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Finnian R Mc Causland, Brian Claggett, Emmanuel A Burdmann, Kai-Uwe Eckardt, Reshma Kewalramani, Andrew S Levey, John J V McMurray, Patrick Parfrey, Giuseppe Remuzzi, Ajay K Singh, Scott D Solomon, Robert D Toto, Marc A Pfeffer
BACKGROUND: To better understand a potential association of elevated C-reactive protein (CRP) level with progression of chronic kidney disease (CKD), we examined the relationship of CRP level with the development of end-stage renal disease (ESRD) in the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT). STUDY DESIGN: Post hoc analysis of a randomized controlled trial. SETTING & PARTICIPANTS: 4,038 patients with type 2 diabetes, CKD, and anemia in TREAT...
September 16, 2016: American Journal of Kidney Diseases: the Official Journal of the National Kidney Foundation
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
Marwa A Sabe, Brian Claggett, Emmanuel A Burdmann, Akshay S Desai, Peter Ivanovich, Reshma Kewalramani, Eldrin F Lewis, John J V McMurray, Kurt A Olson, Patrick Parfrey, Scott D Solomon, Marc A Pfeffer
BACKGROUND: Although clear evidence shows that chronic kidney disease is a predictor of cardiovascular events, death, and accelerated coronary artery disease (CAD) progression, it remains unknown whether CAD is a predictor of progression of chronic kidney disease to end-stage renal disease. We sought to assess whether CAD adds prognostic information to established predictors of progression to dialysis in patients with chronic kidney disease, diabetes, and anemia. METHODS AND RESULTS: Using the previously described Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT) population, we compared baseline characteristics of patients with and without CAD...
April 2016: Journal of the American Heart Association
Clément Menuet, Hanan Khemiri, Théodora de la Poëze d'Harambure, Christian Gestreau
Changes in arterial Po2, Pco2, and pH are the strongest stimuli sensed by peripheral and central chemoreceptors to adjust ventilation to the metabolic demand. Erythropoietin (Epo), the main regulator of red blood cell production, increases the hypoxic ventilatory response, an effect attributed to the presence of Epo receptors in both carotid bodies and key brainstem structures involved in integration of peripheral inputs and control of breathing. However, it is not known whether Epo also has an effect on the hypercapnic chemoreflex...
May 15, 2016: American Journal of Physiology. Regulatory, Integrative and Comparative Physiology
T S Fakeeva, I Krysanov
No abstract text is available yet for this article.
November 2015: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
Natalie A Bello, Eldrin F Lewis, Akshay S Desai, Inder S Anand, Henry Krum, John J V McMurray, Kurt Olson, Scott D Solomon, Karl Swedberg, Dirk J van Veldhuisen, James B Young, Marc A Pfeffer
AIMS: The use of an erythropoesis-stimulating agent, darbepoetin alfa (DA), to treat anaemia in patients with diabetes mellitus and chronic kidney disease was associated with a heightened risk of stroke and neutral efficacy in the Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT), despite epidemiological data suggesting the contrary. However, this association has not been evaluated in another randomized, placebo-controlled trial. METHODS AND RESULTS: Reduction of Events by Darbepoetin Alfa in Heart Failure (RED-HF) was a randomized placebo-controlled trial of DA in 2278 patients with systolic heart failure and anaemia, enrolled from 2006 to 2012 and followed for a median of 28 months...
November 2015: European Journal of Heart Failure
Imari Mimura, Tetsuhiro Tanaka, Masaomi Nangaku
Renal anemia is caused by the deficiency of endogenous erythropoietin (Epo) due to renal dysfunction. We think that it is possible to slow the progression of chronic kidney disease (CKD) in case we initiate Epo early in pre-dialysis patients, especially in the non-diabetic population. Erythropoiesis stimulating agent (ESA) treatments targeting mild anemia (10-12 g/dl) can decrease the risk of occurrence of cardiovascular disease (CVD) in patients with hypertension, diabetes mellitus and congestive heart failure...
2015: Nephron
Mark Timms, Rohan Steel, John Vine
The recombinant human erythropoietins epoetin alfa (Eprex®), darbepoetin (Aranesp®) and methoxy polyethylene glycol-epoetin beta (Mircera®) were administered to greyhounds for 7, 10 and 14 days respectively. Blood and urine samples were collected and analysed for erythropoietin by ELISA, LC-MS/MS and western blotting. Limits of confirmation in plasma for western blotting and LC-MS/MS methods ranged from a low of 2.5mIU/mL, and closely matched the sensitivity of ELISA screening.
February 2016: Drug Testing and Analysis
William R Strohl
The purpose of making a "biobetter" biologic is to improve on the salient characteristics of a known biologic for which there is, minimally, clinical proof of concept or, maximally, marketed product data. There already are several examples in which second-generation or biobetter biologics have been generated by improving the pharmacokinetic properties of an innovative drug, including Neulasta(®) [a PEGylated, longer-half-life version of Neupogen(®) (filgrastim)] and Aranesp(®) [a longer-half-life version of Epogen(®) (epoetin-α)]...
August 2015: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
David M Charytan, Eldrin F Lewis, Akshay S Desai, Larry A Weinrauch, Peter Ivanovich, Robert D Toto, Brian Claggett, Jiankang Liu, L Howard Hartley, Peter Finn, Ajay K Singh, Andrew S Levey, Marc A Pfeffer, John J V McMurray, Scott D Solomon
BACKGROUND: The cause of death in patients with chronic kidney disease (CKD) varies with CKD severity, but variation has not been quantified. STUDY DESIGN: Retrospective analysis of prospective randomized clinical trial. SETTING & PARTICIPANTS: We analyzed 4,038 individuals with anemia and diabetic CKD from TREAT, a randomized trial comparing darbepoetin alfa and placebo. PREDICTORS: Baseline estimated glomerular filtration rate (eGFR) and protein-creatinine ratio (PCR)...
September 2015: American Journal of Kidney Diseases: the Official Journal of the National Kidney Foundation
S Theilade, B Claggett, T W Hansen, H Skali, E F Lewis, S D Solomon, H-H Parving, M Pfeffer, J J McMurray, P Rossing
Pulse pressure (PP) remains an elusive cardiovascular risk factor with inconsistent findings. We clarified the prognostic value in patients with type 2 diabetes, chronic kidney disease (CKD) and anemia in the Trial to Reduce cardiovascular Events with Aranesp (darbepoetin alfa) Therapy. In 4038 type 2 diabetes patients, darbepoetin alfa treatment did not affect the primary outcome. Risk related to PP at randomization was evaluated in a multivariable model including age, gender, kidney function, cardiovascular disease (CVD) and other conventional risk factors...
January 2016: Journal of Human Hypertension
Magdalena Sobaszek-Pitas, Katarzyna Krzanowska, Władysław Sułowicz
INTRODUCTION: Anemia is a common complication in patients with chronic renal failure (CRF) especially on maintenance hemodialysis. There are some data that the use of biocompatible high-flux dialyzers is more efficient than low-flux dialyzers in controlling some uremia related diseases including anemia. The aim of the study was to assess the iron metabolism and degree of anemia correction in patients on maintenance hemodialysis performed based on low-flux dialyzers (HD-LF), with polysulfone membrane and high- flux dialyzers (HD-HF), with helixone membrane...
2014: Przegla̧d Lekarski
Natalie A Bello, Marc A Pfeffer, Hicham Skali, Janet B McGill, Jerome Rossert, Kurt A Olson, Larry Weinrauch, Mark E Cooper, Dick de Zeeuw, Peter Rossing, John J V McMurray, Scott D Solomon
OBJECTIVE: Retinopathy is an established microvascular complication of type 2 diabetes mellitus (T2DM), but its independent relationship with macrovascular and other microvascular complications is less well defined across the spectrum of kidney disease in T2DM. We examined the prognostic value of retinopathy in assessing the risk of developing end-stage renal disease (ESRD), cardiovascular morbidity or death among patients in the Trial to Reduce cardiovascular Events with Aranesp Therapy (TREAT)...
2014: BMJ Open Diabetes Research & Care
Cécile Vigneau, Sylvie Le Stum, Corinne Isnard-Bagnis, Gabriel Choukroun, Yannick Lemeur, Nassim Kamar, Emmanuel Oger
INTRODUCTION: Erythropoiesis Stimulating Agents (ESA) are largely prescribed before dialysis stage to chronic kidney disease patients. In accordance to current international guidelines, lots have been made by pharmacological companies in order to improve self management of ESAs: subcutaneaous administration, pencil devices, mutidose cartridges, low injection volume, very fine needles, once a month injections but none is currently known on the percentage of patients who actually do self administration of ESAs...
December 2014: Néphrologie & Thérapeutique
Iain C Macdougall, Nicole Casadevall, Francesco Locatelli, Christian Combe, Gerard M London, Salvatore Di Paolo, Andreas Kribben, Danilo Fliser, Hans Messner, John McNeil, Paul Stevens, Antonio Santoro, Angel L M De Francisco, Paul Percheson, Anna Potamianou, Arnaud Foucher, Daniel Fife, Véronique Mérit, Els Vercammen
BACKGROUND: Subcutaneous administration of Eprex(®) (epoetin alfa) in patients with chronic kidney disease (CKD) was contraindicated in the European Union between 2002 and 2006 after increased reports of anti-erythropoietin antibody-mediated pure red cell aplasia (PRCA). The Prospective Immunogenicity Surveillance Registry (PRIMS) was conducted to estimate the incidence of antibody-mediated PRCA with subcutaneous administration of a new coated-stopper syringe presentation of Eprex(®) and to compare this with the PRCA incidence with subcutaneous NeoRecormon(®) (epoetin beta) and Aranesp(®) (darbepoetin alfa)...
March 2015: Nephrology, Dialysis, Transplantation
Mae Thamer, Yi Zhang, Onkar Kshirsagar, Dennis J Cotter, James S Kaufman
BACKGROUND: In a landmark study, TREAT (Trial to Reduce Cardiovascular Events With Aranesp Therapy) examined the use of erythropoiesis-stimulating agent (ESA) therapy to treat anemia among patients with chronic kidney disease (CKD) and found no benefit compared to placebo. STUDY DESIGN: A retrospective observational design was used to determine the impact of TREAT on clinical practice. SETTING & PARTICIPANTS: A large US health plan database with more than 1...
November 2014: American Journal of Kidney Diseases: the Official Journal of the National Kidney Foundation
Anila Thomas, Leif E Peterson
BACKGROUND: Ferric citrate is a novel phosphate binder which has the potential to reduce usage of erythropoietin-stimulating agents (ESAs) and intravenous (IV) iron used for anemia management during hemodialysis (HD) among patients with end-stage renal disease (ESRD). Currently, the potential health care cost savings on a national scale due to the use of ferric citrate in ESRD are undetermined. METHODS: Per-patient-per-year costs of ESAs (Epogen(®) and Aranesp(®) [Amgen Inc...
2014: International Journal of Nephrology and Renovascular Disease
Bassam Bernieh, Samra Abouchacra, Yousef Boobes, Mohammad R Al Hakim, Nico Nagelkerke, Ahmad Chaaban, Mohamad Ahmed, Qutaiba Hussain, Hanan El Jack, Faiz Abayechi, Imran Khan, Nicole Gebran
PURPOSE: Maintaining target hemoglobin (Hb) with minimal variability is a challenge in hemodialysis (HD) patients. The aim of this study is to compare the long- and short-acting erythropoietin-stimulating agents such as Aranesp and Eprex in achieving these targets. METHODS: Randomized, prospective, open-labeled study of 24 weeks includes stable patients on HD >3 months, age >18 years, and on Eprex for >3 months. Patients were randomized into two groups: A-(Aranesp group):HD patients on Eprex Q TIW or BIW were converted to Aranesp Q weekly, by using the conversion factor of 200:1 and those on Eprex Q weekly to Aranesp Q 2 weeks; B-(Eprex group):patients continued on Eprex treatment...
February 2014: International Urology and Nephrology
Peter Choi, Mourad Farouk, Nick Manamley, Janet Addison
INTRODUCTION: There is limited information published on switching erythropoiesis-stimulating agent (ESA) treatment for anemia associated with chronic kidney disease (CKD) from darbepoetin alfa (DA) to methoxy polyethylene glycol-epoetin beta (PEG-Epo) outside the protocol of interventional clinical studies. AFFIRM (Aranesp Efficiency Relative to Mircera) was a retrospective, multi-site, observational study designed to estimate the population mean maintenance dose conversion ratio [DCR; dose ratio achieving comparable hemoglobin level (Hb) between two evaluation periods] in European hemodialysis patients whose treatment was switched from DA to PEG-Epo...
November 2013: Advances in Therapy
Simon D Roger, Sarbjit V Jassal, Michael C Woodward, Steven Soroka, Lawrence P McMahon
BACKGROUND: The prevalence of chronic kidney disease (CKD) increases with age, and the risk of significant anaemia increases as renal function declines. The objectives of this study were to assess the effect of darbepoetin alfa administration on health-related quality of life (HRQOL) through treatment for anaemia in older patients with CKD. METHODS: In this multicentre, randomised, placebo-controlled trial, older patients (aged ≥ 70 years) with CKD (Stages 3-5, predialysis) and haemoglobin (Hb) < 11...
February 2014: International Urology and Nephrology
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