Recombinant human erythropoietin in the anemia of prematurity: Results of a placebo-controlled pilot study

Shannon, Kevin; Mentzer, William C.; Abels, Robert I.; Freeman, Patricia R.; Newton, Nancy; Thompson, Dawn; Sniderman, Susan; Ballard, Roberta A.; Phibbs, Roderic H.

doi:10.1016/s0022-3476(05)82217-6

Cited by 135 publications

(74 citation statements)

References 17 publications

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“…Although the pattern of erythropoiesis in healthy infant rhesus monkeys differs from that in anemic premature babies, the results of our study provide new information that augments limited data from recent studies on use of r-HuEPO in anemia of prematurity (26,27). The lack of any adverse effects of r-HuEPO in infant monkeys supports the concept that further placebocontrolled clinical trials of r-HuEPO therapy in anemia of prematurity are warranted.…”

Section: Methodssupporting

confidence: 58%

Age-Related Differences in Erythropoietic Response to Recombinant Human Erythropoietin: Comparison in Adult and Infant Rhesus Monkeys

et al. 1990

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ABSTRACT. Human recombinant erythropoietin (rHuEPO) was given i.v. to rhesus monkeys to compare its safety, erythropoietic effects, and pharmacokinetics in healthy adult and infant animals. Eighteen adult and 18 infant (9-to 15-d-old) monkeys were divided into three groups each of six animals. One group was given 250 U/ kg twice weekly, another was given 100 U/kg twice weekly, and a control group was given the drug vehicle for 6 wk.All animals were healthy throughout this period, and for 10 wk after that. Administration of r-HuEPO at these dosages did not produce any changes in leukocytes, platelets, urea nitrogen, bilirubin, creatinine, alkaline phosphatase, alanine amino transferase, y-glutamyl transferase, and blood pressure in either age group. At 6 wk, both adult treatment groups had statistically significant increases in Hb concentration. The same dosages that produced these increases in Hb concentration in adults produced no changes in Hb concentration in infant monkeys. Despite active erythropoiesis, as determined by reticulocytosis and increased total body Hb, Hb concentration decreased similarly in the infant treatment and control groups. Pharmacokinetic profiles were obtained at 5 wk of dosing. One h after administration, both doses of r-HuEPO produced significantly lower serum r-HuEPO concentration in the infant monkeys compared with the adults. These differences appeared to be due to a larger volume of distribution of r-HuEPO in the infant monkeys. The tn12 of r-HuEPO in circulation was the same in both age groups. (Pediatr Res 28: 567-571,1990) Abbreviations EPO, erythropoietin r-HuEPO, recombinant human erythropoietin The anemia of prematurity, a common complication of preterm birth, is characterized by a progressive fall in Hb concentration, reticulocytopenia, and bone marrow erythroid hypopla-

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Section: Methodssupporting

confidence: 58%

Age-Related Differences in Erythropoietic Response to Recombinant Human Erythropoietin: Comparison in Adult and Infant Rhesus Monkeys

et al. 1990

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“…Dessa forma, as diferenças observadas nas contagens finais de Ht e Hb não podem ser explicadas pelas contagens iniciais dessas variáveis. Os resultados mostraram que os Hts finais foram significativamente maiores nos pacientes que receberam EPO, diariamente ou fracionada em duas vezes na semana, quando comparados aos do grupo controle, concordando com vários estudos da literatura 1,3,17,24,28 .…”

Section: Discussionunclassified

“…Durante as primeiras semanas de vida, todos os RNs apresentam declínio dos glóbulos vermelhos, o que representa uma adaptação fisiológica ao ambiente extra-uterino [1][2][3] . Nos prematuros essa diminuição da hemoglobina (Hb) é mais rápida 4,5 , e seu valor mínimo é mais baixo 6 quando comparado ao dos RNs a termo 2 , denominando-se de anemia da prematuridade.…”

Section: Introductionunclassified

O efeito da eritropoetina humana recombinante no tratamento da anemia da prematuridade

Rocha

Benjamin²,

Procianoy³

2001

J. Pediatr. (Rio J.)

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Objective: to assess the efficacy of erythropoietin in the prevention and treatment of anemia of prematurity, correlating the use of this drug with weight gain, length, and head circumference and comparing two administration schemes of he same weekly dose: daily use and twice a week.Methods: the study comprised 42 premature newborns with gestational age up to 33 weeks, birthweight up to 1550 g, and postnatal age between 10 and 35 days. The newborns were randomized into three groups: patients in group 1 received seven daily doses of 100 U/kg erythropoietin per week; patients in group 2 received two 350 U/kg erythropoietin doses per week; and patients in group 3 did not receive the drug. Hematologic measurements, blood transfusion requirements, and growth rates were followed during therapy.Results: cases and controls did not differ with respect to weight, length, head circumference, and total time of hospital stay. At the end of the study, no significant difference was observed in the platelet count measurement means, white blood cell count, and ferritin levels in the three groups. However, the final hematocrit and hemoglobin values of patients who did not receive erythropoietin were significantly lower than those of patients who received the drug. The absolute reticulocyte count mean was significantly higher in patients who received erythropoietin after two weeks of treatment when compared with those patients who did not receive the drug. Patients in group 1 e 2 received fewer excessive transfusions (2 or more) than patients in group 3. The administration of 700 U/kg/week erythropoietin significantly reduced the number of excessive blood transfusions. There is no significant difference in blood transfusion volume between patients who received erythropoietin on a daily basis and those who received the drug twice weekly.Conclusions: the use of erythropoietin did not influence weight gain and growth. The administration of 700 U/kg/week erythropoietin in premature infants with gestational age up to 33 weeks and birthweight up to 1550 g stimulates erythropoiesis and significantly reduces excessive blood transfusion requirements. Erythropoietin showed to be a safe and well tolerated medication, with no short-term side effects in the study population.J Pediatr (Rio J) 2001; 77 (2): 75-83: erythropoietin, anemia of prematurity, transfusion, premature. ResumoObjetivos: a proposta do presente estudo foi avaliar a eficácia da eritropoetina na prevenção e tratamento da anemia da prematuridade, correlacionar o uso desta medicação com o ganho de peso, comprimento e perímetro cefálico dos pacientes. Foi realizada também uma comparação entre o uso de eritropoetina diariamente e o uso duas vezes por semana, na mesma dose semanal.Métodos: ensaio clínico que avaliou 42 recém-nascidos prematuros, com até 33 semanas de idade gestacional, peso de nascimento até 1550g e idade pós-natal entre 10 e 35 dias de vida. Os recém-nascidos foram randomizados em três grupos. Os pacientes do grupo 1 receberam 7 doses diárias, de 100U/kg c...

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“…4,8,9 Two pilot studies (n ϭ 28) and one multicenter trial (n ϭ 22) were conducted at the University of California, San Francisco between 1988 and 1993.…”

Section: Methodsmentioning

confidence: 99%

Neurodevelopmental Outcome of Prematurely Born Children Treated With Recombinant Human Erythropoietin in Infancy

et al. 1999

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Recombinant human erythropoietin in the anemia of prematurity: Results of a placebo-controlled pilot study

Cited by 135 publications

References 17 publications

Age-Related Differences in Erythropoietic Response to Recombinant Human Erythropoietin: Comparison in Adult and Infant Rhesus Monkeys

Age-Related Differences in Erythropoietic Response to Recombinant Human Erythropoietin: Comparison in Adult and Infant Rhesus Monkeys

O efeito da eritropoetina humana recombinante no tratamento da anemia da prematuridade

Neurodevelopmental Outcome of Prematurely Born Children Treated With Recombinant Human Erythropoietin in Infancy

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