Randomized Controlled Open-Label Trial of Vitamin E-Bonded Polysulfone Dialyzer and Erythropoiesis-Stimulating Agent Response

Abstract

the VEESA Study Group Summary Background and objectives A 1-year multicenter prospective randomized controlled study was conducted on the effects of vitamin E-bonded polysulfone dialyzers on erythropoiesis-stimulating agent response in hemodialysis patients.Design, setting, participants, & measurements Major inclusion criteria were use of high-flux polysulfone dialyzers with 50-70 ml/min b 2 -microglobulin clearance over 3 months, transferrin saturation over 20%, same erythropoiesisstimulating agent for over 3 months, and hemoglobin at 10-12 g/dl. Hemodialysis patients were placed in four interventional groups: two hemoglobin ranges (10.0-10.9 or 11.0-11.9 g/dl) and two dialyzers. Patients were randomly assigned by central registration to a vitamin E-bonded polysulfone dialyzers or polysulfone control group. Primary end point was relative erythropoiesis resistance index at baseline between groups at 12 months. Erythropoiesis resistance index was defined as total weekly erythropoiesis-stimulating agent dose divided by hemoglobin.Results There were no statistically significant differences in age or sex. There was no significant difference in relative erythropoiesis resistance index between vitamin E-bonded polysulfone dialyzers and control groups at 12 months (vitamin E-bonded polysulfone dialyzers: 1.1, control: 1.3). The vitamin E-bonded polysulfone dialyzers group showed better relative erythropoiesis resistance index than the control group at 11.0-11.9 g/dl hemoglobin (vitamin E-bonded polysulfone dialyzers: 1.0, control: 1.4 at 12 months, significant difference) but no difference at 10.0-10.9 g/dl hemoglobin. ConclusionsThe overall relative erythropoiesis resistance index showed no difference between the vitamin Ebonded polysulfone dialyzers and control groups, although the change in relative erythropoiesis resistance index differed according to hemoglobin level.

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

“…The effect of vitamin E-coated dialyzer on HB level was assessed in six trials, 8,14,15,21,23,25 this meta-analysis showed a nonsignificant increase in HB level compared with that of control (MD, À0.03; 95% CI, À0.18 to 0.13; p ¼ 0.74; Figure 3), with significant heterogeneity between studies (p ¼ 0.06; I 2 ¼ 50%). Six studies reported the EPO dose as mean and standard deviation, 8,[13][14][15]23,25 the fixed model was performed for 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.…”

“…Incomplete outcome data: Four studies reported withdrawals, 15,16,22,24 but the results were not analyzed on an intention-to-treat basis. Ten trials were assessed to be low risk of attrition bias.…”

“…8,13,14 However, there was controversy about these effects of vitamin E-coated dialyzer. 15,16 . Therefore, we undertook the present meta-analysis mainly to reconcile the various strands within the dispute about the effects of vitamin E-coated dialyzer on renal anemia, resistance to EPO, malnutrition, dyslipidemia and atherosclerosis in HD patients.…”