Generic Versus Brand-Name Immunosuppression Following Heart Transplant: An Analysis of the UNOS Database

IF 1.9 4区医学 Q2 SURGERY

Clinical Transplantation Pub Date : 2025-06-01 DOI:10.1111/ctr.70196

Aviral Mahajan, Jiwon Park, Timothy E. Moore, William L. Baker, Cesar Rodrigo Zoni, Stephen Akinfenwa, Mirghani Mohamed, Matthew Dean, Chittoor Sai-Sudhakar, Yazhini Ravi

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引用次数: 0

Abstract

Background

Immunosuppressant medications, such as tacrolimus and mycophenolate mofetil (MMF), are crucial for preventing graft rejection after heart transplantation (HTx). Generic formulations have become available, offering potential cost savings, but concerns exist regarding their clinical bioequivalence compared to brand-name formulations. Current guidelines suggest no increased risk with generic use, but research remains limited. Therefore, this study aims to explore whether the type of immunosuppressant formulation at hospital discharge influences post-transplant outcomes.

Methods

This retrospective analysis utilized data from the United Network for Organ Sharing (UNOS) registry, including HTx recipients from January 2015 to March 2022. Patients were grouped based on their discharge immunosuppressant regimen: dual generic, dual brand-name, or a mix of both tacrolimus and MMF. Demographic and clinical variables were collected. The primary outcome was all-cause mortality and graft failure, assessed using Kaplan-Meier analysis and Cox proportional hazards regression. Multivariable Cox regression was adjusted for recipient and donor characteristics. Statistical significance was set at p < 0.05. This approach allows for a thorough examination of the relationships between immunosuppressant formulations and outcomes.

Results

The study included 16 529 HTx recipients. The majority (52.0%) were discharged on a dual generic regimen. At 1-year post-transplant, significant differences were observed in treatment for rejection, graft failure, and all-cause mortality among the groups. The dual generic group demonstrated the lowest rates of graft failure (13.6%) and all-cause mortality (13.1%) at 5 years. However, after adjusting for demographic and clinical characteristics using multivariable Cox regression, no significant differences in graft failure or mortality were observed among the immunosuppressant regimens.

Conclusion

Despite initial differences in unadjusted outcomes, adjusted analyses did not demonstrate a significant difference in graft failure or mortality between brand-name and generic immunosuppressant regimens. These findings suggest that clinicians can confidently prescribe generic immunosuppressants without compromising patient outcomes, potentially leading to substantial healthcare savings.

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心脏移植后通用与品牌免疫抑制：UNOS数据库分析

免疫抑制药物，如他克莫司和霉酚酸酯（MMF），对于预防心脏移植后的移植排斥反应至关重要。仿制制剂已经成为可能，提供了潜在的成本节约，但与品牌制剂相比，存在关于其临床生物等效性的担忧。目前的指南建议通用用药不会增加风险，但研究仍然有限。因此，本研究旨在探讨出院时免疫抑制剂制剂的类型是否会影响移植后的预后。方法回顾性分析联合器官共享网络（UNOS）登记处的数据，包括2015年1月至2022年3月的HTx接受者。患者根据他们的出院免疫抑制剂方案进行分组：双通用，双品牌，或他克莫司和MMF的混合。收集人口学和临床变量。主要终点是全因死亡率和移植物衰竭，使用Kaplan-Meier分析和Cox比例风险回归进行评估。根据受体和供体特征调整多变量Cox回归。p <；0.05. 这种方法允许对免疫抑制剂配方和结果之间的关系进行彻底检查。结果共纳入16 529例HTx受体。大多数（52.0%）出院时采用双通用方案。移植后1年，两组间在排斥反应、移植失败和全因死亡率方面观察到显著差异。双通用组在5年时表现出最低的移植失败率（13.6%）和全因死亡率（13.1%）。然而，在使用多变量Cox回归调整人口统计学和临床特征后，在免疫抑制方案中观察到移植物衰竭或死亡率没有显着差异。结论：尽管未经调整的结果存在初始差异，但调整后的分析并未显示品牌免疫抑制剂和非专利免疫抑制剂方案在移植物失败或死亡率方面存在显著差异。这些研究结果表明，临床医生可以自信地开出通用免疫抑制剂，而不会影响患者的预后，从而潜在地节省大量医疗费用。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical Transplantation 医学-外科

CiteScore

3.70

自引率

4.80%

发文量

286

审稿时长

2 months

期刊介绍： Clinical Transplantation: The Journal of Clinical and Translational Research aims to serve as a channel of rapid communication for all those involved in the care of patients who require, or have had, organ or tissue transplants, including: kidney, intestine, liver, pancreas, islets, heart, heart valves, lung, bone marrow, cornea, skin, bone, and cartilage, viable or stored. Published monthly, Clinical Transplantation’s scope is focused on the complete spectrum of present transplant therapies, as well as also those that are experimental or may become possible in future. Topics include: Immunology and immunosuppression; Patient preparation; Social, ethical, and psychological issues; Complications, short- and long-term results; Artificial organs; Donation and preservation of organ and tissue; Translational studies; Advances in tissue typing; Updates on transplant pathology;. Clinical and translational studies are particularly welcome, as well as focused reviews. Full-length papers and short communications are invited. Clinical reviews are encouraged, as well as seminal papers in basic science which might lead to immediate clinical application. Prominence is regularly given to the results of cooperative surveys conducted by the organ and tissue transplant registries. Clinical Transplantation: The Journal of Clinical and Translational Research is essential reading for clinicians and researchers in the diverse field of transplantation: surgeons; clinical immunologists; cryobiologists; hematologists; gastroenterologists; hepatologists; pulmonologists; nephrologists; cardiologists; and endocrinologists. It will also be of interest to sociologists, psychologists, research workers, and to all health professionals whose combined efforts will improve the prognosis of transplant recipients.