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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
#1
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
#2
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
#3
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
#4
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
#5
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
#6
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
#7
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
#8
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) mRNA expression...
April 24, 2017: Blood
https://www.readbyqxmd.com/read/28416170/hepcidin-serum-levels-and-resistance-to-recombinant-human-erythropoietin-therapy-in-hemodialysis-patients
#9
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
#10
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
#11
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...
March 27, 2017: Nephrology, Dialysis, Transplantation
https://www.readbyqxmd.com/read/28344481/stability-of-erythropoietin-repackaging-in-polypropylene-syringes-for-clinical-use
#12
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
#13
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
#14
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
https://www.readbyqxmd.com/read/28283484/comparative-effectiveness-and-safety-of-erythropoiesis-stimulating-agents-biosimilars-vs-originators-in-clinical-practice-a-population-based-cohort-study-in-italy
#15
Francesco Trotta, Valeria Belleudi, Danilo Fusco, Laura Amato, Alessandra Mecozzi, Flavia Mayer, Massimo Sansone, Marina Davoli, Antonio Addis
OBJECTIVES: To evaluate the benefit/risk profile of epoetin α biosimilar with the erythropoiesis-stimulating agents (ESAs) originators when administered to naïve patients from clinical practice. DESIGN: Population-based observational cohort study. SETTING: All residents in the Lazio Region, Italy, with chronic kidney disease (CKD) or cancer retrieved from the Electronic Therapeutic Plan (ETP) Register for ESA between 2012 and 2014. PARTICIPANTS: Overall, 13 470 incident ESA users were available for the analysis, 8161 in the CKD and 5309 in the oncology setting, respectively...
March 10, 2017: BMJ Open
https://www.readbyqxmd.com/read/28280364/biosimilar-retacrit-%C3%A2-epoetin-zeta-in-the-treatment-of-chemotherapy-induced-symptomatic-anemia-in-hematology-and-oncology-in-germany-orheo-non-interventional-study
#16
Christoph Losem, Michael Koenigsmann, Christine Rudolph
BACKGROUND: Symptomatic anemia is a frequent and severe complication of chemotherapy that is commonly treated with erythropoiesis-stimulating agents. The primary objective of this study was to assess the change in hemoglobin levels in patients with chemotherapy-induced anemia (CIA) following treatment with biosimilar Retacrit(®) (epoetin zeta). Secondary objectives included changes in hematologic parameters and tolerability. METHODS: This was a non-interventional, multicenter, long-term observational study that is part of an ongoing surveillance program for epoetin zeta...
2017: OncoTargets and Therapy
https://www.readbyqxmd.com/read/28272424/restricted-use-of-erythropoiesis-stimulating-agent-is-safe-and-associated-with-deferred-dialysis-initiation-in-stage-5-chronic-kidney-disease
#17
Szu-Yu Pan, Wen-Chih Chiang, Ping-Min Chen, Heng-Hsiu Liu, Yu-Hsiang Chou, Tai-Shuan Lai, Chun-Fu Lai, Yen-Ling Chiu, Wan-Yu Lin, Yung-Ming Chen, Tzong-Shinn Chu, Shuei-Liong Lin
The effect of erythropoiesis-stimulating agent (ESA) on dialysis initiation in advanced chronic kidney disease (CKD) patients is not clear. We retrospectively analyzed the outcome of dialysis initiation in a stage 5 CKD cohort with ESA reimbursement limited to the maximal standardized monthly ESA dose equivalent to epoetin beta 20,000 U by the National Health Insurance program. Totally 423 patients were followed up for a median of 1.37 year. A time-dependent Cox regression model, adjusted for monthly levels of estimated glomerular filtration rate (eGFR) and hemoglobin, was constructed to investigate the association between ESA and outcome...
March 8, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28255868/biosimilar-epoetin-alfa-increases-haemoglobin-levels-and-brings-cognitive-and-socio-relational-benefits-to-elderly-transfusion-dependent-multiple-myeloma-patients-results-from-a-pilot-study
#18
Roberto Castelli, Simona Sciara, Giorgio Lambertenghi Deliliers, Giuseppe Pantaleo
Anaemia is a complication reported in up to 70% of the multiple myeloma patients (MM), with remarkable clinical, cognitive and socio-relational consequences. Anaemia relates to the course of MM, normalizing in patients during remission and reappearing in relapsing/non-responding patients. In a pilot study with 31 patients with MM and transfusion-dependent anaemia, we evaluated the effects of Binocrit (biosimilar epoetin alfa) on transfusions, haemoglobin levels, mental status (mini-mental state evaluation) and the patients' social-relational functioning and quality of life (QoL)...
May 2017: Annals of Hematology
https://www.readbyqxmd.com/read/28249030/low-versus-high-dose-erythropoiesis-stimulating-agents-in-hemodialysis-patients-with-anemia-a-randomized-clinical-trial
#19
Valeria Saglimbene, Suetonia C Palmer, Jonathan C Craig, Marinella Ruospo, Antonio Nicolucci, Marcello Tonelli, David Johnson, Giuseppe Lucisano, Gabrielle Williams, Miriam Valentini, Daniela D'Alonzo, Fabio Pellegrini, Paolo Strippoli, Mario Salomone, Antonio Santoro, Stefano Maffei, Jörgen Hegbrant, Gianni Tognoni, Giovanni F M Strippoli
The increased risks of death and adverse events with erythropoiesis-stimulating agent (ESA) therapy targeting a higher hemoglobin level are established. It is uncertain whether the adverse effects of ESA therapy are related to dose and are mitigated when a fixed low ESA dose is used. We conducted a multicenter, prospective randomized open-label, blinded-endpoint (PROBE) trial to evaluate fixed low versus high dose ESA therapy on patient outcomes. We intended to recruit 2104 hemodialysis patients >18 years with anemia or receiving ESA treated at dialysis clinics in Italy...
2017: PloS One
https://www.readbyqxmd.com/read/28203295/management-of-anaemia-in-oncohaematological-patients-treated-with-biosimilar-epoetin-alfa-results-of-an-italian-observational-retrospective-study
#20
Giovanni Rosti, Mario Petrini, Alberto Bosi, Piero Galieni, Daniele Bernardi, Gianfranco Giglio, Laura Dorotea, Brunangelo Falini, Elvira Scelzi, Enzo Veltri, Roberto Castelli, Chiara Longagnani, Tommaso Raggi, Federico Simonetti
BACKGROUND: Many patients with solid tumours or nonmyeloid haematopoietic tumours develop symptomatic anaemia, which has a major impact on quality of life (QoL). The efficacy of erythropoiesis-stimulating agents (ESAs) in improving QoL and reducing blood transfusions has been widely demonstrated. Binocrit® (biosimilar epoetin alfa) is an ESA indicated in the European Union for treating chemotherapy-induced anaemia. The aim of this study was to investigate the effect of Binocrit® on haemoglobin (Hb) levels in anaemic cancer patients in Italian clinical practice...
January 2017: Therapeutic Advances in Medical Oncology
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