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https://www.readbyqxmd.com/read/29441494/cost-minimisation-analysis-of-erythropoiesis-stimulating-agents-in-the-treatment-of-anaemia-in-dialysed-patients-a-pilot-study
#1
Astrid Darsonval, Virginie Besson, Claire Cavalin
OBJECTIVE: This study aimed to assess the cost impact of administering erythropoiesis-stimulating agents once every 4 weeks instead of one to three times a week to treat anaemia in patients undergoing dialysis. METHODS: This was a monocentric retrospective study involving 27 patients who underwent haemodialysis between 2009 and 2013 in a university hospital in Angers, France. The study was a cost-minimisation analysis from the hospital perspective. Only direct medical costs were considered...
September 2017: PharmacoEconomics Open
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
#2
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/29417431/epoetin-biosimilars-in-the-treatment-of-chemotherapy-induced-anemia-10%C3%A2-years-experience-gained
#3
REVIEW
Matti Aapro, Andriy Krendyukov, Martin Schiestl, Pere Gascón
High-quality, safe, and effective biosimilars have the potential to increase access to biological therapies worldwide and to reduce cancer care costs. The European Medicines Agency (EMA) was the first regulatory authority to establish legislative procedures for the approval of biosimilars when they published their guidelines on similar biological medicinal products in 2005. Biosimilar epoetins were first approved in 2007, and a wealth of data has been collected over the last decade. Two biosimilar epoetins (under five commercial names) have been approved by the EMA so far...
February 7, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
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
#4
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...
January 31, 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
#5
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/29374477/epoetin-beta-pegol-for-treatment-of-anemia-ameliorates-deterioration-of-erythrocyte-quality-associated-with-chronic-kidney-disease
#6
Ken Aizawa, Ryohei Kawasaki, Yoshihito Tashiro, Yasushi Shimonaka, Michinori Hirata
BACKGROUND: Epoetin beta pegol (continuous erythropoietin receptor activator; C.E.R.A.) is currently widely used for the treatment of anemia associated with chronic kidney disease (CKD). Therapeutic control of anemia is assessed by monitoring haemoglobin (Hb) levels. However, certain qualitative aspects of erythrocytes are also impaired in CKD, including loss of deformability and shortened life-span. Therefore, monitoring Hb alone could potentially fail to reveal pathological changes in erythrocytes...
January 27, 2018: BMC Nephrology
https://www.readbyqxmd.com/read/29296077/hx575-established-biosimilarity-in-the-treatment-of-renal-anemia-and-10-years-of-clinical-experience
#7
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
#8
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...
December 22, 2017: Critical Care Medicine
https://www.readbyqxmd.com/read/29228453/effects-of-erythropoietin-on-spontaneous-and-oxytocin-induced-myometrial-contractions-in-the-nonpregnant-rat
#9
N Tug, H Ayvaci Tasan, M A Sargin, B Dogan Taymur, A Ayar, E Kilic, B Yilmaz
OBJECTIVE: Erythropoietin (EPO) is a glycoprotein hormone that regulates erythropoiesis. EPO activity has also been detected in a variety of tissue including the nervous system, and female and male reproductive organs. It has been shown that EPO causes relaxation in vascular smooth muscle. In the present study, we have investigated effects of EPO on spontaneous and oxytocin-induced contractions of non-pregnant rat myometrium. MATERIALS AND METHODS: Myometrial stripes were obtained from adult Wistar rats at the oestrous stage...
November 2017: European Review for Medical and Pharmacological Sciences
https://www.readbyqxmd.com/read/29220885/indexes-of-the-erythropoietin-level-in-the-blood-plasma-of-chronic-heart-failure-patients-with-anemia
#10
Kamala Kh Zahidova
BACKGROUND: Anemia aggravates the disease course and the survival rate of chronic heart failure (CHF) patients. The purpose of the study was to investigate the level of erythropoietin (EPO) in CHF patients with anemic syndrome, with the aim to more accurately assess the severity of the disease and its treatment, depending on the anemia degree. METHODS: Patients with ischemic CHF of I-IV functional class (FC) with and without anemia were examined (total number of patients=208, patients with anemia=174)...
December 7, 2017: Journal of Basic and Clinical Physiology and Pharmacology
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
#11
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
#12
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/29168688/long-term-treatment-with-biosimilar-epoetin-%C3%AE-hx575-in-hemodialysis-patients-with-renal-anemia-real-world-effectiveness-and-safety-in-the-monitor-ckd5-study%C3%A2
#13
Gérard London, Johannes Mann, David Goldsmith, Christian Combe, Frank Dellanna, Philippe Zaoui, Nadja Hoebel, Andriy Krendyukov, Karen MacDonald, Ivo Abraham
AIMS: To assess real-world effectiveness and safety of intravenous (IV) HX575, a biosimilar epoetin-α, in hemodialysis (HD) patients. MATERIALS AND METHODS: This prospective, observational, pharmacoepidemiological study of adult HD patients treated with IV HX575 for renal anemia for up to 24 months was conducted in 114 centers in 10 European countries. Of 2,086 enrolled subjects (safety sample), 2,023 had ≥ 1 follow-up visit (effectiveness sample). RESULTS: Most (59...
November 23, 2017: Clinical Nephrology
https://www.readbyqxmd.com/read/29149162/-switching-from-one-drug-therapy-to-another-with-the-same-therapeutic-indication-without-harms
#14
Valeria Belleudi, Antonio Addis
The loss of exclusivity from several drug therapies largely used bring new attention the issues of safety, efficacy and following the switch from one drug to another (i.e., biosimilar and/or generics) with the same indication. This is not a problem that can be related to regulatory or economical factors. The increase of patients exposed to chronic conditions and the introductions or more pharmaceutical alternatives with same therapeutic indications yield for studies able to verify the effectiveness and safety even when switch from more drugs is considered by practitioners...
November 2017: Recenti Progressi in Medicina
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
#15
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/29127105/epor2-%C3%A3-cr2-independendent-effects-of-low-dose-epoetin-a-in-porcine-liver-transplantation
#16
Linus Kebschull, Leon Franz Christoph Theilmann, Annika Mohr, Wencke Uennigmann, Sandra Stoeppeler, Barbara Heitplatz, Hans-Ullrich Spiegel, Ralf Bahde, Daniel Michael Palmes, Felix Becker
Ischemia-reperfusion injury (IRI) remains the key component of graft damage during transplantation. Erythropoietin (EPO) induces anti-inflammatory and anti-apoptotic effects via the EPOR2/ßcR2-complex, with the potential risk of thrombosis. Previous work indicates that EPO has EPOR2/ßcR2-independent protective effects via direct effects on the endothelium. As the EPOR2/ßcR2-receptor has a very low affinity for EPO, we aimed to test the hypothesis that EPO doses below the level that stimulate this receptor elicit cytoprotective effects via endothelial stimulation in a porcine liver transplantation model...
November 10, 2017: Bioscience Reports
https://www.readbyqxmd.com/read/29108928/transitioning-from-first-to-second-generation-biosimilars-an-appraisal-of-regulatory-and-post-marketing-challenges
#17
REVIEW
Corrado Blandizzi, Mauro Galeazzi, Guido Valesini
Second-generation biosimilars (i.e. monoclonal antibodies or proteins generated by fusion of antibody and receptor moieties) differ in several respects as compared to first-generation ones (e.g. epoetins, bone marrow stimulating factors, somatotropins). In this respect, as second-generation biosimilars are endowed with much greater structural and molecular complexity, which might translate into a number of pharmacological and therapeutic issues, they raise new challenges for manufacturers and regulatory authorities as well as new concerns for clinicians...
November 3, 2017: Pharmacological Research: the Official Journal of the Italian Pharmacological Society
https://www.readbyqxmd.com/read/29098093/epoetin-alfa-a-cause-of-coronary-artery-thrombosis
#18
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
#19
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...
November 2, 2017: 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
#20
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
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