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Greater Epoetin alfa Responsiveness Is Associated With Improved Survival in Hemodialysis Patients

Ryan D. Kilpatrick^*, Cathy W. Critchlow^*, Steven Fishbane, Anatole Besarab, Catherine Stehman-Breen, Mahesh Krishnan^||, and Brian D. Bradbury^*

Departments of ^* Biostatistics & Epidemiology, Clinical Development, and ^|| Medical Affairs, Amgen Inc, Thousand Oaks, California; Division of Nephrology & Hypertension, Department of Medicine, SUNY at Stony Brook, Stony Brook, New York; and Division of Nephrology and Hypertension, Henry Ford Hospital, Detroit, Michigan

Correspondence: Dr. Ryan D. Kilpatrick, Department of Biostatistics & Epidemiology, Amgen Inc, One Amgen Center Drive, MS 24-2-A, Thousand Oaks, CA 91320. Phone: 805-313-4271; Fax: 805-447-1984; E-mail: rkilpatr{at}amgen.com

Background and objectives: Among hemodialysis patients, achieved hemoglobin is associated with Epoetin alfa dose and erythropoietin responsiveness. A prospective erythropoietin responsiveness measure was developed and its association with mortality evaluated.

Design, setting, participants, & measurements: Data from 321 participants were used and randomized to the hematocrit normalization arm of the Normal Hematocrit Cardiac Trial. Subjects were to receive a 50% Epoetin alfa dose increase at randomization. The prospective erythropoietin responsiveness measure was defined as the ratio of weekly hematocrit change (over the 3 wk after randomization) per Epoetin alfa dose increase (1000 IU/wk) corresponding to the mandated 50% dose increase at randomization. The distribution of responsiveness was divided into quartiles. Over a 1-yr follow-up, Cox proportional hazard modeling evaluated associations between this responsiveness measure and mortality.

Results: Erythropoietin responsiveness values ranged from –2.1% to 2.4% per week per 1000 IU. Although subjects were similar across response quartiles, mortality ranged between 14% and 34% among subjects in the highest and lowest response quartiles (P = 0.0004), respectively. After adjusting for baseline prognostic indicators, highest versus lowest responsiveness was associated with a hazard ratio of 0.41 (95% confidence interval, 0.20 to 0.87).

Conclusion: Lower erythropoietin responsiveness is a strong, independent predictor of mortality risk and should be considered when evaluating associations between clinical outcomes and potential prognostic indicators, such as Epoetin alfa dose and achieved hemoglobin values.

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Erythropoietin Stimulating Agents and Epoetin Alfa Revisited: What's Really Relevant?

Rowan G. Walker
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				R. G. Walker Erythropoietin Stimulating Agents and Epoetin Alfa Revisited: What's Really Relevant? Clin. J. Am. Soc. Nephrol., July 1, 2008; 3(4): 935 - 937. [Full Text] [PDF]