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Comparative risk/benefit profile of biosimilar and originator erythropoiesis-stimulating agents (ESAs): data from an Italian observational study in nephrology

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العنوان: Comparative risk/benefit profile of biosimilar and originator erythropoiesis-stimulating agents (ESAs): data from an Italian observational study in nephrology
المؤلفون: Alberto Vaccheri, Anna Covezzoli, Monia Donati, Piera Polidori, Domenico Motola, Giulia Bonaldo, Andrea Roncadori, Stefano Bianchi
المساهمون: Motola, Domenico, Vaccheri, Alberto, Roncadori, Andrea, Donati, Monia, Bonaldo, Giulia, Covezzoli, Anna, Polidori, Piera, Bianchi, Stefano
المصدر: European journal of clinical pharmacology. 74(6)
سنة النشر: 2017
مصطلحات موضوعية: Nephrology, Adult, Male, medicine.medical_specialty, Erythropoiesis-stimulating agent, 030204 cardiovascular system & hematology, Risk Assessment, 03 medical and health sciences, 0302 clinical medicine, Hematinic, Observational study, Internal medicine, medicine, Humans, Pharmacology (medical), Darbepoetin alfa, Renal Insufficiency, Chronic, Prospective cohort study, Biosimilar Pharmaceuticals, Erythropoietin, Aged, Pharmacology, Aged, 80 and over, business.industry, Biosimilar, Epoetin alfa, Anemia, General Medicine, Recombinant Protein, Middle Aged, medicine.disease, Recombinant Proteins, Epoetin Alfa, Treatment Outcome, Risk/benefit profile, Epoetin Zeta, Hematinics, Erythropoiesis, Female, business, 030217 neurology & neurosurgery, Biosimilar Pharmaceutical, Human, Kidney disease, medicine.drug
الوصف: 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. Patients were treated with epoetin alfa, beta, and darbepoetin as originator and epoetin zeta as biosimilar. Hemoglobin levels have been analyzed at baseline and after 3, 6, and 12 months. Descriptive statistics were used to analyze the results. Results: At baseline, 47 patients were in the biosimilar group and 57 in the originator; the basal level of hemoglobin was similar between the groups (mean Hb 9.4 and 9.3 g/dL, respectively). Median age, weight, and comorbidities were almost comparable. After 3 months, 44 patients remained in the biosimilar group and 48 in the originator; hemoglobin increase was significantly greater in patients treated with biosimilar [absolute increase 1.6 vs 1.0 g/dL, p < 0.001]. After 6 and 12 months, number of patients fall furthermore. Hemoglobin levels increased more in the biosimilar group after 6 months (2.1 vs 1.1 g/dL, p < 0.001) and 12 months (2.0 vs 1.0 g/dL, p < 0.001). Conclusions: Biosimilar ESAs have similar risk/benefit profile compared to originators. Our data are in agreement with relevant scientific literature and, on the other hand, they are in contrast with common thought that considers biosimilar less efficacious and less safe than originators.
وصف الملف: STAMPA
تدمد: 1432-1041
URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e3bd5df4a60b7c273f57a0809625dc01
https://pubmed.ncbi.nlm.nih.gov/29429032
حقوق: CLOSED
رقم الأكسشن: edsair.doi.dedup.....e3bd5df4a60b7c273f57a0809625dc01
قاعدة البيانات: OpenAIRE
الوصف
تدمد:14321041