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

• 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
• 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

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.

项目摘要/摘要 心血管疾病(CVD)影响着70%的老年人，仍然是发病率和更多疾病的主要原因。 美国的死亡率。最近有几种新药被批准用于心血管疾病，但还不够清楚。 关于它们在虚弱的老年患者中的使用情况、益处和风险。自从在虚弱的老年人身上进行临床试验以来 可能是昂贵和不切实际的，迫切需要创新的战略来产生关于新的 及时用药治疗心血管疾病。该应用程序目标是建立近乎实时的预期 医疗保险数据中的监测计划，以评估新的心血管疾病药物对虚弱的老年人的好处。一个 前瞻性监测计划寻求通过更新发现新药的早期有效性和安全性信号 当新的医疗保险数据可用时，定期进行分析。调查人员将纳入一项 将新的基于索赔的脆弱性指数纳入监测计划，以及时生成关于特定疾病和 以患者为中心的脆弱状态下的新药净收益。中心假设是疾病特有的益处 和净收益取决于病人的虚弱程度。将使用以下方法评估特定疾病的收益 有效性(例如，心血管事件)和安全性(例如，出血)的临床试验终点，以及以下方面的净收益 活着并在家中度过的天数，或“家的时间”。为了进行这项工作，调查人员将分析 2011-2017年度批准的6种心血管疾病新药的医疗保险数据：3种抗凝药物与华法林治疗房颤，2种 抗血小板药物与氯吡格雷治疗动脉粥样硬化性心血管疾病以及血管紧张素受体奈普利素抑制剂与依那普利的比较 治疗收缩性心力衰竭。结果的有效性和再现性将通过与 将医疗保险数据子集添加到电子健康记录和补充临床信息的全国调查中， 以及在2个大型商业数据库中对医疗保险数据分析进行外部验证。在未来的4年里， 研究人员将完成3个具体目标：1)评估新的心血管疾病药物的时间趋势和预测因素 2011-2020年对患有心血管疾病的虚弱和非虚弱老年人使用；2)确定特定疾病的益处(死亡， 与替代疗法相比，6种新型心血管疾病药物的净效益(家庭时间)和净效益(心血管疾病和安全事件)； 3)确定可以预测新心血管疾病药物的净收益(家庭时间)的患者特征 另类疗法。这项建议的创新方法，结合了近实时的前瞻性监测- ING，一个基于索赔的脆弱评分，以及以患者为中心的家庭时间结果，提供了一个易于扩展和 对新批准的药物进行有效性和安全性比较研究的可行框架。其影响 这项拟议的研究具有重要意义，因为从现实世界的医疗数据中生成的及时证据可以 使临床医生能够根据患者的虚弱程度和预期的净收益来优化新药的处方。

项目成果

Development and Validation of an Intracranial Hemorrhage Risk Score in Older Adults with Atrial Fibrillation Treated with Oral Anticoagulant.

口服抗凝剂治疗的房颤老年人颅内出血风险评分的制定和验证。

• DOI: 10.2147/clep.s438013
• 发表时间: 2024
• 期刊: Clinical epidemiology
• 影响因子: 3.9
• 作者: Bessette,LilyG;Singer,DanielE;Pawar,Ajinkya;Wong,Vincent;Kim,DaeHyun;Lin,KueiyuJoshua
• 通讯作者: Lin,KueiyuJoshua