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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
#1
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
#2
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
#3
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
#4
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
#5
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
#6
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)...
March 2, 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
#7
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
#8
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/28168382/molecular-design-expression-and-evaluation-of-pasylated-human-recombinant-erythropoietin-with-enhanced-functional-properties
#9
Mohammad Hossein Hedayati, Dariush Norouzian, Mahdi Aminian, Shahram Teimourian, Reza Ahangari Cohan, Soroush Sardari, M Reza Khorramizadeh
Erythropoietin (EPO) is the principal hormone which, has somewhat short half-life involved in the differentiation and regulation of circulating red blood cells. The present study was carried out to evaluate the capability of a polyethylene glycol mimetic technology as a biological alternative to improve pharmaceutical properties of human recombinant EPO. In silico models of EPO fused to 200 amino acids of proline, alanine, and serine (PAS) were initially generated and assessed by molecular dynamic (MD) simulation...
February 2017: Protein Journal
https://www.readbyqxmd.com/read/28142147/history-of-erythropoiesis-stimulating-agents-the-development-of-biosimilars-and-the-future-of-anemia-treatment-in-nephrology
#10
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/28137221/methoxy-polyethylene-glycol-epoetin-beta-as-a-novel-erythropoiesis-stimulating-agent-with-possible-nephroprotective-and-cardiovascular-protective-effects-in-non-dialysis-chronic-kidney-disease-patients
#11
Bartnicki Piotr, Stępień Mariusz, Rysz Jacek
Chronic kidney disease (CKD) is an important health problem, because of unsuccessful outcomes such as CKD progression to end stage renal disease and high risk of cardiovascular disease (CVD). Anemia, associated with CKD, is considered a non-traditional risk factor for CVD which may contribute to faster CKD progression. Anemia treatment with erythropoiesis-stimulating agents (ESAs) seems to exert non-hematopoietic effects on different tissues and organs, including cardiovascular system and kidneys. On the other hand, clinical use of high doses of short-acting ESAs and higher target hemoglobin level were associated with higher risk of CVD...
January 26, 2017: Current Pharmaceutical Biotechnology
https://www.readbyqxmd.com/read/28119134/erythropoietin-as-a-performance-enhancing-drug-its-mechanistic-basis-detection-and-potential-adverse-effects
#12
Olivier Salamin, Tiia Kuuranne, Martial Saugy, Nicolas Leuenberger
Erythropoietin (EPO) is the main hormone regulating red blood cell (RBC) production. The large-scale production of a recombinant human erythropoietin (rHuEPO) by biotechnological methods has made possible its widespread therapeutic use as well as its misuse in sports. Since the marketing of the first epoetin in 1989, the development has progressed to the third-generation analogs. However, the production of rHuEPO is costly, and the frequent administration of an injectable formula is not optimal for compliance of therapeutic patients...
January 21, 2017: Molecular and Cellular Endocrinology
https://www.readbyqxmd.com/read/28109258/effect-of-erythropoietin-in-patients-with-acute-myocardial-infarction-five-year-results-of-the-revival-3-trial
#13
Birgit Steppich, Philip Groha, Tareq Ibrahim, Heribert Schunkert, Karl-Ludwig Laugwitz, Martin Hadamitzky, Adnan Kastrati, Ilka Ott
BACKGROUND: Erythropoietin (EPO) has been suggested to promote cardiac repair after MI. However, the randomized, double-blind, placebo controlled REVIVAL-3 trial showed that short term high dose EPO in timely reperfused myocardium does not improve left ventricular ejection fraction after 6 months. Moreover, the study raised safety concerns due to a trend towards a higher incidence of adverse clinical events as well as a increase in neointima formation after treatment with EPO. The present study therefore aimed to assess the 5-year clinical outcomes...
January 21, 2017: BMC Cardiovascular Disorders
https://www.readbyqxmd.com/read/28078434/a-retrospective-open-label-uncontrolled-study-of-epoetin-zeta-on-the-treatment-of-chemotherapy-induced-anemia-in-solid-tumors
#14
Constantinos E Alifieris, Kyriakos Orfanakos, Aristina Papanota, George P Stathopoulos, Nikolaos Sitaras, Dimitrios T Trafalis
PURPOSE: This is a single-center uncontrolled retrospective study to evaluate the efficacy and safety of the biosimilar epoetin zeta after approval in chemotherapy-induced anemia (CIA). METHODS: Patients screened were >18 years old suffering from solid malignancies and CIA with Hg ≤10 or <11 g/dl if symptomatic anemia. Patients had measurable disease by TNM and Eastern Cooperative Oncology Group (ECOG). Patients were treated for at least 12 weeks and the primary endpoint was to determine the incidence of blood transfusions, and secondarily, the overall safety and efficacy defined as ≥1 g/dl rise in Hb concentration or ≥40,000 cells/μl rise in reticulocyte count...
April 2017: Journal of Cancer Research and Clinical Oncology
https://www.readbyqxmd.com/read/28066881/short-acting-erythropoiesis-stimulating-agents-for-anaemia-in-predialysis-patients
#15
REVIEW
Deirdre Hahn, Christopher I Esezobor, Noha Elserafy, Angela C Webster, Elisabeth M Hodson
BACKGROUND: The benefits of erythropoiesis-stimulating agents (ESA) for chronic kidney disease (CKD) patients have been previously demonstrated. However, the efficacy and safety of short-acting epoetins administered at larger doses and reduced frequency as well as of new epoetins and biosimilars remains uncertain. OBJECTIVES: This review aimed to evaluate the benefits and harms of different routes, frequencies and doses of epoetins (epoetin alpha, epoetin beta and other short-acting epoetins) for anaemia in adults and children with CKD not receiving dialysis...
January 9, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28054454/epoetin-beta-pegol-ameliorates-flow-mediated-dilation-with-improving-enos-coupling-state-in-non-obese-diabetic-rats
#16
Kenichi Serizawa, Kenji Yogo, Yoshihito Tashiro, Ryohei Kawasaki, Koichi Endo, Yasushi Shimonaka, Michinori Hirata
BACKGROUND/AIMS: Patients with diabetic nephropathy have a high cardiovascular mortality. Epoetin beta pegol (continuous erythropoietin receptor activator, C.E.R.A.) is a drug for the treatment of renal anemia. In this study, we investigated the effect of C.E.R.A. on vascular endothelial function as evaluated by flow-mediated dilation (FMD) and the relationship between hematopoiesis and FMD in diabetic nephropathy rats. METHODS: Male Spontaneously Diabetic Torii rats (SDT, 22 weeks old) were used...
January 5, 2017: Cardiovascular Therapeutics
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
#17
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/27942203/pharmacoutilization-of-epoetins-in-na%C3%A3-ve-patients-with-hematological-malignancies-in-an-unselected-italian-population-under-clinical-practice-setting-a-comparative-analysis-between-originator-and-biosimilars
#18
Valentina Perrone, Stefania Saragoni, Stefano Buda, Alessandro Broccoli, Luca Degli Esposti
AIM: The purpose of this study was to assess the prescription of epoetins and consumption of health care resources (in terms of drug treatments) in naïve patients with hematological malignancies in a real-world setting; in particular, we compared the results between reference product and biosimilar products. METHODS: An observational retrospective study based on administrative and laboratory databases of three local health units was conducted. All adults diagnosed with hematological malignancies and who had received at least one epoetin (either reference product or biosimilars) prescription for the first time between 1 January 2010 and 30 April 2012 (enrollment period) were included...
2016: Biologics: Targets & Therapy
https://www.readbyqxmd.com/read/27932518/epoetin-%C3%AE-induced-pure-red-cell-aplasia-an-unintended-consequence
#19
Muhammad Masoom Javaid, Priyanka Khatri, Srinivas Subramanian
Pure red cell aplasia is a rare condition associated with the use of recombinant human erythropoietin preparations. It has predominantly been associated with the subcutaneous use of a particular epoetin-α product, Eprex, and is rarely associated with intravenous use or with other commercially available products. Only a few cases of pure red cell aplasia secondary to epoetin-β have been reported. On account of its rarity, the condition can often be missed on initial presentation, leading to unnecessary investigations and delayed diagnosis...
March 2017: Postgraduate Medical Journal
https://www.readbyqxmd.com/read/27855097/combination-with-intravenous-iron-supplementation-or-doubling-erythropoietin-dose-for-patients-with-chemotherapy-induced-anaemia-inadequately-responsive-to-initial-erythropoietin-treatment-alone-study-protocol-for-a-randomised-controlled-trial
#20
Lin Chen, Hong Jiang, Wei Gao, Ye Tu, Ying Zhou, Xi Li, Zhe Zhu, Qixin Jiang, Haifeng Zhan, Jiangming Yu, Chuangang Fu, Yong Gao
INTRODUCTION: Erythropoietin (EPO) is a commonly used option in the treatment of chemotherapy-induced anaemia (CIA). However, ∼30-50% of patients fail to achieve an adequate response after initial treatment. Prior studies have demonstrated that intravenous iron might synergistically improve therapeutic response to EPO treatment in this patient population. METHODS AND ANALYSIS: We will perform this multicentre, randomised, open-label, parallel-group, active controlled non-inferiority study to compare the two combination therapies of EPO plus intravenous iron regimen versus doubling the dose of EPO in patients with CIA who have an inadequate response to initial EPO treatment at a routine dose...
October 7, 2016: BMJ Open
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