Recombinant Human Erythropoietin in Anemic Patients with End-Stage Renal Disease

Eschbach, Joseph W.

doi:10.7326/0003-4819-111-12-992

Cited by 752 publications

(355 citation statements)

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“…It is highly effective at correcting the anaemia, restoring energy levels, and increasing patient well being and quality of life (Winearls et al, 1986;Eschbach et al, 1987Eschbach et al, , 1989Evans et al, 1990). 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.…”

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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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Development and characterization of novel erythropoiesis stimulating protein (NESP)

2001

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“…Thus, it is now possible to manipulate erythropoiesis independently of endogenous erythropoietin production (Spivak, 1994). Recombinant erythropoietin (r-HuEPO) has previously been shown to increase the haematocrit and reduce the transfusion requirement in patients with end-stage renal disease undergoing haemodialysis (Esbach et al, 1989) and in AIDS patients treated with zidovudine (Fischl et al, 1990). In addition, there are now a number of reports on the use of r-HuEPO to correct anaemia in cancer patients (Platanias et al, 1991;Abels, 1992aAbels, ,b, 1993Miller et al, 1992;Case et al, 1993;Lavey and Dempsey, 1993;Ludwig et al, 1993Ludwig et al, , 1994Vijayakumar et al, 1993;Dusenbery et al, 1994;Leitgeh et al, 1994;deCampos et al, 1995).…”

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Effect of subcutaneous recombinant human erythropoetin in cancer patients receiving radiotherapy: final report of a randomized, open-labelled, phase II trial

Sweeney

Nicolae²,

Ignacio³

et al. 1998

Br J Cancer

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Summary The purpose of this study was to determine the safety, efficacy and impact on quality of life of recombinant human erythropoietin (r-HuEPO) for cancer patients undergoing radiotherapy (RT). An open-labelled randomized design was used, with patients randomized to either treatment or control arms. Patients in the treatment arm received r-HuEPO given by subcutaneous injection at a dose of 200 units kg-' day-' plus oral iron supplements (ferrous sulphate 325 mg p.o. t.i.d.). Entry was restricted to patients with carcinoma of the lung, uterine cervix, prostate or breast who presented for RT with anaemia parameters reflective of 'the anaemia of chronic disease'. Radiotherapy policies (portals, doses, fraction size, etc.) were determined by the site and stage of disease. Complete blood counts (CBCs) were obtained weekly. The target level of haemoglobin was 15 g dl-1 for men and 14 g dl-1 for women. Quality of life (QOL) was assessed weekly by using an analogue scale to judge energy, activities of daily living and overall quality of life. Forty-eight patients were entered in the study, 24 in the treatment arm and 24 in the control arm. The prerandomization demographic characteristics and mean laboratory values were comparable in both arms. The mean haemoglobin at completion was 13.6 g dl-1 for r-HuEPO-treated patients compared with 11.0 g dl-1 for control subjects (P= 0.0012). Patients who received r-HuEPO demonstrated a mean weekly haemoglobin increase of 0.41 g dl-1 compared with a decrease in mean haemoglobin level in controls for 6 of the 7 weeks of the study (mean weekly decrease of 0.073 g dl-'). Target levels of haemoglobin were achieved by 41.6% of r-HuEPO-treated patients compared with none of the control subjects. The mean platelet count declined in both arms of the study with RT but the decline from pretreatment was less rapid in r-HuEPO-treated patients (11.2% decrease) compared with controls (26.3% decrease) and was statistically significant during weeks 4-6. Toxicity was minor with only mild irritation at the injection site. Mean quality of life end points were superior in the treatment arm but not statistically significant. r-HuEPO had a beneficial effect on weekly haemoglobin levels in patients undergoing RT with response rates similar to other studies. There was also a less rapid decline in weekly platelet counts in r-HuEPO-treated patients compared with control subjects. Further studies are needed to address the optimum dose and scheduling as well as the impact of r-HuEPO on clinical outcomes.

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“…11 Untreated anemia contributes to the increased CVD burden in CKD populations. 7 Timely treatment of anemia with an emphasis on raising hematocrit to at least 36% can improve patient's quality of life, 12 decrease the need of blood transfusions, 13,14 improve cognitive function 15 and muscle strength, 16 and decrease hospitalizations and mortality. 17,18 This study aimed at estimating the prevalence and severity of anemia in adult pre-dialysis patients.…”

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Prevalence and management of anemia in pre-dialysis Malaysian patients: A hospital-based study

Salman

Khan

Adnan

et al. 2016

Rev. Assoc. Med. Bras.

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Summary Objective: Anemia, a common complication of chronic kidney diseases (CKD), is involved in significant cardiovascular morbidity. Therefore, the objective of our study was to investigate the prevalence and severity of anemia in pre-dialysis patients, as well as to determine the predictors of anti-anemic therapy. Method: A retrospective, observational study was conducted on adult pre-dialysis patients receiving treatment at the Hospital Universiti Sains Malaysia from January 2009 to December 2013. Results: A total of 615 eligible cases were included. The mean age of patients was 64.1±12.0 years. The prevalence of anemia was 75.8%, and the severity of anemia was mild in 47.7% of the patients, moderate in 32.2%, and severe in 20%. Based on morphological classification of anemia, 76.9% of our patients had normochromic-normocytic anemia whereas 21.8 and 1.3% had hypochromic-microcytic anemia and macrocytic anemia, respectively. Oral iron supplements were prescribed to 38.0% of the patients and none of the patients was given erythropoietin stabilizing agents (ESA) or intravenous iron preparations. In logistic regression, significant predictors of anti-anemic preparation use were decreased hemoglobin and hematocrit, and advanced stages of CKD. Conclusion: The results of the present study suggest that the prevalence of anemia in pre-dialysis patients is higher than currently accepted and it is found to be correlated with renal function; prevalence increases with declined renal function. An earlier identification as well as appropriate management of anemia will not only have a positive impact on quality of life but also reduce hospitalizations of CKD patients due to cardiovascular events.

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Recombinant Human Erythropoietin in Anemic Patients with End-Stage Renal Disease

Cited by 752 publications

References 21 publications

Development and characterization of novel erythropoiesis stimulating protein (NESP)

Development and characterization of novel erythropoiesis stimulating protein (NESP)

Effect of subcutaneous recombinant human erythropoetin in cancer patients receiving radiotherapy: final report of a randomized, open-labelled, phase II trial

Prevalence and management of anemia in pre-dialysis Malaysian patients: A hospital-based study

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