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

描述（由申请人提供）：HIV 感染者被认为是心血管疾病 (CVD) 发病率升高的高危人群，但尚不清楚传统的心血管预防指南是否适用于该人群。具体而言，尚未确定他汀类药物治疗是否会降低 HIV 感染患者发生急性心肌梗死 (AMI) 的风险，以及他汀类药物的使用标准是否应根据国家胆固醇教育计划成人治疗小组 III (NCEP ATPIII) 血脂异常管理指南来确定，该指南是为一般人群制定的。数据表明，HIV 人群的 CVD 机制可能与一般人群不同，并且可能在很大程度上是由 HIV 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有所不同。在拟议的研究中，我们将评估 NCEP ATPIII 指南对 HIV 人群的适用性。目标 1 将涉及确定他汀类药物的处方是否符合使用标准，确定 根据患者在开始使用他汀类药物之前是否达到了 LDL 目标，研究了 HIV 患者和匹配对照患者的他汀类药物使用率。在目标 2 中，我们将研究他汀类药物治疗与 HIV 感染患者中 AMI 事件的关联，回答他汀类药物降低 AMI 风险是否因患者在开始用药前是否满足他汀类药物使用标准而不同的问题。我们预期的发现——他汀类药物甚至可以降低不符合常规使用标准的 HIV 感染者的心血管风险——将表明 HIV 感染者值得采用不同的、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，其基础设施已经定制，用于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，从而提供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评分分析，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，可以使用针对普通人群的最新建议来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危亚组心血管流行病学和预防领域的发展，回答以下关键且之前未解答的问题：艾滋病毒提供者是否应该使用与普通人群相同的标准为患者开他汀类药物？作为第一项评估他汀类药物在艾滋病毒感染者中降低心血管风险的研究，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，并通过临床试验影响艾滋病毒特定的他汀类药物使用标准的制定。这些发现将与艾滋病毒临床护理模式和降低具有新的心血管疾病危险因素的高危人群的心血管风险具有广泛的相关性。

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.