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Joré Céline, Brun Jean-Frédéric, Varlet-Marie Emmanuelle
Erythropoietin (EPO) is a major regulator of blood viscosity. Its long lasting action analogue methoxy polyethylene glycol-epoetin-β (MIRCERA®) seems to be also employed in modern doping. We took the opportunity of a study aiming at developing a detection of recent MIRCERATM injection in the context of doping detection to assess the effects of this EPO analogue on red blood cells (RBC) aggregation. A single dose 200 μg of MIRCERA® was injected to 10 male volunteers and blood samplings were drawn over 24 days...
October 17, 2016: Clinical Hemorheology and Microcirculation
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...
October 3, 2016: Anesthesia and Analgesia
Patrick Biggar, Frank Leistikow, Andreas Walper
AIMS: The aim of this study was to investigate the effectiveness, safety, and tolerability of iron isomaltoside in routine practical care of iron deficiency anemia (IDA) in patients with chronic renal failure. METHODS: The study included 698 patients with IDA on dialysis or with nondialysis chronic kidney disease (CKD) stages 3 - 5 designated by their physicians for treatment with iron isomaltoside. Data were recorded at baseline and after 3 and 9 months. Effectiveness data included measurement of hemoglobin (Hb), hematocrit, s-iron, transferrin saturation (TSAT), and s-ferritin...
October 14, 2016: Clinical Nephrology
Valeria Cernaro, Alessandra Sfacteria, Claudia Rifici, Francesco Macrì, Giulia Maricchiolo, Antonio Lacquaniti, Carlo Alberto Ricciardi, Antoine Buemi, Giuseppe Costantino, Domenico Santoro, Michele Buemi
BACKGROUND: Gentamicin is an aminoglycoside antibiotic widely used in the treatment of infections caused by Gram-negative bacteria. The main limitation to its therapeutic effectiveness is the potential nephrotoxicity. Erythropoietin has a tissue protective effect widely demonstrated in the kidney. The aim of the present study was to evaluate the renoprotective effects of erythropoietin in a model of zebrafish (Danio rerio) after administration of gentamicin. METHODS: Sixty adult zebrafish were subdivided into three groups: group A was treated with gentamicin; group B received gentamicin and, 24 h later, epoetin alpha; group C received drug diluent only...
September 27, 2016: Journal of Nephrology
Vincenzo Panichi, Guido Ricchiuti, Alessia Scatena, Lucia Del Vecchio, Francesco Locatelli
Pure red cell aplasia (PRCA) may develop in patients with chronic kidney disease receiving erythropoiesis-stimulating agents (ESA). We report on a 72-year-old patient who developed hypo-proliferative anaemia unresponsive to ESA following the administration of epoetin zeta subcutaneously for 7 months. On the basis of severe isolated hypoplasia of the erythroid line in the bone marrow and high-titre neutralizing anti-erythropoietin antibodies (Ab), a diagnosis of Ab-mediated PRCA was made. Epoetin zeta was discontinued and the patient was given steroids...
August 2016: Clinical Kidney Journal
Dennis Stalker, Susan Reid, Atulkumar Ramaiya, Wayne A Wisemandle, Nancy E Martin
PURPOSE: The purpose of this study was to evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of single 100 U/kg subcutaneous doses of Epoetin Hospira and Epogen in healthy male subjects as part of an overall program to demonstrate biosimilarity of Epoetin Hospira to the reference product Epogen. METHODS: This single-center, open-label, randomized, 2-period, crossover study was conducted in 81 healthy male subjects. Subjects were randomized to Sequence 1, in which they received 100 U/kg of Epoetin Hospira or to sequence 2, in which they received 100 U/kg Epogen subcutaneously in the first study period and the alternative treatment in the second study period...
August 2016: Clinical Therapeutics
Séverine Lamon, Evelyn Zacharewicz, Emily Arentson-Lantz, Paul A Della Gatta, Lobna Ghobrial, Frederico Gerlinger-Romero, Andrew Garnham, Douglas Paddon-Jones, Aaron P Russell
PURPOSE: Erythropoietin (EPO) is a renal cytokine that is primarily involved in hematopoiesis while also playing a role in non-hematopoietic tissues expressing the EPO-receptor (EPOR). The EPOR is present in human skeletal muscle. In mouse skeletal muscle, EPO stimulation can activate the AKT serine/threonine kinase 1 (AKT) signaling pathway, the main positive regulator of muscle protein synthesis. We hypothesized that a single intravenous EPO injection combined with acute resistance exercise would have a synergistic effect on skeletal muscle protein synthesis via activation of the AKT pathway...
2016: Frontiers in Physiology
Keitaro Nishizawa, Toshiyuki Yano, Masaya Tanno, Takayuki Miki, Atsushi Kuno, Toshiyuki Tobisawa, Makoto Ogasawara, Shingo Muratsubaki, Kouhei Ohno, Satoko Ishikawa, Tetsuji Miura
Chronic kidney disease (CKD) is known to increase myocardial infarct size after ischemia/reperfusion. However, a strategy to prevent the CKD-induced myocardial susceptibility to ischemia/reperfusion injury has not been developed. Here, we examined whether epoetin β pegol, a continuous erythropoietin receptor activator (CERA), normalizes myocardial susceptibility to ischemia/reperfusion injury by its effects on protective signaling and metabolomes in CKD. CKD was induced by 5/6 nephrectomy in rats (subtotal nephrectomy, SNx), whereas sham-operated rats served controls (Sham)...
September 2016: Hypertension
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
Filipe C Araújo, João Gonçalves, João Eurico Fonseca
Despite representing a breakthrough in the treatment of immune-mediated rheumatic diseases, the direct costs of biotechnological therapies represent a burden to healthcare budgets worldwide. Furthermore, several studies demonstrated that socioeconomically constrained countries have poorer access to these therapies and this has consequences on the optimal management of rheumatic patients. Experience with small peptide biosimilars like filgrastim and epoetin confirmed significant cost savings but revealed variable market uptake...
August 2016: Current Rheumatology Reports
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
Wolfgang Jelkmann
Total hemoglobin (Hb) mass is an important determinant of aerobic power. The glycoprotein erythropoietin (Epo) promotes the production of red blood cells (RBCs). The present article reviews the regulation of erythropoiesis and ways of its manipulation. The various Epos, e.g. recombinant human (rh)Epo and (epoetin), and their long-acting analogues can be misused by cheating athletes, but the drugs are detectable by chemical tests, because their glycan isoform structures differ from those of endogenous Epo. Still, anti-doping control has become more difficult, since additional erythropoiesis-stimulating agents have become available (Epo mimetics, activin inhibitors, and small-molecule chemical drugs activating EPO expression)...
2016: Frontiers of Hormone Research
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
Koji Hashimoto, Makoto Harada, Yuji Kamijo
Anti-erythropoietin (anti-EPO) antibody-related pure red cell aplasia (PRCA) is a rare but serious complication that can occur during the administration of erythropoiesis-stimulating agents. Treatment with the calcineurin inhibitor cyclosporine has shown benefits in patients with anti-EPO PRCA. The efficacy of tacrolimus, another calcineurin inhibitor, in patients with anti-EPO PRCA has not been determined. The present report is the first our knowledge to describe the successful treatment of a patient with anti-EPO PRCA using tacrolimus...
October 2016: International Journal of Hematology
Amit B Agarwal, Ali McBride
The World Health Organization defines a biosimilar as "a biotherapeutic product which is similar in terms of quality, safety and efficacy to an already licensed reference biotherapeutic product." Biosimilars are biologic medical products that are very distinct from small-molecule generics, as their active substance is a biological agent derived from a living organism. Approval processes are highly regulated, with guidance issued by the European Medicines Agency and US Food and Drug Administration. Approval requires a comparability exercise consisting of extensive analytical and preclinical in vitro and in vivo studies, and confirmatory clinical studies...
August 2016: Critical Reviews in Oncology/hematology
Kazuhiko Tsuruya, Yukari Uemura, Hideki Hirakata, Takanari Kitazono, Yoshiharu Tsubakihara, Masashi Suzuki, Yasuo Ohashi
AIM: The association between responsiveness to continuous erythropoietin-receptor activator (C.E.R.A.) and renal survival in patients with non-dialysis-dependent chronic kidney disease (NDD-CKD) is uncertain. METHODS: We performed a pooled analysis of individual patient-level data drawn from five clinical trials involving C.E.R.A. administration. Based on the responsiveness to C.E.R.A., patients were classified into poor- or good-response groups. Primary endpoints were defined as the initiation of dialysis or a 30% decrease in the estimated glomerular filtration rate (eGFR) from baseline...
June 17, 2016: Nephrology
Elani Streja, Jongha Park, Ting-Yan Chan, Janet Lee, Melissa Soohoo, Connie M Rhee, Onyebuchi A Arah, Kamyar Kalantar-Zadeh
It has been previously reported that a higher erythropoiesis stimulating agent (ESA) dose in hemodialysis patients is associated with adverse outcomes including mortality; however the causal relationship between ESA and mortality is still hotly debated. We hypothesize ESA dose indeed exhibits a direct linear relationship with mortality in models of association implementing the use of a marginal structural model (MSM), which controls for time-varying confounding and examines causality in the ESA dose-mortality relationship...
2016: International Journal of Nephrology
Yu S Milovanov, N A Mukhin, L V Kozlovskaya, S Yu Milovanova, M M Markina
AIM: To investigate the impact of anemia correction with erythropoiesis stimulants on the serum level of the circulating morphogenetic protein α-Klotho in patients with Stages 3B--4 chronic kidney disease (CKD). SUBJECTS AND METHODS: 64 patients aged 42±8 years with Stages 3B--4 nondiabetic CKD were examined and divided into 2 groups: 1) 32 patients with anemia (the target hemoglobin levels could be achieved and kept with erythropoietin and iron saccharate in 20 patients (Group A) and those could not be done in 12 patients (Group 1B)...
2016: Terapevticheskiĭ Arkhiv
Sylvain Thépot, Raouf Ben Abdelali, Sylvie Chevret, Aline Renneville, Odile Beyne-Rauzy, Thomas Prébet, Sophie Park, Aspasia Stamatoullas, Agnes Guerci-Bresler, Stéphane Cheze, Gérard Tertian, Bachra Choufi, Laurence Legros, Jean Noel Bastié, Jacques Delaunay, Marie Pierre Chaury, Laurence Sanhes, Eric Wattel, Francois Dreyfus, Norbert Vey, Fatiha Chermat, Claude Preudhomme, Pierre Fenaux, Claude Gardin
The efficacy of azacitidine in patients with anemia and with lower-risk myelodysplastic syndromes, if relapsing after or resistant to erythropoietic stimulating agents, and the benefit of combining these agents to azacitidine in this setting are not well known. We prospectively compared the outcomes of patients, all of them having the characteristics of this subset of lower-risk myelodysplastic syndrome, if randomly treated with azacitidine alone or azacitidine combined with epoetin-β. High-resolution cytogenetics and gene mutation analysis were performed at entry...
August 2016: Haematologica
Theodor Dingermann, Florian Scotte
INTRODUCTION: There is an essential need for clinicians to understand the development and approval process of biosimilars. Extrapolation of efficacy and safety data from one indication to another may be considered by a comprehensive comparability program including safety, efficacy and immunogenicity, which detect potentially clinically relevant differences. AREAS COVERED: This article specifically discusses the approval of epoetin zeta (Retacrit™, Hospira, a Pfizer company) and the EMA reasoning for extrapolation of indications...
July 2016: Expert Opinion on Biological Therapy
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