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https://www.readbyqxmd.com/read/29157782/comparative-assessment-of-the-effect-of-hyper-glycosylation-on-the-pattern-and-kinetics-of-degradation-of-darbepoetin-alfa-using-a-stability-indicating-orthogonal-testing-protocol
#1
Eman M Moenes, Medhat A Al-Ghobashy, Abeer A Mohamed, Maissa Y Salem
Darbepoetin alfa (DA); hyper-glycosylated Erythropoietin alfa (EPO) is an essential treatment of anemia in patients with chronic kidney failure and cancer. In this study, DA and EPO were subjected to physicochemical stress factors that might be encountered during production, transport and storage (pH, temperature, agitation, repeated freeze-thaw and oxidation). An orthogonal stability-indicating assay protocol comprised of SE-HPLC, RP-HPLC, ELISA and SDS-PAGE was developed and validated to investigate the effect of further glycosylation of DA on the pattern and kinetics of degradation...
November 4, 2017: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
https://www.readbyqxmd.com/read/29145693/early-erythropoiesis-stimulating-agents-in-preterm-or-low-birth-weight-infants
#2
REVIEW
Arne Ohlsson, Sanjay M Aher
BACKGROUND: Preterm infants have low plasma levels of erythropoietin (EPO), providing a rationale for the use of erythropoiesis-stimulating agents (ESAs) to prevent or treat anaemia and to provide neuro protection and protection against necrotising enterocolitis (NEC). Darbepoetin (Darbe) and EPO are currently available ESAs. OBJECTIVES: To assess the effectiveness and safety of ESAs (erythropoietin (EPO) and/or Darbe) initiated early (before eight days after birth) compared with placebo or no intervention in reducing red blood cell (RBC) transfusions, adverse neurological outcomes, and feeding intolerance including necrotising enterocolitis (NEC) in preterm and/or low birth weight infants...
November 16, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/29135158/-the-role-of-pharmacological-preconditioning-in-renal-ischemic-and-reperfusion-injury
#3
D A Kostina, T G Pokrovskaya, Yu V Olefir, A N Yavorskii, V V Elagin
Renal ischemic and reperfusion injury resulting in acute renal failure is a multidisciplinary problem at the junction of pathophysiology, transplantology, urology, nephrology, cardiac surgery and pharmacology. One of renal protection strategies is using the phenomenon of preconditioning. Preconditioning is one of the ways to adopt a tissue to repeated short-term effects of damaging factors to induce an enhanced tolerance to the long period of hypoxia and/or ischemia. There are multiple cellular and molecular mechanisms of the renal protective effects of preconditioning stimuli, but the key effectors and signaling molecules are ATP-dependent potassium channels, nitric oxide synthase, nitric oxide, and mitochondrial pore...
October 2017: Urologii︠a︡
https://www.readbyqxmd.com/read/29097481/efficacy-and-long-term-safety-of-c-e-r-a-maintenance-in-pediatric-hemodialysis-patients-with-anemia-of-ckd
#4
Michel Fischbach, Elke Wühl, Sylvie C Meyer Reigner, Zoe Morgan, Franz Schaefer
BACKGROUND AND OBJECTIVES: The study was conducted to identify a conversion factor for switching from previous erythropoiesis-stimulating agents (ESAs) to continuous erythropoietin receptor activator-methoxy polyethylene glycol-epoetin beta (C.E.R.A.) and to document the efficacy and long-term safety of C.E.R.A. in pediatric patients with anemia of CKD undergoing hemodialysis. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: In this open-label, multicenter study, patients aged 6-17 years, with stable chronic anemia of CKD, undergoing hemodialysis received C...
November 2, 2017: Clinical Journal of the American Society of Nephrology: CJASN
https://www.readbyqxmd.com/read/29094099/improving-access-to-cancer-treatments-the-role-of-biosimilars
#5
Rakesh Chopra, Gilberto Lopes
Biologics play a key role in cancer treatment and are principal components of many therapeutic regimens. However, they require complex manufacturing processes, resulting in high cost and occasional shortages in supply. The cost of biologics limits accessibility of cancer treatment for many patients. Effective and affordable cancer therapies are needed globally, more so in developing countries, where health care resources can be limited. Biosimilars, which have biologic activity comparable to their corresponding reference drugs and are often more cost effective, have the potential to enhance treatment accessibility for patients and provide alternatives for decision makers (ie, prescribers, regulators, payers, policymakers, and drug developers)...
October 2017: Journal of Global Oncology
https://www.readbyqxmd.com/read/29092738/optimizing-the-use-of-darbepoetin-%C3%AE-with-a-split-strategy-a-concept-change%C3%A2
#6
Marco Mendes, Ana Carina Ferreira, David Navarro, Bruno Pinto, Fernanda Gomes, Patrícia Matias, Cristina Jorge, Inês Aires, Aníbal Ferreira
As erythropoiesis is a continuous process, we hypothesized that a new approach with smaller doses of darbepoetin-α administered more regularly could result in fewer variations of its serum levels and be more effective. In a prevalent hemodialysis population, we evaluated the effects of the darbepoetin splitting in "mini-doses". A 34-month prospective study was performed in a cohort of 110 patients, with a mean age of 66.6 ± 14.2 years, median dialysis vintage of 63.6 months (IQ range: 27 - 86), 46.4% (n = 51) male gender, 36...
October 26, 2017: Clinical Nephrology
https://www.readbyqxmd.com/read/29047386/epoetin-%C3%AE-pegol-continuous-erythropoietin-receptor-activator-cera-is-another-choice-for-the-treatment-of-anemia-in-myelodysplastic-syndrome-a-case-report
#7
Tatsuyoshi Ikenoue, Hiroshi Naito, Tetsuya Kitamura, Hideki Hattori
BACKGROUND: In most patients, anemia is present when myelodysplastic syndrome is diagnosed. Although darbepoetin α is the first-choice supportive therapy for low-risk myelodysplastic syndrome, half of all patients develop a loss of response to darbepoetin α within 12 months. However, few reports have described supportive therapy after the loss of response to darbepoetin α. CASE PRESENTATION: We herein present a case involving a 65-year-old Japanese woman with low-risk myelodysplastic syndrome whose erythropoiesis-stimulating agent treatment was switched from darbepoetin α to epoetin β pegol (continuous erythropoietin receptor activator) to treat transfusion-dependent anemia...
October 19, 2017: Journal of Medical Case Reports
https://www.readbyqxmd.com/read/28975386/a-predictive-model-of-response-to-erythropoietin-stimulating-agents-in-myelodysplastic-syndrome-from-the-canadian-mds-patient-registry
#8
Brett L Houston, Jennifer Jayakar, Richard A Wells, Martha Lenis, Liying Zhang, Nancy Zhu, Heather A Leitch, Thomas J Nevill, Karen W L Yee, Brian Leber, Mitchell Sabloff, Eve St-Hilaire, Rajat Kumar, Michelle Geddes, April Shamy, John M Storring, Mary-Margaret Keating, Mohamed Elemary, Robert Delage, Alex Mamedov, Rena Buckstein
Prediction of response to erythropoietin stimulating agents (ESAs) in anemic MDS patients is often based on the Nordic score. We wished to validate the Nordic score (IWG 2006 response criteria) in a larger cohort and determine if other variables such as IPSS/IPSS-R, ferritin, LDH, and a novel European ESA response score (Santini 2013) were of prognostic importance. We analyzed 208 ESA-treated MDS patients (WHO 2008 criteria) from a prospective registry. Ninety-four and 93% had lower risk scores by IPSS (low/int - 1) and IPSS-R (low/very low), respectively...
October 3, 2017: Annals of Hematology
https://www.readbyqxmd.com/read/28960777/prognostic-importance-of-emerging-cardiac-inflammatory-and-renal-biomarkers-in-chronic-heart-failure-patients-with-reduced-ejection-fraction-and-anaemia-red-hf-study
#9
Paul Welsh, Lei Kou, Changhong Yu, Inder Anand, Dirk J van Veldhuisen, Aldo P Maggioni, Akshay S Desai, Scott D Solomon, Marc A Pfeffer, Sunfa Cheng, Lars Gullestad, Pål Aukrust, Thor Ueland, Karl Swedberg, James B Young, Michael W Kattan, Naveed Sattar, John J V McMurray
AIMS: To test the prognostic value of emerging biomarkers in the Reduction of Events by Darbepoetin Alfa in Heart Failure (RED-HF) trial. METHODS AND RESULTS: Circulating cardiac [N-terminal pro-B-type natriuretic peptide (NT-proBNP), and high-sensitivity troponin T (hsTnT)], neurohumoral [mid-regional pro-adrenomedullin (MR-proADM) and copeptin], renal (cystatin C), and inflammatory [high-sensitivity C-reactive protein (hsCRP)] biomarkers were measured at randomization in 1853 participants with complete data...
September 27, 2017: European Journal of Heart Failure
https://www.readbyqxmd.com/read/28875480/erratum-to-rationale-and-design-of-observational-clinical-research-in-chronic-kidney-disease-patients-with-renal-anemia-renal-prognosis-in-patients-with-hyporesponsive-anemia-to-erythropoiesis-stimulating-agents-darbepoetin-alfa-brighten-trial
#10
Hideki Kato, Masaomi Nangaku, Hideki Hirakata, Takashi Wada, Terumasa Hayashi, Hiroshi Sato, Yasushi Yamazaki, Takao Masaki, Tatsuo Kagimura, Hiroyasu Yamamoto, Hiroki Hase, Masahiro Kamouchi, Enyu Imai, Kyoichi Mizuno, Manabu Iwasaki, Tadao Akizawa, Yoshiharu Tsubakihara, Shoichi Maruyama, Ichiei Narita
No abstract text is available yet for this article.
September 5, 2017: Clinical and Experimental Nephrology
https://www.readbyqxmd.com/read/28815341/de-novo-weekly-and-biweekly-darbepoetin-alfa-dosing-in-pediatric-patients-with-chronic-kidney-disease
#11
Bradley A Warady, John Barcia, Nadine Benador, Augustina Jankauskiene, Kurt Olson, Ludmila Podracka, Aleksey Shavkin, Poyyapakkam Srivaths, Cynthia J Wong, Jeffrey Petersen
BACKGROUND: Darbepoetin alfa is a commonly prescribed erythropoiesis-stimulating agent (ESA) for correcting anemia in pediatric chronic kidney disease (CKD) patients. However, little information exists on its use in ESA-naïve patients. This study evaluated the efficacy and safety of darbepoetin alfa in pediatric patients initiating ESA therapy. METHODS: One-hundred sixteen pediatric ESA-naïve subjects (aged 1-18 years) with CKD stages 3-5D and hemoglobin (Hb) <10 g/dl from 43 centers in the US, Europe, and Mexico were randomized by age (three groups) and dialysis status (yes vs...
August 17, 2017: Pediatric Nephrology: Journal of the International Pediatric Nephrology Association
https://www.readbyqxmd.com/read/28814194/real-world-utilization-of-darbepoetin-alfa-in-cancer-chemotherapy-patients
#12
Xiaoyun Lucy Pan, Beth L Nordstrom, Sharon MacLachlan, Junji Lin, Hairong Xu, Anjali Sharma, David Chandler, Xiaoyan Shawn Li
Objectives To provide an understanding of darbepoetin alfa dose patterns in cancer patients undergoing myelosuppressive chemotherapy starting from 2011. Study design This is a retrospective cohort study using a proprietary outpatient oncology database. Methods Metastatic, solid tumor cancer patients receiving concomitant myelosuppressive chemotherapy and darbepoetin alfa with an associated hemoglobin <10 g/dL during 2011-2015 were identified. The analysis was restricted to the first continuous exposure to chemotherapy agents (maximum allowable gap of 90 days between consecutive exposures) with darbepoetin alfa for each eligible patient...
January 1, 2017: Journal of Oncology Pharmacy Practice
https://www.readbyqxmd.com/read/28782299/continuous-erythropoiesis-receptor-activator-cera-for-the-anaemia-of-chronic-kidney-disease
#13
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/28748874/variables-affecting-darbepoetin-resistance-index-in-hemodialysis-patients
#14
Fayez Hejaili, Ehtsham Hafeez, Burhan Bhutto, Lulwa Al Turki, Abdul Kareem Alsuwida, Hammad Raza, Abdulla Al-Sayyari
Erythropoietin resistance index calculation has been used as a tool to evaluate anemia response to erythropoietin therapy. Very little has been reported in its use when using darbepoetin and factors influencing in Arab patients. Darbepoetin resistance index (DRI) was calculated in all our patients using darbepoetin. This was correlated to demographic, clinical, and laboratory parameters. Of the 250 patients, 40.4% were diabetic, 71.1% on hemodialysis, and 28.6% on hemodiafiltration), 23.9% with PermCaths (PC), and 76...
July 2017: Saudi Journal of Kidney Diseases and Transplantation
https://www.readbyqxmd.com/read/28717516/costs-associated-with-intravenous-darbepoetin-versus-epoetin-therapy-in-hemodialysis-patients-a-randomized-controlled-trial
#15
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/28691421/effects-of-long-and-short-term-darbepoetin-%C3%AE-treatment-on-oxidative-stress-inflammation-and-endothelial-injury-in-apo-e-knockout-mice
#16
Evrim Dursun Özdemir, Aysegul Hanikoglu, Aysegul Cort, Beste Ozben, Gultekin Suleymanlar, Tomris Ozben
BACKGROUND: Atherosclerosis and atherosclerosis related complications are the main cause of death in the world. Vascular injury in response to inflammation, enhanced oxidant stress promotes endothelial dysfunction and leads to atherosclerotic lesions. OBJECTIVES: Low-dose treatment with Darbepoetin-α may be a potential therapeutic tool for endothelial injury and atherosclerosis. MATERIAL AND METHODS: In order to study the effect of Darbepoetin-α on endothelial injury and atherosclerosis, we used Apo E-/- mice as the atherosclerotic mice model...
June 27, 2017: Advances in Clinical and Experimental Medicine: Official Organ Wroclaw Medical University
https://www.readbyqxmd.com/read/28660446/rationale-and-design-of-observational-clinical-research-in-chronic-kidney-disease-patients-with-renal-anemia-renal-prognosis-in-patients-with-hyporesponsive-anemia-to-erythropoiesis-stimulating-agents-darbepoetin-alfa-brighten-trial
#17
Hideki Kato, Masaomi Nangaku, Hideki Hirakata, Takashi Wada, Terumasa Hayashi, Hiroshi Sato, Yasushi Yamazaki, Takao Masaki, Tatsuo Kagimura, Hiroyasu Yamamoto, Hiroki Hase, Masahiro Kamouchi, Enyu Imai, Kyoichi Mizuno, Manabu Iwasaki, Tadao Akizawa, Yoshiharu Tsubakihara, Shoichi Maruyama, Ichiei Narita
BACKGROUND: Renal anemia is an important complication in non-dialysis chronic kidney disease (CKD) patients as well as in dialysis patients. Although recombinant human erythropoietin has dramatically improved prognosis and quality of life in these patients, there have been issues among non-dialysis CKD patients who exhibit hyporesponsiveness to erythropoiesis-stimulating agent (ESA). The causes and definition of ESA hyporesponsiveness, as well as the incidence of renal and cardiovascular disease (CVD) events in such patients, are yet to be clarified...
June 28, 2017: Clinical and Experimental Nephrology
https://www.readbyqxmd.com/read/28646375/comparative-efficacy-and-safety-in-esa-biosimilars-vs-originators-in-adults-with-chronic-kidney-disease-a-systematic-review-and-meta-analysis
#18
REVIEW
Laura Amato, Antonio Addis, Rosella Saulle, Francesco Trotta, Zuzana Mitrova, Marina Davoli
BACKGROUND: Several Erythropoiesis-stimulating agents (ESAs) are available to treat anemia in patients with chronic kidney disease (CKD). Questions about the comparability of such therapeutic options are not purely a regulatory or economical matter. Appropriate use of originator or biosimilar in these patients need to be supported by clinical data. Regarding the prevention of blood transfusion, reduction of fatigue, breathlessness and mortality or cardiovascular events, a summary of the comparative efficacy and safety data of these drugs is lacking...
June 23, 2017: Journal of Nephrology
https://www.readbyqxmd.com/read/28626220/a-phase-3-randomized-placebo-controlled-trial-of-darbepoetin-alfa-in-patients-with-anemia-and-lower-risk-myelodysplastic-syndromes
#19
RANDOMIZED CONTROLLED TRIAL
U Platzbecker, A Symeonidis, E N Oliva, J S Goede, M Delforge, J Mayer, B Slama, S Badre, E Gasal, B Mehta, J Franklin
The use of darbepoetin alfa to treat anemia in patients with lower-risk myelodysplastic syndromes (MDS) was evaluated in a phase 3 trial. Eligible patients had low/intermediate-1 risk MDS, hemoglobin ⩽10 g/dl, low transfusion burden and serum erythropoietin (EPO) ⩽500 mU/ml. Patients were randomized 2:1 to receive 24 weeks of subcutaneous darbepoetin alfa 500 μg or placebo every 3 weeks (Q3W), followed by 48 weeks of open-label darbepoetin alfa. A total of 147 patients were randomized, with median hemoglobin of 9...
September 2017: Leukemia: Official Journal of the Leukemia Society of America, Leukemia Research Fund, U.K
https://www.readbyqxmd.com/read/28547536/a-comparative-study-of-the-hemoglobin-maintaining-effects-between-epoetin-%C3%AE-pegol-and-darbepoetin-%C3%AE-in-patients-with-chronic-kidney-disease-during-3%C3%A2-months-before-dialysis-initiation
#20
Satoru Oka, Yoko Obata, Kenta Torigoe, Miki Torigoe, Shinichi Abe, Kumiko Muta, Yuki Ota, Mineaki Kitamura, Satoko Kawasaki, Misaki Hirose, Tadashi Uramatsu, Hiroshi Yamashita, Hideyuki Arai, Hiroshi Mukae, Tomoya Nishino
BACKGROUND AND OBJECTIVE: We compared the hemoglobin-maintaining effects between continuous erythropoietin receptor activator (CERA) and darbepoetin-α (DA) in patients with chronic kidney disease (CKD) during the 3 months before dialysis initiation. METHODS: This study was conducted with 37 CERA-administered patients and 26 DA-administered patients who had initiated dialysis at a participating facility between January 2012 and December 2014. We investigated clinical laboratory data 3 months before and at dialysis initiation, and compared these data between the CERA and DA groups...
September 2017: Drugs in R&D
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