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Epoetin Alfa

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https://www.readbyqxmd.com/read/29921734/intravenous-epoetin-alfa-epbx-versus-epoetin-alfa-for-treatment-of-anemia-in-end-stage-kidney-disease
#1
Steven Fishbane, Bhupinder Singh, Seema Kumbhat, Wayne A Wisemandle, Nancy E Martin
BACKGROUND AND OBJECTIVES: This study was conducted to compare the safety and efficacy of intravenous epoetin alfa-epbx, an epoetin alfa biosimilar, to epoetin alfa in patients on hemodialysis with ESKD and anemia. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: In this 24-week, multicenter, double-blind comparative efficacy and safety study, 612 patients on hemodialysis with ESKD and anemia who had stable hemoglobin and were receiving stable doses of intravenous epoetin alfa were randomized (1:1) to intravenous epoetin alfa or epoetin alfa-epbx...
June 19, 2018: Clinical Journal of the American Society of Nephrology: CJASN
https://www.readbyqxmd.com/read/29742267/epoetin-alfa-resistance-in-hemodialysis-patients-with-chronic-kidney-disease-a-longitudinal-study
#2
E J F Santos, E V Hortegal, H O Serra, J S Lages, N Salgado-Filho, A M Dos Santos
Anemia is an inevitable complication of hemodialysis, and the primary cause is erythropoietin deficiency. After diagnosis, treatment begins with an erythropoiesis-stimulating agent (ESA). However, some patients remain anemic even after receiving this medication. This study aimed to investigate the factors associated with resistance to recombinant human erythropoietin therapy with epoetin alfa (αEPO). We performed a prospective, longitudinal study of hemodialysis patients receiving treatment with αEPO at our reference hospital from July 2015 to June 2016...
2018: Brazilian Journal of Medical and Biological Research, Revista Brasileira de Pesquisas Médicas e Biológicas
https://www.readbyqxmd.com/read/29707043/development-and-10-year-history-of-a-biosimilar-the-example-of-binocrit-%C3%A2
#3
REVIEW
Matti Aapro, Andriy Krendyukov, Nadja Höbel, Andreas Seidl, Pere Gascón
Patent expirations for several biological products have prompted the development of alternative versions, termed 'biosimilars', which have comparable quality, safety and efficacy to a licensed biological medicine (also referred to as the 'reference' medicine). The first biosimilars developed in oncology were the supportive-care agents filgrastim and epoetin. Binocrit® (HX575) is a biosimilar version of epoetin alfa, indicated in the oncology setting for the treatment of chemotherapy-induced anemia (CIA). The process for development and approval of Binocrit® as a biosimilar included extensive analytical characterization and comparison with the reference epoetin alfa...
2018: Therapeutic Advances in Medical Oncology
https://www.readbyqxmd.com/read/29672740/effects-of-vadadustat-on-hemoglobin-concentrations-in-patients-receiving-hemodialysis-previously-treated-with-erythropoiesis-stimulating-agents
#4
Volker H Haase, Glenn M Chertow, Geoffrey A Block, Pablo E Pergola, Emil M deGoma, Zeeshan Khawaja, Amit Sharma, Bradley J Maroni, Peter A McCullough
Background: Vadadustat, an inhibitor of hypoxia-inducible factor prolyl-4-hydroxylase domain dioxygenases, is an oral investigational agent in development for the treatment of anemia secondary to chronic kidney disease. Methods: In this open-label Phase 2 trial, vadadustat was evaluated in 94 subjects receiving hemodialysis, previously maintained on epoetin alfa. Subjects were sequentially assigned to one of three vadadustat dose cohorts by starting dose: 300 mg once daily (QD), 450 mg QD or 450 mg thrice weekly (TIW)...
April 16, 2018: Nephrology, Dialysis, Transplantation
https://www.readbyqxmd.com/read/29578404/priapism-and-hemodialysis-case-report-and-literature-review
#5
Weiwen Vivian Shih, Cynthia Wong
BACKGROUND: Priapism is a known but rarely described complication of patients on dialysis. The incidence of priapism in the general population is estimated at 1.5 in 100,000 patients and 2.9 in 100,000 patients in males over 40 years of age; however there is little current literature describing priapism in adult dialysis patients and no current literature in pediatric dialysis patients [1]. We describe two pediatric patients who developed priapism concurrent with hemodialysis, each with differing severity and therapeutic management...
March 26, 2018: Clinical Nephrology
https://www.readbyqxmd.com/read/29545827/a-novel-outpatient-desensitization-protocol-for-recombinant-human-erythropoietin-allergy-in-a-pediatric-patient
#6
Jaime S Rosa, Van B Vuong, Orly Haskin, Anne Y Liu
Background: Recombinant human erythropoietin, such as epoetin alfa and darbepoetin alfa, is an important therapy for anemia due to chronic renal failure. Allergy to recombinant human erythropoietin and the need for desensitization are rare. Case presentation: We report here a novel epoetin alfa outpatient desensitization protocol in a girl who developed delayed cutaneous hypersensitivity to subcutaneous epoetin alfa and intravenous darbepoetin alfa. An initial attempt at traditional epoetin alfa desensitization failed, so we created a slower 17-day outpatient desensitization that succeeded and allowed treatment continuation...
2018: Allergy, Asthma, and Clinical Immunology
https://www.readbyqxmd.com/read/29429032/comparative-risk-benefit-profile-of-biosimilar-and-originator-erythropoiesis-stimulating-agents-esas-data-from-an-italian-observational-study-in-nephrology
#7
Domenico Motola, Alberto Vaccheri, Andrea Roncadori, Monia Donati, Giulia Bonaldo, Anna Covezzoli, Piera Polidori, Stefano Bianchi
PURPOSE: The aim of this multicenter prospective study was to evaluate efficacy and safety of biosimilar erythropoiesis-stimulating agents (ESAs) vs originator, based on data from clinical practice in patients with chronic kidney disease (CKD). METHODS: We collected data of the patients with diagnosis of CKD on conservative treatment from nine Italian structures. Patients were enrolled applying different exclusion criteria, and various individual parameters were registered at the beginning for descriptive analysis...
February 10, 2018: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29408510/structure-function-relationships-for-recombinant-erythropoietins-a-case-study-from-a-proposed-manufacturing-change-with-implications-for-erythropoietin-biosimilar-study-designs
#8
Gustavo Grampp, Patricia L McElroy, Gary Camblin, Allan Pollock
Comparability studies used to assess a proposed manufacturing change for a biological product include sensitive analytical studies to confirm there are no significant differences in structural or functional attributes that may contribute to clinically meaningful changes in efficacy or safety. When a proposed change is relatively complex or when clinically relevant differences between the product before and after the change cannot be ruled out based on analytical studies, nonclinical and clinical bridging studies are generally required to confirm overall comparability...
February 2, 2018: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29390245/a-strategy-to-reduce-inflammation-and-anemia-treatment-s-related-costs-in-dialysis-patients
#9
Biagio R Di Iorio, Lucia Di Micco, Luigi Russo, Luca Nardone, Emanuele De Simone, M L Sirico, Gabriella Di Natale, Domenico Russo
This is a post-hoc analysis evaluating erythropoiesis stimulating agents' (ESA) related costs while using an additional ultrafilter (Estorclean PLUS) to produce ultrapure dialysis water located within the fluid pathway after the treatment with reverse osmosis and before the dialysis machine. Twenty-nine patients (19 treated with epoetin alfa and 10 with darboepoetin alfa) were included in the analysis. We showed to gain savings of 210 € per patient (35 € per patient each month) with epoetin alfa during the experimental period of 6 months, compared to the control period and of 545 € per patient (90 € per patient each month) with darboepoetin alfa...
February 2018: Giornale Italiano di Nefrologia: Organo Ufficiale Della Società Italiana di Nefrologia
https://www.readbyqxmd.com/read/29296077/hx575-established-biosimilarity-in-the-treatment-of-renal-anemia-and-10-years-of-clinical-experience
#10
REVIEW
Frank Dellanna, David Goldsmith, Andriy Krendyukov, Andreas Seidl, Nadja Höbel, Christian Combe
Erythropoiesis-stimulating agents, such as recombinant human erythropoietin, are commonly used for the treatment of anemia in patients with chronic kidney disease (CKD). In 2007, HX575 (Binocrit® ) became the first biosimilar epoetin alfa to be approved by the European Medicines Agency (EMA). The decision to approve a biosimilar is based on the totality of evidence obtained in a comprehensive comparability exercise that involves extensive analytical characterization, nonclinical studies and clinical studies...
2018: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/29278529/erythropoietin-does-not-alter-serum-profiles-of-neuronal-and-axonal-biomarkers-after-traumatic-brain-injury-findings-from-the-australian-epo-tbi-clinical-trial
#11
Sarah C Hellewell, Stefania Mondello, Alison Conquest, Gerry Shaw, Irina Madorsky, Jay V Deng, Lorraine Little, Firas Kobeissy, Nicole Bye, Rinaldo Bellomo, David J Cooper, Shirley Vallance, Jasmine Board, Maria C Morganti-Kossmann
OBJECTIVE: To determine profiles of serum ubiquitin carboxy-terminal hydrolase L1 and phosphorylated neurofilament heavy-chain, examine whether erythropoietin administration reduce their concentrations, and whether biomarkers discriminate between erythropoietin and placebo treatment groups. DESIGN: Single-center, prospective observational study. SETTING: A sub-study of the erythropoietin-traumatic brain injury clinical trial, conducted at the Alfred Hospital, Melbourne, Australia...
April 2018: Critical Care Medicine
https://www.readbyqxmd.com/read/29211140/pharmacotherapeutic-profile-of-users-and-expenditure-on-high-cost-drugs-in-s%C3%A3-o-leopoldo-rio-grande-do-sul-state-brazil-2014
#12
Mariani Sopelsa, Fabiane Raquel Motter, Nêmora Tregnago Barcellos, Heloísa Marquardt Leite, Vera Maria Vieira Paniz
OBJECTIVE: to describe the pharmacotherapeutic profile of users of the Specialized Program for Pharmaceutical Assistance, and to measure the expenditure on the most prevalent and the most expensive medications. METHODS: descriptive study conducted in São Leopoldo-RS, Brazil, with secondary data regarding information about requests accepted in 2014, through administrative proceedings; delivery notes of the State Health Department/RS were used to assess the costs...
October 2017: Epidemiologia e Servicos de Saude: Revista do Sistema Unico de Saude do Brasil
https://www.readbyqxmd.com/read/29172979/pharmacovigilance-of-biologics-in-a-multisource-environment
#13
Sreedhar Sagi, Hillel P Cohen, Gillian R Woollett
It is important that systems are in place to ensure that appropriate and comprehensive records are kept for use of all medications. It is fundamental to an effective pharmacovigilance system that patient medical records contain sufficient information to identify which medication has been prescribed, when it was administered, and at what dose. The availability of biologics from multiple sponsors has raised questions by some health care providers about the ability of current pharmacovigilance systems to trace specific biologics...
December 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/29138535/comparable-pharmacokinetics-and-pharmacodynamics-of-two-epoetin-alfa-formulations-eporon-%C3%A2-and-eprex-%C3%A2-following-a-single-subcutaneous-administration-in-healthy-male-volunteers
#14
Sumin Yoon, Su-Jin Rhee, Sun Ju Heo, Tae Young Oh, Seo Hyun Yoon, Joo-Youn Cho, SeungHwan Lee, Kyung-Sang Yu
Purpose: This study aimed to assess and compare the pharmacokinetic (PK) and pharmacodynamic (PD) properties following a single subcutaneous injection of epoetin alfa (Eporon® ) with those of the comparator (Eprex® ) in healthy male subjects. Subjects and methods: A randomized, double-blind, two-sequence, crossover study was conducted. Subjects were randomly assigned to receive a single dose, that is, 4,000 IU, of the test or comparator epoetin alfa. After 4 weeks, all subjects received the alternative formulation...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/29098093/epoetin-alfa-a-cause-of-coronary-artery-thrombosis
#15
Muhammad Umer Siddiqui, Yelena Galumyan, James Klein, Zunaira Naeem, Aron Schwarcz
Introduction: Epoetin alfa is an erythrocyte-stimulating factor. We here present a case of an anemic patient, who was given epogen before a coronary artery bypass (CABG) surgery and developed periprocedural myocardial infarction. To our knowledge, there has been no previous case reported of epogen causing myocardial infarction. Case Presentation: 66-year-old female presented with substernal chest pain. EKG showed ST segment elevations in aVf and L-III. Patient underwent left heart catheterization (LHC) and had triple vessel disease...
2017: Case Reports in Cardiology
https://www.readbyqxmd.com/read/29097481/efficacy-and-long-term-safety-of-c-e-r-a-maintenance-in-pediatric-hemodialysis-patients-with-anemia-of-ckd
#16
Michel Fischbach, Elke Wühl, Sylvie C Meyer Reigner, Zoe Morgan, Franz Schaefer
BACKGROUND AND OBJECTIVES: The study was conducted to identify a conversion factor for switching from previous erythropoiesis-stimulating agents (ESAs) to continuous erythropoietin receptor activator-methoxy polyethylene glycol-epoetin beta (C.E.R.A.) and to document the efficacy and long-term safety of C.E.R.A. in pediatric patients with anemia of CKD undergoing hemodialysis. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: In this open-label, multicenter study, patients aged 6-17 years, with stable chronic anemia of CKD, undergoing hemodialysis received C...
January 6, 2018: Clinical Journal of the American Society of Nephrology: CJASN
https://www.readbyqxmd.com/read/29084409/a-comparison-of-the-safety-and-efficacy-of-hx575-epoetin-alfa-proposed-biosimilar-with-epoetin-alfa-in-patients-with-end-stage-renal-disease
#17
Matthew R Weir, Pablo E Pergola, Rajiv Agarwal, Jeffrey C Fink, Nelson P Kopyt, Ajay K Singh, Jayant Kumar, Susanne Schmitt, Gregor Schaffar, Anita Rudy, Jim P McKay, Radmila Kanceva
BACKGROUND: HX575 (biosimilar epoetin alfa) was approved in Europe in 2007 for the treatment of chronic kidney disease (CKD)-related anemia. This study assessed the clinical equivalence of HX575 with the US-licensed reference epoetin alfa (Epogen®/Procrit®, Amgen/Janssen) following subcutaneous (SC) administration in dialysis patients with CKD-related anemia. METHODS: This randomized, double-blind, parallel-group, multicenter study (NCT01693029) was conducted at 49 US clinical sites...
2017: American Journal of Nephrology
https://www.readbyqxmd.com/read/29020866/cause-and-timing-of-death-and-sub-group-differential-effects-of-erythropoietin-in-the-epo-tbi-study
#18
Markus Benedict Skrifvars, Craig French, Michael Bailey, Jeffrey Presneill, Alistair Nichol, Lorraine Little, Jacques Duranteau, Olivier Huet, Samir Haddad, Yaseen Arabi, Colin McArthur, D James Cooper, Rinaldo Bellomo
The EPO-TBI study randomised 606 patients with moderate or severe traumatic brain injury (TBI) to be treated with weekly epoetin alfa (EPO) or placebo. Six-month mortality was lower in EPO treated patients in an analysis adjusting for TBI severity. Knowledge of possible differential effects by TBI injury subtype and acute neurosurgical treatment as well as timing and cause of death (COD) will facilitate the design of future interventional TBI trials. We defined COD as cerebral (brain death, cerebral death with withdrawal or death during maximal care) and non-cerebral (death following withdrawal or during maximal care due to a non-cerebral cause)...
October 12, 2017: Journal of Neurotrauma
https://www.readbyqxmd.com/read/28974331/major-publications-in-the-critical-care-pharmacotherapy-literature-january-december-2016
#19
REVIEW
Deanna Horner, Diana Altshuler, Chris Droege, Joel Feih, Kevin Ferguson, Mallory Fiorenza, Kasey Greathouse, Leslie Hamilton, Caitlin Pfaff, Lauren Roller, Joanna Stollings, Adrian Wong
PURPOSE: To summarize select critical care pharmacotherapy guidelines and studies published in 2016. SUMMARY: The Critical Care Pharmacotherapy Literature Update (CCPLU) Group screened 31 journals monthly for relevant pharmacotherapy articles and selected 107 articles for review over the course of 2016. Of those included in the monthly CCPLU, three guidelines and seven primary literature studies are reviewed here. The guideline updates included are as follows: hospital-acquired pneumonia and ventilator-associated pneumonia management, sustained neuromuscular blocking agent use, and reversal of antithrombotics in intracranial hemorrhage (ICH)...
February 2018: Journal of Critical Care
https://www.readbyqxmd.com/read/28947525/successful-treatment-of-chronic-hepatitis-c-virus-infection-in-a-patient-receiving-daily-peritoneal-dialysis
#20
Jennifer E Stark, Jennifer Cole
PURPOSE: Successful use of a 4-drug oral fixed-dose combination therapy to treat chronic hepatitis C in a patient receiving peritoneal dialysis (PD) is reported. SUMMARY: New highly effective treatments for chronic hepatitis C virus (HCV) infection are now available, but safety and efficacy data on the use of anti-HCV therapies in patients with renal failure, particularly those requiring PD, remain limited. A 73-year-old black man with chronic HCV genotype 1a infection and stage 5 chronic renal disease requiring daily automated PD was referred for HCV treatment prior to renal transplantation...
October 1, 2017: American Journal of Health-system Pharmacy: AJHP
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