UPLC-MS assessment on the structural similarity of recombinant human erythropoietin (rhEPO) analogues from manufacturers in China for attribute monitoring.
Abstract
Recombinant human erythropoietin (rhEPO) is a glycoprotein that acts as the main hormone involved in regulating red blood cell production to treat anemia caused by chronic kidney disease or chemotherapy. Since the expiration of the patent of the innovator epoetin alfa, numerous rhEPO products have emerged in global markets. As described here, multiple complementary analytical approaches are utilized for the extensive characterization of rhEPO molecules, and more importantly for the structural comparison of the rhEPO analogues on the Chinese market. The focus of this study is placed on the overall ...
Source: Talanta - September 17, 2020 Category: Chemistry Authors: Alley W, Tao L, Shion H, Yu YQ, Rao C, Chen W Tags: Talanta Source Type: research
Oral Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitor Roxadustat (FG-4592) for Treatment of Anemia in Chronic Kidney Disease: A Placebo-Controlled Study of Pharmacokinetic and Pharmacodynamic Profiles in Hemodialysis Patients.
Abstract
Roxadustat (FG-4592), an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that stimulates erythropoiesis, was evaluated in a phase 1b study in patients with end-stage renal disease with anemia on hemodialysis. Seventeen patients, on epoetin-alfa maintenance therapy with stable hemoglobin levels ≥10 g/dL, had epoetin-alfa discontinued on day 3 and were enrolled in this double-blind placebo-controlled study. Two cohorts were randomized 3:1 (roxadustat: placebo). Patients received single doses of roxadustat (1 or 2 mg/kg) or placebo 1 hour after hemodialysis on day 1 and 2 hours before ...
Source: The Journal of Clinical Pharmacology - June 29, 2020 Category: Drugs & Pharmacology Authors: Provenzano R, Tumlin J, Zabaneh R, Chou J, Hemmerich S, Neff TB, Yu KP Tags: J Clin Pharmacol Source Type: research
Conversion from Epoetin Alfa to Darbepoetin Alfa in Hemodialysis Patients: Effectiveness and Variability in Anemia Treatment
(Source: Journal of Renal Nutrition)
Source: Journal of Renal Nutrition - February 27, 2020 Category: Urology & Nephrology Source Type: research
Surgical prescription of epoetin alfa in contemporary total hip arthroplasty: a prospective comparative study
ConclusionsThe amended protocol does not lead to increased peri-operative bleeding. Advances in intra-operative methods to reduce the bleeding allow changing indications of EPO in patients undergoing THA with a low level of Hb. (Source: International Orthopaedics)
Source: International Orthopaedics - January 18, 2020 Category: Orthopaedics Source Type: research
Real-world treatment patterns of renal anemia in hemodialysis patients: A multicenter cohort study performed using DialysisNet (RRAHD study)
In this study, detailed information on the actual anemia treatment patterns were obtained using the DialysisNet. We expect that DialysisNet will simplify and improve the renal anemia management for both dialysis patients and health care providers. (Source: Medicine)
Source: Medicine - January 1, 2020 Category: Internal Medicine Tags: Research Article: Observational Study Source Type: research
Glycan analysis of erythropoiesis-stimulating agents
In this study, a combination of chromatography and mass spectrometry analysis has been used to characterise and compare the glycosylation profiles of five ESA products; Eprex® (epoetin alfa), NeoRecormon® (epoetin beta), Binocrit® (epoetin alfa biosimilar), Silapo (epoetin alfa biosimilar) and Aranesp® (darbepoetin alfa). The methods utilised include mixed-mode anion-exchange/hydrophilic interaction chromatography (AEX/HILIC-MS) for N-glycan identification and quantitation, and HILIC-MS for O-glycan characterisation. The products exhibit notable differences in N- and O-glycosylation, including attributes such as sialic...
Source: Journal of Pharmaceutical and Biomedical Analysis - December 6, 2019 Category: Drugs & Pharmacology Source Type: research
Severe anemia may not be a contraindication to debridement in a Jehovah’s witness patient with necrotizng fasciitis of the lower extremity – A case report
ConclusionSeverely anemic patients in critical condition can survive necrotizing fasciitis with a well-planned interdisciplinary approach without compromising patient autonomy. (Source: International Journal of Surgery Case Reports)
Source: International Journal of Surgery Case Reports - September 20, 2019 Category: Surgery Source Type: research
Survival of a Severely Anemic Jehovah’s Witness Patient with Necrotizing Fasciitis of the Lower Extremity—A Case Report
CONCLUSIONSeverely anemic patients in critical condition can survive necrotizing fasciitis with a well-planned interdisciplinary approach without compromising patient autonomy. (Source: International Journal of Surgery Case Reports)
Source: International Journal of Surgery Case Reports - September 5, 2019 Category: Surgery Source Type: research
Biosimilar Erythropoiesis-Stimulating Agents in Chronic Kidney Disease
Publication date: July 2019Source: Advances in Chronic Kidney Disease, Volume 26, Issue 4Author(s): Hitesh H. Shah, Steven FishbaneAnemia is a well-known complication of advanced CKD and treatment with erythropoietin analogues (epoetin) remains a key component of management. Although biologic agents, including epoetin, play an extremely important role in the treatment of various medical conditions, their cost can be prohibitive. As a result, several biosimilar agents have now been approved by the U.S. Food and Drug Administration. Biosimilar epoetin has been used in Europe since 2007. In this article, we will review biosim...
Source: Advances in Chronic Kidney Disease - August 31, 2019 Category: Urology & Nephrology Source Type: research
Cardiovascular Safety and All-Cause Mortality of Methoxy Polyethylene Glycol-Epoetin Beta and Other Erythropoiesis-Stimulating Agents in Anemia of CKD: A Randomized Noninferiority Trial.
CONCLUSIONS: In patients with anemia of CKD, once-monthly methoxy polyethylene glycol-epoetin beta was noninferior to conventional, shorter-acting erythropoiesis-stimulating agents with respect to rates of major adverse cardiovascular events or all-cause mortality.
PMID: 31420350 [PubMed - as supplied by publisher] (Source: Clinical Journal of the American Society of Nephrology : CJASN)
Source: Clinical Journal of the American Society of Nephrology : CJASN - August 15, 2019 Category: Urology & Nephrology Authors: Locatelli F, Hannedouche T, Fishbane S, Morgan Z, Oguey D, White WB Tags: Clin J Am Soc Nephrol Source Type: research
Cost-minimization analysis between intravenous iron sucrose and iron sucrose similar in hemodialysis patients.
Conclusion: This cost minimization analysis suggests that for chronic hemodialysis patients, iron sucrose and iron sucrose similar have the same efficacy and that using iron sucrose similar was more expensive in 66.7% of iterations.
PMID: 31257944 [PubMed - as supplied by publisher] (Source: Expert Review of Pharmacoeconomics and Outcomes Research)
Source: Expert Review of Pharmacoeconomics and Outcomes Research - July 2, 2019 Category: Health Management Tags: Expert Rev Pharmacoecon Outcomes Res Source Type: research
Efficacy and Safety of Supportive Care Biosimilars Among Cancer Patients: A Systematic Review and Meta-Analysis
ConclusionExisting evidence suggests highly comparable efficacy and safety profiles for supportive care biosimilars and their reference biologics in oncology. (Source: BioDrugs)
Source: BioDrugs - June 2, 2019 Category: Drugs & Pharmacology Source Type: research
Analysis of Pharmacokinetic and Pharmacodynamic Parameters in EU- Versus US-Licensed Reference Biological Products: Are In Vivo Bridging Studies Justified for Biosimilar Development?
ConclusionOur analysis reveals that, in most cases, the reference biological products originated from the EU and those from the USA are almost indistinguishable in terms of PK/PD properties. Additional in vivo bridging studies between reference products from different global regions may not be required if similar physicochemical and structural properties are evident in vitro. (Source: BioDrugs)
Source: BioDrugs - May 19, 2019 Category: Drugs & Pharmacology Source Type: research
Time spent on erythropoietin stimulating agents administration in hemodialysis centers in Panama: a time and motion study.
CONCLUSIONS: Data from a real-world setting showed that the adoption of CERA could potentially lead to a reduction in active HCP time.
PMID: 30915883 [PubMed - as supplied by publisher] (Source: Journal of Medical Economics)
Source: Journal of Medical Economics - March 29, 2019 Category: Health Management Tags: J Med Econ Source Type: research
Definition and Validation of a Novel Metric of Erythropoiesis-Stimulating Agent Response in Hemodialysis Patients.
Abstract
Erythropoiesis-stimulating agents (eg, epoetin alfa) are the primary treatment for anemia in patients with end-stage renal disease . Hemoglobin variability in and out of a narrow target range is common and associated with higher morbidity and mortality risk. More robust erythropoiesis-stimulating agent response metrics are needed to define optimal dosing and their association with clinical outcomes. In this cross-sectional, single-center, retrospective study, 49 patients with end-stage renal disease on hemodialysis were followed over 12 months. To quantify hemoglobin deviations outside the target ...
Source: The Journal of Clinical Pharmacology - November 9, 2018 Category: Drugs & Pharmacology Authors: Meaney CJ, Karas S, Robinson B, Gaesser J, Forrest A, Krzyzanski W, Panesar M, Rao GG Tags: J Clin Pharmacol Source Type: research
