of Work Anemia is common among patients with chronic kidney disease (CKD) and is associated with increased mortality, increased rates of cardiovascular disease and hospitalization, and decreased quality of life. Treatment of anemia with epoetin-alfa in CKD patients improves most quality of life parameters including energy and activity level, functional ability, sleep and eating behavior, health status, satisfaction with health, sex life, well- being, psychological effect, life satisfaction, and happiness, exercise capacity, energy, and strength with a significant reduction in aching dizziness, anxiety, shortness of breath, muscle weakness, and leg cramps. Counterintuitive to these findings, the Correction of Hemoglobin and Outcomes in Renal Insufficiency (CHOIR) Trials demonstrated a trend or a statistically significant increase in the risk of cardiovascular events or death. Given that prior observational work demonstrated an increased risk of death associated with higher doses of epoetin alfa, these findings are particularly interesting. This application is offered by investigators at the Duke Clinical Research Institute which served as the data coordinating center for the CHOIR Trial and has the right to use its'retained copy of the CHOIR dataset for its own research. This application outlines the secondary analyses to be performed utilizing the CHOIR dataset to provide the clinical community with a greater depth of understanding as to the factors associated anemia correction that may have contributed most to the increased risk caused by targeting a higher hemoglobin.
Since the introduction of epoetin alfa, its use in the chronic kidney disease and dialysis populations has been popular and endorsed by thought leaders and professional societies due to its demonstrated effects on hemoglobin levels and quality of life. Because anemia correction has been associated with beneficial effects for many outcomes such as quality of life and higher hemoglobin is associated with improved survival, anemia correction became a national clinical performance measure. Given the counterintuitive findings of the CHOIR trial that greater anemia correction causes an increase in the risk of cardiovascular morbidity and mortality, this application will examine the complex associations between anemia correction and outcomes to generate hypotheses that will guide the need for future research and assist the clinician in choosing target, dose, and treatment strategy.
