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Epoetin Alfa

Dafna Willner, Valeria Spennati, Shelly Stohl, Giulia Tosti, Simone Aloisio, Federico Bilotta
Spine surgery has been growing rapidly as a neurosurgical operation, with an increase of 220% over a 15-year period. Intraoperative blood transfusion is a major outcome determinant of spine procedures. Various approaches, including pharmacologic and nonpharmacologic therapies, have been tested to decrease both intraoperative and postoperative blood loss. The aim of this systematic review is to report clinical evidence on the relationship between intraoperative blood loss (primary outcome) and on transfusion requirements and postoperative complications (secondary outcomes) in patients undergoing spine surgery...
October 3, 2016: Anesthesia and Analgesia
Ch Asadov, Z Alimirzoyeva, M Hasanova, T Mammadova, A Shirinova
Research objective is to study the efficacy of recombinant erythropoietin (epoetin alfa) as alternative method of treatment beta-thalassemia intermedia. Study involved 58 patients with beta-thalassemia intermedia (23 women and 35 men). In all observed patients was defined levels of hemoglobin (Hb), red blood cells (RBC), erythrocyte indexes (MCV, MCH, MCHC), hemoglobin fractions (HbA, HbA2, HbF), serum ferritin, serum erythropoietin before and after administrated rEPO. All patients received rEPO during 6 month at the dose - 10000 IU subcutaneously...
June 2016: Georgian Medical News
Alain Cariou, Nicolas Deye, Benoît Vivien, Olivier Richard, Nicolas Pichon, Angèle Bourg, Loïc Huet, Clément Buleon, Jérôme Frey, Pierre Asfar, Stéphane Legriel, Sophie Narcisse, Armelle Mathonnet, Aurélie Cravoisy, Pierre-François Dequin, Eric Wiel, Keyvan Razazi, Cédric Daubin, Antoine Kimmoun, Lionel Lamhaut, Jean-Sébastien Marx, Didier Payen de la Garanderie, Patrick Ecollan, Alain Combes, Christian Spaulding, Florence Barat, Myriam Ben Boutieb, Joël Coste, Jean-Daniel Chiche, Frédéric Pène, Jean-Paul Mira, Jean-Marc Treluyer, Olivier Hermine, Pierre Carli
BACKGROUND: Preliminary data suggested a clinical benefit in treating out-of-hospital cardiac arrest (OHCA) patients with a high dose of erythropoietin (Epo) analogs. OBJECTIVES: The authors aimed to evaluate the efficacy of epoetin alfa treatment on the outcome of OHCA patients in a phase 3 trial. METHODS: The authors performed a multicenter, single-blind, randomized controlled trial. Patients still comatose after a witnessed OHCA of presumed cardiac origin were eligible...
July 5, 2016: Journal of the American College of Cardiology
Chuen Wen Tan, Wei-Chuen Tan-Koi, Jennifer Ng, Choong Meng Chan, William Ying Khee Hwang
Antibody-mediated pure red cell aplasia is a rare but serious complication in chronic kidney disease patients receiving recombinant human erythropoietin (r-HuEpo). Between April 2012 and May 2013, eight such cases were reported in our institution. Their clinical features were reviewed and their HLA alleles were compared with those of healthy controls. All patients were exposed to epoetin alfa (Eprex(®)) with polysorbate-80 as stabilizer via subcutaneous route with a mean age of 61.9 years and mean exposure of 11...
June 27, 2016: Pharmacogenomics
Craig J French, Neil J Glassford, Dashiell Gantner, Alisa M Higgins, David James Cooper, Alistair Nichol, Markus B Skrifvars, Georgina Imberger, Jeffrey Presneill, Michael Bailey, Rinaldo Bellomo
OBJECTIVE: To perform a meta-analysis of all relevant randomized controlled trials assessing the effect of erythropoiesis-stimulating agents (ESAs) in critically ill trauma patients. BACKGROUND: ESAs have effects beyond erythropoiesis. The administration of the ESA epoetin alfa to critically ill trauma patients has been associated with a reduction in mortality. METHODS: We performed a systematic review and meta-analysis with trial sequential analysis...
April 8, 2016: Annals of Surgery
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
Julia T Molony, Keri L Monda, Suying Li, Anne C Beaubrun, David T Gilbertson, Brian D Bradbury, Allan J Collins
BACKGROUND: Little is known about epoetin alfa (EPO) dosing at dialysis centers after implementation of the US Medicare prospective payment system and revision of the EPO label in 2011. STUDY DESIGN: Retrospective cohort study. SETTING & PARTICIPANTS: Approximately 412,000 adult hemodialysis patients with Medicare Parts A and B as primary payer in 2009 to 2012 to describe EPO dosing and hemoglobin patterns; of these, about 70,000 patients clustered in about 1,300 dialysis facilities to evaluate facility-level EPO titration practices and patient-level outcomes in 2012...
August 2016: American Journal of Kidney Diseases: the Official Journal of the National Kidney Foundation
Glenn M Chertow, Jiannong Liu, Keri L Monda, David T Gilbertson, M Alan Brookhart, Anne C Beaubrun, Wolfgang C Winkelmayer, Allan Pollock, Charles A Herzog, Akhtar Ashfaq, Til Sturmer, Kenneth J Rothman, Brian D Bradbury, Allan J Collins
Erythropoiesis-stimulating agents (ESAs) are commonly used to treat anemia in patients with CKD, including those receiving dialysis, although clinical trials have identified risks associated with ESA use. We evaluated the effects of changes in dialysis payment policies and product labeling instituted in 2011 on mortality and major cardiovascular events across the United States dialysis population in an open cohort study of patients on dialysis from January 1, 2005, through December 31, 2012, with Medicare as primary payer...
February 25, 2016: Journal of the American Society of Nephrology: JASN
Francesco Saccà, Giorgia Puorro, Angela Marsili, Antonella Antenora, Chiara Pane, Carlo Casali, Christian Marcotulli, Giovanni Defazio, Daniele Liuzzi, Chiara Tatillo, Donata Maria Cambriglia, Giuseppe Schiano di Cola, Luigi Giuliani, Vincenzo Guardasole, Andrea Salzano, Antonio Ruvolo, Anna De Rosa, Antonio Cittadini, Giuseppe De Michele, Alessandro Filla
BACKGROUND: Friedreich ataxia is an autosomal recessive disease with no available therapy. Clinical trials with erythropoietin in Friedreich ataxia patients have yielded conflicting results, and the long-term effect of the drug remains unknown. METHODS: We designed a double-blind, placebo-controlled, multicenter trial to test the efficacy of epoetin alfa on 56 patients with Friedreich ataxia. The primary endpoint of the study was the effect of epoetin alfa on peak oxygen uptake (VO2 max) at the cardiopulmonary exercise test...
May 2016: Movement Disorders: Official Journal of the Movement Disorder Society
Brian Leyland-Jones, Igor Bondarenko, Gia Nemsadze, Vitaliy Smirnov, Iryna Litvin, Irakli Kokhreidze, Lia Abshilava, Mikheil Janjalia, Rubi Li, Kuntegowda C Lakshmaiah, Beka Samkharadze, Oksana Tarasova, Ranjan Kumar Mohapatra, Yaroslav Sparyk, Sergey Polenkov, Vladimir Vladimirov, Liang Xiu, Eugene Zhu, Bruce Kimelblatt, Kris Deprince, Ilya Safonov, Peter Bowers, Els Vercammen
PURPOSE: An open-label, noninferiority study to evaluate the impact of epoetin alfa (EPO) on tumor outcomes when used to treat anemia in patients receiving chemotherapy for metastatic breast cancer. METHODS: Women with hemoglobin ≤ 11.0 g/dL, receiving first- or second-line chemotherapy for metastatic breast cancer, were randomly assigned to EPO 40,000 IU subcutaneously once a week or best standard of care. The primary end point was progression-free survival (PFS)...
April 10, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
Robert Provenzano, Anatole Besarab, Steven Wright, Sohan Dua, Steven Zeig, Peter Nguyen, Lona Poole, Khalil G Saikali, Gopal Saha, Stefan Hemmerich, Lynda Szczech, K H Peony Yu, Thomas B Neff
BACKGROUND: Roxadustat (FG-4592) is an oral hypoxia-inducible factor prolyl-hydroxylase inhibitor that promotes erythropoiesis through increasing endogenous erythropoietin, improving iron regulation, and reducing hepcidin. STUDY DESIGN: Phase 2, randomized (3:1), open-label, active-comparator, safety and efficacy study. SETTING & PARTICIPANTS: Patients with stable end-stage renal disease treated with hemodialysis who previously had hemoglobin (Hb) levels maintained with epoetin alfa...
June 2016: American Journal of Kidney Diseases: the Official Journal of the National Kidney Foundation
Mony Shuvy, Jumana Mewa, Rafael Wolff, Jordan Hutson, Peter C Austin, Diane Bentley, Mark Iacovelli, Jeannie Callum, Sam Radhakrishnan, Stephen E Fremes, Harindra C Wijeysundera, Yulia Lin
BACKGROUND: Periprocedural blood transfusions are associated with long-term mortality in patients undergoing transcatheter aortic valve implantation (TAVI). We sought to assess the impact of a preoperative blood conservation approach in treating anemia and preventing blood transfusions in patients undergoing TAVI. METHODS: Our cohort consisted of all patients evaluated in our structural heart clinic between January 1, 2012 and December 31, 2014. From March 2013, all anemic TAVI candidates were referred to the blood conservation clinic (BCC)...
June 2016: Canadian Journal of Cardiology
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
Lan Chen, Yi-Sheng Ling, Chun-Hua Lin, Jin-Xuan He, Tian-Jun Guan
OBJECTIVE: Anemia and secondary hyperparathyroidism are the two most common complications associated with chronic kidney disease. Erythropoiesis-stimulating agents (ESAs) are widely used in the management of anemia in hemodialysis patients. A reverse correlation has been established between hyperparathyroidism and hemoglobin levels. The aim of this retrospective study is to evaluate the relationship of high-dose ESAs and hyperparathyroidism in hemodialysis patients with anemia. METHODS: A total of 240 uremic patients maintained on regular hemodialysis were enrolled in this study...
2015: Frontiers in Public Health
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
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
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
Benjamin C Chaon, Michael S Lee
PURPOSE OF REVIEW: The purpose of this study is to discuss current controversies surrounding the proposed treatments for traumatic optic neuropathy (TON) and review recent evidence from the literature relating to these therapeutic options. RECENT FINDINGS: No recent randomized controlled trials investigating surgical or medical interventions for TON exist. The current literature regarding treatment of TON consists mainly of small, mostly retrospective, observational studies...
November 2015: Current Opinion in Ophthalmology
Anne M Butler, Abhijit V Kshirsagar, Andrew F Olshan, Matthew E Nielsen, Stephanie B Wheeler, M Alan Brookhart
BACKGROUND: Erythropoiesis-stimulating agents (ESAs), intravenous iron, and blood transfusion are used to treat anemia in both end-stage renal disease (ESRD) and cancer. However, anemia treatment patterns have not been described among ESRD patients undergoing hemodialysis with concurrent cancer, especially in the recent era of ESA-related safety concerns. METHODS: We analyzed Medicare data from a cohort of hemodialysis patients diagnosed with incident cancer. We used multivariable generalized linear models to estimate trends and patterns in ESA use, iron use, transfusion use, epoetin alfa (EPO) dose, iron dose, and resulting hemoglobin levels (2000-2011)...
2015: American Journal of Nephrology
MinKyung Oh, Jaeseung Yoon, Doo-Yeoun Cho
BACKGROUND AND OBJECTIVES: A new biosimilar human recombinant epoetin alfa product (PDA10) has been developed by PanGen Biotech Inc., Korea. This study was planned to demonstrate the pharmacokinetic and pharmacodynamic comparability of PDA10 to an existing epoetin alfa (Eprex) after a single intravenous administration to healthy adult male volunteers. METHODS: A randomized, double-blinded, single-dose, crossover study was conducted in 30 subjects. The subjects were assigned randomly to one of two sequence groups, and single doses of 100 IU/kg PDA10 or Eprex were administered intravenously on each of 2 treatment days separated by a 4-week washout period...
October 2015: Clinical Drug Investigation
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