Evaluation of safety and therapeutic efficacy of a new erythropoiesis stimulating epoetin b product in maintaining stable target hemoglobin level in patients on chronic hemodialysis
Abstract
In an unmasked study 31 hemodialysis patients were transferred from rh-EPO products of other manufacturers to the equal doses of Epostim®, a new erythropoietin product manufactured by Pharmapark LLC (Russia) from in-house produced pharmacological substance. The study has demonstrated that the alternative antianemic therapy in comparable doses is adequate and maintains stable hemoglobin level. In the course of the study none of the patients had to be switched back to the original therapy. No adverse effects attributable to the product, individual intolerance or local reactions were observed.
Keywords
нефрогенная анемия,
эритропоэтин,
биоаналоги,
Эпостим,
renal anemia,
erythropoietin,
biosimilars,
Epostim
About the Authors
L. S. Biryukova
City clinical hospital No 52, Moscow; Pharmapark LLC, Moscow
Russian Federation
Russian Federation
A. I. Ushakova
City clinical hospital No 52, Moscow; Pharmapark LLC, Moscow
Russian Federation
Russian Federation
N. I. Kamshilova
City clinical hospital No 52, Moscow; Pharmapark LLC, Moscow
Russian Federation
Russian Federation
I. V. Ose
City clinical hospital No 52, Moscow; Pharmapark LLC, Moscow
Russian Federation
Russian Federation
A. V. Akimov
City clinical hospital No 52, Moscow; Pharmapark LLC, Moscow
Russian Federation
Russian Federation
T. F. Skobeleva
City clinical hospital No 52, Moscow; Pharmapark LLC, Moscow
Russian Federation
Russian Federation
A. L. Badmayev
City clinical hospital No 52, Moscow; Pharmapark LLC, Moscow
Russian Federation
Russian Federation
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Review
For citations:
Biryukova L.S., Ushakova A.I., Kamshilova N.I., Ose I.V., Akimov A.V., Skobeleva T.F., Badmayev A.L. Evaluation of safety and therapeutic efficacy of a new erythropoiesis stimulating epoetin b product in maintaining stable target hemoglobin level in patients on chronic hemodialysis. Nephrology and Dialysis. 2011;13(2):128-132. (In Russ.)
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