Prospective Monitoring of Newly Approved Cardiovascular Drugs in Older Adults with Frailty

新批准的心血管药物对虚弱老年人的前瞻性监测

基本信息

批准号：
10338082
负责人：
Dae Hyun Kim
金额：
$ 51.75万
依托单位：
BRIGHAM AND WOMEN'S HOSPITAL
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-06-01 至 2024-01-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10338082
关键词：
Affect Age Alternative Therapies Angiotensin Receptor Anticoagulants Atherosclerosis Atrial Fibrillation Benefits and Risks Cardiovascular Agents Cardiovascular Diseases Cessation of life Characteristics Clinical Clinical Trials Data Data Analyses Data Set Databases Dementia Disease Drug usage Effectiveness Elderly Electronic Health Record Enalapril Evaluation Event Frail Elderly Frequencies Future Goals Health Care Costs Healthcare Hemorrhage Home Measures Medicare Mission Monitor Morbidity - disease rate National Institute on Aging Neprilysin Outcome Measure Patient-Focused Outcomes Patients Pharmaceutical Preparations Pharmacoepidemiology Pharmacotherapy Public Health Race Reproducibility Reproducibility of Results Research Research Personnel Safety Signal Transduction Source Surveys Systolic heart failure Time Time trend Treatment Efficacy United States Update Validation Warfarin Work base cardiovascular disorder risk clinical trial analysis clopidogrel cohort comorbidity comparative effectiveness study cost frailty head-to-head comparison indexing inhibitor innovation machine learning algorithm medical specialties mortality non-drug novel novel therapeutics older patient patient oriented programs prospective real time monitoring safety study sex

项目摘要

PROJECT SUMMARY/ABSTRACT Cardiovascular disease (CVD) affects 70% of older adults and remains the leading cause of morbidity and mor- tality in the United States. Several new drugs have recently been approved for CVD, but not enough is known about their utilization, benefits and risks in frail older patients. Since conducting a clinical trial in frail older adults can be costly and impractical, there is a pressing need for innovative strategies to generate evidence on new CVD drugs in a timely manner. The objective of this application is to establish a near-real-time prospective monitoring program in Medicare data to evaluate the benefit of new CVD drugs for older adults with frailty. A prospective monitoring program seeks to find early effectiveness and safety signals of new drugs by updating the analysis at regular intervals as new Medicare data become available. The investigators will incorporate a novel claims-based frailty index into the monitoring program to generate timely evidence on disease-specific and patient-centered net benefit of new drugs by frailty status. The central hypothesis is that disease-specific benefit and net benefit are determined by a patient's degree of frailty. Disease-specific benefit will be evaluated using clinical trial endpoints of effectiveness (e.g., CVD events) and safety (e.g., bleeding), and net benefit in terms of the number of days alive and spent at home, or “home time”. To conduct this work, the investigators will analyze Medicare data on 6 new CVD drugs approved in 2011-2017: 3 anticoagulants vs warfarin for atrial fibrillation, 2 antiplatelets vs clopidogrel for atherosclerotic CVD, and an angiotensin receptor-neprilysin inhibitor vs enalapril for systolic heart failure. The validity and reproducibility of the results will be enhanced through the linkage of a subset of Medicare data to electronic health records and a national survey to supplement clinical information, and external validation of the Medicare data analysis in 2 large commercial databases. In the next 4 years, the investigators will accomplish 3 specific aims: 1) evaluate the temporal trends and predictors of new CVD drug use in frail and non-frail older adults with CVD over 2011-2020; 2) determine disease-specific benefit (deaths, CVD and safety events) and net benefit (home time) of 6 new CVD drugs compared with alternative therapies; 3) identify patient characteristics that can predict net benefit (home time) with new CVD drugs compared with alternative therapies. This proposal's innovative approach, which combines near-real-time prospective monitor- ing, a claims-based frailty score, and the patient-centered outcome of home time, offers a readily scalable and feasible framework for comparative effectiveness and safety studies of newly approved medications. The impact of the proposed research is significant because timely evidence generated from real-world healthcare data can enable clinicians to optimize prescribing of new CVD drugs based on a patient's frailty and expected net benefit.

项目概要/摘要心血管疾病 (CVD) 影响 70% 的老年人，并且仍然是发病率和死亡率的主要原因。美国最近批准了几种用于治疗 CVD 的新药，但目前所知还不够。自从在体弱的老年人中进行临床试验以来，关于它们在体弱的老年患者中的利用、益处和风险。可能成本高昂且不切实际，因此迫切需要创新策略来生成新的证据该应用程序的目标是建立近乎实时的前瞻性药物。医疗保险数据中的监测计划，用于评估新的 CVD 药物对虚弱老年人的益处 A。前瞻性监测计划旨在通过更新发现新药的早期有效性和安全性信号随着新的医疗保险数据的出现，研究人员将定期进行分析。将新颖的基于索赔的虚弱指数纳入监测计划，以生成有关特定疾病和疾病的及时证据以患者为中心的新药净获益（按虚弱状态划分）的中心假设是疾病特异性获益。净效益由患者的虚弱程度决定，将使用疾病特异性效益进行评估。有效性（例如 CVD 事件）和安全性（例如出血）的临床试验终点，以及净效益为了进行这项工作，研究人员将分析在家中度过的活着的天数。 2011-2017 年批准的 6 种新 CVD 药物的医疗保险数据：3 种抗凝剂 vs 华法林治疗房颤，2 抗血小板药物与氯吡格雷治疗动脉粥样硬化性 CVD，以及血管紧张素受体脑啡肽酶抑制剂与依那普利对于收缩性心力衰竭，结果的有效性和可重复性将通过链接得到增强。医疗保险数据的子集到电子健康记录和补充临床信息的全国调查，以及 2 个大型商业数据库中医疗保险数据分析的外部验证在接下来的 4 年内，研究人员将实现 3 个具体目标：1）评估新 CVD 药物的时间趋势和预测因素 2011-2020 年在患有 CVD 的虚弱和非虚弱老年人中使用；2) 确定特定疾病的益处（死亡、 CVD 和安全事件）以及 6 种新的 CVD 药物与替代疗法相比的净效益（在家时间）； 3) 确定可以预测新 CVD 药物与传统 CVD 药物相比的净效益（在家时间）的患者特征该提案的创新方法结合了近实时的前瞻性监测- ing、基于索赔的虚弱评分以及以患者为中心的家庭时间结果，提供了易于扩展和新批准药物的比较有效性和安全性研究的可行框架。拟议研究的意义重大，因为从现实世界的医疗数据中生成的及时证据可以能够根据患者的虚弱情况和预期净效益优化新的 CVD 药物处方。