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

工作概述(由申请人提供)：贫血在慢性肾脏疾病(CKD)患者中很常见，并与死亡率增加、心血管疾病和住院率增加以及生活质量下降有关。使用Epeetin-Alfa治疗CKD患者的贫血可以改善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、健康满意度、性生活、幸福感、心理效果、生活满意度以及幸福感、运动量、能量和力量，并显著减少疼痛、头晕、焦虑、呼吸急促、肌肉无力和腿部抽筋。与这些发现背道而驰的是，肾功能不全(CHIIR)试验中的血红蛋白纠正和结果试验显示出心血管事件或死亡风险的趋势或统计上的显著增加。鉴于先前的观察工作表明，与较高剂量的促红细胞生成素α相关的死亡风险增加，这些发现特别有趣。该应用程序由杜克临床研究所的研究人员提供，该研究所作为合唱团试验的数据协调中心，有权使用其保留的合唱团数据集副本进行自己的研究。本申请概述了将利用COLIR数据集执行的二次分析，以使临床社区更深入地了解与贫血纠正相关的因素，这些因素可能是导致目标更高的血红蛋白导致风险增加的主要原因。公共卫生相关性：自从Epeetin Alfa被引入以来，由于其对血红蛋白水平和生活质量的影响，它在慢性肾脏疾病和透析人群中的应用一直很受欢迎，并得到了思想领袖和专业协会的支持。由于纠正贫血对生活质量等许多结果都有好处，而且较高的血红蛋白与改善存活率有关，因此纠正贫血成为一项全国性的临床表现衡量标准。考虑到COLIR试验的违反直觉的发现，即更大的贫血纠正会导致心血管发病率和死亡率的增加，这一应用程序将检查贫血纠正和结果之间的复杂关联，以产生假设，这些假设将指导未来研究的需要，并帮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.