Statin Use and Efficacy Among HIV-Infected Patients by Cholesterol Risk Category

按胆固醇风险类别划分的 HIV 感染患者他汀类药物的使用和疗效

• 批准号: 8659563
• 负责人: Virginia Athena Triant
• 金额: $ 13.05万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-01-03 至 2015-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8659563
• 关键词: Acute myocardial infarction; Adherence; Adult; Anti-Inflammatory Agents; Anti-inflammatory; Cardiovascular Diseases; Cardiovascular system; Categories; Characteristics; Cholesterol; Clinical; Clinical Trials; Control Groups; Data; Data Analyses; Databases; Development; Dyslipidemias; Education; Evaluation; General Population; Goals; Guidelines; HIV; Health Services; Healthcare Systems; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Immunologics; Inflammation; Inflammatory; Knowledge; Life; Lipids; Longevity; Low-Density Lipoproteins; Measures; Methodology; Methods; Myocardial Infarction; Natural Language Processing; Patients; Pattern; Pharmaceutical Preparations; Population; Populations at Risk; Prevention; Prevention strategy; Provider; Public Health; Publishing; Recommendation; Research; Research Design; Research Infrastructure; Risk; Risk Factors; Risk Reduction; Subgroup; Techniques; Time; Update; antiretroviral therapy; base; cardiovascular disorder epidemiology; cardiovascular disorder risk; cardiovascular risk factor; care delivery; clinical care; cohort; data registry; innovation; meetings; novel; population based; prevent; programs; public health relevance; tool

DESCRIPTION (provided by applicant): HIV-infected patients are thought to be an at-risk group for elevated rates of cardiovascular disease (CVD), yet it is not known whether traditional cardiovascular preventative guidelines are applicable to this group. Specifically, it has not been determined whether treatment with statins reduces risk of acute myocardial infarction (AMI) for HIV-infected patients and whether criteria for statin use should be determined based on the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATPIII) guidelines for management of dyslipidemia, which were developed for use in general populations. Data indicate that the mechanism of CVD in HIV populations may differ from the general population and may be driven in large part by HIV-associated inflammatory and immunologic changes, suggesting that strategies for cardiovascular prevention may differ as well. In the proposed study, we will assess the applicability of the NCEP ATPIII guidelines to HIV populations. Aim 1 will involve ascertaining whether statins are prescribed according to criteria for use, determining rates of statin use in HIV and matched control patients according to whether patients had attained their LDL goal prior to statin initiation. In Aim 2, we will investigate the association o statin therapy with incident AMI among HIV-infected patients, answering the question of whether AMI risk reduction with statins differs based on whether patients had met criteria for statin use prior to drug initiation. The finding we anticipate - that statins reduce cardiovascular risk even n HIV-infected patients who do not meet conventional criteria for use - would indicate that HIV-infected patients merit different and tailored criteria for statin use. The research design will harness the power of a large health care system-based data registry with infrastructure already tailored to assess specific CVD-related and HIV-related variables in HIV and matched control patients, thereby offering an innovative and efficient approach to answer the research questions. Advanced analytic techniques, including natural language processing tools and propensity score analysis, will be employed to enable the most rigorous observational data study. Moreover, the anticipated update of the NCEP guidelines provides a potential opportunity to assess our study hypotheses using the most up-to date recommendations for the general population. The proposed study will leverage existing data to advance the field of cardiovascular epidemiology and prevention in an at-risk subgroup, answering the following key and previously unanswered question: Should HIV providers prescribe statins to patients using the same criteria as for the general population? As the first study assessing cardiovascular risk reduction with statins among HIV-infected patients, the data will fill a critical knowledge gap, providing knowledge on the applicability of standard cardiovascular preventative guidelines for HIV populations and impacting the development of HIV-specific criteria for statin use through clinical trials. The findings will have broad relevance to both HIV clinical care paradigms and to cardiovascular risk reduction for at-risk populations with novel risk factors for CVD.

描述（由申请人提供）：艾滋病毒感染的患者被认为是升高心血管疾病率（CVD）的高危组，但尚不清楚传统的心血管预防准则是否适用于该组。具体而言，尚未确定他汀类药物的治疗是否会降低针对HIV感染的患者急性心肌梗塞（AMI）的风险，以及是否应基于国家胆固醇教育计划成人治疗小组（NCEP ATPIII）指南确定他汀类药物使用的标准用于血脂异常的管理，这些血症是用于普通人群中使用的。数据表明，HIV种群中CVD的机制可能与普通人群有所不同，并且可能在很大程度上由HIV相关的炎症和免疫学变化驱动，这表明预防心血管预防的策略也可能有所不同。在拟议的研究中，我们将评估NCEP ATPIII指南对HIV种群的适用性。 AIM 1将涉及确定是否根据使用标准开出他汀类药物，确定 根据患者在他汀类药物启动之前是否达到了其LDL目标，在艾滋病毒中使用他汀类药物和对照患者的率。在AIM 2中，我们将研究艾滋病毒感染患者中的汀类药物治疗与AMI的关联，回答了一个问题，即根据患者是否达到药物开始前的汀类药物标准，汀类药物的风险降低是否有所不同。我们预期的发现 - 他汀类药物即使是不符合常规使用标准的N HIV感染的患者也会降低心血管风险 - 这表明感染HIV的患者值得汀类药物使用不同和量身定制的标准。研究设计将利用基于医疗保健系统的大型数据注册机构的功能，其基础设施已经量身定制，以评估HIV中与CVD相关的特定和HIV相关的变量，并匹配对照患者，从而提供了一种创新和有效的方法来回答研究问题。将采用高级分析技术，包括自然语言处理工具和倾向得分分析，以实现最严格的观察数据研究。此外，NCEP指南的预期更新提供了一个潜在的机会，可以使用对普通人群的最新建议评估我们的研究假设。拟议的研究将利用现有数据来推进高风险亚组中心血管流行病学和预防的领域，回答以下关键和以前未解决的问题：HIV提供者是否应该使用与普通人群相同的标准向患者开pin毒素？作为第一项评估艾滋病毒感染患者汀类药物的心血管风险降低的研究，数据将填补关键的知识差距，从而提供有关标准心血管预防指南对HIV种群的适用性的知识，并影响了HIV特异性标准用于他汀类药物的发展通过临床试验。这些发现将与HIV临床护理范式以及与CVD的新风险因素相关的HIV临床护理范式和降低心血管风险的相关性。