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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
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...
November 23, 2016: Cancer Medicine
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...
October 5, 2016: Drug Testing and Analysis
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
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
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
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
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
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
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
Anvarsadat Kianmehr, Abdolkarim Mahrooz, Morteza Oladnabi, Yaghoub Safdari, Javad Ansari, Kamal Veisi, Mehdi Evazalipour, Hamid Shahbazmohammadi, Eskandar Omidinia
Darbepoetin alfa is a biopharmaceutical glycoprotein that stimulates erythropoiesis and is used to treat anemia, which associated with renal failure and cancer chemotherapy. We herein describe the structural characterization of recombinant darbepoetin alfa produced by Leishmania tarentolae T7-TR host. The DNA expression cassette was integrated into the L. tarentolae genome through homologous recombination. Transformed clones were selected by antibiotic resistance, diagnostic PCRs, and protein expression analysis...
September 2016: Molecular Biotechnology
Wen-Sheng Liu, Hsiang-Lin Chan, Yen-Ting Lai, Ya-Hsu Yang, Hao-Wei Teng, Chih-Kuang Liu, Szu-Yuan Li, Chih-Yu Yang, Tsung-Yun Liu, Chih-Ching Lin
OBJECTIVE: The response of erythropoietic stimulating agents (ESA) in uremic patients may be associated with the changes of biochemical parameters, metal elements and inflammation status during the shift from one ESA to another. METHOD: We compared changes in above mentioned factors after switching from darbepoetin-α (DPO) 20μg weekly for 10 weeks to continuous erythropoietin receptor activator (CERA) 100μg monthly for 10 weeks in uremic patients on hemodialysis...
July 2016: Environmental Toxicology and Pharmacology
Francisco Maduell, Raquel Ojeda, Marta Arias-Guillen, Florencia Rossi, Néstor Fontseré, Manel Vera, Nayra Rico, Leonardo Nicolás Gonzalez, Gastón Piñeiro, Mario Jiménez-Hernández, Lida Rodas, José Luis Bedini
BACKGROUND: New haemodialysis therapeutic regimens are required to improve patient survival. Longer and more frequent dialysis sessions have produced excellent survival and clinical advantages, while online haemodiafiltration (OL-HDF) provides the most efficient form of dialysis treatment. METHODS: In this single-centre observational study, 57 patients on 4-5-hour thrice-weekly OL-HDF were switched to nocturnal every-other-day OL-HDF. Inclusion criteria consisted of stable patients with good prospects for improved occupational, psychological and social rehabilitation...
2016: Nephron
Carlo Barbieri, Manuel Molina, Pedro Ponce, Monika Tothova, Isabella Cattinelli, Jasmine Ion Titapiccolo, Flavio Mari, Claudia Amato, Frank Leipold, Wolfgang Wehmeyer, Stefano Stuard, Andrea Stopper, Bernard Canaud
Managing anemia in hemodialysis patients can be challenging because of competing therapeutic targets and individual variability. Because therapy recommendations provided by a decision support system can benefit both patients and doctors, we evaluated the impact of an artificial intelligence decision support system, the Anemia Control Model (ACM), on anemia outcomes. Based on patient profiles, the ACM was built to recommend suitable erythropoietic-stimulating agent doses. Our retrospective study consisted of a 12-month control phase (standard anemia care), followed by a 12-month observation phase (ACM-guided care) encompassing 752 patients undergoing hemodialysis therapy in 3 NephroCare clinics located in separate countries...
August 2016: Kidney International
Sophie Park, Pierre Fenaux, Peter Greenberg, Bhakti Mehta, Fiona Callaghan, Christopher Kim, Dianne Tomita, Hairong Xu
We conducted a systematic review and meta-analysis to estimate the efficacy of darbepoetin alpha (DA) for treatment of myelodysplastic syndrome (MDS)-related anaemia. Eligible studies were prospective, interventional, and reported World Health Organization, French-American-British, or International Prognostic Scoring System (IPSS) criteria. Outcomes included erythroid response rate (primary); haemoglobin response; change in haemoglobin, transfusion status, and quality-of-life (QoL); and safety. Ten studies (N = 647) were analysed...
September 2016: British Journal of Haematology
Jeehoon Kang, Jonghanne Park, Joo Myung Lee, Jin Joo Park, Dong-Ju Choi
BACKGROUND: Although anemia is common in chronic heart failure (CHF), the use of erythropoiesis stimulating agents (ESAs) in CHF patients remains controversial. In this meta-analysis, we sought to clarify the efficacy and safety of ESAs in anemic patients with CHF. METHODS: We searched PubMed, Embase, Cochrane Central Register of Controlled Trials, the U.S. National Institutes of Health registry of clinical trials. We included 13 randomized clinical trials (RCTs) in the meta-analysis...
September 1, 2016: International Journal of Cardiology
Jan-Christoph Galle, Janet Addison, Michael G Suranyi, Kathleen Claes, Salvatore Di Giulio, Alain Guerin, Hans Herlitz, István Kiss, Mourad Farouk, Nick Manamley, Gerhard Wirnsberger, Christopher Winearls
BACKGROUND: Extended dosing of the erythropoiesis-stimulating agent (ESA) darbepoetin alfa (DA) once biweekly or monthly reduces anaemia treatment burden. This observational study assessed outcomes and dosing patterns in patients with chronic kidney disease not on dialysis (CKD-NoD) commencing extended dosing of DA. METHODS: Adult CKD-NoD patients starting extended dosing of DA in Europe or Australia in June 2006 or later were followed up until December 2012. Outcomes included haemoglobin (Hb) concentration, ESA dosing, mortality rates and receipt of dialysis and renal transplantation...
April 15, 2016: Nephrology, Dialysis, Transplantation
Daniele Marcelli, Inga Bayh, José I Merello, Pedro Ponce, Alex Heaton, Fatih Kircelli, Charles Chazot, Attilio Di Benedetto, Cristina Marelli, Erzsebet Ladanyi, Miroslaw Kroczak, Stefano Stuard, Aileen Grassmann, Laura Scatizzi, Katharina Brand, Bernard Canaud
Hyporesponsiveness to erythropoiesis-stimulating agent therapy in dialysis patients is poorly understood. Some studies report an improvement in the erythropoiesis-stimulating agent resistance index (ERI) with hemodiafiltration (HDF) versus high-flux hemodialysis (HD). We explored ERI dynamics in 38,340 incident HDF and HD patients treated in 22 countries over a 7-year period. Groups were matched by propensity score at baseline (6 months after dialysis initiation). The follow-up period (mean of 1.31 years) was stratified into 1 month intervals with delta analyses performed for key ERI-related parameters...
July 2016: Kidney International
Shang-Chih Liao, Cheng-Chieh Hung, Chien-Te Lee, Chih-Hsiung Lee, Chin-Chan Lee, Chun-Liang Lin, Chiao-Yin Sun, Ben-Chung Cheng, Chih-Chao Yang, Chien-Hsing Wu, Jin-Bor Chen
This multicenter study was designed to assess the hemoglobin (Hb) stability and conversion ratio of the switch from epoetin beta to darbepoetin alfa in Taiwanese hemodialysis (HD) patients. A total of 135 HD patients were enrolled and randomized with intravenous darbepoetin alfa or epoetin beta. The study duration was 24 weeks. Equivalent doses and conversion ratios were assessed with respect to Hb stratification: low Hb (≥8.0 g/dL to ≤10.0 g/dL) and high Hb (>10.0 g/dL to ≤11.0 g/dL). The results showed stable Hb levels in the study period...
August 2016: Therapeutic Apheresis and Dialysis
Hirokazu Honda, Yasuna Kobayashi, Shoko Onuma, Keigo Shibagaki, Toshitaka Yuza, Keiichi Hirao, Toshinori Yamamoto, Naohisa Tomosugi, Takanori Shibata
BACKGROUND: We aimed to identify associations between erythroferrone (ERFE), a regulator of hepcidin 25, and biomarkers of erythropoiesis and iron metabolism. We also aimed to determine the effects of erythropoiesis-stimulating agents (ESA), continuous erythropoietin receptor activator (CERA) and darbepoetin-α (DA) on ERFE production in patients on hemodialysis (HD). METHODS: Blood samples were obtained from 59 patients before HD sessions on day 0 (baseline). Twenty patients who were injected with either CERA (N = 10) or DA (N = 10) at the end of the dialysis week (day 0), who had ferritin ≥ 100 ng/mL and/or transferrin saturation ≥ 20%, and hemoglobin > 9 g/dL were selected from among the 59 patients...
2016: PloS One
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