Erythropoietin therapy, hemoglobin targets, and quality of life in healthy hemodialysis patients: a randomized trial
Clinical Journal of the American Society of Nephrology. 2009;4((4):):726-33.
BACKGROUND AND OBJECTIVES The effects of different hemoglobin targets when using erythropoiesis-stimulating agents on quality of life are somewhat controversial, and predictors of change in quality of life in endstage renal disease have not been well characterized. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS Five hundred ninety-six incident hemodialysis patients without symptomatic cardiac disease were randomly assigned to hemoglobin targets of 9. 5 to 11. 5 g/dl or 13. 5 to 14. 5 g/dl for 96 weeks, using epoetin_alfa as primary therapy. Patients and attending physicians were masked to treatment assignment. Quality of life, a secondary outcome, was prospectively recorded using the Kidney Disease Quality of Life (KDQoL) questionnaire at weeks 0, 24, 36, 48, 60, 72, 84, and 96, with prespecified outcomes being fatigue and quality of social interaction. RESULTS The mean age and prior duration of dialysis therapy of the study population were 50. 8 and 0. 8 yr. Mortality was low, reflecting the relatively healthy group enrolled. Of 20 domains within the KDQoL only the prespecified domain of fatigue showed significant change over time between the two groups. Improvement in fatigue scores in the high-target group ranged from 3. 2 to 7. 9 over time (P = 0. 007) compared with change in the low-target group. Higher body mass index and lower erythropoietin dose at baseline were independent predictors of improvement in multiple KDQoL domains. CONCLUSIONS In relatively healthy hemodialysis patients, normal hemoglobin targets may have beneficial effects on fatigue. Improvement in multiple domains of quality of life is associated with higher body mass index and lower erythropoietin requirements.
Hemoglobin targets and blood transfusions in hemodialysis patients without symptomatic cardiac disease receiving erythropoietin therapy
Clinical Journal of the American Society of Nephrology. 2008;3((6):):1669-75.
BACKGROUND AND OBJECTIVES Optimal hemoglobin targets for chronic kidney disease patients receiving erythropoiesis-stimulating agents remain controversial. The effects of different hemoglobin targets on blood transfusion requirements have not been well characterized, despite their relevance to clinical decision-making. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS Five hundred ninety-six incident hemodialysis patients without symptomatic cardiac disease were randomly assigned to hemoglobin targets of 9. 5 to 11. 5 g/dl or 13. 5 to 14. 5 g/dl for 96 wk using epoetin alfa as primary therapy and changes in left ventricular structure as the primary outcome (previously reported). Patients were masked to treatment assignment. Blood transfusion data were prospectively collected at 4-wk intervals. RESULTS The mean age and prior duration of dialysis therapy of the study population were 50. 8 and 0. 8 yr, respectively. Previously reported mortality was similar in low and high-target subjects, at 4. 7 (95% confidence interval 3. 0, 7. 3) and 3. 1 (1. 8, 5. 4) per hundred patient years, respectively. Transfusion rates were 0. 66 (0. 59, 0. 74) units of blood per year in low and 0. 26 (0. 22, 0. 32) in high-target subjects (P < 0. 0001). Hemoglobin level at transfusion (7. 7 [7. 5, 7. 9]) versus 8. 1 [7. 6, 8. 5] g/dl) were similar with both groups. High hemoglobin target was a significant predictor of time to first transfusion independent of baseline associations (hazard ratio = 0. 42; 95% confidence interval = 0. 26-0. 67). CONCLUSIONS In hemodialysis patients with comparatively low mortality risks, normal hemoglobin targets may reduce the need for transfusions.
Effect of hemoglobin levels in hemodialysis patients with asymptomatic cardiomyopathy
Kidney International. 2000;58((3):):1325-35.
BACKGROUND Hemoglobin levels below 10 g/dL lead to left ventricular (LV) hypertrophy, LV dilation, a lower quality of life, higher cardiac morbidity, and a higher mortality rate in end-stage renal disease. The benefits and risks of normalizing hemoglobin levels in hemodialysis patients without symptomatic cardiac disease are unknown. METHODS One hundred forty-six hemodialysis patients with either concentric LV hypertrophy or LV dilation were randomly assigned to receive doses of epoetin alpha designed to achieve hemoglobin levels of 10 or 13.5 g/dL. The study duration was 48 weeks. The primary outcomes were the change in LV mass index in those with concentric LV hypertrophy and the change in cavity volume index in those with LV dilation. RESULTS In patients with concentric LV hypertrophy, the changes in LV mass index were similar in the normal and low target hemoglobin groups. The changes in cavity volume index were similar in both targets in the LV dilation group. Treatment-received analysis of the concentric LV hypertrophy group showed no correlation between the change in mass index and a correlation between the change in LV volume index and mean hemoglobin level achieved (8 mL/m2 per 1 g/dL hemoglobin decrement, P = 0.009). Mean hemoglobin levels and the changes in LV mass and cavity volume index were not correlated in patients with LV dilation. Normalization of hemoglobin led to improvements in fatigue (P = 0.009), depression (P = 0.02), and relationships (P = 0.004). CONCLUSIONS Normalization of hemoglobin does not lead to regression of established concentric LV hypertrophy or LV dilation. It may, however, prevent the development of LV dilation, and it leads to improved quality of life.