The safety of treatment with recombinant human erythropoietin in clinical use: a review of controlled studies.

Sowade, Birgit; Sowade, Olaf; Möcks, Joachim; Franke, Werner W.; Warnke, H

doi:10.3892/ijmm.1.2.303

Cited by 25 publications

(24 citation statements)

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“…Prothrombotic effects of Epo, possibly by increasing blood viscosity, increasing platelet production, and inducing the endothelium to increase platelet aggregation, were first raised because of an increase in arteriovenous shunt thrombosis in dialysis patients. Investigations of rheology, hemostasis, and fibrinolysis, 30,31 2 meta-analyses of rHuEpo for perioperative reduction of allogenic blood exposure, 32,33 and a randomized controlled trial of 1302 critically ill patients 34 have not found clear evidence of increased thrombotic risk. However, although short-term use in acute indications may appear safe at present, chronic use in cancer patients may lead to intravascular thrombosis and fatalities.…”

Section: Discussionmentioning

confidence: 99%

The Erythropoietin NeuroProtective Effect: Assessment in CABG Surgery (TENPEAKS)

Haljan

Maitland

Buchan

et al. 2009

Stroke

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Background and Purpose-Neurocognitive dysfunction complicates coronary artery bypass surgery. Erythropoietin may be neuroprotective. We sought to determine whether human recombinant erythropoietin would reduce the incidence of neurocognitive dysfunction after surgery. Methods-We randomly assigned 32 elective first-time coronary artery bypass graft patients to receive placebo or 375 U/kg, 750 U/kg, or 1500 U/kg of recombinant human erythropoietin divided in 3 daily doses, starting the day before surgery. Primary outcomes were feasibility and safety, and secondary outcomes were neurocognitive dysfunction at discharge and 2 months. Results-All subjects were male, mean age 60 years (range 46 to 73). No significant differences were found in pump time, cross-clamp time, or hospital length of stay. Mortality and pure red cell aplasia were not observed. One patient in the 375 U/kg group had ST changes compatible with myocardial injury immediately postoperative, but no other thrombotic complications were observed. Neurocognitive dysfunction occurred in 21/32 (66%) of patients at discharge and 5/32 (16%) at 2 months. Neurocognitive dysfunction at discharge by group was: placebo 6/8 (75%), 375 U/kg 4/8 (50%), 750 U/kg 6/8 (75%), and 1500 U/kg 5/8 (63%). Neurocognitive dysfunction at 2 months by group was: placebo 3/8 (38%), 375 U/kg 1/8 (13%), 750 U/kg 1/8 (13%), and 1500 U/kg 0/8 (0%). Neurocognitive dysfunction at 2 months for erythropoietin at any dose was 2/24 (8.3%) versus 3/8 (38%) for placebo (Pϭ0.085). Conclusions-This

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Section: Discussionmentioning

confidence: 99%

The Erythropoietin NeuroProtective Effect: Assessment in CABG Surgery (TENPEAKS)

Haljan

Maitland

Buchan

et al. 2009

Stroke

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“…There are currently three rHuEPO agents on the market: EPO-α, EPO-β (in Europe only) and darbepoetin alpha, a structurally different synthetic longer-acting analogue of EPO-α. They are approved for the treatment of anaemia associated with chronic renal failure, cancer, HIV infection and in the surgical setting, to reduce allogeneic blood transfusion [Sowade et al, 1998;Elliott et al, 2008]. EPO-α and EPO-β, both produced by Chinese hamster ovary cells, share the same amino acid sequence as endogenous EPO and have the same physiological effects.…”

Section: Discussionmentioning

confidence: 99%

“…Many physicians have begun using rHuEPO "off-label" to manage anaemia in patients with chronic hepatitis C. Administration of rHuEPO stimulates red blood cell production and predictably increases haemoglobin concentrations; it has also proved to be remarkably well tolerated and highly effective [Sowade et al, 1998]. However, because of the time required for erythroid progenitors to mature and be released into the circulation, a significant increase in haemoglobin concentration does not usually occur for 2 weeks and may take up to 6 weeks.…”

Section: Discussionmentioning

confidence: 99%

Use of epoetin beta during combination therapy of infection with hepatitis c virus with ribavirin improves a sustained viral response

Falasca

Ucciferri

Mancino

et al. 2009

Journal of Medical Virology

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The aim of the study was to evaluate the effects of epoetin‐beta on anemia and sustained viral response in patients with chronic hepatitis C receiving treatment with pegylated interferon and ribavirin. Forty‐two Caucasian patients with chronic hepatitis C infection, treated with pegylated interferon α‐2a or α‐2b plus ribavirin, who experienced at least a 2 log decline in HCV‐RNA in the first month of therapy and a ≥2.5 g/dl hemoglobin drop from baseline, were recruited. They were divided into two groups: 22 patients received epoetin‐beta 30,000 U administered s.c. q.w. (group A) and 20 patients received a reduced ribavirin dose of 600 mg daily (group B). The end‐of‐treatment response was 95.4% (21/22) in group A and 80% (16/20) (P = 0.2) in group B. Sustained viral response in group A was 81.8% (18/22), statistically higher than in group B (45%, 9/20) (P = 0.03). Mean corpuscular volume of erythrocytes was statistically lower in group A than in group B 4 weeks after starting epoetin‐beta or reduced ribavirin dose (P < 0.001), end‐of‐treatment (P < 0.001) and after 6 months follow‐up (P < 0.001). A negative correlation between the levels of ferritin serum was found in group A at the baseline and mean corpuscular volume value after 1 month of combination antiviral therapy (r = −0.45; P = 0.35), 4 weeks after starting epoetin‐beta (r = −0.43; P = 0.04) and after 6 months follow‐up (r = −0.45; P = 0.03). Administration of epoetin‐beta increases sustained viral response rates among patients developing anemia, because the standard dose of ribavirin is maintained, thereby reducing the side‐effects of antiviral treatment. J. Med. Virol. 82:49–56, 2010. © 2009 Wiley‐Liss, Inc.

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“…It has also been approved for the treatment of anaemia associated with cancer, HIV infection, and use in the surgical setting to decrease the need for allogeneic blood transfusions. For all indications, it has proven to be remarkably well tolerated and highly efficacious (Markham and Bryson, 1995;Cazzola et al, 1997;Sowade et al, 1998).…”

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confidence: 99%

Development and characterization of novel erythropoiesis stimulating protein (NESP)

2001

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Studies on human erythropoietin (EPO) demonstrated that there is a direct relationship between the sialic acid-containing carbohydrate content of the molecule and its serum half-life and in vivo biological activity, but an inverse relationship with its receptor-binding affinity. These observations led to the hypothesis that increasing the carbohydrate content, beyond that found naturally, would lead to a molecule with enhanced biological activity. Hyperglycosylated recombinant human EPO (rHuEPO) analogues were developed to test this hypothesis. Darbepoetin alfa (novel erythropoiesis stimulating protein, NESP, ARANESP TM , Amgen Inc, Thousand Oaks, CA), which was engineered to contain 5 N-linked carbohydrate chains (two more than rHuEPO), has been evaluated in preclinical animal studies. Due to its increased sialic acid-containing carbohydrate content, NESP is biochemically distinct from rHuEPO, having an increased molecular weight and greater negative charge. Compared with rHuEPO, it has an approximate 3-fold longer serum half-life, greater in vivo potency, and can be administered less frequently to obtain the same biological response. NESP is currently being evaluated in human clinical trials for treatment of anaemia and reduction in its incidence.© 2001 Cance Cance Cancer Research Campaign

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The safety of treatment with recombinant human erythropoietin in clinical use: a review of controlled studies.

Cited by 25 publications

References 0 publications

The Erythropoietin NeuroProtective Effect: Assessment in CABG Surgery (TENPEAKS)

The Erythropoietin NeuroProtective Effect: Assessment in CABG Surgery (TENPEAKS)

Use of epoetin beta during combination therapy of infection with hepatitis c virus with ribavirin improves a sustained viral response

Development and characterization of novel erythropoiesis stimulating protein (NESP)

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