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https://www.readbyqxmd.com/read/29220885/indexes-of-the-erythropoietin-level-in-the-blood-plasma-of-chronic-heart-failure-patients-with-anemia
#1
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
#2
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
#3
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
#4
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
#5
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
#6
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
#7
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
#8
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
#9
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
#10
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
#11
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/29047386/epoetin-%C3%AE-pegol-continuous-erythropoietin-receptor-activator-cera-is-another-choice-for-the-treatment-of-anemia-in-myelodysplastic-syndrome-a-case-report
#12
Tatsuyoshi Ikenoue, Hiroshi Naito, Tetsuya Kitamura, Hideki Hattori
BACKGROUND: In most patients, anemia is present when myelodysplastic syndrome is diagnosed. Although darbepoetin α is the first-choice supportive therapy for low-risk myelodysplastic syndrome, half of all patients develop a loss of response to darbepoetin α within 12 months. However, few reports have described supportive therapy after the loss of response to darbepoetin α. CASE PRESENTATION: We herein present a case involving a 65-year-old Japanese woman with low-risk myelodysplastic syndrome whose erythropoiesis-stimulating agent treatment was switched from darbepoetin α to epoetin β pegol (continuous erythropoietin receptor activator) to treat transfusion-dependent anemia...
October 19, 2017: Journal of Medical Case Reports
https://www.readbyqxmd.com/read/29020866/cause-and-timing-of-death-and-sub-group-differential-effects-of-erythropoietin-in-the-epo-tbi-study
#13
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
#14
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)...
September 22, 2017: 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
#15
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
https://www.readbyqxmd.com/read/28898593/biosimilars-implications-for-clinical-practice
#16
Robert M Rifkin, Susan R Peck
In 2015, the United States Food and Drug Administration (FDA) approved the first biosimilar, filgrastim-sndz, a biosimilar of the granulocyte colony-stimulating factor filgrastim. Since that time, the FDA has approved four additional biosimilar tumor necrosis factor α inhibitors, and, in May 2017, the Oncology Drug Advisory Committee voted in favor of approval of an epoetin alfa biosimilar. The patents of several widely used biologic cancer therapies (including trastuzumab, rituximab, bevacizumab, cetuximab, and pegfilgrastim) are recently expired or due to expire in the near future, so the introduction of biosimilars into the oncology treatment armamentarium is imminent...
September 2017: Journal of Oncology Practice
https://www.readbyqxmd.com/read/28871421/biosimilar-uptake-by-british-local-formularies-a-cross-sectional-study
#17
Saja Alnahar, Rachel A Elliott, Murray D Smith
Background Biological medicines are starting to lose their patent protection, so similar, inexact copies (biosimilars) are being developed and licensed. The high acquisition costs of biologics for healthcare providers could be reduced by switching to biosimilars, thus alleviating budgetary pressures and increasing patient access. Therefore, the acceptance of biosimilars by prescribers in Great Britain (GB; England, Scotland, Wales) needs to be described and understood. Objective To determine uptake of the first wave of biosimilars (somatropin, epoetin, filgrastim) by local formularies (lists of preferred medicines for prescribing in local healthcare settings)...
September 4, 2017: International Journal of Clinical Pharmacy
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
#18
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...
November 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
#19
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
#20
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...
October 2017: Clinical Nephrology
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