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Normalization of hemoglobin level in patients with chronic kidney disease and anemia

Drueke, Tilman B. ; Locatelli, Francesco ; Clyne, Naomi LU orcid ; Eckardt, Kai-Uwe ; Macdougall, Iain C. ; Tsakiris, Dimitrios ; Burger, Hans-Ulrich and Scherhag, Armin (2006) In New England Journal of Medicine 355(20). p.2071-2084
Abstract
Background: Whether correction of anemia in patients with stage 3 or 4 chronic kidney disease improves cardiovascular outcomes is not established. Methods: We randomly assigned 603 patients with an estimated glomerular filtration rate (GFR) of 15.0 to 35.0 ml per minute per 1.73 m(sup 2) of body-surface area and mild-to-moderate anemia (hemoglobin level, 11.0 to 12.5 g per deciliter) to a target hemoglobin value in the normal range (13.0 to 15.0 g per deciliter, group 1) or the subnormal range (10.5 to 11.5 g per deciliter, group 2). Subcutaneous erythropoietin (epoetin beta) was initiated at randomization (group 1) or only after the hemoglobin level fell below 10.5 g per deciliter (group 2). The primary end point was a composite of eight... (More)
Background: Whether correction of anemia in patients with stage 3 or 4 chronic kidney disease improves cardiovascular outcomes is not established. Methods: We randomly assigned 603 patients with an estimated glomerular filtration rate (GFR) of 15.0 to 35.0 ml per minute per 1.73 m(sup 2) of body-surface area and mild-to-moderate anemia (hemoglobin level, 11.0 to 12.5 g per deciliter) to a target hemoglobin value in the normal range (13.0 to 15.0 g per deciliter, group 1) or the subnormal range (10.5 to 11.5 g per deciliter, group 2). Subcutaneous erythropoietin (epoetin beta) was initiated at randomization (group 1) or only after the hemoglobin level fell below 10.5 g per deciliter (group 2). The primary end point was a composite of eight cardiovascular events; secondary end points included left ventricular mass index, quality-of-life scores, and the progression of chronic kidney disease. Results: During the 3-year study, complete correction of anemia did not affect the likelihood of a first cardiovascular event (58 events in group 1 vs. 47 events in group 2; hazard ratio, 0.78; 95% confidence interval, 0.53 to 1.14; P=0.20). Left ventricular mass index remained stable in both groups. The mean estimated GFR was 24.9 ml per minute in group 1 and 24.2 ml per minute in group 2 at baseline and decreased by 3.6 and 3.1 ml per minute per year, respectively (P=0.40). Dialysis was required in more patients in group 1 than in group 2 (127 vs. 111, P=0.03). General health and physical function improved significantly (P=0.003 and P<0.001, respectively, in group 1, as compared with group 2). There was no significant difference in the combined incidence of adverse events between the two groups, but hypertensive episodes and headaches were more prevalent in group 1. Conclusions: In patients with chronic kidney disease, early complete correction of anemia does not reduce the risk of cardiovascular events. (Less)
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author
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organization
publishing date
type
Contribution to journal
publication status
published
subject
in
New England Journal of Medicine
volume
355
issue
20
pages
2071 - 2084
publisher
Massachusetts Medical Society
external identifiers
  • wos:000241997300004
  • scopus:33751002326
ISSN
0028-4793
language
English
LU publication?
yes
id
29c86c18-f9ef-4029-88be-6f7de9b7520f (old id 378292)
alternative location
http://content.nejm.org/cgi/content/abstract/355/20/2071
date added to LUP
2016-04-01 12:28:14
date last changed
2021-03-21 06:09:46
@article{29c86c18-f9ef-4029-88be-6f7de9b7520f,
  abstract     = {Background: Whether correction of anemia in patients with stage 3 or 4 chronic kidney disease improves cardiovascular outcomes is not established. Methods: We randomly assigned 603 patients with an estimated glomerular filtration rate (GFR) of 15.0 to 35.0 ml per minute per 1.73 m(sup 2) of body-surface area and mild-to-moderate anemia (hemoglobin level, 11.0 to 12.5 g per deciliter) to a target hemoglobin value in the normal range (13.0 to 15.0 g per deciliter, group 1) or the subnormal range (10.5 to 11.5 g per deciliter, group 2). Subcutaneous erythropoietin (epoetin beta) was initiated at randomization (group 1) or only after the hemoglobin level fell below 10.5 g per deciliter (group 2). The primary end point was a composite of eight cardiovascular events; secondary end points included left ventricular mass index, quality-of-life scores, and the progression of chronic kidney disease. Results: During the 3-year study, complete correction of anemia did not affect the likelihood of a first cardiovascular event (58 events in group 1 vs. 47 events in group 2; hazard ratio, 0.78; 95% confidence interval, 0.53 to 1.14; P=0.20). Left ventricular mass index remained stable in both groups. The mean estimated GFR was 24.9 ml per minute in group 1 and 24.2 ml per minute in group 2 at baseline and decreased by 3.6 and 3.1 ml per minute per year, respectively (P=0.40). Dialysis was required in more patients in group 1 than in group 2 (127 vs. 111, P=0.03). General health and physical function improved significantly (P=0.003 and P&lt;0.001, respectively, in group 1, as compared with group 2). There was no significant difference in the combined incidence of adverse events between the two groups, but hypertensive episodes and headaches were more prevalent in group 1. Conclusions: In patients with chronic kidney disease, early complete correction of anemia does not reduce the risk of cardiovascular events.},
  author       = {Drueke, Tilman B. and Locatelli, Francesco and Clyne, Naomi and Eckardt, Kai-Uwe and Macdougall, Iain C. and Tsakiris, Dimitrios and Burger, Hans-Ulrich and Scherhag, Armin},
  issn         = {0028-4793},
  language     = {eng},
  number       = {20},
  pages        = {2071--2084},
  publisher    = {Massachusetts Medical Society},
  series       = {New England Journal of Medicine},
  title        = {Normalization of hemoglobin level in patients with chronic kidney disease and anemia},
  url          = {http://content.nejm.org/cgi/content/abstract/355/20/2071},
  volume       = {355},
  year         = {2006},
}