzej; Blackorby, Allison; Cizman, Borut; Cobitz, Alexander R.; Davies, Rich; Dole, Jo; Kler, Lata; Meadowcroft, Amy M.

doi:10.1056/NEJMoa2113379

Daprodustat for the Treatment of Anemia in Patients Undergoing Dialysis

Journal

New England Journal of Medicine

ISSN

0028-4793

1533-4406

Date Issued

2021

Author(s)

Singh, Ajay K.

Carroll, Kevin

Perkovic, Vlado

Solomon, Scott

Jha, Vivekanand

Johansen, Kirsten L.

Lopes, Renato D.

Macdougall, Iain C.

Obrador, Gregorio

Facultad de Ciencias de la Salud - CampCM

Waikar, Sushrut S.

Wanner, Christoph

Wheeler, David C.

Wiecek, Andrzej

Blackorby, Allison

Cizman, Borut

Cobitz, Alexander R.

Davies, Rich

Dole, Jo

Kler, Lata

Meadowcroft, Amy M.

Zhu, Xinyi

McMurray, John J. V.

Type

text::journal::journal article

DOI

10.1056/NEJMoa2113379

URL

https://scripta.up.edu.mx/handle/20.500.12552/2170

Abstract

Background: Among patients with chronic kidney disease (CKD), the use of recombinant human erythropoietin and its derivatives for the treatment of anemia has been linked to a possibly increased risk of stroke, myocardial infarction, and other adverse events. Several trials have suggested that hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitors (PHIs) are as effective as erythropoiesis-stimulating agents (ESAs) in increasing hemoglobin levels. Methods: In this randomized, open-label, phase 3 trial, we assigned patients with CKD who were undergoing dialysis and who had a hemoglobin level of 8.0 to 11.5 g per deciliter to receive an oral HIF-PHI (daprodustat) or an injectable ESA (epoetin alfa if they were receiving hemodialysis or darbepoetin alfa if they were receiving peritoneal dialysis). The two primary outcomes were the mean change in the hemoglobin level from baseline to weeks 28 through 52 (noninferiority margin, −0.75 g per deciliter) and the first occurrence of a major adverse cardiovascular event (a composite of death from any cause, nonfatal myocardial infarction, or nonfatal stroke), with a noninferiority margin of 1.25. Copyright © Massachusetts Medical Society.