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Darbepoetin alfa

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https://www.readbyqxmd.com/read/27900963/initiation-of-darbepoetin-for-management-of-anemia-in-non-dialysis-dependent-patients-with-chronic-kidney-disease
#1
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
#2
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
https://www.readbyqxmd.com/read/27706921/mass-spectrometric-characterisation-of-darbepoetin-alfa-biosimilars-with-c-terminal-arginine-residues
#3
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
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
#4
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/27282622/purification-and-characterization-of-recombinant-darbepoetin-alfa-from-leishmania-tarentolae
#5
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
https://www.readbyqxmd.com/read/27201337/cost-consequence-analysis-of-darbepoetin-alfa-for-the-treatment-of-anemia-due-to-chronic-kidney-disease-ckd-in-greece
#6
G Kourlaba, I Boletis, D Goumenos, C Iatrou, V Papagiannopoulou, G Tritaki, N Maniadakis
No abstract text is available yet for this article.
November 2014: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/27190334/outcomes-in-patients-with-chronic-kidney-disease-not-on-dialysis-receiving-extended-dosing-regimens-of-darbepoetin-alfa-long-term-results-of-the-extend-observational-cohort-study
#7
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
https://www.readbyqxmd.com/read/27178833/dynamics-of-the-erythropoiesis-stimulating-agent-resistance-index-in-incident-hemodiafiltration-and-high-flux-hemodialysis-patients
#8
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
https://www.readbyqxmd.com/read/27060362/switch-from-epoetin-beta-to-darbepoetin-alfa-treatment-of-anemia-in-taiwanese-hemodialysis-patients-dose-equivalence-by-hemoglobin-stratification
#9
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
https://www.readbyqxmd.com/read/26939055/performance-of-a-predictive-model-for-long-term-hemoglobin-response-to-darbepoetin-and-iron-administration-in-a-large-cohort-of-hemodialysis-patients
#10
Carlo Barbieri, Elena Bolzoni, Flavio Mari, Isabella Cattinelli, Francesco Bellocchio, José D Martin, Claudia Amato, Andrea Stopper, Emanuele Gatti, Iain C Macdougall, Stefano Stuard, Bernard Canaud
Anemia management, based on erythropoiesis stimulating agents (ESA) and iron supplementation, has become an increasingly challenging problem in hemodialysis patients. Maintaining hemodialysis patients within narrow hemoglobin targets, preventing cycling outside target, and reducing ESA dosing to prevent adverse outcomes requires considerable attention from caregivers. Anticipation of the long-term response (i.e. at 3 months) to the ESA/iron therapy would be of fundamental importance for planning a successful treatment strategy...
2016: PloS One
https://www.readbyqxmd.com/read/26908704/preschool-assessment-of-preterm-infants-treated-with-darbepoetin-and-erythropoietin
#11
RANDOMIZED CONTROLLED TRIAL
Robin K Ohls, Daniel C Cannon, John Phillips, Arvind Caprihan, Shrena Patel, Sarah Winter, Michael Steffen, Ronald A Yeo, Richard Campbell, Susan Wiedmeier, Shawna Baker, Sean Gonzales, Jean Lowe
BACKGROUND: We previously reported improved neurodevelopmental outcomes at 2 years among infants treated with the erythropoiesis-stimulating agents (ESAs) darbepoetin alfa (darbepoetin) or erythropoietin. Here we characterize 4-year outcomes. METHODS: Former preterm infants randomly assigned to receive darbepoetin (10 μg/kg, once per week), erythropoietin (400 U/kg, 3 times/week), or placebo through 35 weeks' postconceptual age were evaluated at 3.5 to 4 years of age...
March 2016: Pediatrics
https://www.readbyqxmd.com/read/26855598/hemoglobin-levels-and-quality-of-life-in-patients-with-symptomatic-chemotherapy-induced-anemia-the-eaqua-study
#12
Jean-Loup Mouysset, Beata Freier, Joan van den Bosch, Charles Briac Levaché, Alain Bols, Hans Werner Tessen, Laura Belton, G Chet Bohac, Jan-Henrik Terwey, Giuseppe Tonini
PURPOSE: To assess hemoglobin (Hb) outcomes and fatigue-related quality-of-life (QoL) (electronic assessment) in patients with solid tumors and symptomatic chemotherapy-induced anemia receiving cytotoxic chemotherapy and darbepoetin alfa (DA) or another erythropoiesis-stimulating agent according to European indication. METHODS: eAQUA was a Phase IV prospective observational study. The primary outcome (assessed in the primary analysis set [PAS]: patients receiving one or more DA dose who had baseline and week 9 assessments for Hb and QoL) was the proportion of patients receiving DA having both Hb increases ≥1 g/dL and improved QoL between baseline and week 9...
2016: Cancer Management and Research
https://www.readbyqxmd.com/read/26730453/effectiveness-of-darbepoetin-alfa-for-chemotherapy-induced-anemia-when-initiated-at-hemoglobin-%C3%A2-10-g-dl
#13
REVIEW
Robert Pirker, Michael Hedenus, Johan Vansteenkiste, Enrique Hernandez, Laura Belton, Jan-Henrik Terwey
PURPOSE: Limited data are available to describe the effectiveness of darbepoetin alfa (DA) in terms of hemoglobin (Hb) and transfusion outcomes when initiated at Hb ≤10 g/dL (the threshold specified in the summary of prescribing characteristics). We assessed DA, initiated according to current labeling (Hb ≤10 g/dL), in chemotherapy-induced anemia (CIA). METHODS: Data for patients with cancer and CIA who initiated DA at Hb ≤10 g/dL were extracted from a database of Amgen-sponsored trials...
January 1, 2016: Clinical Therapeutics
https://www.readbyqxmd.com/read/26665615/-comparison-of-benefits-to-non-dialysis-ckd-patients-between-darbepoetin-alpha-and-epoetin-beta-pegol
#14
COMPARATIVE STUDY
Chiharu Ito, Tetsu Akimoto, Yoshiyuki Morishita, Hisashi Yamamoto, Manabu Ogura, Tomoyuki Yamazaki, Atsushi Miki, Sumiko Homma, Eiji Kusano, Yasushi Asano, Daisuke Nagata
BACKGROUND: Erythropoiesis-stimulating agents (ESAs) are the mainstay of treatment for renal anemia in chronic kidney disease (CKD) patients. However, the difference in hematopoietic effect between darbepoetin alfa (DA) and continuous erythropoiesis receptor activator (CERA) has remained unclear in non-dialysis CKD patients. Another purpose of this study was to analyze the red blood cells indices under treatment with these two ESAs in ESA-naïve CKD patients. METHODS: This study was designed as a multicenter retrospective observational investigation, and included 61 patients receiving DA (group DA) and 36 patients receiving CERA (group CERA) for at least six months...
2015: Nihon Jinzo Gakkai Shi
https://www.readbyqxmd.com/read/26583202/time-savings-of-weekly-versus-three-times-per-week-administration-of-erythropoiesis-stimulating-agents-in-united-states-dialysis-patients
#15
MULTICENTER STUDY
J Mark Stephens, Larry C Emerson, Leslie A Spry, John P Caloyeras, Ernest R Anderson, John F Reitan, Akhtar Ashfaq
OBJECTIVE: Previous research suggests that erythropoiesis stimulating agent (ESA) administration in dialysis is a time-consuming task and switching to less frequently dosed ESAs may offer operational efficiencies. Our objective was to describe and measure the time spent on tasks in the ESA administration process in US dialysis centers, and to estimate potential efficiency gains of using weekly (QW) administration vs three-times-per-week (TIW) administration. METHODS: We conducted a time and motion study of staff time required to prepare, administer and document ESA doses...
2016: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/26546410/cloning-and-expression-of-codon-optimized-recombinant-darbepoetin-alfa-in-leishmania-tarentolae-t7-tr
#16
Anvarsadat Kianmehr, Raziyeh Golavar, Mandana Rouintan, Abdolkarim Mahrooz, Pezhman Fard-Esfahani, Morteza Oladnabi, Safoura Khajeniazi, Seyede Samaneh Mostafavi, Eskandar Omidinia
Darbepoetin alfa is an engineered and hyperglycosylated analog of recombinant human erythropoietin (EPO) which is used as a drug in treating anemia in patients with chronic kidney failure and cancer. This study desribes the secretory expression of a codon-optimized recombinant form of darbepoetin alfa in Leishmania tarentolae T7-TR. Synthetic codon-optimized gene was amplified by PCR and cloned into the pLEXSY-I-blecherry3 vector. The resultant expression vector, pLEXSYDarbo, was purified, digested, and electroporated into the L...
February 2016: Protein Expression and Purification
https://www.readbyqxmd.com/read/26511877/early-response-to-erythropoiesis-stimulating-agents-in-non-dialysis-chronic-kidney-disease-patients
#17
Michio Kuwahara, Youhei Arai, Eriko Takehara, Yasunori Sasaki, Tomoharu Yoshimine, Keita Kusaka, Satomi Shikuma, Wataru Akita, Shinichi Uchida
BACKGROUND: Renal anemia complicated with chronic kidney disease is usually treated with erythropoiesis-stimulating agents (ESAs). However, few studies have compared the early response of hemoglobin (Hb) to different kinds of ESAs. METHODS: The effects of three types of ESAs-epoetin alfa or beta (EPO), darbepoetin alfa (DPO), and epoetin beta pegol (EPObp)-on renal anemia were followed in 416 pre-dialysis chronic kidney disease (CKD) patients. After the initial 12-week administration of ESAs, ΔHb/ESA dose/kg was calculated as an index of efficacy of each ESA...
August 2016: Clinical and Experimental Nephrology
https://www.readbyqxmd.com/read/26509851/impact-of-hematopoietic-growth-factors-on-blood-transfusion-needs-incidence-of-neutropenia-and-overall-survival-among-elderly-advanced-ovarian-cancer-patients-treated-with-chemotherapy
#18
Insiya B Poonawalla, Linda B Piller, David R Lairson, Wenyaw Chan, Xianglin L Du
OBJECTIVE: To determine the effectiveness of erythropoietin-stimulating agent (ESA) and granulocyte colony-stimulating factor (CSF) in reducing blood transfusion needs and neutropenia incidence in community-dwelling elderly ovarian cancer patients. METHODS: The SEER (Surveillance Epidemiology and End Results)-Medicare database was used to identify 5572 women with stage III/IV ovarian cancer who received chemotherapy. To assess clinical effectiveness, we categorized patients based on the number of administrations of ESA (ie, epoetin-alfa and darbepoetin-alfa) and CSF (ie, filgrastim and pegfilgrastim)...
January 2016: International Journal of Gynecological Cancer
https://www.readbyqxmd.com/read/26502332/acute-onset-anterior-uveitis-after-darbepoetin-alfa-infusion
#19
Jonathan Li, Stephen E Orlin, Karen E Revere, John H Kempen
A 79-year-old female with a 2-month history of newly diagnosed myelodysplastic syndrome for which she received blood transfusion with darbepoetin alfa presented with bilateral anterior uveitis 1 day after her fourth transfusion. On exam, visual acuity was 20/20 in both eyes with biomicroscopy notable for conjunctival injection and anterior chamber cell and flare consistent with anterior uveitis. She had no systemic symptoms, no history of eye trauma, and no known infections. This case, along with prior reports in the literature, suggests that anterior uveitis may be an idiosyncratic complication of darbepoetin alfa therapy...
December 2015: Journal of Ophthalmic Inflammation and Infection
https://www.readbyqxmd.com/read/26482252/safety-and-usage-of-darbepoetin-alfa-in-children-with-chronic-kidney-disease-prospective-registry-study
#20
Franz Schaefer, Bernd Hoppe, Therese Jungraithmayr, Günter Klaus, Lars Pape, Mourad Farouk, Janet Addison, Nick Manamley, Karel Vondrak
BACKGROUND: Limited prospective data are available on the long-term safety of darbepoetin alfa (DA) for treating anemia in children with chronic kidney disease (CKD). METHODS: In this prospective, phase IV, observational registry study, children ≤16 years of age with CKD anemia and receiving DA were observed for ≤2 years. Adverse events (AEs), DA dosing, hemoglobin (Hb) concentrations, and transfusions were recorded. RESULTS: A total of 319 patients were included in the analysis (mean age, 9...
March 2016: Pediatric Nephrology: Journal of the International Pediatric Nephrology Association
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