New data show cardiovascular benefits of anemia drug for patients with CKD, ESKD
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BOSTON — New research presented during the late-breaking trials program at the National Kidney Foundation Spring Clinical Meetings showed the anemia drug daprodustat has cardiovascular benefits comparable to erythropoiesis-stimulating agents.
Daprodustat is an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor targeted to treat anemia of chronic kidney disease in both patients on dialysis and not on dialysis.
“Anemia is an important and frequent complication of chronic kidney disease, an increasing global health burden affecting 700 million patients worldwide with one in seven patients also developing anemia that may impact quality of life and increase complications in these patients,” Ajay K. Singh, MBBS, associate dean of Harvard Medical School and the principal investigator on the daprodustat trials, said in a press release. “Previous clinical trials with ESAs have raised safety concerns when normalizing hemoglobin, and they have demonstrated no clear benefit in quality of life. Given these concerns with ESAs, paired with the need for injection, more convenient, efficacious and safe treatments for anemia are needed for patients.”
Daprodustat is under development by pharmaceutical company GlaxoSmithKline. The company’s ASCEND program includes five phase 3 clinical trials to investigate the efficacy and safety of daprodustat across a spectrum of CKD in patients.
Singh presented new efficacy and safety data from two cardiovascular outcome trials – Anemia Studies in CKD: Erythropoiesis via a Novel PHI Daprodustat-Non-Dialysis (ASCEND-ND) and Anemia Studies in CKD: Erythropoiesis via a Novel PHI Daprodustat-Dialysis (ASCEND-D), as well as a dedicated trial in incident dialysis patients in more than 7,000 patients across 41 countries.
“The cardiovascular outcomes trials demonstrated that daprodustat was noninferior to ESA with respect to [cardiovascular] safety and no new safety signals were observed,” Singh said.
Daprodustat is approved in Japan as Duvroq for patients with renal anemia and is under review by the European Medicines Agency.
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Singh A. Late-breaking clinical trials. Presented at: National Kidney Foundation Spring Clinical Meetings; April 5-10, 2022; Boston.
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