Researchers in Europe have concluded that infants with very low birthweights have less need of multiple blood transfusions if given epoetinbeta (recombinant human erythropoietin) during the first six weeks oflife, a study in the April 28 issue of The New England Journal ofMedicine reports. However, an accompanying editorial suggests thatthese conclusions should be applied with caution.Epoetin beta, developed by Amgen Inc., of Thousand Oaks, Calif., isone of the true success stories of the biopharmaceutical industry. Itincreases hematocrits or red blood cell counts, and is used to treatanemia associated with chronic renal failure and in the treatment ofpatients receiving kidney dialysis.The study, conducted by the European Multicentre ErythropoeitinStudy Group, set out to determine whether recombinant humanerythropoietin would reduce the need for multiple blood transfusions invery low birth weight babies affected by anemia of prematurity. Thisform of anemia is characterized by low reticulocyte counts andinadequate natural erythropoietin response.The study was conducted at 12 centers in six European countries, and241 infants were enrolled. Only babies with birth weights of less than1,500 grams and gestational ages of less than 34 weeks were studied.Infants requiring prolonged ventilation were excluded. The three-day-old babies were randomly assigned to the experimental or controlgroup.The researchers reported that the rate of success, defined as an absenceof need for transfusions and a hematocrit that never fell below 32percent was 4.1 percent in the control group and 27.5 percent in theepoetin group. Epoetin was most beneficial in boys with birth weightsof 1,200 grams or more and a baseline hematocrit of 48 percent ormore. However, the epoetin group had an increased incidence ofsepticemia and reduced weight gain."We recommend early epoetin treatment for all such infants [with verylow birth weights], but further studies of nutrition and ironsupplementation during treatment are needed," the researchersconcluded.That recommendation was not shared, however, by Ronald Strauss, ofthe University of Iowa College of Medicine, who wrote the editorialanalysis for the journal.Noting that most infants born in the U.S. who weigh more than 1,000grams do not receive transfusions, Strauss suggested that the Europeanexperience may not be directly comparable to that of the U.S. He statedthat there has been a decline in the rate of transfusion in the U.S.independent of erythropoeitin treatment. "It was due to treatment withsurfactant, the use of modern ventilators, smaller blood losses duringphlebotomy, and conservative transfusion practices," Strauss wrote.Strauss noted that side effects of treatment to date have been minimal,while infections were reported in babies receiving erythropoeitin aspart of the European group's study.He also argued that other potential risks require further study.Conservative use of erythropoeitin by pediatricians is in order, Straussconcluded. "Benefits have not been clearly established for infantsweighing less than 1,000 grams early in life, who are sick, or forinfants weighing more than 1,300 grams who are healthy, and it seemswise to give such infants erythropoeitin only in the setting of a clinicaltrial," he stated. n
-- Philippa Maister
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