Clinical Impact and Epidemiology of Nonsteroidal Anti-inflammatory Drug Allergies

非甾体抗炎药过敏的临床影响和流行病学

基本信息

批准号：
10424588
负责人：
Lily Li
金额：
$ 17.92万
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：
2021
资助国家：
美国
起止时间：
2021-06-08 至 2026-05-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10424588
关键词：
Acute Pain Adverse effects Adverse reactions Affect Allergic Anaphylaxis Angioneurotic Edema Anxiety Aspirin Award Biological Biostatistical Methods Boston Cardiovascular system Caring Clinical Clinical Data Clinical Informatics Clinical Investigator Clinical Research Coronary heart disease Data Data Set Databases Development Disease Dose Drug Hypersensitivity Drug Prescriptions Electronic Health Record Environment Epidemiology Evaluation Event Female Goals Health Heart Diseases Hemorrhage Hospitals Hypersensitivity Informatics Integrated Health Care Systems Intervention Label Lead Mentorship Methodology Modeling Morbidity - disease rate National Institute of Allergy and Infectious Disease Natural History Non-Steroidal Anti-Inflammatory Agents Operative Surgical Procedures Opioid Outcome Pain Patient Care Patient Recruitments Patient Self-Report Patient-Focused Outcomes Patients Pattern Persons Pharmaceutical Preparations Population Positioning Attribute Postoperative Pain Postoperative Period Protocols documentation Reaction Regimen Regression Analysis Reporting Research Research Design Research Methodology Research Personnel Resources Rest Risk Risk Factors Specialist Survival Analysis Therapeutic Uses Time Training United States United States National Institutes of Health Urticaria Vocational Guidance Woman Work acute coronary syndrome base career chronic back pain chronic pain clinical epidemiology cohort comorbidity cost effective therapy epidemiology study evidence base experience gastrointestinal high risk high risk population improved insight large datasets longitudinal analysis mortality nephrotoxicity opioid use opioid use disorder patient oriented prescription opioid research and development rheumatologist risk stratification sex side effect skills

项目摘要

PROJECT SUMMARY/ABSTRACT Nonsteroidal anti-inflammatory drugs (NSAIDs) are indicated for first-line treatment of many conditions ranging from pain to heart disease, but therapeutic use of the entire medication class can be precluded by reported allergy. While NSAIDs represent the second most commonly reported class of drug allergies, it is estimated that <20% of reported NSAID-induced reactions are consistent with allergic hypersensitivity (eg, urticaria, angioedema, anaphylaxis), with the rest representing non-allergic side effects or intolerances (eg, gastrointestinal upset, bleeding, nephrotoxicity). Allergy over-reporting and lack of reaction clarification can lead to unnecessary drug avoidance, and increased use of second line, more costly, and less effective alternative medications, with resultant downstream adverse effects on patient outcomes. The primary objective of this proposal is to determine the impact of reported NSAID allergies on prescribing patterns and clinical outcomes in distinct populations and to define predictors for true NSAID-induced allergic hypersensitivity. The proposed study has three Aims: (1) to assess the impact of reported NSAID allergy on postoperative opioid prescribing and sustained opioid use in a large electronic health record-derived cohort of patients undergoing common surgical procedures; (2) to evaluate differences in aspirin administration and adverse cardiovascular outcomes in patients with acute coronary syndromes with and without reported NSAID allergy; (3) to use a well-defined cohort of subjects who have undergone allergist-observed NSAID drug challenge to determine patient- and drug-specific risk factors for NSAID-induced hypersensitivity. Dr. Li’s research plan will be supported by coursework and training in clinical and epidemiological study design, advanced biostatistical methods for research with large datasets, informatics, patient recruitment, and drug-challenge protocols, and the exceptional scientific environment at the Brigham and Women’s Hospital. She will receive mentorship from Dr. Tanya Laidlaw, an allergy specialist and expert in aspirin- and NSAID-induced hypersensitivity, and Dr. Karen Costenbader, a rheumatologist with extensive experience in investigating risk factors for disease and long-term outcomes in affected patients using large national cohorts and datasets. Dr. Li will obtain additional scientific input and career guidance from a team of three scientific advisors, including Drs. Joshua Boyce, Elena Losina, and Kimberly Blumenthal, who have committed their time, resources and expertise to facilitate her professional development and research goals. This K23 proposal is well-aligned with NIH initiatives to reduce unnecessary opioid prescribing and NIAID support of drug allergy research, and will position the candidate to submit an R01 application during the award period and to establish herself as an independent patient-oriented investigator with a focus on improving the care and health of patients with drug allergies.

项目摘要/摘要非甾体类抗炎药（NSAIDS）用于许多条件的一线治疗从疼痛到心脏病，但是据报道，整个药物类别的治疗都可以阻止过敏。虽然NSAIDS代表了第二常见的药物过敏类，但估计报告的NSAID诱导的反应中有20％与过敏性过敏一致（例如，荨麻疹，血管性水肿，过敏反应），其余代表非过敏性副作用或intlerances（例如，胃肠道不适，出血，肾毒性）。过敏过度报告和缺乏反应澄清可以导致不必要的避免药物，增加第二行的使用，更昂贵，效率较小替代药物，导致下游对患者结局的不利影响。主要目标该建议的是确定报告的NSAID过敏对处方模式和临床的影响不同人群的结果，并定义了真正NSAID诱导的过敏性过敏性的预测因子。这拟议的研究具有三个目的：（1）评估报告的NSAID过敏对术后阿片类药物的影响在大型电子健康记录衍生的患者队列中处方和持续的阿片类药物使用常见的手术程序；（2）评估阿司匹林给药和不良心血管的差异有和没有报告NSAID过敏的急性冠状动脉综合征患者的结局；（3）使用定义明确的受试者队列，这些受试者对过敏症患者进行了过敏症的NSAID药物挑战 NSAID诱导的超敏反应的患者和药物特异性危险因素。李博士的研究计划将是在临床和流行病学研究设计的课程和培训的支持下，先进的生物统计学大型数据集，信息信息，患者招聘和毒品挑战方案的研究方法以及杨百翰和妇女医院的杰出科学环境。她将从阿司匹林和NSAID引起的高敏性过敏专家兼专家Tanya Laidlaw博士，博士风湿病学家Karen Costenbader在研究疾病和疾病风险因素方面具有丰富经验使用大型国家人群和数据集的受影响患者的长期结局。李博士将获得更多包括DRS在内的三个科学顾问团队的科学意见和职业指导。约书亚·博伊斯（Joshua Boyce），埃琳娜·洛西纳（Elena Losina）和金伯利·布卢门塔尔（Kimberly Blumenthal）都花了时间，资源和专业知识来促进她的专业发展和研究目标。该K23提案与NIH倡议非常合适减少不必要的阿片类药物处方和NIAID对药物过敏研究的支持，并将定位候选人在奖励期内提交R01申请，并确立自己为独立的面向患者的研究者着重于改善药物过敏患者的护理和健康。