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A randomized controlled trial of haemoglobin normalization with epoetin alfa in pre-dialysis and dialysis patients
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences. (Renal section)
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences.
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2003 (English)In: Nephrology, Dialysis and Transplantation, ISSN 0931-0509, E-ISSN 1460-2385, Vol. 18, no 2, 353-361 p.Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
2003. Vol. 18, no 2, 353-361 p.
Keyword [en]
anaemia, end‐stage renal failure, erythropoietin, haemoglobin, mortality, quality of life
National Category
Medical and Health Sciences
URN: urn:nbn:se:uu:diva-93117DOI: 10.1093/ndt/18.2.353PubMedID: 12543892OAI: oai:DiVA.org:uu-93117DiVA: diva2:166497
Available from: 2005-05-04 Created: 2005-05-04 Last updated: 2010-10-14Bibliographically approved
In thesis
1. Effects of Hemoglobin Normalization with Epoetin in Chronic Kidney Disease
Open this publication in new window or tab >>Effects of Hemoglobin Normalization with Epoetin in Chronic Kidney Disease
2005 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Anemia is common in patients with chronic kidney disease (CDK), contributes to reduced Quality of Life (QoL) and is associated with cardiovascular disease, morbidity and mortality. Epoetin raises hemoglobin (Hb) and increases QoL and physical exercise capacity. Because of concerns about safety and economics, current anemia treatment with epoetin aims to achieve subnormal Hb (110-120 g/l). Normalization of Hb may be of additional benefit regarding QoL and cardiovascular effects. The present study examines the effects of Hb normalization with epoetin on safety variables, QoL, graft function after kidney transplantation, dialysis adequacy, hemorheology, hemodynamics and cardiac autonomic function in CKD patients.

In a randomized, multicenter study comprising 416 pre-dialysis and dialysis patients no difference was observed between patients treated to a normal or a subnormal Hb level on mortality, thrombovascular events, serious adverse events, vascular access thrombosis and residual renal function. QoL was enhanced in a subgroup of hemodialysis patients. Pretransplant epoetin treatment directed toward normal Hb levels did not result in worse graft function during 6 postoperative months. Dialysis adequacy was reduced in a subgroup of hemodialysis patients after normalization of Hb. The blood flow properties of pre-dialysis patients were altered. The hemorheological investigation demonstrated that Hb normalization caused a parallel increase in hematocrit and blood viscosity without other hemorheological changes. While the total peripheral resistance index increased, the cardiac index (CI) decreased. In a separate study cardiac autonomic function, measured by heart rate variability, was decreased in pre-dialysis patients. It was improved, but not fully normalized, by Hb normalization.

On the basis of this study, Hb normalization with epoetin appears to be safe and increases QoL in hemodialysis patients though may result in lower dialysis adequacy and increased blood pressure. A reduction in CI and improved cardiac autonomic function indicate a positive effect on cardiovascular function.

Place, publisher, year, edition, pages
Uppsala: Acta Universitatis Upsaliensis, 2005. 67 p.
Digital Comprehensive Summaries of Uppsala Dissertations from the Faculty of Medicine, ISSN 1651-6206 ; 44
Internal medicine, Anemia, blood viscosity, cardiac output, chronic kidney disease, renal dialysis, dialysis adequacy, erythopoietin, heart rate variability, hemoglobin, hemorheology, hypertension, kidney transplantation, Kt/V, left ventricular hypertrophy, Quality of Life, Invärtesmedicin
National Category
Clinical Medicine
urn:nbn:se:uu:diva-5816 (URN)91-554-6265-0 (ISBN)
Public defence
2005-05-31, Enghoffsalen, Ing. 50, Akademiska sjukhuset, Uppsala, 13:15
Available from: 2005-05-04 Created: 2005-05-04 Last updated: 2010-10-15Bibliographically approved

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