Hypertension and nephrology

[Biosimilar erythropoietins in nephrology - benedictio seu maledictio?]

KISS István

OCTOBER 20, 2010

Hypertension and nephrology - 2010;14(05)

[Biological medicines of protein or polypeptide origin produced with biotechnology are far more complex in structure than the low molecular weight chemical ones. In conjunction with chemical drugs generic copies are completely the same, while in the field of biological medicines only similarity can be stated, as identical molecules cannot be produced. Spatial structure, isomers and side chains cause difference and for this reason these are called biosimilar drugs. Immunogenity of biosimilar drugs is very different and the risk of antibody production against them is diverse. Pure red cell aplasia, a rare side effect of erythropoietins is a life-threatening condition so every effort must be done for its prevention. Biosimilar drugs are not to be replaced with each other, and even the reference drugs should not be substituted in order to identify easily the side effects of each drug. Importantly financing should support these clinical principles namely a cheaper drug could be started as a new treatment but a former treatment should not be replaced because of cost sensitivity. It is important to provide the availability of the very expensive biologically active drugs to each patient but it is acceptable that the treatment should be as cost-effective as possible. Similarly to the generic copy program of chemical drugs biosimilar drugs are also important for the clinical practice, however their use needs appropriate regulation and farmacovigilance.]



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Hypertension and nephrology

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[Oxidative stress plays an important role in the elevation of the cardiovascular risk of patients with chronic kidney insufficiency. The oxidative stress becomes more severe together with the deterioration of the renal function, and the hemodialysis sessions may also induce repetitive oxidative insults. Erythropoesis-stimulating agents (ESAs) may alter the level of oxidative stress via their effects on hematopoiesis, resulting in indirect effects on changes of iron metabolism and the levels of antioxidants. We review the current knowledge about the administration of ESAs as concerns effects on oxidative parameters in hemodialysis patients. We discuss the relationship between the characteristics of the ESA therapy (type, administration frequency and dosage of ESA, length of the therapy, administration withdrawal) and the oxidative stress in view of earlier and recent research.]

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