权益分类	功能权益	普通用户	{{item.name}}会员
{{category.name}}	{{benefitItem.name}}

Comparative Effectiveness and Safety of Newer Agents for Anemia Treatment in HD

治疗 HD 贫血的新型药物的有效性和安全性比较

基本信息

批准号：
8540416
负责人：
WOLFGANG CHRISTOPH WINKELMAYER
金额：
$ 8.29万
依托单位：
STANFORD UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-09-25 至 2014-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8540416
关键词：
Address American Anaphylaxis Anemia Attention Benefits and Risks Bolus Infusion Bundling Cardiovascular system Caring Cessation of life Characteristics Chronic Kidney Failure Complex Computerized Medical Record Data Diabetes Mellitus Dialysis procedure Digestive System Disorders Dose Drug Formulations Effectiveness End stage renal failure Epidemiologic Methods Epidemiologist Epoetin Alfa Erythropoiesis Erythropoietin Event Ferritin Formularies Funding Future Goals Hematological Disease Hematologist Hemodialysis Hemoglobin Hospitals Incentives Incidence Individual Infection Institutes Intravenous Iron Kidney Kidney Diseases Laboratories Legal patent Light Longitudinal Studies Maintenance Malignant Neoplasms Marketing Medicare Mission Natural experiment New Agents Outcome Paint Patient Care Patients Pattern Pharmaceutical Preparations Population Provider Quality of Care Randomized Reaction Regulation Relative (related person)Renal dialysis Research Research Personnel Resistance Risk Safety Series Sodium Testing Therapeutic Transferrin Transfusion Urologic Diseases Work adverse outcome base cardiovascular infection cardiovascular risk factor comparative comparative effectiveness compare effectiveness darbepoetin alfa experience expiration ferric gluconate ferumoxytol improved innovation interest iron supplement iron supplementation mortality novel patient oriented patient population payment response saccharated ferric oxide

项目摘要

DESCRIPTION (provided by applicant): More than 575,000 Americans have end-stage renal disease, which is typically complicated by anemia, and most of these patients receive maintenance dialysis treatment. The proposed work will compare the effectiveness and safety of darbepoetin alfa, a novel injectible drug for the treatment of anemia, with its established cousin, epoetin alfa. Similarly, ferumoxytol, a new intravenous iron supplement for the treatment of anemia will be compared with an established iron supplement, iron sucrose. Both drugs were approved using information from randomized studies that evaluated their efficacy on reducing anemia. Very limited information, however, is available for either drug regarding their longer-term efficacy and safety. We are proposing to study the effectiveness and safety of these two medications when compared to their established cousins. Events of scientific interest include short-term outcomes (anaphylaxis, laboratory parameters including hemoglobin, iron saturation, ferritin) and longer- term outcomes including infection, cardiovascular events, cancer, and mortality. We will use already collected data from Medicare billing claims and electronic medical records of dialysis providers to address these research questions. Since facilities choose among these treatment options based on what is available in their formulary, and not necessarily based on patient characteristics, we can exploit natural experiments that occur when facilities switch their ESA or iron agent for their entire patient population. We will apply modern epidemiological techniques to eliminate bias and aspire to provide valid estimates of relative benefits and risks. Findings from the proposed work have the potential to immediately impact and improve the care that patients with end-stage renal disease receive. Our results may improve the quality of care received and, thus, the outcomes of this vulnerable patient population. The aims and scope of work are in full congruence with the mission of the National Institutes of Diabetes and Digestive and Kidney Diseases, and more specifically the Division of Kidney, Urologic, and Hematologic Diseases, which will consider this application for funding.

描述(申请人提供)：超过575,000名美国人患有终末期肾脏疾病，通常合并贫血，这些患者中的大多数接受维持性透析治疗。这项拟议的工作将比较治疗贫血的新型注射药物Darbepoetin alfa与其表亲Epoetin alfa的有效性和安全性。同样，治疗贫血的一种新的静脉补铁剂阿魏酸甘油将与现有的补铁剂蔗糖铁进行比较。这两种药物都是根据随机研究的信息批准的，这些研究评估了它们在减少贫血方面的效果。然而，关于这两种药物的长期疗效和安全性的信息都非常有限。我们建议研究这两种药物的有效性和安全性，并将其与现有的表亲药物进行比较。引起科学关注的事件包括短期结果(过敏反应、包括血红蛋白、铁饱和度、铁蛋白在内的实验室参数)和长期结果，包括感染、心血管事件、癌症和死亡率。我们将使用已经从医疗保险账单索赔和透析提供者的电子医疗记录中收集的数据来解决这些研究问题。由于医疗机构根据处方中提供的治疗方案进行选择，而不一定是基于患者的特征，因此我们可以利用当医疗机构为其整个患者群体切换ESA或铁剂时发生的自然实验。我们将应用现代流行病学技术来消除偏见，并渴望提供对相对收益和风险的有效估计。这项拟议工作的发现有可能立即影响和改善终末期肾病患者所接受的护理。我们的结果可能会改善接受的护理质量，从而改善这一脆弱患者群体的结果。工作的目标和范围与国家糖尿病、消化和肾脏疾病研究所的使命完全一致，更具体地说，是与肾脏、泌尿外科和血液病学部的使命一致，后者将考虑这项资金申请。