SHARP Kidney and Pancreas Transplant Center, San Diego, CA, USA.
Loyola Outpatient Center, Loyola University Medical Center, Maywood, IL, USA.
Ann Transplant. 2021 Apr 16;26:e929535. doi: 10.12659/AOT.929535.
BACKGROUND The pharmacokinetics and metabolism of tacrolimus, an immunosuppressant commonly used to prevent transplant rejection, can differ in specific subpopulations. This analysis examined treatment outcomes and safety of immediate-release tacrolimus (IR-Tac) and LCP-tacrolimus (LCPT) in stable Hispanic kidney transplant recipients. MATERIAL AND METHODS This was a post hoc analysis of clinical trial data from Hispanic adult stable kidney transplant recipients randomized to remain on IR-Tac or convert from IR-Tac to a reduced dose of LCPT (NCT00817206). Composite treatment failure was evaluated at 12 months. Estimated glomerular filtration rate and tacrolimus trough concentrations were evaluated over 12 months. RESULTS Fifty-five stable (LCPT n=26, IR-Tac n=29) kidney transplant recipients who self-identified as Hispanic or Latino were included in this analysis. Composite treatment failure occurred in 1 patient (4%) who converted to LCPT and 1 (3%) who remained on IR-Tac. The estimated glomerular filtration rate was stable over time and similar in the 2 treatment groups (P=0.08). Tacrolimus trough levels for both groups were similar over time in the 2 treatment groups (P=0.98). Treatment-emergent adverse events were similar in patients who converted to LCPT and in those who remained on IR-Tac. CONCLUSIONS Efficacy and safety were similar in Hispanic kidney transplant recipients who converted from IR-Tac to LCPT and in those remaining on IR-Tac.
免疫抑制剂他克莫司常用于预防移植排斥反应，其药代动力学和代谢在特定亚群中可能存在差异。本分析考察了稳定期西班牙裔肾移植受者使用普通他克莫司（IR-Tac）和长循环他克莫司（LCPT）的治疗结局和安全性。
这是一项对西班牙裔成年稳定肾移植受者的临床试验数据的事后分析，这些受者随机继续使用 IR-Tac 或从 IR-Tac 转换为 LCPT 的低剂量（NCT00817206）。在 12 个月时评估复合治疗失败。在 12 个月内评估估算肾小球滤过率和他克莫司谷浓度。
55 例稳定（LCPT n=26，IR-Tac n=29）的自认为是西班牙裔或拉丁裔的肾移植受者被纳入本分析。1 例（4%）转换为 LCPT 的患者和 1 例（3%）继续使用 IR-Tac 的患者发生复合治疗失败。两组的估算肾小球滤过率随时间稳定且相似（P=0.08）。两组在 2 种治疗组中，他克莫司谷浓度随时间相似（P=0.98）。转换为 LCPT 的患者和继续使用 IR-Tac 的患者出现的治疗新发不良事件相似。
从 IR-Tac 转换为 LCPT 的西班牙裔肾移植受者和继续使用 IR-Tac 的受者的疗效和安全性相似。
