Randomized, Double-Blind, Placebo-Controlled Trial of Recombinant Human Erythropoietin, Epoetin Beta, in Hematologic Malignancies

2002 ◽  
Vol 20 (10) ◽  
pp. 2486-2494 ◽  
Author(s):  
A. Österborg ◽  
Y. Brandberg ◽  
V. Molostova ◽  
G. Iosava ◽  
K. Abdulkadyrov ◽  
...  
Keyword(s):  
Recombinant Human Erythropoietin ◽  
Controlled Trial ◽  
Group Versus ◽  
Lymphocytic Leukemia ◽  
Low Grade ◽  
Severe Anemia ◽  
Free Survival ◽  
Epoetin Beta ◽  
Human Erythropoietin ◽  
Beta Group

PURPOSE: To investigate the effect of recombinant human erythropoietin (epoetin beta) on anemia, transfusion need, and quality of life (QOL) in severely anemic patients with low-grade non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), or multiple myeloma (MM). PATIENTS AND METHODS: Transfusion-dependent patients with NHL (n = 106), CLL (n = 126), or MM (n = 117) and a low serum erythropoietin concentration were randomized to receive epoetin beta 150 IU/kg or placebo subcutaneously three times a week for 16 weeks. Primary efficacy criteria were transfusion-free and transfusion- and severe anemia–free survival (hemoglobin [Hb] > 8.5 g/dL) between weeks 5 to 16. Response was defined as an increase in Hb ≥ 2 g/dL with elimination of transfusion need. QOL was assessed by the Functional Assessment of Cancer Therapy scale. RESULTS: Transfusion-free (P = .0012) survival and transfusion- and severe anemia–free survival (P = .0001) were significantly greater in the epoetin beta group versus placebo (Wald χ2 test), giving a relative risk reduction of 43% and 51%, respectively. The response rate was 67% and 27% in the epoetin beta versus the placebo group, respectively (P < .0001). After 12 and 16 weeks of treatment, QOL significantly improved in the epoetin beta group compared with placebo (P < .05); this improvement correlated with an increase in Hb concentration (≥ 2 g/dL). A target Hb that could be generally recommended could not be identified. CONCLUSION: Many severely anemic and transfusion-dependent patients with advanced MM, NHL, and CLL and a low performance status benefited from epoetin therapy, with elimination of severe anemia and transfusion need, and improvement in QOL.

Recombinant Human Erythropoietin Stimulates Erythropoiesis and Reduces Erythrocyte Transfusions in Very Low Birth Weight Preterm Infants

PEDIATRICS ◽  
1995 ◽  
Vol 95 (1) ◽  
pp. 1-8
Author(s):  
Kevin M. Shannon ◽  
Julian F. Keith ◽  
William C. Mentzer ◽  
Richard A. Ehrenkranz ◽  
Mark S. Brown ◽  
...  
Keyword(s):  
Placebo Group ◽  
Birth Weight ◽  
Low Birth Weight ◽  
Preterm Infants ◽  
Recombinant Human Erythropoietin ◽  
Very Low Birth Weight ◽  
Group Versus ◽  
Weekly Dose ◽  
Human Erythropoietin ◽  
Transfusion Requirements

Design and methods. We hypothesized that treatment with recombinant human erythropoietin (r-HuEPO) would stimulate erythropoiesis and would thereby reduce the need for erythrocyte transfusions in preterm infants. We treated 157 preterm infants born at 26.9 ± 1.6 weeks of gestation who weighed 924 ± 183 g at birth with either subcutaneous r-HuEPO (100 U/kg/d, 5 days per week) or placebo for 6 weeks in a randomized, double-blind, controlled clinical trial. All patients received oral iron and were managed according to uniform conservative transfusion guidelines. Results. Treatment with r-HuEPO was associated with fewer erythrocyte transfusions (1.1 ± 1.5 per infant in the r-HuEPO group versus 1.6 ± 1.7 per infant in the placebo group; P = .046) and with a reduction in the volume of packed erythrocytes transfused (16.5 ± 23.0 mL versus 23.9 ± 25.7 mL per infant; P = .023). Overall, 43% of the infants in the r-HuEPO group and 31% of placebo-treated infants were transfusion-free during the study (P = .18). The volume of blood removed for laboratory tests and the need for respiratory support at the start of treatment had major effects on transfusion requirements independent of r-HuEPO. Reticulocyte counts were higher during treatment in the r-HuEPO group (P = .0001), and r-HuEPO-treated infants had higher hematocrit values at the end of the study (32% versus 27.3% in the placebo group; P = .0001). We found no differences in the incidence of major complications of prematurity between the treatment groups. Conclusion. We conclude that treatment with r-HuEPO at a weekly dose of 500 U/kg stimulates erythropoiesis, moderates the course of anemia, is associated with a reduction in erythrocyte transfusions, and appears safe in very low birth weight preterm infants who are receiving iron supplements. Conservative transfusion criteria, minimization of phlebotomy losses, and treatment with r-HuEPO are complementary strategies to reduce erythrocyte transfusions in these infants.

Effect of short term recombinant human erythropoietin (rHuEPO) therapy in the prevention of anemia of prematurity (AOP) in very low birth weight (VLBW) neonates

2013 ◽  
Vol 38 (3) ◽  
pp. 119-123 ◽  
Author(s):  
BHN Yasmeen ◽  
MAKA Chowdhury ◽  
MM Hoque ◽  
MM Hossain ◽  
R Jahan ◽  
...  
Keyword(s):  
Folic Acid ◽  
Birth Weight ◽  
Low Birth Weight ◽  
Recombinant Human Erythropoietin ◽  
Very Low Birth Weight ◽  
Controlled Trial ◽  
Control Group ◽  
Short Term ◽  
Human Erythropoietin ◽  
Anaemia Of Prematurity

Premature infants especially those with birth weight <1500 g suffer from Anaemia of prematurity (AOP) and associated problems. Erythropoietin therapy is a safe effective way to prevent and to treat anaemia of prematurity. To evaluate the effect of short term administration of recombinant human erythropoietin (rHuEPO) with iron and folic acid in very low birth weight (VLBW) neonates in the prevention of anaemia of prematurity. A randomized controlled trial was carried out at Dhaka Shishu Hospital. Sixty preterm very low birth weight (PTVLBW) babies were enrolled in this study. Thirty were assigned to rHuEPO group and 30 as control. Baseline haematologic values were estimated before administration of rHuEPO. From day 7 of life rHuEPO-200 IU/kg/dose subcutaneously every alternate day for 2 weeks was administered to rHuEPO group. All infants in both groups have received oral iron, folic acid from day 14. Clinical and haematological assessment was done at 6 and 10 weeks of life. Baseline clinical characteristics and haematologic values were almost similar in both groups. This study has shown increase in haematological values(haemoglobin and haematocrit) and reduction in the number of blood transfusions during both the 1st and 2nd follow up in rHuEPO group in comparison to control group (p<0.01). Short term rHuEPO appears to be very effective in prevention of Anaemia of prematurity. DOI: http://dx.doi.org/10.3329/bmrcb.v38i3.14340 Bangladesh Med Res Counc Bull 2012; 38(3): 119-123 (December)

Effects of altitude and recombinant human erythropoietin on iron metabolism: a randomized controlled trial

2021 ◽  
Author(s):  
Andreas Breenfeldt Andersen ◽  
Thomas Christian Bonne ◽  
Jacob Bejder ◽  
Grace Jung ◽  
Tomas Ganz ◽  
...  
Keyword(s):  
Sea Level ◽  
Clinical Relevance ◽  
Recombinant Human Erythropoietin ◽  
Controlled Trial ◽  
Venous Blood ◽  
Early Assessment ◽  
Stress Erythropoiesis ◽  
Human Erythropoietin ◽  
The Impact

Current markers of iron deficiency (ID) such as ferritin and hemoglobin have shortcomings, and hepcidin and erythroferrone (ERFE) could be of clinical relevance in relation to early assessment of ID. Here, we evaluate whether exposure to altitude-induced hypoxia (2,320 m) alone, or in combination with recombinant human erythropoietin (rHuEPO) treatment, affects hepcidin and ERFE levels before alterations in routine ID biomarkers and stress erythropoiesis manifest. Two interventions were completed, each comprising a four-week baseline, a four-week intervention at either sea level or altitude, and a four-week follow-up. Participants (n=39) were randomly assigned to 20 IU·kg bw-1 rHuEPO or placebo injections every second day for three weeks during the two intervention periods. Venous blood was collected weekly. Altitude increased ERFE (P≤0.001) with no changes in hepcidin or routine iron biomarkers, making ERFE of clinical relevance as an early marker of moderate hypoxia. rHuEPO treatment at sea level induced a similar pattern of changes in ERFE (P<0.05) and hepcidin levels (P<0.05), demonstrating the impact of accelerated erythropoiesis and not of other hypoxia-induced mechanisms. Compared to altitude alone, concurrent rHuEPO treatment and altitude exposure induced additive changes in hepcidin (P<0.05) and ERFE (P≤0.001) parallel with increases in hematocrit (P<0.001), demonstrating a relevant range of both hepcidin and ERFE. A poor but significant correlation between hepcidin and ERFE was found (R2=0.13, P<0.001). The findings demonstrate that hepcidin and ERFE are more rapid biomarkers of changes in iron demands than routine iron markers. Finally, ERFE and hepcidin may be sensitive markers in an anti-doping context.

Efficacy of recombinant human erythropoietin in the critically ill patient: A randomized, double-blind, placebo-controlled trial

1999 ◽  
Vol 27 (11) ◽  
pp. 2346-2350 ◽  
Author(s):  
Howard L. Corwin ◽  
Andrew Gettinger ◽  
Robert M. Rodriguez ◽  
Ronald G. Pearl ◽  
K. Dean Gubler ◽  
...  
Keyword(s):  
Critically Ill ◽  
Recombinant Human Erythropoietin ◽  
Controlled Trial ◽  
Critically Ill Patient ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Human Erythropoietin

Room F, 10/17/2000 2: 00 PM - 4: 00 PM (PS) Treatment of Experimental Acute Severe Anemia with Recombinant Human Erythropoietin 

2000 ◽  
Vol 93 (3A) ◽  
pp. A-495
Author(s):  
Aryeh Shander ◽  
Feng Qin ◽  
Manoj Mammen ◽  
Jennifer Chuy ◽  
Herbert Dardik
Keyword(s):  
Recombinant Human Erythropoietin ◽  
Severe Anemia ◽  
Human Erythropoietin
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