Epo does not help with neurological damage to newborns: The drug erythropoietin, when combined with cooling therapy, showed no added benefits, study finds

Adding erythropoietin to cooling therapy for term newborns with birth asphyxia has no benefit over cooling therapy alone, a study published today in the New England Journal of Medicine.

The findings contrast with results from small trials in which erythropoietin appeared safe and effective, noted Dr. Sandra “Sunny” Juul, senior author of the study. The Alan Hodson Endowed Professor of Pediatrics at the UW School of Medicine, Juul is also the UW Medicine chief of neonatology (newborn medical care) and practices at Seattle Chldren’s.

Hypoxic ischemic encephalopathy occurs when too little oxygen is going to the brain and other vital organs at or near time of birth. The multicenter trial of 500 infants with moderate or severe hypoxic ischemic encephalopathy found an equal risk of death or neurodevelopmental impairment at 2 to 3 years of age for the placebo group that received hypothermia treatment only, and the hypothermia plus erythropoietin group.

In addition, the study showed an unexpected finding. The erythropoietin group had more serious adverse events during the newborn period than the placebo group.

“It’s a negative outcome, but this is important for clinicians to know,” said Juul. “This study demonstrates how important large prospective randomized controlled trials are. These larger phase III studies have enough statistical power to truly answer a clinical question. The larger study size also was able to demonstrate the unexpected safety concern.”

This does not mean that erythropoietin, or commonly called “epo,” doesn’t have possibilities as a therapeutic for hypoxic ischemic encephalopathy, she said. The drug may be beneficial in treating the hypoxic ischemic encephalopathy in low-resource counties, without the use of hypothermia as a treatment, or where cooling therapies are simply not available, she said.

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