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Daprodustat at least as good as erythropoiesis-stimulating agents for anemia in CKD

Journal
The New England Journal of Medicine
Reuters Health - 05/11/2021 - The team behind the ASCEND-D and ASCEND-ND studies on anemic patients with chronic kidney disease (CKD) are reporting that GlaxoSmithKline's daprodustat is not inferior to darbepoetin alfa for reducing anemia whether or not patients are undergoing peritoneal dialysis.

Among those receiving hemodialysis, daprodustat was not inferior to treatment with epoetin alfa.

Daprodustat was particularly effective among those on dialysis.

The results were released Friday during the American Society of Nephrology's Kidney Week and online by the New England Journal of Medicine.

Daprodustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor. The hope is that such drugs can increase hemoglobin levels as effectively as erythropoiesis-stimulating agents without posing a risk of side effects such as stroke or myocardial infarction.

Among 2,964 dialysis patients in the open-label phase-3 study, the mean hemoglobin level during weeks 28 through 52 increased by 0.28 g/dL with oral daprodustat and 0.10 g/dL with injectable epoetin alfa or darbepoetin alfa, a significant difference.

The odds of myocardial infarction, stroke or death from any cause were 25.2% over a median of 2.5 years among daprodustat recipients versus 26.7% among recipients of either of the erythropoiesis-stimulating agents.

Among 3,872 non-dialysis patients, daprodustat produced a hemoglobin increase of 0.74 g/dL compared to 0.66 g/dL with conventional therapy with darbepoetin alfa.

As in the dialysis patients, the rates of major cardiovascular events were comparable at 19.5% over 1.9 years with daprodustat and 19.2% with darbepoetin alfa.

"The percentages of patients with other adverse events were similar in the two groups" whether or not the patients were on dialysis, the researchers said.

All the volunteers had a hemoglobin level of 8.0 to 11.5 g/dL at enrollment.

GlaxoSmithKline financed the studies.

SOURCES: https://bit.ly/300Nbym and https://bit.ly/3o1SgPg The New England Journal of Medicine, online November 5, 2021.

By Reuters Staff



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