EARLY EPO AND NEUROPROTECTION FOR PREEMIES

Early EPO Offers Neuroprotection for Preemies: Meta-analysis

By Reuters Staff

April 10, 2017

NEW YORK (Reuters Health) - Early prophylactic administration of recombinant human erythropoietin (rhEPO) improves neurodevelopmental outcomes in very preterm babies, a meta-analysis of randomized controlled trials confirms.  However, more work is needed to figure out optimal dosing and timing of administration, the authors say in a report online April 7 in Pediatrics. Improving neurodevelopmental outcomes is a “major goal” in neonatology, especially with regard to the increasing survival rate of very premature infants, and rhEPO is one of the most promising agents to accomplish this, they point out.

Dr. Christof Dame and colleagues from the neonatology department at Charite University Medical Center in Berlin did a pooled analysis of four randomized controlled trials that investigated the use of rhEPO in preterm infants (<= 32 weeks' gestational age) and reported neurodevelopmental outcomes at 18 to 24 months' corrected age. The studies were mostly of high methodological quality with a low risk of bias, they say.

Their analysis showed a significant reduction in the incidence of a Mental Developmental Index (MDI) score lower than 70 on the Bayley Scales of Infant Development with prophylactic rhEPO administration. “The beneficial effect of prophylactic rhEPO on the incidence of MDI lower than 70 at 18 to 24 months' corrected age was consistent across all studies. With an absolute risk reduction from 15.7% to 8.4% and a number needed to treat of 14 patients, the estimated effect is clinically relevant. The observed benefits of rhEPO are robust, because they are in agreement with available evidence from longer-term follow-up studies, which also reported improved cognitive outcomes,” the authors say.

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Pediatrics 2017.

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Cite this article: Early EPO Offers Neuroprotection for Preemies: Meta-analysis - Medscape - Apr 07, 2017.

ANEMIA DRUG MAY HELP BRAIN DAMAGE IN HYPOXIC INFANTS

SAN FRANCISCO, May 3 (UPI) -- Brain damage caused by a condition at birth may be preventable, based on a recent study showing a nearly 30-year-old anemia drug helps the brain heal.

The drug erythropoietin, referred to as EPO, prevents damage and helps the brain heal after hypoxic-ischemic encephalopathy, researchers at the University of California San Francisco report in the study, published in the journal Pediatrics.

HIE is a dysfunction of the nervous system causing a drop in oxygen and blood flow to the brain and other organs, causing disabilities such as cerebral palsy or death in about 40 percent of newborns who have it, regardless of treatment.

EPO is a man-made version of erythropoietin, a hormone made in the kidney that tells stem cells in bone marrow to produce red blood cells. The drug was approved by the U.S. Food and Drug Administration in 1989 to treat anemia, but has been shown in studies to promote nervous tissue recovery and development after oxygen deprivation.

The standard treatment for HIE is hypothermia -- cooling the body to 33.5 degrees Celsius, or 92.3 degrees Fahrenheit, to speed healing -- but one-third of newborns in the new study given EPO as well had no injury to their brains after recovery, and just one in the group had a severe or moderate injury.

"We're hopeful that EPO not only reduces the extent of brain injury, but also allows the brain to be more effective at repairing itself during the recovery process," Dr. Yvonne Wu, a child neurologist and professor neurology and pediatrics at the University of California San Francisco, said in a press release. "While research with more participants is needed to determine whether EPO saves lives, we are heartened by the fact that among those infants that survived, the degree of brain injury was generally less severe than in the placebo group."

For the study, researchers treated 50 16.5-hour-old newborns with HIE, giving 26 hypothermia and placebo and 24 hypothermia and five injections of EPO.

At five days old, 33.3 percent of children in the EPO group had no brain injury detected on MRI, compared to 11.5 percent in the placebo group. In the placebo group, 11 children had moderate or severe brain injuries, compared to just one in the EPO group.

At around 12 months old, the researchers also found motor performance and developmental progress was better among children treated with EPO, compared to those only receiving hypothermia.

"It is clear that this therapy is safe as used in this study and there is a strong suggestion that the patients are doing better than would be expected long term," said Dr. Roberta Ballard, a neonatologist and professor of pediatrics at UCSF. "It would be very encouraging if we find that an inexpensive old drug, costing $60 per infusion, rather than a new drug that costs more than $2 billion to develop may prevent untold suffering. A larger trial will allow a definitive answer to whether there should be a change in clinical care for this devastating condition."

EPO (SYNTHETIC ERYTHROPOIETIN) APPEARS TO PREVENT BRAIN DAMAGE IN PREEMIES

TUESDAY, Aug. 26, 2014 (HealthDay News) -- A hormone used to reduce the need for blood transfusions might also protect the brains of premature babies, a new study suggests.

Synthetic erythropoietin (EPO), which stimulates red blood cell production, appears to prevent brain damage when used shortly after preterm birth, said lead researcher Dr. Petra Huppi, a professor of pediatrics and newborn medicine at the University of Geneva, in Switzerland.

"The real test of whether EPO protects the brains of these children will be when they are evaluated when they are older," she said.

Infants born before the 32nd week of pregnancy face dire health risks, including brain damage and incomplete development of the brain, especially the part of the brain called white matter.

Many are left with long-term developmental disabilities, including motor and thinking problems, and attention and learning difficulties, the researchers noted.

Huppi noted that EPO, commonly used to treat anemia, is safe and has no side effects. It's been used to treat premature infants for decades, she said. Its use as a performance enhancer in sports has been banned.

In the first step of the study, published in the Aug. 27 issue of the Journal of the American Medical Association, researchers reviewed MRI brain scans of 165 infants. Close to half had received three doses of EPO within two days of delivery.

MRI scans done when the infants were the equivalent age of a full-term birth found that the brains of babies who received EPO showed less damage than the brains of infants who hadn't been given the hormone.

According to Huppi, this is the first study that has shown a benefit of EPO on the brains of preterm babies.

However, Dr. David Mendez, a neonatologist at Miami Children's Hospital, remains skeptical.

"The role EPO has in protecting brain tissue is still theoretical and not proven," he said. "This study raises more questions than it answers."

Over the years, many different drugs have been tried to preserve the brain tissue of preemies, Mendez said. "The most recent incarnation of this is the use of EPO," he said. But still more work is needed, Mendez said.

In this study, too few children were given EPO to say the findings weren't purely by chance, he said. The association reported in the study does not prove a cause-and-effect relationship.

Mendez also said that although EPO has been used for years to reduce the need for blood transfusions in preemies, its use is falling out of favor.

"There has been some concern that EPO reduces white blood cell counts and there is some concern that EPO may predispose the baby to have an eye condition called 'retinopathy of prematurity' that can lead to blindness," he said. "A lot of neonatologists don't even use EPO anymore."

As for the brain scans, Mendez said it's easy to tell a completely normal brain from a completely damaged one, but it's not as easy to evaluate the area between the two, which is where most preemies fall, he said.

Huppi said the next stage of the study is to test the children when they are 2 and 5 years old. This assessment will confirm whether or not EPO really protects the brains of premature babies, she said.

"If this does turn out to be the case, this will be an important step in preventing brain damage and its consequences in premature babies," Huppi said.