Roxadustat for the Maintenance Treatment of Anemia in Patients with End-Stage Kidney Disease on Stable Dialysis: A European Phase 3, Randomized, Open-Label, Active-Controlled Study (PYRENEES)
ConclusionRoxadustat was non-inferior to ESAs in maintaining hemoglobin levels in this cohort of patients with anemia of CKD on dialysis for at least 4 months who were previously treated with ESAs. Observed TEAEs were consistent with previous studies. (Source: Advances in Therapy)
Source: Advances in Therapy - September 19, 2021 Category: Drugs & Pharmacology Source Type: research
Higher ‐risk myelodysplastic syndrome in an elderly patient: Long‐term partial remission with low‐dose prednisone, G‐CSF, and epoetin alfa
Currently, most patients with higher-risk MDS are treated with 5-azacitidine or decitabine. These agents are toxic. The treatment described here is safe, devoid of toxicity, fosters improved quality of life, and helps reduce transfusion requirements. AbstractCurrently, most patients with higher-risk MDS are treated with 5-azacitidine or decitabine. These agents are toxic. The treatment described here is safe, devoid of toxicity, fosters improved quality of life, and helps reduce transfusion requirements. (Source: Clinical Case Reports)
Source: Clinical Case Reports - September 7, 2021 Category: General Medicine Authors: Anwarul Islam Tags: CASE REPORT Source Type: research
Safe and Effective Treatment for Anemic Patients With Chronic Kidney Disease: An Updated Systematic Review and Meta-Analysis on Roxadustat
Conclusion: This study confirmed that roxadustat therapy could alleviate the anemia of DD-CKD and NDD-CKD patients by raising the hemoglobin level and regulating iron metabolism, but increased serious incidences of treatment-emergent adverse events (TEAEs) in NDD-CKD patients. (Source: Frontiers in Pharmacology)
Source: Frontiers in Pharmacology - July 2, 2021 Category: Drugs & Pharmacology Source Type: research
The Clinical Efficacy of Epoetin Alfa and Darbepoetin Alfa in Patients with Low-Risk or Intermediate-1-Risk Myelodysplastic Syndrome: Retrospective Multi-center Real-Life Study
This study aimed to evaluate the clinical efficacy of epoetin alfa and darbepoetin alfa in patients with myelodysplastic syndromes (MDS) in the real-life setting. A total of 204 patients with low-risk or intermediate-1-risk MDS who received epoetin alfa or darbepoetin alfa were included. Hemoglobin levels and transfusion need were recorded before and during 12-month treatment. Hemoglobin levels were significantly higher at each follow up visit when compared to baseline levels in both epoetin alfa (mean ± SD 8.68 ± 1.0 g/dL at baseline vs. 9.83 ± 1.45, 9.99 ± 1.55, 10.24 ± 1.77 and 10.2 ± 1.5...
Source: Indian Journal of Hematology and Blood Transfusion - June 26, 2021 Category: Hematology Source Type: research
Incentives to promote the US pharmaceutical innovation: empirical research based on the case of Epogen
Conclusion - We pointed out that Amgen has developed the successful innovation of Epogen taking advantages of the incentives. Effective and flexible incentives and policies are essential to support the entire life cycle of new drugs, ultimately forming a sustainable driver for the long-run pharmaceutical innovation.PMID:34056986 | DOI:10.1080/03639045.2021.1935997 (Source: Drug Development and Industrial Pharmacy)
Source: Drug Development and Industrial Pharmacy - May 31, 2021 Category: Drugs & Pharmacology Authors: Lin Zhang Ji Wang Source Type: research
Stanozolol for the treatment of anemic lower-risk myelodysplastic syndromes without del(5q) after failure of epoetin alfa: findings from a retrospective study
AbstractOptions for anemic lower-risk myelodysplastic syndromes (MDS) without del(5q) after failure of erythropoiesis-stimulating agents (ESAs) are very limited. The effectiveness of second-line treatments is uncertain. We retrospectively reviewed the clinical effectiveness and overall survival (OS) of lower-risk MDS without del(5q) patients exclusively treated with stanozolol (STZ) after failure of epoetin alfa. The response was defined according to the 2006 International Working Group (IWG) criteria. Fifty-six patients were included. The median follow-up time was 55 months (range: 5 –156 months). Twenty-seven patients ...
Source: Annals of Hematology - April 10, 2021 Category: Hematology Source Type: research
Systematic Review of Erythropoietin (EPO) for Neuroprotection in Human Studies.
Abstract
Erythropoietin (EPO) is an exciting neurotherapeutic option. Despite its potential, concerns exist regarding the potential for thrombosis and adverse events with EPO administration in normonemic adults. Systematic review of literature using PRISMA guidelines to examine the application and risks of EPO as a treatment option for neuroprotection in normonemic adults. Independent, systematic searches were performed in July 2019. PubMed (1960-2019) and the Cochrane Controlled Trials Register (1960-2019) were screened. Search terms included erythropoietin, neuroprotection, and humans. The PubMed search ...
Source: Neurochemical Research - February 1, 2021 Category: Neuroscience Authors: Hemani S, Lane O, Agarwal S, Yu SP, Woodbury A Tags: Neurochem Res Source Type: research
Determining optimal treatment to correct preoperative anemia and reduce perioperative allogeneic blood transfusions in cardiac surgery: a retrospective cohort study
: Preoperative anemia management reduces red blood cell (RBC) transfusion and adverse outcomes, but how best to optimize the patient's hemoglobin (Hgb) before cardiac surgery remains unclear. We sought to determine the optimal treatment of anemia using iron and epoetin alfa before cardiac surgery. (Source: Journal of Cardiothoracic and Vascular Anesthesia)
Source: Journal of Cardiothoracic and Vascular Anesthesia - January 4, 2021 Category: Anesthesiology Authors: John K. Peel, Jacqueline Trudeau, Ruby Tano, Saudia Jadunandan, Jeannie Callum, Fuad Moussa, Yulia Lin Source Type: research
Epoetin alfa-epbx: a new entrant into a crowded market. a historical review of the role of erythropoietin stimulating agents and the development of the first epoetin biosimilar in the United States.
Authors: Anand S, Al-Mondhiry J, Fischer K, Glaspy J
Abstract
Introduction: Erythropoietin stimulating agents (ESAs) have been established both to correct anemia and provide the clinical benefits of increased exercise capacity, reduced transfusion requirements, and improved quality of life. An increase in physician and patient adoption of biosimilars, as well as changes to healthcare reimbursement policies have driven market competitors to innovate and expand the range of biosimilar products. While erythropoietin biosimilars have been approved by the EMA since 2007, the FDA's approval of epoetin alfa-epbx ...
Source: Expert Review of Clinical Pharmacology - December 16, 2020 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research
Changes in Erythropoiesis Stimulating Agent Use Under a Risk Evaluation and Mitigation Strategy (REMS) Program
ConclusionREMS program implementation and enforcement were not associated with significant changes in ESA initiation, adding to concerns over the degree to which certain REMS programs enhance patient safety. (Source: Drug Safety)
Source: Drug Safety - November 18, 2020 Category: Drugs & Pharmacology Source Type: research
Evaluation of erythropoietin biosimilars Epotin™, Hemax® and Jimaixin™ by electrophoretic methods used for doping control analysis and specific N-glycan analysis revealed structural differences from original epoetin alfa drug Eprex®
Publication date: Available online 5 November 2020Source: Journal of Pharmaceutical and Biomedical AnalysisAuthor(s): Perrine Capdeville, Laurent Martin, Sophie Cholet, Annelaure Damont, Michel Audran, Magnus Ericsson, François Fenaille, Alexandre Marchand (Source: Journal of Pharmaceutical and Biomedical Analysis)
Source: Journal of Pharmaceutical and Biomedical Analysis - November 6, 2020 Category: Drugs & Pharmacology Source Type: research
Population Pharmacodynamic Modeling of Epoetin Alfa in End ‐Stage Renal Disease Patients Receiving Maintenance Treatment Using Bayesian Approach
The ability to control dosage regimens of erythropoiesis ‐stimulating agents (ESAs) to maintain a desired hemoglobin (HGB) target is still elusive. We utilized a Bayesian approach and informative priors to characterize HGB profiles, using simulated drug concentrations, in patients with end‐stage renal disease receiving maintenance doses of epoetin alf a. We also demonstrated an adaptive Bayesian method, applied to individual patients, to improve the accuracy of HGB predictions over time. The results showed that sparse HGB data from daily clinical practice were characterized successfully. The adaptive Bayesian method ef...
Source: CPT: Pharmacometrics and Systems Pharmacology - September 28, 2020 Category: Drugs & Pharmacology Authors: Ly Minh Nguyen,
Calvin J. Meaney,
Gauri G. Rao,
Mandip Panesar,
Wojciech Krzyzanski Tags: Article Source Type: research
