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A randomized controlled trial of haemoglobin normalization with epoetin alfa in pre-dialysis and dialysis patients

Furuland, H; Linde, T; Ahlmen, J; Christensson, Anders LU ; Strombom, U and Danielson, BG (2003) In Nephrology Dialysis Transplantation 18(2). p.353-361
Abstract
Background. Partial correction of renal anaemia with erythropoietin improves quality of life (QoL). We aimed to examine if normalization of haemoglobin with epoetin alfa in pre-dialysis and dialysis patients further improves QoL and is safe. Methods. 416 Scandinavian patients with renal anaemia [pre-dialysis, haemodialysis (HD) and peritoneal dialysis patients] were randomized to reach a normal haemoglobin of 135-160 g/l (n = 216) or a subnormal haemoglobin of 90-120 g/l (n = 200) with or without epoetin alfa. Study duration was 48-76 weeks. QoL was measured using Kidney Disease Questionnaires in 253 Swedish dialysis patients. Safety was examined in all patients. Results. QoL improved, measured as a decrease in physical symptoms (P =... (More)
Background. Partial correction of renal anaemia with erythropoietin improves quality of life (QoL). We aimed to examine if normalization of haemoglobin with epoetin alfa in pre-dialysis and dialysis patients further improves QoL and is safe. Methods. 416 Scandinavian patients with renal anaemia [pre-dialysis, haemodialysis (HD) and peritoneal dialysis patients] were randomized to reach a normal haemoglobin of 135-160 g/l (n = 216) or a subnormal haemoglobin of 90-120 g/l (n = 200) with or without epoetin alfa. Study duration was 48-76 weeks. QoL was measured using Kidney Disease Questionnaires in 253 Swedish dialysis patients. Safety was examined in all patients. Results. QoL improved, measured as a decrease in physical symptoms (P = 0.02), fatigue (P = 0.05), depression (P = 0.01) and frustration (P = 0.05) in the Swedish dialysis patients when haemoglobin was normalized. In pre-dialysis patients, diastolic blood pressure was higher in the normal compared with the subnormal haemoglobin group after 48 weeks. However, the progression rate of chronic renal failure was comparable. In the normal haemoglobin group (N-Hb), 51% had at least one serious adverse event compared with 49% in the subnormal haemoglobin group (S-Hb) (P = 0.32). The incidence of thrombovascular events and vascular access thrombosis in HD patients did not differ. The mortality rate was 13.4% in the N-Hb group and 13.5% in the S-Hb group (P = 0.98). Mortality decreased with increasing mean haemoglobin in both groups. Conclusions. Normalization of haemoglobin improved QoL in the subgroup of dialysis patients, appears to be safe and can be considered in many patients with end-stage renal disease. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
anaemia, end-stage renal failure, erythropoietin, haemoglobin, quality of life, mortality
in
Nephrology Dialysis Transplantation
volume
18
issue
2
pages
353 - 361
publisher
Oxford University Press
external identifiers
  • pmid:12543892
  • wos:000180901200020
  • scopus:0037317068
ISSN
1460-2385
language
English
LU publication?
yes
id
a55212c4-76c3-4198-8d04-b2f2934cef6f (old id 891306)
alternative location
http://ndt.oxfordjournals.org/cgi/reprint/18/2/353
date added to LUP
2008-01-11 13:52:03
date last changed
2018-02-18 04:26:32
@article{a55212c4-76c3-4198-8d04-b2f2934cef6f,
  abstract     = {Background. Partial correction of renal anaemia with erythropoietin improves quality of life (QoL). We aimed to examine if normalization of haemoglobin with epoetin alfa in pre-dialysis and dialysis patients further improves QoL and is safe. Methods. 416 Scandinavian patients with renal anaemia [pre-dialysis, haemodialysis (HD) and peritoneal dialysis patients] were randomized to reach a normal haemoglobin of 135-160 g/l (n = 216) or a subnormal haemoglobin of 90-120 g/l (n = 200) with or without epoetin alfa. Study duration was 48-76 weeks. QoL was measured using Kidney Disease Questionnaires in 253 Swedish dialysis patients. Safety was examined in all patients. Results. QoL improved, measured as a decrease in physical symptoms (P = 0.02), fatigue (P = 0.05), depression (P = 0.01) and frustration (P = 0.05) in the Swedish dialysis patients when haemoglobin was normalized. In pre-dialysis patients, diastolic blood pressure was higher in the normal compared with the subnormal haemoglobin group after 48 weeks. However, the progression rate of chronic renal failure was comparable. In the normal haemoglobin group (N-Hb), 51% had at least one serious adverse event compared with 49% in the subnormal haemoglobin group (S-Hb) (P = 0.32). The incidence of thrombovascular events and vascular access thrombosis in HD patients did not differ. The mortality rate was 13.4% in the N-Hb group and 13.5% in the S-Hb group (P = 0.98). Mortality decreased with increasing mean haemoglobin in both groups. Conclusions. Normalization of haemoglobin improved QoL in the subgroup of dialysis patients, appears to be safe and can be considered in many patients with end-stage renal disease.},
  author       = {Furuland, H and Linde, T and Ahlmen, J and Christensson, Anders and Strombom, U and Danielson, BG},
  issn         = {1460-2385},
  keyword      = {anaemia,end-stage renal failure,erythropoietin,haemoglobin,quality of life,mortality},
  language     = {eng},
  number       = {2},
  pages        = {353--361},
  publisher    = {Oxford University Press},
  series       = {Nephrology Dialysis Transplantation},
  title        = {A randomized controlled trial of haemoglobin normalization with epoetin alfa in pre-dialysis and dialysis patients},
  volume       = {18},
  year         = {2003},
}