Safety and Comparative Effectiveness of New Medications for Unhealthy Alcohol Use in HIV

针对艾滋病毒不健康饮酒的新药的安全性和比较有效性

• 批准号: 8840795
• 负责人: David Fiellin
• 金额: $ 41.42万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-02-15 至 2018-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8840795
• 关键词: Address; Adverse effects; Adverse event; Aging; Alcohol consumption; Alcohol dependence; Alcohols; Anorexia; Anticonvulsants; Area; Cardiovascular system; Caring; Clinical; Clinical Data; Code; Comorbidity; Data; Data Set; Depression and Suicide; Diagnosis; Disease Progression; Dizziness; Drowsiness; Effectiveness; Epilepsy; Evaluation; Funding; Goals; HIV; Health; High Prevalence; Incidence; Individual; Intervention; Kidney; Laboratories; Mediating; Mediation; Medical; National Institute on Alcohol Abuse and Alcoholism; Nature; Neurologic Effect; Outcome; Patients; Pharmaceutical Preparations; Pharmacotherapy; Pharmacy facility; Prognostic Marker; Relapse; Relative (related person); Research; Safety; Sedation procedure; Smoking; Symptoms; Treatment outcome; Veterans; Viral Load result; alcohol abuse therapy; alcohol effect; alcohol intervention; alcohol misuse; alcohol use disorder; base; clinical decision-making; cohort; comparative; comparative effectiveness; depressive symptoms; effectiveness research; efficacy research; efficacy trial; gabapentin; health care service utilization; improved; indexing; painful neuropathy; programs; public health relevance; response; safety study; smoking cessation; topiramate; varenicline; virtual

DESCRIPTION (provided by applicant): Unhealthy alcohol use threatens the health of HIV-infected individuals. Varenicline, gabapentin, and topiramate decrease alcohol consumption in HIV uninfected patients and show promise to address unhealthy alcohol use in HIV-infected patients. Each of these medications, approved and used for the treatment of non-alcohol-related conditions (e.g. smoking, neuropathic pain, and epilepsy), may cause adverse clinical outcomes. Varenicline may be associated with psychiatric symptoms and cardiovascular complications. Gabapentin and topiramate can cause dizziness and sedation. To date, studies have not examined the association between the use of these medications and adverse clinical outcomes or the comparative effectiveness of these medications for unhealthy alcohol use in HIV-infected patients. It is essential to conduct such studies prior to the widespread evaluation or use of these medications for unhealthy alcohol use in HIV-infected patients. Large clinical datasets, such as the NIAAA-funded Veterans Aging Cohort-Virtual Cohort (VACS-VC) with information on prescriptions, alcohol consumption, depressive symptoms, laboratory values and diagnoses provide the opportunity to investigate the safety and comparative effectiveness of these medications in HIV-infected patients and uninfected comparators. The number of VACS-VC HIV-infected individuals who have received varenicline (1235), gabapentin (10,193) and topiramate (914) presents a unique opportunity to examine safety and comparative effectiveness. The specific aims of this research are to: Determine the incidence of adverse clinical outcomes, by HIV status, associated with the use of varenicline, gabapentin and topiramate (Aim 1), Compare the individual effectiveness of varenicline, gabapentin and topiramate on AUDIT-C scores in HIV- infected and uninfected patients (Aim 2), and Compare the individual effectiveness of varenicline, gabapentin and topiramate on CD4, viral load and the VACS-Index in HIV- infected patients (Aim 3). We will conduct propensity score matched analysis (Aims 1-3) and for Aim 3 we will conduct mediation analyses to investigate the extent to which observed changes are mediated by changes in alcohol. This line of research, conducted in a large and well-characterized cohort of HIV-infected and HIV-uninfected comparators, will provide critical information that is necessary to inform implementation of these medications for unhealthy alcohol use in HIV-infected patients.

描述（由申请人提供）：不健康的饮酒会威胁艾滋病毒感染者的健康。伐尼克兰、加巴喷丁和托吡酯可减少未感染 HIV 的患者的饮酒量，并有望解决 HIV 感染者的不健康饮酒问题。这些被批准用于治疗非酒精相关疾病（例如吸烟、神经性疼痛和癫痫）的药物都可能导致不良的临床结果。伐尼克兰可能与精神症状和心血管并发症有关。加巴喷丁和托吡酯可引起头晕和镇静作用。迄今为止，研究尚未检验这些药物的使用与不良临床结果之间的关联，也没有检验这些药物对 HIV 感染者不健康饮酒的比较有效性。在广泛评估或使用这些药物治疗艾滋病毒感染者的不健康饮酒之前，有必要进行此类研究。大型临床数据集，例如 NIAAA 资助的退伍军人衰老队列-虚拟队列 (VACS-VC)，其中包含有关处方、饮酒、抑郁症状、实验室值和诊断的信息，为研究这些药物的安全性和比较有效性提供了机会。 HIV 感染者和未感染者。 接受伐尼克兰 (1235)、加巴喷丁 (10,193) 和托吡酯 (914) 治疗的 VACS-VC HIV 感染者人数为检查安全性和比较有效性提供了独特的机会。本研究的具体目的是： 根据 HIV 状况确定与使用伐尼克兰、加巴喷丁和托吡酯相关的不良临床结果的发生率（目标 1），比较伐尼克兰、加巴喷丁和托吡酯在 AUDIT-C 上的个体有效性HIV 感染者和未感染者的评分（目标 2），并比较伐尼克兰、加巴喷丁和托吡酯对 CD4、病毒载量和HIV 感染患者的 VACS 指数（目标 3）。我们将进行倾向评分匹配分析（目标 1-3），对于目标 3，我们将进行中介分析，以调查观察到的变化在多大程度上是由酒精变化介导的。这一系列研究是在一个大型且特征明确的艾滋病毒感染者和未感染艾滋病毒对照者队列中进行的，将提供必要的关键信息，以指导对艾滋病毒感染者不健康饮酒的这些药物的实施。