Analysis of associations between anemia correction in CKD and mortality: CHOIR

描述（由申请人提供）：工作总结贫血在慢性肾病（CKD）患者中很常见，与死亡率增加、心血管疾病和住院率增加以及生活质量下降相关。在CKD患者中用促红细胞生成素-α治疗贫血改善了大多数生活质量参数，包括能量和活动水平、功能能力、睡眠和饮食行为、健康状况、对健康的满意度、性生活、幸福感、心理效应、生活满意度和幸福感、运动能力、能量和力量，同时疼痛头晕、焦虑、呼吸急促、肌无力、还有腿抽筋与这些发现相反的是，肾功能不全（CHOIR）试验中血红蛋白和结局的校正显示出心血管事件或死亡风险的趋势或统计学显著性增加。鉴于先前的观察性工作表明，死亡风险增加与更高剂量的依泊苷α相关，这些发现特别有趣。本申请由杜克临床研究所的研究者提供，该研究所是CHOIR试验的数据协调中心，有权将其保留的CHOIR数据集副本用于自己的研究。本申请概述了利用CHOIR数据集进行的二次分析，以使临床社区更深入地了解贫血校正相关因素，这些因素可能是导致较高血红蛋白目标导致风险增加的最大原因。 公共卫生相关性：自epoalfa引入以来，由于其对血红蛋白水平和生活质量的显著影响，其在慢性肾脏疾病和透析人群中的使用一直受到思想领袖和专业协会的欢迎和认可。由于贫血矫正与许多结局（如生活质量）的有益影响相关，且较高的血红蛋白与生存率提高相关，因此贫血矫正成为国家临床性能指标。鉴于CHOIR试验的反直觉发现，即更大的贫血校正会导致心血管发病率和死亡率风险增加，本申请将检查贫血校正与结局之间的复杂关联，以生成假设，指导未来研究的需求，并协助临床医生选择目标，剂量和治疗策略。

DESCRIPTION (provided by applicant): Summary 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. PUBLIC HEALTH RELEVANCE: 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.