- Noninferiority to Epoetin in Maintenance of Hemoglobin (Hb) : The difference between the OMONTYS and epoetin-treated groups in the mean change in Hb levels from baseline to the study evaluation period (calculated as the mean of all measurements during weeks 29-36) in EMERALD 1 and 2 was -0.15 g/dL (95 percent CI: -0.30, -0.01) and 0.10 g/dL (95 percent CI: -0.05, 0.26) respectively.
- Similar Cardiovascular Safety in Hemodialysis Population : In the EMERALD studies, 22.8 percent of OMONTYS patients experienced one of the composite cardiovascular events, compared to 24.4 percent of epoetin patients (hazard ratio for the cardiovascular composite safety endpoint was 0.95 (0.77, 1.17) (95 percent CI)). OMONTYS is not indicated in patients with CKD not on dialysis. These patients experienced increased specific cardiovascular events.
New England Journal Of Medicine Publishes Pivotal Trial Data For OMONTYS® (peginesatide) Injection For Treatment Of Anemia In Adult Chronic Kidney Disease Patients On Hemodialysis
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