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https://www.readbyqxmd.com/read/29672740/effects-of-vadadustat-on-hemoglobin-concentrations-in-patients-receiving-hemodialysis-previously-treated-with-erythropoiesis-stimulating-agents
#1
Volker H Haase, Glenn M Chertow, Geoffrey A Block, Pablo E Pergola, Emil M deGoma, Zeeshan Khawaja, Amit Sharma, Bradley J Maroni, Peter A McCullough
Background: Vadadustat, an inhibitor of hypoxia-inducible factor prolyl-4-hydroxylase domain dioxygenases, is an oral investigational agent in development for the treatment of anemia secondary to chronic kidney disease. Methods: In this open-label Phase 2 trial, vadadustat was evaluated in 94 subjects receiving hemodialysis, previously maintained on epoetin alfa. Subjects were sequentially assigned to one of three vadadustat dose cohorts by starting dose: 300 mg once daily (QD), 450 mg QD or 450 mg thrice weekly (TIW)...
April 16, 2018: Nephrology, Dialysis, Transplantation
https://www.readbyqxmd.com/read/29578404/priapism-and-hemodialysis-case-report-and-literature-review
#2
Weiwen Vivian Shih, Cynthia Wong
BACKGROUND: Priapism is a known but rarely described complication of patients on dialysis. The incidence of priapism in the general population is estimated at 1.5 in 100,000 patients and 2.9 in 100,000 patients in males over 40 years of age; however there is little current literature describing priapism in adult dialysis patients and no current literature in pediatric dialysis patients [1]. We describe two pediatric patients who developed priapism concurrent with hemodialysis, each with differing severity and therapeutic management...
March 26, 2018: Clinical Nephrology
https://www.readbyqxmd.com/read/29545827/a-novel-outpatient-desensitization-protocol-for-recombinant-human-erythropoietin-allergy-in-a-pediatric-patient
#3
Jaime S Rosa, Van B Vuong, Orly Haskin, Anne Y Liu
Background: Recombinant human erythropoietin, such as epoetin alfa and darbepoetin alfa, is an important therapy for anemia due to chronic renal failure. Allergy to recombinant human erythropoietin and the need for desensitization are rare. Case presentation: We report here a novel epoetin alfa outpatient desensitization protocol in a girl who developed delayed cutaneous hypersensitivity to subcutaneous epoetin alfa and intravenous darbepoetin alfa. An initial attempt at traditional epoetin alfa desensitization failed, so we created a slower 17-day outpatient desensitization that succeeded and allowed treatment continuation...
2018: Allergy, Asthma, and Clinical Immunology
https://www.readbyqxmd.com/read/29500617/epoetin-biosimilars-in-the-treatment-of-renal-anemia-what-have-we-learned-from-a-decade-of-european-experience
#4
David Goldsmith, Frank Dellanna, Martin Schiestl, Andriy Krendyukov, Christian Combe
Biosimilars are biological medicines that are approved via stringently defined regulatory pathways on the basis that comparable safety, efficacy, and quality have been demonstrated to their reference medicine. The advantage of biosimilar drugs is that they may be less expensive than the reference medicine, allowing for greater patient access and cost savings in already stretched healthcare budgets. Biosimilar epoetins have been available in Europe for a decade. Complementing in vitro and preclinical characterization, and pharmacokinetic/pharmacodynamic studies, clinical trials provided the additional data needed to reassure European authorities that biosimilar epoetins were sufficiently similar to the reference epoetin to warrant approval...
March 2, 2018: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29492906/correction-to-epoetin-biosimilars-in-the-treatment-of-chemotherapy-induced-anemia-10-years-experience-gained
#5
Matti Aapro, Andriy Krendyukov, Martin Schiestl, Pere Gascón
Figure 1, HX575 column, 5th box down, which previously read "SC HX575 vs. Eprex® /Erypo® 417 patients with CKD-related anemia" as shown here.
February 28, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29466169/-selection-of-optimal-therapy-at-correction-of-the-anemic-syndrome-in-patients-with-chronic-heart-failure
#6
K K Zahidova
PURPOSE: to study efficacy of various schemes of therapy of patients with chronic heart failure (CHF) and anemia. MATERIALS AND METHODS: We included in this study 208 patients with CHF of ishemic etiology (mean age 60.6±1.4 years, 174 with and 34 without anemia). According to therapeutic regimen of the use of methoxy polyethylene glycol-epoetin beta (MEB, 0.60 mсg/kg) and intravenous (IV) iron hydroxide sucrose complex all patients were divided into 4 groups. In all patients before and after treatment we determined Hb, Ht, plasma levels of ferritin, erythropoietin (EPO), NT-proBNP, IL-1, IL-6, TNF-α, transferrin saturation (TS), total vascular peripheral resistance, and parameters of systolic and diastolic function of left ventricular (LV) myocardium (by echocardiography and doppler echocardiography)...
January 2018: Kardiologiia
https://www.readbyqxmd.com/read/29441494/cost-minimisation-analysis-of-erythropoiesis-stimulating-agents-in-the-treatment-of-anaemia-in-dialysed-patients-a-pilot-study
#7
Astrid Darsonval, Virginie Besson, Claire Cavalin
OBJECTIVE: This study aimed to assess the cost impact of administering erythropoiesis-stimulating agents once every 4 weeks instead of one to three times a week to treat anaemia in patients undergoing dialysis. METHODS: This was a monocentric retrospective study involving 27 patients who underwent haemodialysis between 2009 and 2013 in a university hospital in Angers, France. The study was a cost-minimisation analysis from the hospital perspective. Only direct medical costs were considered...
September 2017: PharmacoEconomics Open
https://www.readbyqxmd.com/read/29429032/comparative-risk-benefit-profile-of-biosimilar-and-originator-erythropoiesis-stimulating-agents-esas-data-from-an-italian-observational-study-in-nephrology
#8
Domenico Motola, Alberto Vaccheri, Andrea Roncadori, Monia Donati, Giulia Bonaldo, Anna Covezzoli, Piera Polidori, Stefano Bianchi
PURPOSE: The aim of this multicenter prospective study was to evaluate efficacy and safety of biosimilar erythropoiesis-stimulating agents (ESAs) vs originator, based on data from clinical practice in patients with chronic kidney disease (CKD). METHODS: We collected data of the patients with diagnosis of CKD on conservative treatment from nine Italian structures. Patients were enrolled applying different exclusion criteria, and various individual parameters were registered at the beginning for descriptive analysis...
February 10, 2018: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29417431/epoetin-biosimilars-in-the-treatment-of-chemotherapy-induced-anemia-10%C3%A2-years-experience-gained
#9
REVIEW
Matti Aapro, Andriy Krendyukov, Martin Schiestl, Pere Gascón
High-quality, safe, and effective biosimilars have the potential to increase access to biological therapies worldwide and to reduce cancer care costs. The European Medicines Agency (EMA) was the first regulatory authority to establish legislative procedures for the approval of biosimilars when they published their guidelines on similar biological medicinal products in 2005. Biosimilar epoetins were first approved in 2007, and a wealth of data has been collected over the last decade. Two biosimilar epoetins (under five commercial names) have been approved by the EMA so far...
February 7, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29408510/structure-function-relationships-for-recombinant-erythropoietins-a-case-study-from-a-proposed-manufacturing-change-with-implications-for-erythropoietin-biosimilar-study-designs
#10
Gustavo Grampp, Patricia L McElroy, Gary Camblin, Allan Pollock
Comparability studies used to assess a proposed manufacturing change for a biological product include sensitive analytical studies to confirm there are no significant differences in structural or functional attributes that may contribute to clinically meaningful changes in efficacy or safety. When a proposed change is relatively complex or when clinically relevant differences between the product before and after the change cannot be ruled out based on analytical studies, nonclinical and clinical bridging studies are generally required to confirm overall comparability...
January 31, 2018: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29390245/a-strategy-to-reduce-inflammation-and-anemia-treatment-s-related-costs-in-dialysis-patients
#11
Biagio R Di Iorio, Lucia Di Micco, Luigi Russo, Luca Nardone, Emanuele De Simone, M L Sirico, Gabriella Di Natale, Domenico Russo
This is a post-hoc analysis evaluating erythropoiesis stimulating agents' (ESA) related costs while using an additional ultrafilter (Estorclean PLUS) to produce ultrapure dialysis water located within the fluid pathway after the treatment with reverse osmosis and before the dialysis machine. Twenty-nine patients (19 treated with epoetin alfa and 10 with darboepoetin alfa) were included in the analysis. We showed to gain savings of 210 € per patient (35 € per patient each month) with epoetin alfa during the experimental period of 6 months, compared to the control period and of 545 € per patient (90 € per patient each month) with darboepoetin alfa...
February 2018: Giornale Italiano di Nefrologia: Organo Ufficiale Della Società Italiana di Nefrologia
https://www.readbyqxmd.com/read/29374477/epoetin-beta-pegol-for-treatment-of-anemia-ameliorates-deterioration-of-erythrocyte-quality-associated-with-chronic-kidney-disease
#12
Ken Aizawa, Ryohei Kawasaki, Yoshihito Tashiro, Yasushi Shimonaka, Michinori Hirata
BACKGROUND: Epoetin beta pegol (continuous erythropoietin receptor activator; C.E.R.A.) is currently widely used for the treatment of anemia associated with chronic kidney disease (CKD). Therapeutic control of anemia is assessed by monitoring haemoglobin (Hb) levels. However, certain qualitative aspects of erythrocytes are also impaired in CKD, including loss of deformability and shortened life-span. Therefore, monitoring Hb alone could potentially fail to reveal pathological changes in erythrocytes...
January 27, 2018: BMC Nephrology
https://www.readbyqxmd.com/read/29296077/hx575-established-biosimilarity-in-the-treatment-of-renal-anemia-and-10-years-of-clinical-experience
#13
REVIEW
Frank Dellanna, David Goldsmith, Andriy Krendyukov, Andreas Seidl, Nadja Höbel, Christian Combe
Erythropoiesis-stimulating agents, such as recombinant human erythropoietin, are commonly used for the treatment of anemia in patients with chronic kidney disease (CKD). In 2007, HX575 (Binocrit® ) became the first biosimilar epoetin alfa to be approved by the European Medicines Agency (EMA). The decision to approve a biosimilar is based on the totality of evidence obtained in a comprehensive comparability exercise that involves extensive analytical characterization, nonclinical studies and clinical studies...
2018: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/29278529/erythropoietin-does-not-alter-serum-profiles-of-neuronal-and-axonal-biomarkers-after-traumatic-brain-injury-findings-from-the-australian-epo-tbi-clinical-trial
#14
Sarah C Hellewell, Stefania Mondello, Alison Conquest, Gerry Shaw, Irina Madorsky, Jay V Deng, Lorraine Little, Firas Kobeissy, Nicole Bye, Rinaldo Bellomo, David J Cooper, Shirley Vallance, Jasmine Board, Maria C Morganti-Kossmann
OBJECTIVE: To determine profiles of serum ubiquitin carboxy-terminal hydrolase L1 and phosphorylated neurofilament heavy-chain, examine whether erythropoietin administration reduce their concentrations, and whether biomarkers discriminate between erythropoietin and placebo treatment groups. DESIGN: Single-center, prospective observational study. SETTING: A sub-study of the erythropoietin-traumatic brain injury clinical trial, conducted at the Alfred Hospital, Melbourne, Australia...
April 2018: Critical Care Medicine
https://www.readbyqxmd.com/read/29228453/effects-of-erythropoietin-on-spontaneous-and-oxytocin-induced-myometrial-contractions-in-the-nonpregnant-rat
#15
N Tug, H Ayvaci Tasan, M A Sargin, B Dogan Taymur, A Ayar, E Kilic, B Yilmaz
OBJECTIVE: Erythropoietin (EPO) is a glycoprotein hormone that regulates erythropoiesis. EPO activity has also been detected in a variety of tissue including the nervous system, and female and male reproductive organs. It has been shown that EPO causes relaxation in vascular smooth muscle. In the present study, we have investigated effects of EPO on spontaneous and oxytocin-induced contractions of non-pregnant rat myometrium. MATERIALS AND METHODS: Myometrial stripes were obtained from adult Wistar rats at the oestrous stage...
November 2017: European Review for Medical and Pharmacological Sciences
https://www.readbyqxmd.com/read/29220885/indexes-of-the-erythropoietin-level-in-the-blood-plasma-of-chronic-heart-failure-patients-with-anemia
#16
Kamala Kh Zahidova
BACKGROUND: Anemia aggravates the disease course and the survival rate of chronic heart failure (CHF) patients. The purpose of the study was to investigate the level of erythropoietin (EPO) in CHF patients with anemic syndrome, with the aim to more accurately assess the severity of the disease and its treatment, depending on the anemia degree. METHODS: Patients with ischemic CHF of I-IV functional class (FC) with and without anemia were examined (total number of patients=208, patients with anemia=174)...
January 26, 2018: Journal of Basic and Clinical Physiology and Pharmacology
https://www.readbyqxmd.com/read/29211140/pharmacotherapeutic-profile-of-users-and-expenditure-on-high-cost-drugs-in-s%C3%A3-o-leopoldo-rio-grande-do-sul-state-brazil-2014
#17
Mariani Sopelsa, Fabiane Raquel Motter, Nêmora Tregnago Barcellos, Heloísa Marquardt Leite, Vera Maria Vieira Paniz
OBJECTIVE: to describe the pharmacotherapeutic profile of users of the Specialized Program for Pharmaceutical Assistance, and to measure the expenditure on the most prevalent and the most expensive medications. METHODS: descriptive study conducted in São Leopoldo-RS, Brazil, with secondary data regarding information about requests accepted in 2014, through administrative proceedings; delivery notes of the State Health Department/RS were used to assess the costs...
October 2017: Epidemiologia e Servicos de Saude: Revista do Sistema Unico de Saude do Brasil
https://www.readbyqxmd.com/read/29172979/pharmacovigilance-of-biologics-in-a-multisource-environment
#18
Sreedhar Sagi, Hillel P Cohen, Gillian R Woollett
It is important that systems are in place to ensure that appropriate and comprehensive records are kept for use of all medications. It is fundamental to an effective pharmacovigilance system that patient medical records contain sufficient information to identify which medication has been prescribed, when it was administered, and at what dose. The availability of biologics from multiple sponsors has raised questions by some health care providers about the ability of current pharmacovigilance systems to trace specific biologics...
December 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/29168688/long-term-treatment-with-biosimilar-epoetin-%C3%AE-hx575-in-hemodialysis-patients-with-renal-anemia-real-world-effectiveness-and-safety-in-the-monitor-ckd5-study
#19
Gérard London, Johannes Mann, David Goldsmith, Christian Combe, Frank Dellanna, Philippe Zaoui, Nadja Hoebel, Andriy Krendyukov, Karen MacDonald, Ivo Abraham
AIMS: To assess real-world effectiveness and safety of intravenous (IV) HX575, a biosimilar epoetin-α, in hemodialysis (HD) patients. MATERIALS AND METHODS: This prospective, observational, pharmacoepidemiological study of adult HD patients treated with IV HX575 for renal anemia for up to 24 months was conducted in 114 centers in 10 European countries. Of 2,086 enrolled subjects (safety sample), 2,023 had ≥ 1 follow-up visit (effectiveness sample). RESULTS: Most (59...
January 2018: Clinical Nephrology
https://www.readbyqxmd.com/read/29149162/-switching-from-one-drug-therapy-to-another-with-the-same-therapeutic-indication-without-harms
#20
Valeria Belleudi, Antonio Addis
The loss of exclusivity from several drug therapies largely used bring new attention the issues of safety, efficacy and following the switch from one drug to another (i.e., biosimilar and/or generics) with the same indication. This is not a problem that can be related to regulatory or economical factors. The increase of patients exposed to chronic conditions and the introductions or more pharmaceutical alternatives with same therapeutic indications yield for studies able to verify the effectiveness and safety even when switch from more drugs is considered by practitioners...
November 2017: Recenti Progressi in Medicina
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