Effectiveness and Safety of Switching Originator and Biosimilar Epoetins in Patients with Chronic Kidney Disease in a Large-Scale Italian Cohort Study

ConclusionsIn this large-scale Italian observational multi-database study, switching versus non-switching as well as switching from biosimilar/originator ESA  α to any other epoetin in CKD patients is not associated with any effectiveness and safety outcomes.
Source: Drug Safety - Category: Drugs & Pharmacology Source Type: research

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Chronic kidney disease (CKD) affects more than 10% of the population worldwide and burdens citizens with heavy medical expenses in many countries. Because a vital erythroid growth factor, erythropoietin (EPO), is secreted from renal interstitial fibroblasts [renal EPO-producing (REP) cells], anemia arises as a major complication of CKD. We determined that hypoxia-inducible factor 2α (HIF2α), which is inactivated by HIF-prolyl hydroxylase domain-containing proteins (PHDs) in an oxygen-dependent manner, tightly regulates EPO production in REP cells at the gene transcription level to maintain oxygen homeostasis. H...
Source: Frontiers in Genetics - Category: Genetics & Stem Cells Source Type: research
Authors: Shahbazi M, Smailnejad Ganji K, Mirzakhani M, Mohammadnia-Afrouzi M, Akbari R Abstract Chronic kidney disease (CKD) is a common disease in the world that has adverse outcomes.  Immune systems and its components have important roles in the initiation, progression and complications of this disease by systemic inflammation.  Regarding the role of kidneys in the body's natural homeostasis and its relationship with other organs, CKD causes impairments in other organs. Patients with chronic renal failure have variety of complications, such as cardiovascular disease, anemia, bone disorders, immune dysfu...
Source: Iranian Journal of Kidney Diseases - Category: Urology & Nephrology Tags: Iran J Kidney Dis Source Type: research
CONCLUSION: Hb level at>10 g/dL could be maintained for 8 weeks of treatment with both originator and biosimilar EPO (more consistent with originator EPO and more fluctuations with biosimilar EPO), with similar epoetin dose and no drug-related adverse event. PMID: 31699946 [PubMed - in process]
Source: Acta medica Indonesiana - Category: Internal Medicine Tags: Acta Med Indones Source Type: research
In conclusion, common chronic non-communicable diseases, including hypertension, diabetes, obesity, hyperhomocysteinemia, hyperuricemia, and hypertriglyceridemia, were associated with greater prevalence of CKD.
Source: International Journal of Environmental Research and Public Health - Category: Environmental Health Authors: Tags: Article Source Type: research
This study enrolled consecutive 615 hospitalized patients with heart failure. We investigated the associations between circulating acetoacetate and clinical characteristics or prognosis in HF patients.ResultsWe divided the patients into two groups based on circulating acetoacetate levels (high group: acetoacetate ≥35 µmoL/L, n = 313; and low group: acetoacetate
Source: IJC Heart and Vasculature - Category: Cardiology Source Type: research
This study aimed to determine the prevalence of anemia and its associated factors among CKD patients at the University of Gondar hospital, Northwest Ethiopia. Methods: A hospital-based cross-sectional study was conducted from May 1, to September 30, 2018. Consecutive sampling was used to recruit 251 study subjects. Patients were interviewed to obtain demographic data, and the patients' medical records were reviewed to obtain information on relevant medical history and laboratory parameters. Data was analyzed using SPSS version 20. Bivariate and multivariate logistic regression analyses were used to identify independent...
Source: International Journal of Nephrology and Renovascular Disease - Category: Urology & Nephrology Tags: Int J Nephrol Renovasc Dis Source Type: research
Condition:   Anaemia Associated With Chronic Kidney Disease Interventions:   Drug: efepoetin alfa;   Drug: Mircera Sponsors:   PT Kalbe Genexine Biologics;   Novotech (Australia) Pty Limited Not yet recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
7 November 2019 -- AstraZeneca today presented detailed results from the Phase III OLYMPUS and ROCKIES trials showing that roxadustat significantly increased hemoglobin (Hb) levels in both non-dialysis-dependent (NDD) and dialysis-dependent...
Source: Drugs.com - Clinical Trials - Category: Pharmaceuticals Source Type: clinical trials
We report a case of a 27-day-old male neonate admitted in our clinic for fever, foul-smelling urine, and diarrhea. A previous abdominal ultrasound at the age of 2 weeks revealed enlarged, hyperechoic kidneys, no abnormalities of the urinary exam. Clinical examination revealed poor general status, ill-looking face, diminished cutaneous turgor, distended abdomen, and palpable kidneys. Laboratory tests pointed out leukopenia, anemia, border-line platelet count, elevated inflammatory biomarker level, hyponatremia, hypoalbuminemia, proteinuria, leukocyturia, and hematuria. Both urine and blood cultures were positive for E. coli...
Source: Medicine - Category: Internal Medicine Tags: Research Article: Clinical Case Report Source Type: research
Hu E Abstract Daprodustat (GSK1278863) is a hypoxia-inducible factor (HIF)-prolyl hydroxylase (PHD) inhibitor in development for treatment of anemia of chronic kidney disease. Daprodustat's biological activity simulates components of the natural response to hypoxia; inhibition of PHDs results in HIF stabilization and modulation of HIF-controlled gene products, including erythropoietin. The carcinogenic potential of daprodustat was evaluated in 2-year carcinogenicity studies in Sprague-Dawley rats and CD-1 mice, where once-daily doses were administered. The mouse study also included evaluation of daprodustat's 3 m...
Source: Toxicologic Pathology - Category: Pathology Authors: Tags: Toxicol Pathol Source Type: research
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