Effect of Synthetic Vitamin E-Bonded Membrane on Responsiveness to Erythropoiesis-Stimulating Agents in Hemodialysis Patients: A Pilot Study

Abstract

Background: Oxidative stress, a recently identified factor related to the response to erythropoiesis-stimulating agents (ESAs), is increased in hemodialysis patients. The aim of this study was to verify whether ESA responsiveness improves if the anti-oxidant vitamin E (Vi-E) is placed on the blood-side layer of a synthetic polysulfone (PS) dialyzer. Methods: This 8-month, controlled and open randomized study involved 2 groups of patients on stable ESA therapy undergoing hemodialysis using a PS dialyzer with or without Vi-E treatment. Hemoglobin, albumin, high-sensitivity C-reactive protein, interleukin-6, iron status, parathyroid hormone (PTH), Vi-E (α- and γ-tocopherol levels) and the oxidative stress markers, advanced oxidation protein products, carbonyls and advanced glycation end products were evaluated every 2 months. The primary outcome measure was ESA resistance, the weekly ESA dose divided by the product between hemoglobin level and end-dialysis body weight. Results: Nineteen of the 20 randomized patients completed the study. During the follow-up, the ESA resistance significantly decreased (p = 0.024), greater in the Vi-E group (37%) than in the PS group (20%), but this difference was not statistically significant (p = 0.596). Baseline PTH and Vi-E levels were associated with ESA resistance. In the secondary analysis, including these covariates in the model, the difference between groups in ESA resistance became significant (p = 0.042). Conclusions: Vi-E placed on the blood-side of a dialyzer may have a possible beneficial effect on ESA resistance in hemodialysis patients; baseline PTH levels seem to predict ESA resistance and were useful in showing the possible beneficial effect of Vi-E and should be considered in designing adequate-sized trials for testing this hypothesis.

Effects of vitamin E-coated dialysis membranes on anemia, nutrition and dyslipidemia status in hemodialysis patients: a meta-analysis

“…Among them, duplicate records, non-RCTs or quasi-RCTs, review and letter, article not in English, other intervention and concerning other outcome were excluded. After the progressive selection process, 14 eligibility studies 1,8,[13][14][15][16][21][22][23][24][25][26][27][28] including five crossover and nine parallel-arm trials were included in this meta-analysis ( Figure 1). …”

“…These 14 studies enrolled a total of 975 HD patients, among them, 473 were treated with vitamin E-coated dialyzer and 502 were treated with conventional dialyzer. Of these 14 included studies, seven of the 14 included studies compared vitamin E-coated dialyzer with polysulfone dialyzer 8,[14][15][16]22,25,28 while four studies compared with cellulose membrane dialyzer. 1,13,21,26 Mean age of study participants ranged from 51.9 to 72.3 years, with follow-up ranged from 1 to 12 months.…”

Review of the Effectiveness of Cellulose- and Polysulfone-Based Vitamin E-Bonded Dialysis Membranes

“…This aspect was investigated in clinical trials that www.intechopen.com compared VitabranE with polysulfone membranes. A pilot study by Andrulli et al, 2010, carried out with a 2-arm randomized controlled design showed that 8-month treatment with VitabranE decreased the erythropoiesis-stimulating agent (ESA)-resistance index (ERI); ERI is calculated as the ratio between ESA dosage (IU/kg/w) and hemoglobin levels (g/dL). In the primary analysis, ERI showed no significant deference between the groups treated with VitabranE and the control polysulfone membrane.…”

“…Preliminary investigations of blood levels of advanced protein oxidation products (AOPP) and fluorescent AGEs were performed in the randomized controlled pilot trial reported by www.intechopen.com Andrulli et al, 2010. In this study, these protein-damaged markers were investigated as oxidative and carbonyl stress indices associated with the correction of ERI.…”

A Systematic Review of the Effect of Vitamin C Infusion and Vitamin E-Coated Membrane on Hemodialysis-Induced Oxidative Stress

“…However, there is a limited number of preliminary studies on that area. For example, one preliminary study published as a pilot study states a positive effect of vitamin E-bonded membranes on anemia in hypo-responder dialysis patients (Andrulli et al, 2010). Another study shows new positive effects of vitamin E-coated membranes on blood pressure level in dialysed patients (Matsamura et al, 2010).…”