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Epoetin Alfa

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https://www.readbyqxmd.com/read/28465779/is-a-biologic-produced-15-years-ago-a-biosimilar-of-itself-today
#1
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
#2
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/28371815/phase-2-studies-of-oral-hypoxia-inducible-factor-prolyl-hydroxylase-inhibitor-fg-4592-for-treatment-of-anemia-in-china
#3
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
#4
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/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
#5
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
#6
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
#7
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
https://www.readbyqxmd.com/read/28142147/history-of-erythropoiesis-stimulating-agents-the-development-of-biosimilars-and-the-future-of-anemia-treatment-in-nephrology
#8
Kamyar Kalantar-Zadeh
BACKGROUND: Exogenous replacement of erythropoietin (EPO) by recombinant human EPO has been considered a standard of care for the treatment of anemia in patients with chronic kidney disease for more than 20 years. Genetically engineered biologic proteins derived from human, animal, or microorganism sources are a major area of growth in modern medical care, accounting for one-third of new drug approvals in the past decade. Despite benefit to patients, the use of biologics comes at a significant cost, representing one of the fastest growing segments of strained healthcare budgets around the world...
2017: American Journal of Nephrology
https://www.readbyqxmd.com/read/27971732/cost-efectivness-of-darbepoetin-alfa-versus-epoetin-alfa-in-the-management-of-anemic-patients-with-chronic-kidney-disease-health-insurance-perspective
#9
S Fouad
No abstract text is available yet for this article.
November 2016: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/27749350/spine-surgery-and-blood-loss-systematic-review-of-clinical-evidence
#10
Dafna Willner, Valeria Spennati, Shelly Stohl, Giulia Tosti, Simone Aloisio, Federico Bilotta
Spine surgery has been growing rapidly as a neurosurgical operation, with an increase of 220% over a 15-year period. Intraoperative blood transfusion is a major outcome determinant of spine procedures. Various approaches, including pharmacologic and nonpharmacologic therapies, have been tested to decrease both intraoperative and postoperative blood loss. The aim of this systematic review is to report clinical evidence on the relationship between intraoperative blood loss (primary outcome) and on transfusion requirements and postoperative complications (secondary outcomes) in patients undergoing spine surgery...
November 2016: Anesthesia and Analgesia
https://www.readbyqxmd.com/read/27441542/clinical-application-of-recombinant-erythropoietin-in-beta-thalassaemia-intermedia
#11
Ch Asadov, Z Alimirzoyeva, M Hasanova, T Mammadova, A Shirinova
Research objective is to study the efficacy of recombinant erythropoietin (epoetin alfa) as alternative method of treatment beta-thalassemia intermedia. Study involved 58 patients with beta-thalassemia intermedia (23 women and 35 men). In all observed patients was defined levels of hemoglobin (Hb), red blood cells (RBC), erythrocyte indexes (MCV, MCH, MCHC), hemoglobin fractions (HbA, HbA2, HbF), serum ferritin, serum erythropoietin before and after administrated rEPO. All patients received rEPO during 6 month at the dose - 10000 IU subcutaneously...
June 2016: Georgian Medical News
https://www.readbyqxmd.com/read/27364049/early-high-dose-erythropoietin-therapy-after-out-of-hospital-cardiac-arrest-a-multicenter-randomized-controlled-trial
#12
Alain Cariou, Nicolas Deye, Benoît Vivien, Olivier Richard, Nicolas Pichon, Angèle Bourg, Loïc Huet, Clément Buleon, Jérôme Frey, Pierre Asfar, Stéphane Legriel, Sophie Narcisse, Armelle Mathonnet, Aurélie Cravoisy, Pierre-François Dequin, Eric Wiel, Keyvan Razazi, Cédric Daubin, Antoine Kimmoun, Lionel Lamhaut, Jean-Sébastien Marx, Didier Payen de la Garanderie, Patrick Ecollan, Alain Combes, Christian Spaulding, Florence Barat, Myriam Ben Boutieb, Joël Coste, Jean-Daniel Chiche, Frédéric Pène, Jean-Paul Mira, Jean-Marc Treluyer, Olivier Hermine, Pierre Carli
BACKGROUND: Preliminary data suggested a clinical benefit in treating out-of-hospital cardiac arrest (OHCA) patients with a high dose of erythropoietin (Epo) analogs. OBJECTIVES: The authors aimed to evaluate the efficacy of epoetin alfa treatment on the outcome of OHCA patients in a phase 3 trial. METHODS: The authors performed a multicenter, single-blind, randomized controlled trial. Patients still comatose after a witnessed OHCA of presumed cardiac origin were eligible...
July 5, 2016: Journal of the American College of Cardiology
https://www.readbyqxmd.com/read/27348021/a-cluster-of-epoetin-associated-pure-red-cell-aplasia-clinical-features-and-the-possible-association-of-hla-drb1-12-02
#13
Chuen Wen Tan, Wei-Chuen Tan-Koi, Jennifer Ng, Choong Meng Chan, William Ying Khee Hwang
Antibody-mediated pure red cell aplasia is a rare but serious complication in chronic kidney disease patients receiving recombinant human erythropoietin (r-HuEpo). Between April 2012 and May 2013, eight such cases were reported in our institution. Their clinical features were reviewed and their HLA alleles were compared with those of healthy controls. All patients were exposed to epoetin alfa (Eprex(®)) with polysorbate-80 as stabilizer via subcutaneous route with a mean age of 61.9 years and mean exposure of 11...
June 27, 2016: Pharmacogenomics
https://www.readbyqxmd.com/read/27070933/erythropoiesis-stimulating-agents-in-critically-ill-trauma-patients-a-systematic-review-and-meta-analysis
#14
Craig J French, Neil J Glassford, Dashiell Gantner, Alisa M Higgins, David James Cooper, Alistair Nichol, Markus B Skrifvars, Georgina Imberger, Jeffrey Presneill, Michael Bailey, Rinaldo Bellomo
OBJECTIVE: To perform a meta-analysis of all relevant randomized controlled trials assessing the effect of erythropoiesis-stimulating agents (ESAs) in critically ill trauma patients. BACKGROUND: ESAs have effects beyond erythropoiesis. The administration of the ESA epoetin alfa to critically ill trauma patients has been associated with a reduction in mortality. METHODS: We performed a systematic review and meta-analysis with trial sequential analysis...
January 2017: Annals of Surgery
https://www.readbyqxmd.com/read/27060362/switch-from-epoetin-beta-to-darbepoetin-alfa-treatment-of-anemia-in-taiwanese-hemodialysis-patients-dose-equivalence-by-hemoglobin-stratification
#15
Shang-Chih Liao, Cheng-Chieh Hung, Chien-Te Lee, Chih-Hsiung Lee, Chin-Chan Lee, Chun-Liang Lin, Chiao-Yin Sun, Ben-Chung Cheng, Chih-Chao Yang, Chien-Hsing Wu, Jin-Bor Chen
This multicenter study was designed to assess the hemoglobin (Hb) stability and conversion ratio of the switch from epoetin beta to darbepoetin alfa in Taiwanese hemodialysis (HD) patients. A total of 135 HD patients were enrolled and randomized with intravenous darbepoetin alfa or epoetin beta. The study duration was 24 weeks. Equivalent doses and conversion ratios were assessed with respect to Hb stratification: low Hb (≥8.0 g/dL to ≤10.0 g/dL) and high Hb (>10.0 g/dL to ≤11.0 g/dL). The results showed stable Hb levels in the study period...
August 2016: Therapeutic Apheresis and Dialysis
https://www.readbyqxmd.com/read/26980607/effects-of-epoetin-alfa-titration-practices-implemented-after-changes-to-product-labeling-on-hemoglobin-levels-transfusion-use-and-hospitalization-rates
#16
Julia T Molony, Keri L Monda, Suying Li, Anne C Beaubrun, David T Gilbertson, Brian D Bradbury, Allan J Collins
BACKGROUND: Little is known about epoetin alfa (EPO) dosing at dialysis centers after implementation of the US Medicare prospective payment system and revision of the EPO label in 2011. STUDY DESIGN: Retrospective cohort study. SETTING & PARTICIPANTS: Approximately 412,000 adult hemodialysis patients with Medicare Parts A and B as primary payer in 2009 to 2012 to describe EPO dosing and hemoglobin patterns; of these, about 70,000 patients clustered in about 1,300 dialysis facilities to evaluate facility-level EPO titration practices and patient-level outcomes in 2012...
August 2016: American Journal of Kidney Diseases: the Official Journal of the National Kidney Foundation
https://www.readbyqxmd.com/read/26917691/epoetin-alfa-and-outcomes-in-dialysis-amid-regulatory-and-payment-reform
#17
Glenn M Chertow, Jiannong Liu, Keri L Monda, David T Gilbertson, M Alan Brookhart, Anne C Beaubrun, Wolfgang C Winkelmayer, Allan Pollock, Charles A Herzog, Akhtar Ashfaq, Til Sturmer, Kenneth J Rothman, Brian D Bradbury, Allan J Collins
Erythropoiesis-stimulating agents (ESAs) are commonly used to treat anemia in patients with CKD, including those receiving dialysis, although clinical trials have identified risks associated with ESA use. We evaluated the effects of changes in dialysis payment policies and product labeling instituted in 2011 on mortality and major cardiovascular events across the United States dialysis population in an open cohort study of patients on dialysis from January 1, 2005, through December 31, 2012, with Medicare as primary payer...
October 2016: Journal of the American Society of Nephrology: JASN
https://www.readbyqxmd.com/read/26879839/long-term-effect-of-epoetin-alfa-on-clinical-and-biochemical-markers-in-friedreich-ataxia
#18
Francesco Saccà, Giorgia Puorro, Angela Marsili, Antonella Antenora, Chiara Pane, Carlo Casali, Christian Marcotulli, Giovanni Defazio, Daniele Liuzzi, Chiara Tatillo, Donata Maria Cambriglia, Giuseppe Schiano di Cola, Luigi Giuliani, Vincenzo Guardasole, Andrea Salzano, Antonio Ruvolo, Anna De Rosa, Antonio Cittadini, Giuseppe De Michele, Alessandro Filla
BACKGROUND: Friedreich ataxia is an autosomal recessive disease with no available therapy. Clinical trials with erythropoietin in Friedreich ataxia patients have yielded conflicting results, and the long-term effect of the drug remains unknown. METHODS: We designed a double-blind, placebo-controlled, multicenter trial to test the efficacy of epoetin alfa on 56 patients with Friedreich ataxia. The primary endpoint of the study was the effect of epoetin alfa on peak oxygen uptake (VO2 max) at the cardiopulmonary exercise test...
May 2016: Movement Disorders: Official Journal of the Movement Disorder Society
https://www.readbyqxmd.com/read/26858335/a-randomized-open-label-multicenter-phase-iii-study-of-epoetin-alfa-versus-best-standard-of-care-in-anemic-patients-with-metastatic-breast-cancer-receiving-standard-chemotherapy
#19
RANDOMIZED CONTROLLED TRIAL
Brian Leyland-Jones, Igor Bondarenko, Gia Nemsadze, Vitaliy Smirnov, Iryna Litvin, Irakli Kokhreidze, Lia Abshilava, Mikheil Janjalia, Rubi Li, Kuntegowda C Lakshmaiah, Beka Samkharadze, Oksana Tarasova, Ranjan Kumar Mohapatra, Yaroslav Sparyk, Sergey Polenkov, Vladimir Vladimirov, Liang Xiu, Eugene Zhu, Bruce Kimelblatt, Kris Deprince, Ilya Safonov, Peter Bowers, Els Vercammen
PURPOSE: An open-label, noninferiority study to evaluate the impact of epoetin alfa (EPO) on tumor outcomes when used to treat anemia in patients receiving chemotherapy for metastatic breast cancer. METHODS: Women with hemoglobin ≤ 11.0 g/dL, receiving first- or second-line chemotherapy for metastatic breast cancer, were randomly assigned to EPO 40,000 IU subcutaneously once a week or best standard of care. The primary end point was progression-free survival (PFS)...
April 10, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/26846333/roxadustat-fg-4592-versus-epoetin-alfa-for-anemia-in-patients-receiving-maintenance-hemodialysis-a-phase-2-randomized-6-to-19-week-open-label-active-comparator-dose-ranging-safety-and-exploratory-efficacy-study
#20
Robert Provenzano, Anatole Besarab, Steven Wright, Sohan Dua, Steven Zeig, Peter Nguyen, Lona Poole, Khalil G Saikali, Gopal Saha, Stefan Hemmerich, Lynda Szczech, K H Peony Yu, Thomas B Neff
BACKGROUND: Roxadustat (FG-4592) is an oral hypoxia-inducible factor prolyl-hydroxylase inhibitor that promotes erythropoiesis through increasing endogenous erythropoietin, improving iron regulation, and reducing hepcidin. STUDY DESIGN: Phase 2, randomized (3:1), open-label, active-comparator, safety and efficacy study. SETTING & PARTICIPANTS: Patients with stable end-stage renal disease treated with hemodialysis who previously had hemoglobin (Hb) levels maintained with epoetin alfa...
June 2016: American Journal of Kidney Diseases: the Official Journal of the National Kidney Foundation
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