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.
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.
Department of Nephrology and Dialysis, Hospital of Versilia, Versilia, Italy. v.panichi@usl12.toscana.it
Vincenzo
V
Panichi
Alberto
A
Rosati
Sabrina
S
Paoletti
Paolo
P
Ferrandello
Massimiliano
M
Migliori
Sara
S
Beati
Giada
G
Bernabini
Roberto
R
Daini
Aldo
A
Casani
Daniela
D
Angelini
Manuela
M
Parrini
Arturo
A
Rossi
Isabella
I
Petrone
Giuliano
G
Barsotti
Carlo
C
Donadio
Giaclì
G
Donati
Giovanni
G
Grazi
Giovanni
G
Manca Rizza
Guido
G
Garosi
Enrico
E
Sansoni
Beatrice
B
Braccagni
Antonino
A
Sidoti
Donella
D
Boracelli
Marina
M
Biagioli
Luigi
L
Moriconi
Viviana
V
Finato
Antonio
A
Mannarino
Cristina
C
Grimaldi
Filomena
F
Pansa
Patrizio
P
Imperiali
Carlo
C
Mura
Stefano
S
Bianchi
Roberto
R
Bigazzi
D000368:Aged; D000369:Aged, 80 and over; D000975:Antioxidants / Q000494:pharmacology* / Q000627:therapeutic use; D015415:Biomarkers / Q000097:blood*; D002097:C-Reactive Protein / Q000032:analysis; D020099:Coated Materials, Biocompatible / Q000737:chemistry; D018592:Cross-Over Studies; D004797:Enzyme-Linked Immunosorbent Assay; D004921:Erythropoietin / Q000378:metabolism / Q000494:pharmacology*; D005260:Female; D005500:Follow-Up Studies; D006397:Hematinics / Q000378:metabolism / Q000494:pharmacology*; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D015850:Interleukin-6 / Q000097:blood; D007558:Italy; D007676:Kidney Failure, Chronic / Q000097:blood / Q000503:physiopathology / Q000628:therapy*; D015227:Lipid Peroxidation / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D018384:Oxidative Stress / Q000187:drug effects; D011108:Polymers / Q000737:chemistry; D006435:Renal Dialysis / Q000295:instrumentation / Q000379:methods; D016037:Single-Blind Method; D013450:Sulfones / Q000737:chemistry; D014810:Vitamin E / Q000494:pharmacology* / Q000627:therapeutic use
D000975:Antioxidants; D015415:Biomarkers; D020099:Coated Materials, Biocompatible; D006397:Hematinics; D006454:Hemoglobins; D015850:Interleukin-6; D011108:Polymers; D013450:Sulfones; D004921:Erythropoietin; D014810:Vitamin E; C017662:polysulfone P 1700; D002097:C-Reactive Protein