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Epoetin Alfa

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https://www.readbyqxmd.com/read/29020866/cause-and-timing-of-death-and-sub-group-differential-effects-of-erythropoietin-in-the-epo-tbi-study
#1
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
#2
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
#3
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
#4
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/28782299/continuous-erythropoiesis-receptor-activator-cera-for-the-anaemia-of-chronic-kidney-disease
#5
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
#6
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
https://www.readbyqxmd.com/read/28717516/costs-associated-with-intravenous-darbepoetin-versus-epoetin-therapy-in-hemodialysis-patients-a-randomized-controlled-trial
#7
Andrea L Woodland, Sean W Murphy, Bryan M Curtis, Brendan J Barrett
BACKGROUND: Anemia of chronic kidney disease is associated with adverse outcomes and a reduced quality of life. Erythropoiesis-stimulating agents (ESAs) have improved anemia management, and 2 agents are available in Canada, epoetin alfa (EPO) and darbepoetin alfa (DA). EPO and DA are considered equally effective in achieving target hemoglobin (Hb), but it is not clear whether there is a cost difference. There have been few head-to-head comparisons; most published studies are observational switch studies...
2017: Canadian Journal of Kidney Health and Disease
https://www.readbyqxmd.com/read/28642700/pricing-and-reimbursement-of-biosimilars-in-central-and-eastern-european-countries
#8
Paweł Kawalec, Ewa Stawowczyk, Tomas Tesar, Jana Skoupa, Adina Turcu-Stiolica, Maria Dimitrova, Guenka I Petrova, Zinta Rugaja, Agnes Männik, Andras Harsanyi, Pero Draganic
Objectives: The aim of this study was to review the requirements for the reimbursement of biosimilars and to compare the reimbursement status, market share, and reimbursement costs of biosimilars in selected Central and Eastern European (CEE) countries. Methods: A questionnaire-based survey was conducted between November 2016 and January 2017 among experts from the following CEE countries: Bulgaria, Czech Republic, Croatia, Estonia, Hungary, Latvia, Lithuania, Poland, Slovakia, and Romania. The requirements for the pricing and reimbursement of biosimilars were reviewed for each country...
2017: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/28465779/is-a-biologic-produced-15-years-ago-a-biosimilar-of-itself-today
#9
Stanton R Mehr, Marj P Zimmerman
Much of the testing required for the regulatory approval of a biosimilar is focused on proving that the new drug is sufficiently similar to the reference biologic in structure, pharmacokinetics or pharmacodynamics, clinical efficacy, and safety. However, the reference drug may itself have gone through some changes in the years since its approval, including those caused by alterations in the manufacturing process. Do these changes increase the risk that the reference drug may cause unexpected outcomes? It is up to the US Food and Drug Administration to decide whether the changes merit the need for additional studies to confirm that the drug meets the structural or clinical outcomes standard for the reference agent...
December 2016: American Health & Drug Benefits
https://www.readbyqxmd.com/read/28438754/smad1-5-is-required-for-erythropoietin-mediated-suppression-of-hepcidin-in-mice
#10
Chia-Yu Wang, Amanda B Core, Susanna Canali, Kimberly B Zumbrennen-Bullough, Sinan Ozer, Lieve Umans, An Zwijsen, Jodie L Babitt
Anemia suppresses liver hepcidin expression to supply adequate iron for erythropoiesis. Erythroferrone mediates hepcidin suppression by anemia, but its mechanism of action remains uncertain. The bone morphogenetic protein (BMP)-SMAD signaling pathway has a central role in hepcidin transcriptional regulation. Here, we explored the contribution of individual receptor-activated SMADs in hepcidin regulation and their involvement in erythroferrone suppression of hepcidin. In Hep3B cells, SMAD5 or SMAD1 but not SMAD8, knockdown inhibited hepcidin (HAMP) messenger RNA (mRNA) expression...
July 6, 2017: Blood
https://www.readbyqxmd.com/read/28371815/phase-2-studies-of-oral-hypoxia-inducible-factor-prolyl-hydroxylase-inhibitor-fg-4592-for-treatment-of-anemia-in-china
#11
Nan Chen, Jiaqi Qian, Jianghua Chen, Xueqing Yu, Changlin Mei, Chuanming Hao, Gengru Jiang, Hongli Lin, Xinzhou Zhang, Li Zuo, Qiang He, Ping Fu, Xuemei Li, Dalvin Ni, Stefan Hemmerich, Cameron Liu, Lynda Szczech, Anatole Besarab, Thomas B Neff, Kin-Hung Peony Yu, Frank H Valone
Background: FG-4592 (roxadustat) is an oral hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitor (HIF-PHI) promoting coordinated erythropoiesis through the transcription factor HIF. Two Phase 2 studies were conducted in China to explore the safety and efficacy of FG-4592 (USAN name: roxadustat, CDAN name: ), a HIF-PHI, in patients with anemia of chronic kidney disease (CKD), both patients who were dialysis-dependent (DD) and patients who were not dialysis-dependent (NDD). Methods: In the NDD study, 91 participants were randomized to low (1...
August 1, 2017: Nephrology, Dialysis, Transplantation
https://www.readbyqxmd.com/read/28344481/stability-of-erythropoietin-repackaging-in-polypropylene-syringes-for-clinical-use
#12
Angela Marsili, Giorgia Puorro, Chiara Pane, Anna de Rosa, Giovanni Defazio, Carlo Casali, Antonio Cittadini, Giuseppe de Michele, Brunello Ettore Florio, Alessandro Filla, Francesco Saccà
Introduction: Epoetin alfa (Eprex®) is a subcutaneous, injectable formulation of short half-life recombinant human erythropoietin (rHuEPO). To current knowledge there are no published studies regarding the stability of rHuEPO once repackaging occurs (r-EPO) for clinical trial purposes. Materials and methods: We assessed EPO concentration in Eprex® and r-EPO syringes at 0, 60, 90, and 120 days after repackaging in polypropylene syringes. R-EPO was administered to 56 patients taking part in a clinical trial in Friedreich Ataxia...
February 2017: Saudi Pharmaceutical Journal: SPJ: the Official Publication of the Saudi Pharmaceutical Society
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
#13
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)...
May 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
#14
RANDOMIZED CONTROLLED TRIAL
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
#15
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/28142147/history-of-erythropoiesis-stimulating-agents-the-development-of-biosimilars-and-the-future-of-anemia-treatment-in-nephrology
#16
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/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/27749350/spine-surgery-and-blood-loss-systematic-review-of-clinical-evidence
#18
REVIEW
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...
November 2016: Anesthesia and Analgesia
https://www.readbyqxmd.com/read/27441542/clinical-application-of-recombinant-erythropoietin-in-beta-thalassaemia-intermedia
#19
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
https://www.readbyqxmd.com/read/27364049/early-high-dose-erythropoietin-therapy-after-out-of-hospital-cardiac-arrest-a-multicenter-randomized-controlled-trial
#20
RANDOMIZED CONTROLLED TRIAL
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
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