A Vitamin E-Coated Polysulfone Membrane Reduces Serum Levels of Inflammatory Markers and Resistance to Erythropoietin-Stimulating Agents in Hemodialysis Patients: Results of a Randomized Cross-Over Multicenter Trial

Abstract

Background: Oxidative stress is prevalent in dialysis patients and has been implicated in the pathogenesis of cardiovascular disease and anemia. Vitamin E is a fat-soluble antioxidant that plays a central role in reducing lipid peroxidation and inhibiting the generation of reactive oxygen species. The aim of this cross-over randomized study was to compare the effects of a vitamin E-coated polysulfone (Vit E PS) membrane and a non-vitamin E-coated polysulfone (PS) membrane on inflammatory markers and resistance to erythropoietin-stimulating agents (ESAs). Methods: After a 1-month run-in period of standard bicarbonate dialysis with a synthetic membrane, 62 patients of both genders, and older than 18 years, dialysis vintage 48 ± 27 months, BMI 22 ± 3 (from 13 different dialysis units) were randomized (A-B or B-A) in a cross-over design to Vit E PS (treatment A) and to PS (treatment B) both for 6 months. C-reactive protein (CRP) and interleukin-6 (IL-6) concentrations were determined by a sandwich enzyme immunoassay at baseline and every 2 months; red blood cell count, ESA dose and ESA resistance index (ERI) were assessed monthly. Results: Hemoglobin (Hb) levels significantly increased in the Vit E PS group from 11.1 ± 0.6 g/dl at baseline to 11.5 ± 0.7 at 6 months (p < 0.001) and remained unchanged in the PS group. Although ESA dosage remained stable during the observation periods in both groups, ERI was significantly reduced in the Vit E PS group from 10.3 ± 2.2 IU-dl/kg/g Hb week at baseline to 9.2 ± 1.7 at 6 months (p < 0.001). No significant variation of ERI was observed in the PS group. A significant reduction in plasma CRP and IL-6 levels was observed in the Vit E PS group: CRP from 6.7 ± 4.8 to 4.8 ± 2.2 mg/l (p < 0.001) and IL-6 from 12.1 ± 1.4 to 7.5 ± 0.4 pg/ml (p < 0.05). In the PS group, CRP varied from 6.2 ± 4.0 to 6.4 ± 3.7, and IL-6 from 10.6 ± 2.1 to 9.6 ± 3.5 (p = n.s.). Conclusions: Treatment with Vit E PS membranes seems to lead to a reduction in ESA dosage in HD patients; in addition, a low chronic inflammatory response may contribute to a sparing effect on exogenous ESA requirements.

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

“…4 In addition, the circulating biomarkers of oxidative stress and chronic inflammatory cytokines such as malondialdehyde (MDA), C-reactive protein (CRP) or interleukin-6 (IL-6) are significantly elevated in maintenance HD patients. 5,6 There is increasing evidence that increased oxidative stress and inflammatory cytokines play a key role in the pathogenesis of malnutrition, 7 resistance to erythropoietin, 8 …”

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

“…Therefore, the authors concluded that VitabranE membranes have potentially beneficial effects on ERI of HD patients. This conclusion was confirmed in another and more recent multicenter study by Panichi et al, 2011. In this report, a crossover design was employed and 62 HD patients from 13 dialysis units were randomized to receive treatments with VitabranE or polysulfone dialyzer controls.…”

“…In the report by Panichi et al, 2011, the authors observed that beside of ERI reduction, CRP and IL-6 levels decreased during VitabranE treatment, whereas no significant changes were found during the control polysulfone treatment. The study by Mandolfo et al (in press) on catheterized patients with a high inflammatory burden also reported a better control of CRP levels during the VitabranE treatment.…”

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

“…Another study shows new positive effects of vitamin E-coated membranes on blood pressure level in dialysed patients (Matsamura et al, 2010). Recently, there are findings that these membranes may play an effective role in the management of uremic anemia and lead to a reduction in the chronic low-grade inflammatory response of patients with uremic syndrome (Panichi et al, 2011). …”

“…This contributes to the increased cardiovascular morbidity and mortality in that group of patients. Clinical studies point to links between oxidative stress, inflammation, anemia and malnutrition (Panichi et al, 2011). The presence of inflammation and the length of duration of dialysis are the most important determinants of oxidative stress, which make them additional risk factors of cardiovascular disease.…”