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https://www.readbyqxmd.com/read/28819889/visualization-of-57-fe-labeled-heme-isotopic-fine-structure-and-localization-of-regions-of-erythroblast-maturation-in-mouse-spleen-by-maldi-fticr-ms-imaging
#1
Makoto Kihara, Yukari Matsuo-Tezuka, Mariko Noguchi-Sasaki, Keigo Yorozu, Mitsue Kurasawa, Yasushi Shimonaka, Michinori Hirata
Epoetin beta pegol (continuous erythropoiesis receptor activator; C.E.R.A.), or methoxy-polyethylene glycol-modified epoetin beta, is a long-acting erythropoiesis stimulating agent (ESA) that effectively maintains hemoglobin levels. It promotes proliferation of erythroid progenitor cells in hematopoietic organs and leads to increased reticulocyte and hemoglobin levels. However, the detailed erythropoietic effects of various ESAs on their target organs have yet to be clarified, and new approaches are needed to analyze tissue iron localization with structural information...
August 17, 2017: Journal of the American Society for Mass Spectrometry
https://www.readbyqxmd.com/read/28782299/continuous-erythropoiesis-receptor-activator-cera-for-the-anaemia-of-chronic-kidney-disease
#2
REVIEW
Valeria M Saglimbene, Suetonia C Palmer, Marinella Ruospo, Patrizia Natale, Jonathan C Craig, Giovanni Fm Strippoli
BACKGROUND: Continuous erythropoiesis receptor activator (CERA) is a newer, longer acting ESA which might be preferred to other ESAs (epoetin or darbepoetin) based on its lower frequency of administration. Different dosing requirements and molecular characteristics of CERA compared with other ESAs may lead to different health outcomes (mortality, cardiovascular events, quality of life) in people with anaemia and chronic kidney disease (CKD). OBJECTIVES: To assess benefits and harms of CERA compared with other epoetins (darbepoetin alfa and epoetin alfa or beta) or placebo/no treatment or CERA with differing strategy of administration for anaemia in individuals with CKD...
August 7, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28766493/evaluation-of-the-safety-and-immunogenicity-of-subcutaneous-hx575-epoetin-alfa-in-the-treatment-of-anemia-associated-with-chronic-kidney-disease-in-predialysis-and-dialysis-patients%C3%A2
#3
Nicole Casadevall, Vladimir Dobronravov, Kai-Uwe Eckardt, Sehsuvar Ertürk, Liliya Martynyuk, Susanne Schmitt, Gregor Schaffar, Anita Rudy, Andriy Krendyukov, Marité Ode
AIM: To assess the safety and immunogenicity of subcutaneous (SC) HX575 (epoetin-α) in dialysis- and nondialysis-dependent adult patients with chronic kidney disease (CKD). METHODS: Open-label, single-arm, multicenter study in patients (n = 416) from Germany, Italy, Poland, Romania, Russia, Turkey, and Ukraine. RESULTS: Mean (standard deviation (SD)) age was 52.3 (15.8) years, all patients were Caucasian, and similar proportions were male/female...
August 2, 2017: Clinical Nephrology
https://www.readbyqxmd.com/read/28717516/costs-associated-with-intravenous-darbepoetin-versus-epoetin-therapy-in-hemodialysis-patients-a-randomized-controlled-trial
#4
Andrea L Woodland, Sean W Murphy, Bryan M Curtis, Brendan J Barrett
BACKGROUND: Anemia of chronic kidney disease is associated with adverse outcomes and a reduced quality of life. Erythropoiesis-stimulating agents (ESAs) have improved anemia management, and 2 agents are available in Canada, epoetin alfa (EPO) and darbepoetin alfa (DA). EPO and DA are considered equally effective in achieving target hemoglobin (Hb), but it is not clear whether there is a cost difference. There have been few head-to-head comparisons; most published studies are observational switch studies...
2017: Canadian Journal of Kidney Health and Disease
https://www.readbyqxmd.com/read/28713429/treatment-of-severe-refractory-hematuria-due-to-radiation-induced-hemorrhagic-cystitis-with-dexamethasone
#5
José Carlos Rodrigues Nascimento, Márcio Wilker Soares Campelo, Iuri Arruda Aragão, José Fernando Bastos de Moura, Lúcio Flávio Gonzaga Silva, Reinaldo Barreto Oriá
Treatment of pelvic neoplasms with radiotherapy may develop sequelae, especially RHC. An 85-year-old male patient was admitted to a hospital emergency with gross hematuria leading to urinary retention and was diagnosed with RHC. The urinary bladder was probed, unobstructed, and maintained in continuous three-way saline irrigation. During 45 days of hospitalization, the patient underwent two cystoscopic procedures for urinary bladder flocculation, whole blood transfusions, and one platelet apheresis. None of these interventions led to clinical resolution...
2017: Case Reports in Medicine
https://www.readbyqxmd.com/read/28669689/effects-of-erythropoietin-on-cycling-performance-of-well-trained-cyclists-a-double-blind-randomised-placebo-controlled-trial
#6
Jules A A C Heuberger, Joris I Rotmans, Pim Gal, Frederik E Stuurman, Juliëtte van 't Westende, Titiaan E Post, Johannes M A Daniels, Matthijs Moerland, Peter L J van Veldhoven, Marieke L de Kam, Herman Ram, Olivier de Hon, Jelle J Posthuma, Jacobus Burggraaf, Adam F Cohen
BACKGROUND: Substances that potentially enhance performance (eg, recombinant human erythropoietin [rHuEPO]) are considered doping and are therefore forbidden in sports; however, the scientific evidence behind doping is frequently weak. We aimed to determine the effects of rHuEPO treatment in well trained cyclists on maximal, submaximal, and race performance and on safety, and to present a model clinical study for doping research on other substances. METHODS: We did this double-blind, randomised, placebo-controlled trial at the Centre for Human Drug Research in Leiden (Netherlands)...
June 29, 2017: Lancet Haematology
https://www.readbyqxmd.com/read/28646375/comparative-efficacy-and-safety-in-esa-biosimilars-vs-originators-in-adults-with-chronic-kidney-disease-a-systematic-review-and-meta-analysis
#7
REVIEW
Laura Amato, Antonio Addis, Rosella Saulle, Francesco Trotta, Zuzana Mitrova, Marina Davoli
BACKGROUND: Several Erythropoiesis-stimulating agents (ESAs) are available to treat anemia in patients with chronic kidney disease (CKD). Questions about the comparability of such therapeutic options are not purely a regulatory or economical matter. Appropriate use of originator or biosimilar in these patients need to be supported by clinical data. Regarding the prevention of blood transfusion, reduction of fatigue, breathlessness and mortality or cardiovascular events, a summary of the comparative efficacy and safety data of these drugs is lacking...
June 23, 2017: Journal of Nephrology
https://www.readbyqxmd.com/read/28642700/pricing-and-reimbursement-of-biosimilars-in-central-and-eastern-european-countries
#8
Paweł Kawalec, Ewa Stawowczyk, Tomas Tesar, Jana Skoupa, Adina Turcu-Stiolica, Maria Dimitrova, Guenka I Petrova, Zinta Rugaja, Agnes Männik, Andras Harsanyi, Pero Draganic
Objectives: The aim of this study was to review the requirements for the reimbursement of biosimilars and to compare the reimbursement status, market share, and reimbursement costs of biosimilars in selected Central and Eastern European (CEE) countries. Methods: A questionnaire-based survey was conducted between November 2016 and January 2017 among experts from the following CEE countries: Bulgaria, Czech Republic, Croatia, Estonia, Hungary, Latvia, Lithuania, Poland, Slovakia, and Romania. The requirements for the pricing and reimbursement of biosimilars were reviewed for each country...
2017: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/28575883/effects-of-erythropoiesis-stimulating-agents-on-intestinal-flora-in-peritoneal-fibrosis
#9
Muammer Bilici, Ibrahim Ilker Oz, Sevil Uygun Ilikhan, Ali Borazan
INTRODUCTION: This study aimed to investigate the effects of erythropoiesis-stimulating agents (ESAs) on intestinal flora in peritoneal fibrosis. METHODS AND METHODS: Twenty-four Wistar albino rats were divided into 3 groups as the control group, which received 0.9% saline (3 mL/d) intraperitoneally; the chlorhexidine gluconate (CH) group, which received 3 mL/d injections of 0.1% CH intraperitoneally, and the ESA group, which received 3 mL/d injections of 0.1% CH intraperitoneally and epoetin beta (3 doses of 20 IU/kg/wk) subcutaneously...
May 2017: Iranian Journal of Kidney Diseases
https://www.readbyqxmd.com/read/28547536/a-comparative-study-of-the-hemoglobin-maintaining-effects-between-epoetin-%C3%AE-pegol-and-darbepoetin-%C3%AE-in-patients-with-chronic-kidney-disease-during-3%C3%A2-months-before-dialysis-initiation
#10
Satoru Oka, Yoko Obata, Kenta Torigoe, Miki Torigoe, Shinichi Abe, Kumiko Muta, Yuki Ota, Mineaki Kitamura, Satoko Kawasaki, Misaki Hirose, Tadashi Uramatsu, Hiroshi Yamashita, Hideyuki Arai, Hiroshi Mukae, Tomoya Nishino
BACKGROUND AND OBJECTIVE: We compared the hemoglobin-maintaining effects between continuous erythropoietin receptor activator (CERA) and darbepoetin-α (DA) in patients with chronic kidney disease (CKD) during the 3 months before dialysis initiation. METHODS: This study was conducted with 37 CERA-administered patients and 26 DA-administered patients who had initiated dialysis at a participating facility between January 2012 and December 2014. We investigated clinical laboratory data 3 months before and at dialysis initiation, and compared these data between the CERA and DA groups...
May 25, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28509534/analysis-of-three-epoetin-alpha-products-by-lc-and-lc-ms-indicates-differences-in-glycosylation-critical-quality-attributes-including-sialic-acid-content
#11
Rebecca I Thomson, Richard A Gardner, Katja Strohfeldt, Daryl L Fernandes, Graham P Stafford, Daniel I R Spencer, Helen M I Osborn
Erythropoietin (EPO) is one of the main therapeutics used to treat anemic patients, greatly improving their quality of life. In this study, biosimilars Binocrit and a development product, called here CIGB-EPO, were compared to the originator product, Eprex. All three are epoetin alpha products, reputed to have similar glycosylation profiles. The quality, safety, and efficacy of this biotherapeutic depend on the following glycosylation critical quality attributes (GCQAs): sialylation, N-glycolyl-neuraminic acid (Neu5Gc) content, branching, N-acetyl-lactosamine (LacNAc) extensions, and O-acetylation pattern...
June 9, 2017: Analytical Chemistry
https://www.readbyqxmd.com/read/28504901/tale-of-two-erythropoiesis-stimulating-agents-utilization-dosing-litigation-and-costs-of-darbepoetin-and-epoetin-among-south-carolina-medicaid-covered-patients-with-cancer-and-chemotherapy-induced-anemia
#12
Virginia Noxon, Kevin B Knopf, LeAnn B Norris, Brian Chen, Y Tony Yang, Zaina P Qureshi, William Hrushesky, Akida A Lebby, Benjamin Schooley, Neset Hikmet, Michael Dickson, Mae Thamer, Dennis Cotter, Paul R Yarnold, Charles L Bennett
PURPOSE: The US Food and Drug Administration (FDA) has approved epoetin and darbepoetin for chemotherapy-induced anemia (CIA). Approved epoetin and darbepoetin dosing schedules were three times per week and weekly, respectively, although off-label, less frequent scheduling was common. In 2004, 2007, and 2008, a US Food and Drug Administration Advisory Committees warned of risks associated with erythropoiesis-stimulating agents. During this period, lawsuits alleging illegal darbepoetin marketing practices have concluded, resulting in $1...
June 2017: Journal of Oncology Practice
https://www.readbyqxmd.com/read/28465779/is-a-biologic-produced-15-years-ago-a-biosimilar-of-itself-today
#13
Stanton R Mehr, Marj P Zimmerman
Much of the testing required for the regulatory approval of a biosimilar is focused on proving that the new drug is sufficiently similar to the reference biologic in structure, pharmacokinetics or pharmacodynamics, clinical efficacy, and safety. However, the reference drug may itself have gone through some changes in the years since its approval, including those caused by alterations in the manufacturing process. Do these changes increase the risk that the reference drug may cause unexpected outcomes? It is up to the US Food and Drug Administration to decide whether the changes merit the need for additional studies to confirm that the drug meets the structural or clinical outcomes standard for the reference agent...
December 2016: American Health & Drug Benefits
https://www.readbyqxmd.com/read/28438754/smad1-5-is-required-for-erythropoietin-mediated-suppression-of-hepcidin-in-mice
#14
Chia-Yu Wang, Amanda B Core, Susanna Canali, Kimberly B Zumbrennen-Bullough, Sinan Ozer, Lieve Umans, An Zwijsen, Jodie L Babitt
Anemia suppresses liver hepcidin expression to supply adequate iron for erythropoiesis. Erythroferrone mediates hepcidin suppression by anemia, but its mechanism of action remains uncertain. The bone morphogenetic protein (BMP)-SMAD signaling pathway has a central role in hepcidin transcriptional regulation. Here, we explored the contribution of individual receptor-activated SMADs in hepcidin regulation and their involvement in erythroferrone suppression of hepcidin. In Hep3B cells, SMAD5 or SMAD1 but not SMAD8, knockdown inhibited hepcidin (HAMP) messenger RNA (mRNA) expression...
July 6, 2017: Blood
https://www.readbyqxmd.com/read/28416170/hepcidin-serum-levels-and-resistance-to-recombinant-human-erythropoietin-therapy-in-hemodialysis-patients
#15
Kristina Petrulienė, Edita Žiginskienė, Vytautas Kuzminskis, Irena Nedzelskienė, Inga Arūnė Bumblytė
OBJECTIVE: The aim of this study was to analyze the factors that are associated with the response to erythropoiesis-stimulating agents (ESAs) and its association with hospitalization and mortality rates; to evaluate the serum hepcidin level and its associations with iron profile, inflammatory markers, ESA responsiveness, and mortality; and to determine independent factors affecting ERI and hepcidin. MATERIALS AND METHODS: To evaluate a dose-response effect of ESAs we used the erythropoietin resistance index (ERI)...
March 31, 2017: Medicina
https://www.readbyqxmd.com/read/28407666/influence-of-erythropoiesis-stimulating-agents-on-hba1c-and-fructosamine-in-patients-with-haemodialysis
#16
Franz Maximilian Rasche, Thomas Ebert, Julia Beckmann, Volker Busch, Filip Barinka, Wilma Gertrud Rasche, Tom H Lindner, Jochen G Schneider, Stephan Schiekofer
HbA1c is the most accepted laboratory parameter for the long term observation of glucose control. There is still much of a debate about the use of HbA1c as a metabolic indicator in diabetic patients (DM) on haemodialysis (HD) and erythropoiesis-stimulating agent (ESA) therapy because of the altered erythrocyte turn over in patients with chronic kidney disease and haemodialysis (CKD5D). In 102 CKD5 patients with and without diabetes mellitus, we examined the dose dependent variability in HbA1c and fructosamine levels under haemodialysis and treated with epoetin α (n=48) and a new generation agent with continuous stimulation of methoxy polyethylene glycol epoetin beta (C...
June 2017: Experimental and Clinical Endocrinology & Diabetes
https://www.readbyqxmd.com/read/28371815/phase-2-studies-of-oral-hypoxia-inducible-factor-prolyl-hydroxylase-inhibitor-fg-4592-for-treatment-of-anemia-in-china
#17
Nan Chen, Jiaqi Qian, Jianghua Chen, Xueqing Yu, Changlin Mei, Chuanming Hao, Gengru Jiang, Hongli Lin, Xinzhou Zhang, Li Zuo, Qiang He, Ping Fu, Xuemei Li, Dalvin Ni, Stefan Hemmerich, Cameron Liu, Lynda Szczech, Anatole Besarab, Thomas B Neff, Kin-Hung Peony Yu, Frank H Valone
Background: FG-4592 (roxadustat) is an oral hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitor (HIF-PHI) promoting coordinated erythropoiesis through the transcription factor HIF. Two Phase 2 studies were conducted in China to explore the safety and efficacy of FG-4592 (USAN name: roxadustat, CDAN name: ), a HIF-PHI, in patients with anemia of chronic kidney disease (CKD), both patients who were dialysis-dependent (DD) and patients who were not dialysis-dependent (NDD). Methods: In the NDD study, 91 participants were randomized to low (1...
August 1, 2017: Nephrology, Dialysis, Transplantation
https://www.readbyqxmd.com/read/28344481/stability-of-erythropoietin-repackaging-in-polypropylene-syringes-for-clinical-use
#18
Angela Marsili, Giorgia Puorro, Chiara Pane, Anna de Rosa, Giovanni Defazio, Carlo Casali, Antonio Cittadini, Giuseppe de Michele, Brunello Ettore Florio, Alessandro Filla, Francesco Saccà
Introduction: Epoetin alfa (Eprex®) is a subcutaneous, injectable formulation of short half-life recombinant human erythropoietin (rHuEPO). To current knowledge there are no published studies regarding the stability of rHuEPO once repackaging occurs (r-EPO) for clinical trial purposes. Materials and methods: We assessed EPO concentration in Eprex® and r-EPO syringes at 0, 60, 90, and 120 days after repackaging in polypropylene syringes. R-EPO was administered to 56 patients taking part in a clinical trial in Friedreich Ataxia...
February 2017: Saudi Pharmaceutical Journal: SPJ: the Official Publication of the Saudi Pharmaceutical Society
https://www.readbyqxmd.com/read/28332724/efficacy-and-safety-of-biosimilar-epoetin-alpha-in-patients-with-chronic-lymphoid-neoplasms-and-chemotherapy-induced-anaemia-an-observational-retrospective-monocentric-analysis
#19
Alessandro Broccoli, Lisa Argnani, Vittorio Stefoni, Letizia Gandolfi, Pier Luigi Zinzani
Epoetin biosimilars are an alternative to originator erythropoietic agents in the treatment of chemotherapy-induced anaemia; however, their effects in patients with lymphoproliferative disorders remain unclear. This analysis examined the response of patients with lymphoproliferative disorders experiencing chemotherapy-induced anaemia to 4- or 8-week treatment with the biosimilar epoetin alpha. Treatment was initiated at first occurrence of haemoglobin (Hb) < 10 g/dL during chemotherapy and was stopped when Hb was >11 g/dL, when chemotherapy was completed, or in case of transfusion dependency...
March 23, 2017: Hematological Oncology
https://www.readbyqxmd.com/read/28320343/targets-for-adapting-intravenous-iron-dose-in-hemodialysis-a-proof-of-concept-study
#20
N O Peters, N Jay, J Cridlig, G Rostoker, L Frimat
BACKGROUND: Intravenous iron is widely used to control anemia in dialysis patients and limits costs related to erythropoiesis-stimulating agents (ESA). Current guidelines do not clearly set upper limits for serum ferritin (SF) and transferrin saturation (TSAT). International surveys such as the Dialysis Outcomes and Practice Patterns Study (DOPPS) showed that this lack of upper limits potentially led nephrologists to prescribe iron infusions even for patients with a high SF. Recent publications have suggested a risk of short- and long-term adverse effects related to iron overload...
March 20, 2017: BMC Nephrology
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