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

描述(申请人提供)：艾滋病毒感染患者被认为是心血管疾病(CVD)发生率较高的高危群体，但尚不清楚传统的心血管预防指南是否适用于这一群体。具体地说，目前还没有确定他汀类药物治疗是否可以降低艾滋病毒感染患者的急性心肌梗死(AMI)风险，以及他汀类药物的使用标准是否应该根据国家胆固醇教育计划成人治疗小组III(NCEP ATPIII)为管理血脂异常而制定的指南来确定，该指南是为普通人群开发的。数据表明，艾滋病毒人群的心血管疾病机制可能与普通人群不同，可能在很大程度上是由艾滋病毒相关的炎症和免疫变化驱动的，这表明心血管预防策略也可能不同。在拟议的研究中，我们将评估NCEP ATPIII指南对艾滋病毒人群的适用性。目标1将涉及确定他汀类药物是否根据使用标准开出，确定 根据患者是否在服用他汀类药物之前达到他们的低密度脂蛋白目标，HIV患者和匹配的对照组患者中他汀类药物的使用率。在目标2中，我们将调查他汀类药物治疗与HIV感染患者中发生的急性心肌梗死之间的关联，回答他汀类药物降低急性心肌梗死风险的问题是否基于患者在药物开始之前是否满足他汀类药物的使用标准。我们预期的发现--他汀类药物即使在不符合常规使用标准的艾滋病毒感染患者中也能降低心血管风险--将表明艾滋病毒感染患者值得采用不同的、量身定制的他汀类药物使用标准。研究设计将利用基于大型医疗保健系统的数据登记的力量，其基础设施已经为评估艾滋病毒和匹配对照患者中特定的心血管疾病相关和艾滋病毒相关变量而量身定做，从而提供了一种创新和有效的方法来回答研究问题。将采用先进的分析技术，包括自然语言处理工具和倾向得分分析，以实现最严格的观测数据研究。此外，NCEP指南的预期更新为评估我们的研究假设提供了一个潜在的机会，使用面向普通人群的最新建议。这项拟议的研究将利用现有数据在高危人群中推进心血管流行病学和预防领域，回答以下关键和以前未回答的问题：艾滋病毒提供者是否应该使用与普通人群相同的标准给患者开他汀类药物？作为评估在艾滋病毒感染患者中使用他汀类药物降低心血管风险的第一项研究，这些数据将填补一个关键的知识空白，提供有关标准心血管预防指南对艾滋病毒人群的适用性的知识，并影响通过临床试验制定针对艾滋病毒的他汀类药物使用标准。这一发现将对艾滋病毒临床护理范例和具有新的心血管疾病危险因素的高危人群的心血管风险降低具有广泛的相关性。

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.