Comparison of a novel tablet formulation of tacrolimus and conventional capsule formulation in <i>de novo</i> kidney transplant recipients: a systematic review and meta-analysis

作者全名："Liu, Zhenyu; Yin, Kexin; Liu, Huiqian; Wang, Ning; Yao, Junjie; Zhou, Jiangtao; Tang, Yongxi; Yin, Zhikang"

作者地址："[Liu, Zhenyu; Liu, Huiqian; Wang, Ning; Yao, Junjie; Zhou, Jiangtao; Yin, Zhikang] Chongqing Med Univ, Affiliated Hosp 1, Dept Urol, Chongqing, Peoples R China; [Yin, Kexin] Chongqing Med Univ, Clin Coll 1, Chongqing, Peoples R China; [Tang, Yongxi] First Peoples Hosp Chongqing Liang Jiang New Area, Dept Urol, Chongqing, Peoples R China"

通信作者："Yin, ZK (通讯作者)，Chongqing Med Univ, Affiliated Hosp 1, Dept Urol, Chongqing, Peoples R China."

来源：FRONTIERS IN PHARMACOLOGY

ESI学科分类：PHARMACOLOGY & TOXICOLOGY

WOS号：WOS:001128746300001

JCR分区：Q1

影响因子：4.4

年份：2023

卷号：14

期号：　

开始页：　

结束页：　

文献类型：Review

关键词：kidney transplantation; relative bioavailability; pharmacokinetic; tacrolimus; tablet

摘要："Background: The work aimed to compare the pharmacokinetic (PK) profiles and other outcomes reported in observational studies in de novo kidney transplant recipients (KTRs) receiving novel once-daily extended-release tablet tacrolimus (LCPT; LCP-tacrolimus; Envarsus XR) or receiving standard-of-care capsule tacrolimus (PR-Tac; prolonged-release tacrolimus; Advagraf/IR-Tac; immediate-release tacrolimus; Prograf).Methods: A systematic review was conducted for all randomized controlled trials (RCTs) and cohort studies investigating the outcomes in KTRs receiving LCPT or PR-Tac/IR-Tac. We systematically searched PubMed, Web of Science, and EMBASE, with no language restriction. The registered trials and references listed in relevant studies were also searched. Data were extracted for the PK profile, tacrolimus trough level (TTL), and changes in the estimated glomerular filtration rate (eGFR) and serum creatinine (Scr), biopsy-proven acute rejection (BPAR) rate, delayed graft function (DGF) rate, post-transplant diabetes mellitus (PTDM) rate, tremor rate (TR), death rate (DR), and rate of infection by cytomegalovirus (CMV). This study was registered with PROSPERO (registration number: CRD42023403787).Results: A total of seven eligible articles including 1,428 patients with 712 in the LCPT group versus 716 in the PR-Tac/IR-Tac group were included in this study for evidence synthesis. The baseline characteristics of the LCPT, PR-Tac, and IR-Tac groups were similar. The pooled analysis showed a higher PK profile in the LCPT group, and this result was consistent with those of all the included studies. In addition, no significant difference was observed for other outcomes.Conclusion: Considering heterogeneity between studies and potential bias, care providers should select agents based on patient-specific factors and their clinical experience for the immunosuppressive treatment of de novo KTRs."

基金机构：Chongqing Medical University10.13039/501100004374

基金资助正文：No Statement Available