THE SAFETY PROFILE OF THERAPY ERITHROPOIESIS STIMULATING AGENTS IN RENAL ANEMIA IN THE PREDIALYSIS PERIOD: THE IMPORTANCE OF TREAT STUDY

Abstract

Erythropoiesis stimulating agents (erythropoietin), firmly established in clinical practice in the treatment of renal anemia in patients with chronic kidney disease (CKD). At the same time, still be confirmed the safety profile of these drugs, depending on age, presence of cardiovascular disease, cerebrovascular events, diabetes and some other factors. In this review article an analysis of the results of major clinical studies of risk of adverse cardiovascular events during therapy with erythropoietin - CHOIR, CREATE, and the most recent large-scale randomized, placebo-controlled study TREAT (The Trial to Reduce Cardiovascular Events with Aranesp Therapy) with darbopoetin- α in diabetes mellitus complicated by chronic kidney disease are discussed. The organizers of the study on a large evidence base (4,038 patients) demonstrated no statistically significant differences in the frequency of major adverse cardiovascular events and total mortality, as well as a very significant increase in the incidence of stroke on a background therapy darbepoetin-α – up to 5% vs 2.6 % in the placebo group. After the results of the study group of experts TREAT Community European Renal Best Practice highlights the need to more closely monitor the safety profile of treatment with erythropoietin in patients with CKD on the background of diabetic nephropathy, especially with a history of stroke or cardiovascular disease, subject always to the maximum target levels hemoglobin in this patient population no more than 110 – 120 grams per liter.