Transplant Outcomes Using Generic and Brand Name Immunosuppressants: studying medications used by people who have received kidney and liver transplants

使用通用名和品牌免疫抑制剂的移植结果：研究接受肾脏和肝脏移植的人使用的药物

• 批准号: 8875441
• 负责人: Emily Messersmith
• 金额: $ 49.41万
• 依托单位: ARBOR RESEARCH COLLABORATIVE FOR HEALTH
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-10 至 2016-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8875441
• 关键词: Transplant; Outcomes; Using; Generic; Brand

7. Abstract/Project Summary Each year since 2009, more than 28,000 people have received organ transplants in the United States. Immunosuppressive medications are critical to reduce rejection and graft loss in transplant recipients. These medications can be expensive and pose a financial burden to patients, leading to non-adherence. Substituting costly brand name medications with therapeutically equivalent, less expensive generic medications is a potential solution to overcome the financial barrier and improve access and adherence to immunosuppressants. However, there are questions regarding the therapeutic equivalence of generic and brand name immunosuppressants. In addition, generic products have not been compared with each other; thus, there is a concern regarding the substitution of one generic for another generic. This uncertainty is problematic for clinicians who seek to provide the best care for their patients. To examine the utility of generic immunosuppressants, we will study recipients of kidney and liver transplants between 2008 and 2013. The first of three specific aims of the project is to describe patterns of generic and brand immunosuppressant use after transplant. These patterns will be examined for patients by time since transplant and also by calendar date, to carefully tease apart changes that occur as patient needs evolve from changes that coincide with changes in the availability of generic immunosuppressants. We will describe patterns at the level of the transplant program, aggregated across patients, to understand program-level factors associated with the speed of generic immunosuppressant adoption. To address our second specific aim, we will compare risks of biopsy-proven and treated rejection and graft failure for patients on generic and brand name immunosuppressants. We will use time-dependent Cox regressions to model these risks, controlling for variability between recipients, organ donors, and characteristics of the transplant surgery. We will carefully examine heterogeneity of treatment effects in patient subgroups, including pediatric patients and adults, racial and ethnic minorities, women and men, and patients with medical complexities or greater- than-average risk for adverse outcomes. Assuming we find no meaningful difference in the effectiveness of generic medications relative to brand name medications, our third aim will be to quantify the costs associated with each type of medication. We will demonstrate the savings to patients and to payers through the use of generic immunosuppressants in place of brand name immunosuppressants. Ultimately, we expect that this study will provide significant new insights regarding the use of generic and brand name immunosuppressants, leading to improved care for transplant recipients.

7。摘要/项目摘要 自2009年以来，每年都有28,000多人在美国接受器官移植。 免疫抑制药物对于减少移植受者的排斥和移植损失至关重要。这些 药物可能很昂贵，并给患者带来经济负担，导致不遵守。替代 昂贵的品牌名称药物具有治疗等效性，较便宜的通用药物是一种 克服财务障碍并改善对免疫抑制剂的获取和遵守的潜在解决方案。 但是，关于通用和品牌名称的治疗等效性有一些疑问 免疫抑制剂。此外，既没有将通用产品彼此进行比较。因此，有一个 担心将一个通用的替换为另一个通用。这种不确定性是有问题的 试图为患者提供最佳护理的临床医生。 为了检查通用免疫抑制剂的效用，我们将研究肾脏和肝移植的接受者 在2008年至2013年之间。该项目的三个具体目的中的第一个是描述通用模式和 移植后品牌免疫抑制剂使用。这些模式将按时间检查，因为 移植以及按日历日期，仔细嘲笑随着患者的需求而发生的变化 随着通用免疫抑制剂的可用性变化一致的变化。我们将描述 移植程序级别的模式，跨患者汇总，以了解程序级别 与通用免疫抑制剂采用速度相关的因素。解决我们的第二个特定 目的，我们将比较针对仿制药和患者的拒绝和治疗的拒绝和移植失败的风险 品牌名称免疫抑制剂。我们将使用时间依赖的Cox回归来建模这些风险， 控制受体，器官捐献者和移植手术特征之间的变异性。我们 将仔细检查患者亚组的治疗效果的异质性，包括小儿患者 成年人，种族和少数民族，男女，以及具有医学复杂性或更大的患者 不良结果的风险超过平均风险。假设我们发现在有效性上没有有意义的差异 相对于品牌药物的通用药物，我们的第三个目标是量化成本 与每种类型的药物相关。我们将通过 使用通用免疫抑制剂代替品牌免疫抑制剂。最终，我们期望 这项研究将提供有关通用和品牌名称使用的重要新见解 免疫抑制剂，从而改善了移植受者的护理。