Department of Pharmacy, Barnes-Jewish Hospital, 1 Barnes-Jewish Hospital Plaza, Mailstop 90-52-411, Saint Louis, MO, 63130, USA.
Veloxis Pharmaceuticals, Cary, NC, USA.
Drugs Aging. 2021 May;38(5):397-406. doi: 10.1007/s40266-021-00842-w. Epub 2021 Mar 23.
Extended-release tacrolimus (LCP-Tac) prescribing information states that there is insufficient data in older adult patients from which to make recommendations on use in this population. This study sought to provide information on de novo use of LCP-Tac in the older adult kidney transplant population.
This single-center retrospective study had two distinct objectives; to determine if weight-based doses of LCP-Tac differ based on recipient age and to compare safety and efficacy between LCP-Tac and immediate-release tacrolimus (IR-Tac) in older adult transplant recipients. Data was obtained through electronic chart review up to 2 years after transplant with censoring for graft loss and death.
Weight-based doses were compared between patients aged ≥ 65 years (n = 84), 36-64 years (n = 64), and ≤35 years (n = 44). LCP-Tac weight-based doses were lower at all time points in patients ≥ 65 years of age. Both age and race significantly impacted required dose on linear regression. The doses required to achieve therapeutic tacrolimus troughs were significantly lower in all age groups compared with the current FDA de novo dosing recommendation. In the older adult population, graft outcomes and infectious and metabolic complications were compared between recipients of LCP-Tac (n = 84) and IR-Tac (n = 42). Within this cohort, there were no differences between LCP-Tac and IR-Tac on graft function, rejection, graft loss, death, cytomegalovirus viremia, BK viremia, hypertension, diabetes, alopecia, or tremor up to 2 years after transplant.
Older adult recipients required significantly lower LCP-Tac doses compared with younger recipients and with the FDA-labeled starting dose. There were no differences in graft outcomes or adverse effects in older adult patients who received LCP-Tac versus IR-Tac.
缓释他克莫司（LCP-Tac）的说明书指出，在老年患者中，由于缺乏数据，无法对此人群的用药提出建议。本研究旨在提供老年肾移植患者中 LCP-Tac 起始使用的相关信息。
这是一项单中心回顾性研究，有两个不同的目标；确定基于体重的 LCP-Tac 剂量是否因受者年龄而异，以及比较老年移植受者中 LCP-Tac 与即时释放他克莫司（IR-Tac）的安全性和疗效。通过电子病历回顾，在移植后 2 年内获得数据，并对移植物丢失和死亡进行 censoring。
在年龄≥65 岁（n=84）、36-64 岁（n=64）和≤35 岁（n=44）的患者之间比较了基于体重的剂量。在≥65 岁的患者中，所有时间点的 LCP-Tac 基于体重的剂量均较低。年龄和种族在线性回归中显著影响所需剂量。与目前 FDA 的起始剂量建议相比，所有年龄组达到治疗性他克莫司谷浓度所需的剂量均显著降低。在老年人群中，比较了 LCP-Tac（n=84）和 IR-Tac（n=42）受者的移植物结局以及感染和代谢并发症。在该队列中，在移植后 2 年内，LCP-Tac 和 IR-Tac 之间在移植物功能、排斥反应、移植物丢失、死亡、巨细胞病毒病毒血症、BK 病毒血症、高血压、糖尿病、脱发或震颤方面没有差异。
与年轻受者和 FDA 标签起始剂量相比，老年受者需要的 LCP-Tac 剂量显著降低。接受 LCP-Tac 和 IR-Tac 的老年患者在移植物结局或不良反应方面没有差异。
