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Epoetin Alfa (epoetin + alfa)
Selected AbstractsErythropoiesis-stimulating agents: development, detection and dangers,DRUG TESTING AND ANALYSIS, Issue 6 2009Stefan E. Franz Abstract Epoetin alfa, the first member of the family of erythropoiesis stimulating agents (ESAs), was introduced to the market in 1989. Since then development has progressed to epoetins of the third generation. Currently drugs that use alternative approaches to stimulate erythropoiesis are under development. Uptake of all available ESAs into doping has occurred rapidly after their introduction. A multitude of dangers to health are associated with the illicit use of these substances. Different approaches to detect ESAs in doping control have been developed to comply with the very diverse nature of the compounds used. Future developments in the field of ESA require the development of new techniques in doping analysis. This review gives an overview of the development of ESA and its detection methods as well as future developments. [Correction made here after initial online publication] Copyright © 2009 John Wiley & Sons, Ltd. [source] Epoetin alfa corrects anemia and improves quality of life in patients with hematologic malignancies receiving non-platinum chemotherapyHEMATOLOGICAL ONCOLOGY, Issue 4 2003Timothy J. Littlewood Abstract Anemia, a commonly occurring morbidity in patients with cancer, often leads to diminished quality of life (QOL). Numerous clinical trials have shown that epoetin alfa treatment improves hematologic and QOL variables in cancer patients. The clinical trial analysis reported here was performed to assess response to epoetin alfa in patients with hematologic malignancies. Cancer patients with anemia undergoing non-platinum-based chemotherapy who were enrolled in a multinational, randomized (2:1), double-blind, placebo-controlled trial were prospectively stratified by tumor type (hematologic, solid). Efficacy endpoints included proportion of patients transfused after day 28; change in hemoglobin (Hb) level from baseline to last assessment; proportion of treatment responders (increase in Hb ,2,g/dl unrelated to transfusion) and correctors (patients whose Hb levels reached ,12,g/dl during the study); and QOL. The protocol was amended before unblinding to prospectively collect and assess survival data 12 months after the last patient completed the study, and survival for the full study cohort was estimated using Kaplan,Meier techniques. Efficacy analyses of hematologic and QOL variables, as well as Kaplan,Meier estimates of survival, were performed post hoc for the hematologic tumor stratum. Among patients with hematologic malignancies, the mean increase in Hb levels was greater with epoetin alfa than with placebo treatment (2.2 vs. 0.3,g/dl). Transfusion requirements were lower in patients who received epoetin alfa versus placebo (25.2 vs. 43.1%), and the proportion of responders and correctors was higher with epoetin alfa than with placebo (75.2 vs. 16.7% and 72.6 vs. 14.8%, respectively). Patients who received epoetin alfa had improved QOL while patients who received placebo had decreased QOL. These results are similar to those seen in the full study cohort, where differences between epoetin alfa and placebo were significant (P<0.05) for all five primary cancer- and anemia-specific QOL domains evaluated. Although the study was not powered for survival, Kaplan,Meier estimates showed a trend in overall survival favoring epoetin alfa in both the full study cohort and the hematologic subgroup. Epoetin alfa treatment was well tolerated. Epoetin alfa therapy increased Hb levels, reduced transfusion requirements, and improved QOL in patients with anemia undergoing non-platinum chemotherapy for hematologic malignancies. Copyright © 2004 John Wiley & Sons, Ltd. [source] Outcomes and predicting response in anaemic chemotherapy patients treated with epoetin alfa.INTERNAL MEDICINE JOURNAL, Issue 10 20084-month, A multicentre, New Zealand, open-label study in Australia Abstract Background:, The aim of the study was to evaluate the effectiveness, safety, and clinical outcomes of erythropoietin therapy in the treatment of anaemic cancer subjects receiving chemotherapy and to examine hypochromic red blood cell measurement as an indicator of functional iron sufficiency and as a predictor of responsiveness or non-responsiveness to erythropoietin therapy. Methods:, Patients who had a non-myeloid malignancy, had Hb , 11.0 g/dL, had a life expectancy of more than 6 months, were 18 years or older, were receiving chemotherapy and would continue to be treated for at least 2 months were given s.c. epoetin alfa three times a week. Results:, Haemoglobin levels increased significantly at all time periods compared with baseline and the number of transfusions received decreased significantly at all time periods compared with baseline. Quality of life as measured by Functional Assessment of Cancer Therapy-Anaemia showed significant increases at months 2 and 4 and there were significant improvements in the fatigue subscale at both time points (P < 0.05). Significant improvements at end-point were observed for the physical, emotional and functional well-being, and additional concern subscales (all P < 0.05). Haematocrit and reticulocytes increased significantly at end-point compared with at baseline (haematocrit 33.4 vs 28.3%, P < 0.001; reticulocytes 105.8 vs 78.6 × 109/dL, P = 0.005). The percentage of hypochromic red blood cells did not show predictive value for response to treatment status. Conclusion:, Epoetin alfa improved haemoglobin levels and quality of life in anaemic cancer patients receiving chemotherapy. [source] Early epoetin alfa treatment in children with solid tumors,PEDIATRIC BLOOD & CANCER, Issue 4 2002Andreas Zoubek MD Abstract Background Combination chemotherapy is often used for long periods in children with solid malignancies, leading to anemia and necessitating intervention with red blood cell (RBC) transfusions. Transfusions, however, are associated with a variety of adverse events and risks. Recombinant human erythropoietin (rHuEPO, epoetin alfa) has been shown to reduce the need for transfusions and to ameliorate the symptoms of anemia in adults, but few studies have been conducted thus far in pediatric patients. Procedure Thirty-seven children with solid tumors receiving treatment with platinum- or nonplatinum-based chemotherapy were treated with epoetin alfa and supplemental iron in a single-center, open-label, 28-week, case-control study. Results Epoetin alfa significantly reduced the need for RBC (P,=,0.007) and platelet (P,=,0.01) transfusions, and prolonged the time to first RBC transfusion (P,=,0.0004) as compared to the control group. Moreover, epoetin alfa was effective in maintaining mean hemoglobin levels during the course of the study, whereas they declined below baseline after week 9 in the control group. Conclusions Epoetin alfa is effective and safe in reducing transfusion requirements and maintaining adequate hemoglobin levels in children with solid tumors undergoing combination chemotherapy. Med Pediatr Oncol 2002; 39:459,462. © 2002 Wiley-Liss, Inc. [source] Improvement in quality of life for cancer patients treated with epoetin alfaEUROPEAN JOURNAL OF CANCER CARE, Issue 3 2001S.E. Libretto PHD BSC MIBIOL CBIOL Anaemia is a common complication of cancer and cancer therapies, and fatigue is one of the most common symptoms of anaemia, disrupting functional performance and reducing overall quality of life. The positive effects of treating renal patients with recombinant human erythropoietin are well documented. This case report series details the specific effects of fatigue on individual patients with cancer and their way of life, and describes their significant improvement in lifestyle following the reversal of anaemia using recombinant human erythropoietin, epoetin alfa. [source] Erythropoietin-induced, antibody-mediated pure red cell aplasia,EUROPEAN JOURNAL OF CLINICAL INVESTIGATION, Issue 2005The Pure Red Cell Aplasia Global Scientific Advisory Board (GSAB) Abstract Pure red cell aplasia (PRCA) is a rare haematological condition that is characterized by severe aregenerative anaemia due to an almost complete cessation of red blood cell production. While antibody-mediated PRCA was extremely rare before 1998, the incidence of this disorder increased sharply after 1998 in patients receiving subcutaneous epoetin alfa produced by Ortho-Biotech and marketed outside the USA. The diagnosis of antibody-mediated PRCA relies mostly on the results of bone marrow biopsy or aspirate, which shows an absence of erythroid precursors and/or red cell maturation arrest while counts of white cell and platelet precursors are normal, and on the identification of circulating anti-erythropoietin antibodies. Retrospective analysis of PRCA cases has shown that immunosuppressive therapy can induce a disappearance of anti-erythropoietin antibodies in most patients. [source] Epoetin alfa corrects anemia and improves quality of life in patients with hematologic malignancies receiving non-platinum chemotherapyHEMATOLOGICAL ONCOLOGY, Issue 4 2003Timothy J. Littlewood Abstract Anemia, a commonly occurring morbidity in patients with cancer, often leads to diminished quality of life (QOL). Numerous clinical trials have shown that epoetin alfa treatment improves hematologic and QOL variables in cancer patients. The clinical trial analysis reported here was performed to assess response to epoetin alfa in patients with hematologic malignancies. Cancer patients with anemia undergoing non-platinum-based chemotherapy who were enrolled in a multinational, randomized (2:1), double-blind, placebo-controlled trial were prospectively stratified by tumor type (hematologic, solid). Efficacy endpoints included proportion of patients transfused after day 28; change in hemoglobin (Hb) level from baseline to last assessment; proportion of treatment responders (increase in Hb ,2,g/dl unrelated to transfusion) and correctors (patients whose Hb levels reached ,12,g/dl during the study); and QOL. The protocol was amended before unblinding to prospectively collect and assess survival data 12 months after the last patient completed the study, and survival for the full study cohort was estimated using Kaplan,Meier techniques. Efficacy analyses of hematologic and QOL variables, as well as Kaplan,Meier estimates of survival, were performed post hoc for the hematologic tumor stratum. Among patients with hematologic malignancies, the mean increase in Hb levels was greater with epoetin alfa than with placebo treatment (2.2 vs. 0.3,g/dl). Transfusion requirements were lower in patients who received epoetin alfa versus placebo (25.2 vs. 43.1%), and the proportion of responders and correctors was higher with epoetin alfa than with placebo (75.2 vs. 16.7% and 72.6 vs. 14.8%, respectively). Patients who received epoetin alfa had improved QOL while patients who received placebo had decreased QOL. These results are similar to those seen in the full study cohort, where differences between epoetin alfa and placebo were significant (P<0.05) for all five primary cancer- and anemia-specific QOL domains evaluated. Although the study was not powered for survival, Kaplan,Meier estimates showed a trend in overall survival favoring epoetin alfa in both the full study cohort and the hematologic subgroup. Epoetin alfa treatment was well tolerated. Epoetin alfa therapy increased Hb levels, reduced transfusion requirements, and improved QOL in patients with anemia undergoing non-platinum chemotherapy for hematologic malignancies. Copyright © 2004 John Wiley & Sons, Ltd. [source] Outcomes and predicting response in anaemic chemotherapy patients treated with epoetin alfa.INTERNAL MEDICINE JOURNAL, Issue 10 20084-month, A multicentre, New Zealand, open-label study in Australia Abstract Background:, The aim of the study was to evaluate the effectiveness, safety, and clinical outcomes of erythropoietin therapy in the treatment of anaemic cancer subjects receiving chemotherapy and to examine hypochromic red blood cell measurement as an indicator of functional iron sufficiency and as a predictor of responsiveness or non-responsiveness to erythropoietin therapy. Methods:, Patients who had a non-myeloid malignancy, had Hb , 11.0 g/dL, had a life expectancy of more than 6 months, were 18 years or older, were receiving chemotherapy and would continue to be treated for at least 2 months were given s.c. epoetin alfa three times a week. Results:, Haemoglobin levels increased significantly at all time periods compared with baseline and the number of transfusions received decreased significantly at all time periods compared with baseline. Quality of life as measured by Functional Assessment of Cancer Therapy-Anaemia showed significant increases at months 2 and 4 and there were significant improvements in the fatigue subscale at both time points (P < 0.05). Significant improvements at end-point were observed for the physical, emotional and functional well-being, and additional concern subscales (all P < 0.05). Haematocrit and reticulocytes increased significantly at end-point compared with at baseline (haematocrit 33.4 vs 28.3%, P < 0.001; reticulocytes 105.8 vs 78.6 × 109/dL, P = 0.005). The percentage of hypochromic red blood cells did not show predictive value for response to treatment status. Conclusion:, Epoetin alfa improved haemoglobin levels and quality of life in anaemic cancer patients receiving chemotherapy. [source] Early epoetin alfa treatment in children with solid tumors,PEDIATRIC BLOOD & CANCER, Issue 4 2002Andreas Zoubek MD Abstract Background Combination chemotherapy is often used for long periods in children with solid malignancies, leading to anemia and necessitating intervention with red blood cell (RBC) transfusions. Transfusions, however, are associated with a variety of adverse events and risks. Recombinant human erythropoietin (rHuEPO, epoetin alfa) has been shown to reduce the need for transfusions and to ameliorate the symptoms of anemia in adults, but few studies have been conducted thus far in pediatric patients. Procedure Thirty-seven children with solid tumors receiving treatment with platinum- or nonplatinum-based chemotherapy were treated with epoetin alfa and supplemental iron in a single-center, open-label, 28-week, case-control study. Results Epoetin alfa significantly reduced the need for RBC (P,=,0.007) and platelet (P,=,0.01) transfusions, and prolonged the time to first RBC transfusion (P,=,0.0004) as compared to the control group. Moreover, epoetin alfa was effective in maintaining mean hemoglobin levels during the course of the study, whereas they declined below baseline after week 9 in the control group. Conclusions Epoetin alfa is effective and safe in reducing transfusion requirements and maintaining adequate hemoglobin levels in children with solid tumors undergoing combination chemotherapy. Med Pediatr Oncol 2002; 39:459,462. © 2002 Wiley-Liss, Inc. [source] Recombinant human erythropoietin in pediatric oncology: A review,PEDIATRIC BLOOD & CANCER, Issue 4 2002James Feusner MD Abstract Background Numerous reports on recombinant human erythropoietin (rHuEPO, epoetin alfa) treatment of cancer-related anemia in adult patients have been published to date. These have shown that epoetin increases hemoglobin levels, significantly ameliorates symptoms of anemia, and improves adult patients' quality of life. Unfortunately, less is known about the impact of epoetin on anemia in pediatric cancer patients. Procedure It is the objective of this review to summarize and analyze data of clinical trials of epoetin treatment of anemia in pediatric cancer patients. Results A total of 15 studies were reviewed; eight were considered for detailed analysis and demonstrated important variabilities in study methods. Four of the eight were controlled, randomized trials and four were open label. Conclusions These studies suggested an overall beneficial effect of epoetin alfa for treating anemia in children with cancer. Three large, multicenter clinical trials of the efficacy and safety of epoetin alfa in anemic children with cancer are currently underway, one in Europe and two in North America. Med Pediatr Oncol 2002; 39:463,468. © 2002 Wiley-Liss, Inc. [source] Hematologic abnormalities in children and young adults receiving tacrolimus-based immunosuppression following cardiothoracic transplantationPEDIATRIC TRANSPLANTATION, Issue 2 2001Nancy C. Dobrolet Abstract: To define the incidence, course, and etiology of hematologic abnormalities in children on tacrolimus-based immunosuppression, we reviewed records of 106 transplant patients (70 heart, 16 heart and lung, 20 double lung), 0,21 yr of age, who were transplanted at the Children's Hospital of Pittsburgh from 1989 to 1997. Fifty-four of the 106 patients (51%) developed 65 abnormal hematologic episodes (32 anemia, nine neutropenia, nine thrombocytopenia, 15 simultaneous anemia and neutropenia with or without thrombocytopenia). Common etiologies included: infections, post-transplant lymphoproliferative disease, and medications. Eleven episodes (seven anemia, one neutropenia, and three simultaneous anemia and neutropenia) had unclear etiologies and process of elimination suggested an association with tacrolimus. Interventions included filgrastim (effective in 15 of 15 patients, with resolution of neutropenia in a median of 5 days) and epoetin alfa (effective in five of 16 patients, including four of four patients with anemia possibly related to tacrolimus). Five patients (two with neutropenia and three with simultaneous neutropenia and anemia) were switched to cyclosporin A (CsA); rapid resolution occured in four of the five patients, suggesting a possible association of the hematologic abnormalities with tacrolimus. In summary, hematologic abnormalities are common in children on tacrolimus-based immunosuppression. Most of these hematologic abnormalities are caused by common etiologies; however, a sub-population exists where tacrolimus may be the etiologic agent. Anemia and neutropenia respond to treatment with epoetin alfa and filgrastim. After thorough investigation, a trial switch to CsA may be warranted. [source] Comparative pharmacokinetics, safety, and tolerability after subcutaneous administration of recombinant human erythropoietin formulated with different stabilizersBIOPHARMACEUTICS AND DRUG DISPOSITION, Issue 6 2000Wing K. Cheung Abstract This report summarizes the results of two double-blind, single-center, randomized studies that used a two-period crossover design. The objective of these two studies was to compare the safety, tolerability, pharmacokinetics, and pain score at the subcutaneous (sc) injection site of a phosphate-buffered recombinant human erythropoietin (EPREX®, epoetin alfa, r-HuEPO) formulated with a new stabilizer (glycine and Polysorbate 80) with the commercially available EPREX® formulations, which uses human serum albumin (HSA) as the stabilizer. Twenty-four healthy male volunteers were enrolled in each of the two studies. In the first study, subjects received a single 150 IU/kg sc dose of r-HuEPO using the 2000 IU/mL (2K) phosphate-buffered formulation with or without the new stabilizer (12 subjects/group). In the second study, subjects received a single 750 IU/kg sc dose of r-HuEPO using the 40,000 IU/mL (40K) phosphate-buffered formulation with or without the new stabilizer (12 subjects/group). In each study, r-HuEPO was administered over two separate dosing periods, each separated with a 28-day washout period. There were no significant differences in AUC and Cmax for either strength of r-HuEPO formulated with or without the new stabilizer, indicating that the absorption and disposition characteristics of the two formulations were similar after sc administration. Both r-HuEPO strengths with and without the new stabilizer were safe and well tolerated; the safety and tolerability profiles of both formulations for each r-HuEPO concentration were comparable. There were no statistically significant differences in pain score for either strength of r-HuEPO with and without the new stabilizer. It was concluded that the two phosphate-buffered r-HuEPO concentrations formulated with and without the new stabilizer are pharmacokinetically equivalent. Copyright © 2000 John Wiley & Sons, Ltd. [source] | ||||||||||