Evaluation of a biosimilar recombinant alpha epoetin in the management of anemia in hemodialysis patients

Beiraghdar, F. and Panahi, Y. and Einollahi, B. and Nemati, E. and Sahebkar, A. and Hassanzadeh, A. and Khosroshahi, H. T. and Azar, S. A. and Safa, J. and Hashemi, S. R. and Etemadi, J. and Marzony, E. T. and Noshad, H. (2015) Evaluation of a biosimilar recombinant alpha epoetin in the management of anemia in hemodialysis patients. Saudi Pharmaceutical Journal, 23 (5). pp. 544-548.

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Abstract

Background: The efficacy of human recombinant erythropoietins (rHuEPOs) in the treatment of anemia with different etiologies is proven. Development of biosimilar rHuEPO products with lower cost and wider availability is important for the care of anemic patients. Objective: The aim of the present study was to determine the bioequivalence and safety of a biosimilar rHuEPO (Pastopoitin®) and compare it with the innovator product Eprex®, as a standard rHuEPO. Methods: One hundred and seven anemic patients on stable hemodialysis were recruited to this randomized double-blind comparative trial and assigned to either subcutaneous Pastopoitin (n=50) or Eprex (n=57). Each study group received rHuEPO at a dose of 80-120IU/kg/week in 2-3 divided doses for a period of 3months. Hematologic parameters including Hemoglobin, hematocrit, RBC, EBC, platelet, MCV, MCH and MCHC were checked every 2weeks. Blood iron, ferritin, TIBC, creatinine, BUN and electrolytes (Na, K, Ca and P) were evaluated monthly over the 3months. Results: A significant increase in hemoglobin, hematocrit and RBC was observed by the end of study in both Pastopoitin and Eprex groups (p<0.001). However, these factors were not significantly different between the groups, neither at baseline nor at the end of study (p<0.05). Likewise, the groups were comparable regarding MCV, MCH, MCHC, iron, ferritin, TIBC, creatinine, BUN and electrolytes at baseline as well as at the end of trial. Adverse events were not serious and occurred with the same frequency in the study groups. Conclusion: Pastopoitin showed comparable efficacy and safety profile with Eprex in anemic patients on hemodialysis. Hence, Pastopoitin may be considered as a rHuEPO with a lower cost and wider availability compared with the innovator product Eprex. © 2015 The Authors.

Item Type: Article
Additional Information: Export Date: 16 February 2020 CODEN: SPJOE Correspondence Address: Panahi, Y.; Chemical Injuries Research Center, Baqiyatallah University of Medical Sciences, Molla-Sadra Street, P.O. Box: 19945-581, Iran
Uncontrolled Keywords: Anemia Biosimilar Eprex Hemodialysis Pastopoitin calcium creatinine hemoglobin iron nitrogen phosphorus potassium recombinant erythropoietin sodium urea adult arthralgia Article bioequivalence controlled study diarrhea dizziness double blind procedure drug efficacy drug safety erythrocyte fatigue female ferritin blood level headache hematocrit hemodialysis patient human hypertension iron blood level major clinical study male mean corpuscular hemoglobin mean corpuscular volume middle aged nausea randomized controlled trial thorax pain thrombocyte thrombosis urea nitrogen blood level vomiting weakness
Subjects: WH Hemic and Lymphatic System
WJ Urogenital System
Divisions: Mashhad University of Medical Sciences
Depositing User: mr lib5 lib5
Date Deposited: 06 May 2020 03:49
Last Modified: 06 May 2020 03:49
URI: http://eprints.mums.ac.ir/id/eprint/18794

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