Correction of anemia with epoetin alfa in chronic kidney disease - PubMed (original) (raw)
Randomized Controlled Trial
. 2006 Nov 16;355(20):2085-98.
doi: 10.1056/NEJMoa065485.
Affiliations
- PMID: 17108343
- DOI: 10.1056/NEJMoa065485
Free article
Randomized Controlled Trial
Correction of anemia with epoetin alfa in chronic kidney disease
Ajay K Singh et al. N Engl J Med. 2006.
Free article
Abstract
Background: Anemia, a common complication of chronic kidney disease, usually develops as a consequence of erythropoietin deficiency. Recombinant human erythropoietin (epoetin alfa) is indicated for the correction of anemia associated with this condition. However, the optimal level of hemoglobin correction is not defined.
Methods: In this open-label trial, we studied 1432 patients with chronic kidney disease, 715 of whom were randomly assigned to receive a dose of epoetin alfa targeted to achieve a hemoglobin level of 13.5 g per deciliter and 717 of whom were assigned to receive a dose targeted to achieve a level of 11.3 g per deciliter. The median study duration was 16 months. The primary end point was a composite of death, myocardial infarction, hospitalization for congestive heart failure (without renal replacement therapy), and stroke.
Results: A total of 222 composite events occurred: 125 events in the high-hemoglobin group, as compared with 97 events in the low-hemoglobin group (hazard ratio, 1.34; 95% confidence interval, 1.03 to 1.74; P=0.03). There were 65 deaths (29.3%), 101 hospitalizations for congestive heart failure (45.5%), 25 myocardial infarctions (11.3%), and 23 strokes (10.4%). Seven patients (3.2%) were hospitalized for congestive heart failure and myocardial infarction combined, and one patient (0.5%) died after having a stroke. Improvements in the quality of life were similar in the two groups. More patients in the high-hemoglobin group had at least one serious adverse event.
Conclusions: The use of a target hemoglobin level of 13.5 g per deciliter (as compared with 11.3 g per deciliter) was associated with increased risk and no incremental improvement in the quality of life. (ClinicalTrials.gov number, NCT00211120 [ClinicalTrials.gov].).
Copyright 2006 Massachusetts Medical Society.
Comment in
- Correction of anemia--payoffs and problems.
Remuzzi G, Ingelfinger JR. Remuzzi G, et al. N Engl J Med. 2006 Nov 16;355(20):2144-6. doi: 10.1056/NEJMe068233. N Engl J Med. 2006. PMID: 17108347 No abstract available. - Understanding recent haemoglobin trials in CKD: methods and lesson learned from CREATE and CHOIR.
Levin A. Levin A. Nephrol Dial Transplant. 2007 Feb;22(2):309-12. doi: 10.1093/ndt/gfl824. Nephrol Dial Transplant. 2007. PMID: 17234670 No abstract available. - Chronic kidney disease, anemia, and epoetin.
Riley DS. Riley DS. N Engl J Med. 2007 Mar 1;356(9):956; author reply 958-9. doi: 10.1056/NEJMc063535. N Engl J Med. 2007. PMID: 17329706 No abstract available. - Chronic kidney disease, anemia, and epoetin.
Mikhail A, Goldsmith D. Mikhail A, et al. N Engl J Med. 2007 Mar 1;356(9):956-7; author reply 958-9. N Engl J Med. 2007. PMID: 17338045 No abstract available. - Chronic kidney disease, anemia, and epoetin.
Go AS, Ayus JC. Go AS, et al. N Engl J Med. 2007 Mar 1;356(9):957; author reply 958-9. N Engl J Med. 2007. PMID: 17338046 No abstract available. - Chronic kidney disease, anemia, and epoetin.
Roger SD. Roger SD. N Engl J Med. 2007 Mar 1;356(9):958; author reply 958-9. N Engl J Med. 2007. PMID: 17338047 No abstract available. - Chronic kidney disease, anemia, and epoetin.
Ashrani AA, Rajkumar SV. Ashrani AA, et al. N Engl J Med. 2007 Mar 1;356(9):957-8; author reply 958-9. N Engl J Med. 2007. PMID: 17338048 No abstract available. - Anemia in patients with chronic kidney disease: defining the optimal hemoglobin target.
Dember LM. Dember LM. Nat Clin Pract Nephrol. 2007 May;3(5):244-5. doi: 10.1038/ncpneph0463. Epub 2007 Apr 3. Nat Clin Pract Nephrol. 2007. PMID: 17406381 No abstract available. - CHOIR, CREATE, and anemia treatment in patients with CKD.
Berns JS, Fishbane S. Berns JS, et al. Semin Dial. 2007 May-Jun;20(3):277-9. doi: 10.1111/j.1525-139X.2007.00290.x. Semin Dial. 2007. PMID: 17555496 No abstract available.
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