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Darbepoetine

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https://www.readbyqxmd.com/read/28504901/tale-of-two-erythropoiesis-stimulating-agents-utilization-dosing-litigation-and-costs-of-darbepoetin-and-epoetin-among-south-carolina-medicaid-covered-patients-with-cancer-and-chemotherapy-induced-anemia
#1
Virginia Noxon, Kevin B Knopf, LeAnn B Norris, Brian Chen, Y Tony Yang, Zaina P Qureshi, William Hrushesky, Akida A Lebby, Benjamin Schooley, Neset Hikmet, Michael Dickson, Mae Thamer, Dennis Cotter, Paul R Yarnold, Charles L Bennett
PURPOSE: The US Food and Drug Administration (FDA) has approved epoetin and darbepoetin for chemotherapy-induced anemia (CIA). Approved epoetin and darbepoetin dosing schedules were three times per week and weekly, respectively, although off-label, less frequent scheduling was common. In 2004, 2007, and 2008, a US Food and Drug Administration Advisory Committees warned of risks associated with erythropoiesis-stimulating agents. During this period, lawsuits alleging illegal darbepoetin marketing practices have concluded, resulting in $1...
May 15, 2017: Journal of Oncology Practice
https://www.readbyqxmd.com/read/28484169/current-diagnosis-and-treatment-for-myelodysplastc-syndromes
#2
Tomoko Hata
Genetic analysis of myelodysplastic syndrome (MDS) using next-generation sequencing yields medcially important information, showing gene mutations in 90% of MDS cases. The World Health Organization (WHO) classification was revised in 2016 to incorporate SF3B1 gene mutations, frequently seen in MDS with ringed sideroblasts, into the diagnostic criteria. Unlike the poor prognosis seen in cases with ASXL1, EZH2, RUNX1 and in particular, TP53 MDS-related mutations, SF3B1 gene mutations show a favorable prognosis...
2017: [Rinshō Ketsueki] the Japanese Journal of Clinical Hematology
https://www.readbyqxmd.com/read/28391437/oral-sucrosomial-iron-versus-intravenous-iron-in-anemic-cancer-patients-without-iron-deficiency-receiving-darbepoetin-alfa-a-pilot-study
#3
Antonino Mafodda, D Giuffrida, A Prestifilippo, D Azzarello, R Giannicola, M Mare, R Maisano
PURPOSE: Erythropoiesis-stimulating agents (ESAs) are often used in treatment of patients with chemotherapy-induced anemia. Many studies have demonstrated an improved hemoglobin (Hb) response when ESA is combined with intravenous iron supplementation and a higher effectiveness of intravenous iron over traditional oral iron formulations. A new formulation of oral sucrosomial iron featuring an increased bioavailability compared to traditional oral formulations has recently become available and could provide a valid alternative to those by intravenous (IV) route...
April 9, 2017: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
https://www.readbyqxmd.com/read/28256075/the-use-of-darbepoetin-to-stimulate-erythropoiesis-in-the-treatment-of-anemia-of-chronic-kidney-disease-in-dogs
#4
E H Fiocchi, L D Cowgill, D C Brown, J E Markovich, S Tucker, M A Labato, M B Callan
BACKGROUND: Darbepoetin alfa (darbepoetin) is an erythropoiesis-stimulating agent used for the treatment of anemia secondary to chronic kidney disease (CKD) in dogs, but reports describing response are lacking. HYPOTHESIS/OBJECTIVES: To evaluate the effectiveness of darbepoetin in dogs with anemia secondary to CKD, dosing protocols, and adverse events. ANIMALS: Thirty-three client-owned dogs with naturally occurring CKD, including 26 with comorbidities...
March 2017: Journal of Veterinary Internal Medicine
https://www.readbyqxmd.com/read/28168382/molecular-design-expression-and-evaluation-of-pasylated-human-recombinant-erythropoietin-with-enhanced-functional-properties
#5
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/28104159/similar-anemic-control-between-chronic-kidney-diseases-in-patients-with-and-without-transplantation-on-entry-to-dialysis
#6
K Yamazaki, K Sakai, Y Ohashi, H Nihei, T Itabashi, M Muramatsu, T Kawamura, S Shishido, A Aikawa
BACKGROUND: Transplant recipients are supposedly in a more anemic, catabolic, and even inflammatory state at re-entering hemodialysis due to chronic rejection. The goal of this study was to clarify how transplant recipients can re-enter dialysis safely by focusing on control of anemia. METHODS: From 2012 to 2014, a total of 29 transplant recipients re-entered hemodialysis because of chronic rejection (ie, the chronic kidney disease with transplant [CKDT] group)...
January 2017: Transplantation Proceedings
https://www.readbyqxmd.com/read/28067195/combined-erythropoietin-and-iron-therapy-for-anemic-patients-undergoing-transcatheter-aortic-valve-replacement-the-epicure-randomized-clinical-trial
#7
Marina Urena, Maria Del Trigo, Omar Abdul-Jawad Altisent, Francisco Campelo-Prada, Ander Regueiro, Robert DeLarochellière, Daniel Doyle, Siamak Mohammadi, Jean-Michel Paradis, François Dagenais, Eric Dumont, Rishi Puri, Vincent Laroche, Josep Rodés-Cabau
AIMS: The aim of this study was to evaluate, in anemic patients, the efficacy of erythropoietin (EPO) in reducing red-cell (RC) transfusion rates post-TAVI. METHODS AND RESULTS: This was a randomized double-blind trial. Patients with severe symptomatic aortic stenosis and concomitant anemia with an indication for TAVI were randomized (1:1) to receive 2 weight-based doses of EPO (darbepoetin alfa) + iron or placebo at days 10 (±4 days) and 1 (±1 day) pre- TAVI...
January 10, 2017: EuroIntervention
https://www.readbyqxmd.com/read/27994865/morbidity-mortality-and-quality-of-life-in-the-ageing-haemodialysis-population-results-from-the-elderly-study
#8
Joerg Seckinger, Wilfried Dschietzig, Gerd Leimenstoll, Peter M Rob, Martin K Kuhlmann, Wolfgang Pommer, Uwe Fraass, Eberhard Ritz, Vedat Schwenger
BACKGROUND: The physical-functional and social-emotional health as well as survival of the elderly (≥75 years of age) haemodialysis patient is commonly thought to be poor. In a prospective, multicentre, non-interventional, observational study, the morbidity, mortality and quality of life (QoL) in this patient group were examined and compared with a younger cohort. METHODS: In 92 German dialysis centres, 2507 prevalent patients 19-98 years of age on haemodialysis for a median of 19...
December 2016: Clinical Kidney Journal
https://www.readbyqxmd.com/read/27990008/anemia-treatment-by-erythropoiesis-stimulating-agents-during-the-6-months-before-initiation-of-hemodialysis-comparison-between-darbepoetin-alfa-and-continuous-erythropoietin-receptor-activator
#9
Tadashi Yoshida, Matsuhiko Hayashi
Anemia in chronic kidney disease (CKD) is a risk factor for cardiovascular diseases and is treated by long-acting erythropoiesis-stimulating agents (ESA). Although results of previous studies showed that the hemoglobin level could not be maintained at initiation of dialysis in CKD patients treated with recombinant human erythropoietin, it remains undetermined if long-acting ESA are effective to prevent the progression of anemia at initiation of dialysis. In the present study, hemoglobin levels in 40 CKD patients treated with darbepoetin alfa (DA) and 15 CKD patients treated with a continuous erythropoietin receptor activator (CERA) were retrospectively compared during the 6 months period prior to initiation of dialysis...
December 19, 2016: Keio Journal of Medicine
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
#10
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/27900963/initiation-of-darbepoetin-for-management-of-anemia-in-non-dialysis-dependent-patients-with-chronic-kidney-disease
#11
Fatma Al Raisi, Issa Al Salmi, Pramod Kamble, Muna Al Shehri, Faissal A M Shaheen
The anemia of chronic kidney disease (CKD) is a common comorbidity seen in kidney diseases. It is also associated with increased cardiovascular morbidity and mortality and diminished quality of life. Often, patients with CKD of different stages require erythropoiesis-stimulating agents (ESAs) to maintain their hemoglobin (Hb) within the target range. Darbepoetin alfa is a newer ESA with a longer half-life than recombinant human erythropoietin (EPO). The objective of this study is to assess the efficacy and safety profile of twice-monthly (Q2W) and once a month (1QM) darbepoetin alfa in CKD patients, not on dialysis...
November 2016: Saudi Journal of Kidney Diseases and Transplantation
https://www.readbyqxmd.com/read/27882724/efficacy-and-safety-of-darbepoetin-alfa-initiated-at-hemoglobin-%C3%A2-10%C3%A2-g-dl-in-patients-with-stage-iv-cancer-and-chemotherapy-induced-anemia
#12
Ralph V Boccia, David H Henry, Laura Belton, Chet Bohac, Hassan H Ghazal
Data on efficacy and safety of darbepoetin alfa (DA) administered at hemoglobin (Hb) ≤10 g/dL are limited. In this analysis, we examined DA's efficacy and safety in patients with Stage IV cancers and chemotherapy-induced anemia (CIA) initiated on DA at Hb ≤10 g/dL. Data for patients with Stage IV cancers and CIA and who initiated DA at Hb ≤10 g/dL were extracted from three phase 3 trials identified in a central database of Amgen-sponsored DA studies in CIA. Efficacy outcomes were assessed by achievement of Hb increases of ≥1 g/dL and ≥2 g/dL and red blood cell (RBC) or whole blood transfusion requirements...
December 2016: Cancer Medicine
https://www.readbyqxmd.com/read/27706921/mass-spectrometric-characterisation-of-darbepoetin-alfa-biosimilars-with-c-terminal-arginine-residues
#13
Masato Okano, Mitsuhiko Sato, Shinji Kageyama
Human erythropoietin (EPO) and recombinant human EPO (rEPO) are approximately 30-kDa glycosylated proteins comprising 165 amino acids. Darbepoetin alfa (NESP) is a glycosylated protein encompassing five changes in the amino acid sequence of human EPO, which contains two extra sugar chains. NESP is under patent protection in the USA until May 2024 and in Europe until July 2016, which suggests that the number of NESP biosimilars might substantially increase. The detailed characterisation of biosimilar products are required to ensure the identity and purity of the biosimilar products in terms of safety and efficacy for patients...
November 2016: Drug Testing and Analysis
https://www.readbyqxmd.com/read/27676535/p1-50-long-term-safety-and-efficacy-of-darbepoetin-alfa-in-subjects-with-advanced-stage-nsclc-receiving-multi-cycle-chemotherapy-track-supportive-care-and-others
#14
Pere Gascón, Rajnish Nagarkar, Martin Šmakal, Kostas Syrigos, Carlos H Barrios, Jesús Cárdenas Sánchez, Li Zhang, David H Henry, Alex Fleishman, Cisio De Oliveira Brandao
No abstract text is available yet for this article.
October 2016: Journal of Thoracic Oncology
https://www.readbyqxmd.com/read/27641052/modulation-of-circulating-endothelial-progenitor-cells-by-erythropoiesis-stimulating-agents-in-patients-with-chronic-kidney-disease-stage-g5-and-5d%C3%A2
#15
Takashi Naito, Tsutomu Sanaka, Hayato Mikami, Asuka Soga, Kotoko Yamatani, Kaori Segawa, Moe Kawashima, Tetsuya Yoshikura, Jun Niwayama, Hideki Nishimura, Tetsuya Ogawa, Akitoshi Ando, Akira Teramoto, Kosaku Nitta
AIMS: Circulating endothelial progenitor cells (EPCs) play a pivotal role in vasculogenesis and promote angiogenesis by secreting growth factors. Recent studies have suggested that erythropoietin (EPO) may accelerate not only angiogenesis but also vasculogenesis, beyond erythropoiesis. The aim of this study was to investigate whether two erythropoiesis-stimulating agents (ESAs) modulate vascular-related factors and EPC mobilization in patients with chronic kidney disease stage G5 and dialysis (CKD G5 and 5D)...
November 2016: Clinical Nephrology
https://www.readbyqxmd.com/read/27551882/peginesatide-for-the-treatment-of-anemia-due-to-chronic-kidney-disease-an-unfulfilled-promise
#16
REVIEW
Terhi Hermanson, Charles L Bennett, Iain C Macdougall
INTRODUCTION: The introduction of recombinant human erythropoietin revolutionized the management of anemia in patients with chronic kidney disease (CKD). In order to circumvent costly recombinant DNA technology, synthetic chemistry techniques were used to manufacture peginesatide, a synthetic peptide that bore no resemblance to previous erythropoiesis-stimulating agents (ESAs), and yet was capable of stimulating erythropoiesis. Compared with other ESAs, peginesatide was deemed to have advantages related to immunogenicity, administration schedule, and cost...
October 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27521836/novel-selective-epo-receptor-ligands-lacking-erythropoietic-activity-reduce-infarct-size-in-acute-myocardial-infarction-in-rats
#17
Krisztina Kiss, Csaba Csonka, János Pálóczi, Judit Pipis, Anikó Görbe, Gabriella F Kocsis, Zsolt Murlasits, Márta Sárközy, Gergő Szűcs, Christopher P Holmes, Yijun Pan, Ashok Bhandari, Tamás Csont, Mehrdad Shamloo, Kathryn W Woodburn, Péter Ferdinandy, Péter Bencsik
Erythropoietin (EPO) has been shown to protect the heart against acute myocardial infarction in pre-clinical studies, however, EPO failed to reduce infarct size in clinical trials and showed significant safety problems. Here, we investigated cardioprotective effects of two selective non-erythropoietic EPO receptor ligand dimeric peptides (AF41676 and AF43136) lacking erythropoietic activity, EPO, and the prolonged half-life EPO analogue, darbepoetin in acute myocardial infarction (AMI) in rats. In a pilot study, EPO at 100U/mL significantly decreased cell death compared to vehicle (33...
August 10, 2016: Pharmacological Research: the Official Journal of the Italian Pharmacological Society
https://www.readbyqxmd.com/read/27475338/intravenous-vitamin-b6-increases-resistance-to-erythropoiesis-stimulating-agents-in-hemodialysis-patients-a-randomized-controlled-trial
#18
Yoshitsugu Obi, Satoshi Mikami, Takayuki Hamano, Yasue Obi, Hirotaka Tanaka, Akihiro Shimomura, Hiromi Rakugi, Toru Inoue, Yoshitaka Isaka
OBJECTIVE: Vitamin B6 deficiency is common in hemodialysis patients and may contribute to anemia and abnormal bone metabolism in this population. DESIGN: 6-month, open-label, randomized controlled parallel-group study in hemodialysis centers. SUBJECTS: Fifty-six maintenance hemodialysis patients with relatively high resistance to erythropoiesis-stimulating agents (ESA). INTERVENTION: Intravenous vitamin B6 (60 mg of intravenous pyridoxal 5'-phosphate after each thrice-weekly hemodialysis session)...
November 2016: Journal of Renal Nutrition
https://www.readbyqxmd.com/read/27473489/capillary-electrophoresis-method-for-the-assessment-of-erythropoiesis-stimulating-agents-in-final-formulations
#19
Michel Girard, Anita Kane, Sylvie Boucher
Capillary electrophoresis (CE) comprises several separation modes that can be used to characterize proteins in terms of physico-chemical properties such as isoelectric point or molecular weight, or in terms of purity/heterogeneity for the presence of charge or size variants. In glycoproteins the heterogeneity occurring as a consequence of variable amounts of terminal sialic acid residues on glycan moieties can be detected by CE. As such, a capillary zone electrophoresis (CZE) method was found suitable for the detection of isoforms of several erythropoiesis-stimulating agents (Bietlot and Girard, J Chromatogr A 759:177-184, 1997; Boucher et al...
2016: Methods in Molecular Biology
https://www.readbyqxmd.com/read/27296257/-impact-of-anemia-correction-on-the-production-of-the-circulating-morphogenetic-protein-%C3%AE-klotho-in-patients-with-stages-3b-4-chronic-kidney-disease-a-new-direction-of-cardionephroprotection
#20
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
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