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Published ahead of print on May 18, 2005
J Am Soc Nephrol 16: 2180-2189, 2005
© 2005 American Society of Nephrology
doi: 10.1681/ASN.2004121039
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Clinical Dialysis

Double-Blind Comparison of Full and Partial Anemia Correction in Incident Hemodialysis Patients without Symptomatic Heart Disease

Patrick S. Parfrey*, Robert N. Foley{dagger}, Barbara H. Wittreich{ddagger}, Daniel J. Sullivan§, Martin J. Zagari{ddagger}, Dieter Frei{ddagger} for the Canadian European Study

* Memorial University of Newfoundland, St. John’s, Newfoundland, Canada; {dagger} Chronic Disease Research Group, Minneapolis, Minnesota; {ddagger} Ortho Biotech, Bridgewater, New Jersey; and § Johnson and Johnson, Pharmaceutical Research, LLC, Raritan, New Jersey

Address correspondence to: Dr. Patrick Parfrey, Division of Nephrology, Health Sciences Center, Memorial University of Newfoundland, Prince Philip Drive, St. John’s, Newfoundland A1B 3V6, Canada. Phone: 709-777-7261; Fax: 709-777-6995; pparfrey{at}mun.ca

Received for publication December 3, 2004. Accepted for publication April 6, 2005.

It is unclear whether physiologic hemoglobin targets lead to cardiac benefit in incident hemodialysis patients without symptomatic heart disease and left ventricular dilation. In this randomized, double-blind study, lower (9.5 to 11.5 g/dl) and higher (13.5 to 14.5 g/dl) hemoglobin targets were generated with epoetin {alpha} over 24 wk and maintained for an additional 72 wk. Major eligibility criteria included recent hemodialysis initiation and absence of symptomatic cardiac disease and left ventricular dilation. The primary outcome measure was left ventricular volume index (LVVI). The study enrolled 596 patients. Mean age, duration of dialysis therapy, baseline predialysis hemoglobin, and LVVI were 50.8 yr, 0.8 yr, 11.0 g/dl, and 69 ml/m2, respectively; 18% had diabetic nephropathy. Mean hemoglobin levels in the higher and lower target groups were 13.3 and 10.9 g/dl, respectively, at 24 wk. Percentage changes in LVVI between baseline and last value were similar (7.6% in the higher and 8.3% in the lower target group) as were the changes in left ventricular mass index (16.8 versus 14.2%). For the secondary outcomes, the only between-group difference was an improved SF-36 Vitality score in the higher versus the lower target group (1.21 versus –2.31; P = 0.036). Overall adverse event rates were similar in both target groups; higher (P < 0.05) rates of skeletal pain, surgery, and dizziness were seen in the lower target group, and headache and cerebrovascular events were seen in the higher target group. Normalization of hemoglobin in incident hemodialysis patients does not have a beneficial effect on cardiac structure, compared with partial correction.




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