The Medical Letter on Drugs and Therapeutics
Peginesatide (Omontys) for Anemia in Chronic Kidney Disease
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The FDA has approved the erythropoiesis-stimulating agent (ESA) peginesatide (Omontys – Affymax/Takeda), a synthetic peptide analog of erythropoietin, for treatment of anemia in patients with chronic kidney disease (CKD) who are on dialysis. Peginesatide is the third ESA to become available in the US. Overuse of the other two, which have broader indications, has been a concern.1,2

Labels for all three ESAs include a boxed warning stating that in controlled trials, patients experienced a greater risk for death, stroke and other serious cardiovascular events when ESAs were used to raise hemoglobin levels to more than 11 g/dL in patients with CKD, and that no trial has identified a hemoglobin target level that would decrease these risks.

CLINICAL STUDIES — Two unpublished, open-label, studies, both available only as abstracts, compared peginesatide with epoetin ... more      

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Title: Peginesatide (Omontys) for Anemia in Chronic Kidney Disease
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