Efficacy and safety of once-daily prolonged-release tacrolimus versus twice-daily tacrolimus in kidney transplant recipients - A meta-analysis and trial sequential analysis

Sep 29, 2026

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Kidney transplantation is a key treatment for end-stage renal disease, and immunosuppressive therapy reduces acute rejection risk. Tacrolimus is commonly used post-transplant, while once-daily dosing may enhance adherence. This meta-analysis compared clinical outcomes of once-daily versus twice-daily prolonged-release tacrolimus in de novo renal transplant recipients using randomized controlled trials, pooling effect estimates with random-effects models and applying trial sequential analysis.

LanguageEnglish

CategoryHealthcare

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Pages8

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Introduction

J Chin MedAssoc Original article Efficacy and safety of once-daily prolongedrelease tacrolimus versus twice-daily tacrolimusin kidney transplant recipients: A meta-analysis and trial sequential analysis Tair-Shin Wanga,b, Kuan-Hua Huangc, Kuan-Chun Hsuehd, Hsin-An Chene,f, Ka-Wai Tame, Shu-Hui Sunb, Cheng-Fong Cheng, Chien-Ying Wangh, Min-Che Tungi, Yuan-Hung Wanga,j,* aGraduate Institute of Clinical Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan, ROC.; bDepartment of Pharmacy, Far Eastern Memorial Hospital, New Taipei City, Taiwan, ROC.; cDepartment of Urology, Chi Mei Medical Center, Tainan, Taiwan, ROC.; dDivision of General Surgery, Department of Surgery, Tungs’ Taichung MetroHarbor Hospital, Taichung, Taiwan, ROC.; eDivision of General Surgery, Department of Surgery, Shuang Ho Hospital, Taipei Medical University, New Taipei City, Taiwan, ROC.; fTMU Research Center of Urology and Kidney, Taipei Medical University, Taipei, Taiwan, ROC.; gDepartment of Surgery, School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan, ROC.; hDepartment of Critical Care Medicine, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.; iDivision of Urology, Department of Surgery, Tungs’ Taichung MetroHarbor Hospital, Taichung, Taiwan, ROC.; jDepartment of Medical Research, Shuang Ho Hospital, Taipei Medical University, New Taipei City, Taiwan, ROC. Abstract Background: Kidney transplantation is the most important treatment for end-stage renal disease. Immunosuppressive therapies can prevent acute rejection for kidney transplant recipients. Tacrolimus is usually administered to prevent graft rejection after transplantation. Previous studies have indicated that once-daily tacrolimus may improve medication adherence. Therefore, this metaanalysis aimed to compare clinical outcomes between once-daily and twice-daily tacrolimus in de novo renal transplant patients. Methods: Eligible studies were identified from the Cochrane Library Database, PubMed, and Embase until July 2022. Those randomized controlled trials (RCTs) evaluating once-daily versus twice-daily tacrolimus formulations in de novo renal transplantation were included. A summary risk ratio (RR) and standardized mean difference (SMD) with the 95% confidence interval (CI) were estimated using a random-effects model. Results: In total, nine RCTs were included. There were no differences in biopsy-confirmed acute rejection rates between patients with once-daily and those with twice-daily tacrolimus (RR, 0.91; 95% CI, 0.73-1. 13) in 12 months. Regarding renal function, there was no significant difference between the once-daily and twice-daily tacrolimus groups (SMD, −0 .03; 95% CI, −0.12 to 0 .07) . In addition, the risk of graft failure, death, and adverse events in the first year was similar for the once-daily and twice-daily tacrolimus groups. Conclusion: Our major findings suggest that de novo renal transplantation recipients receiving once-daily tacrolimus immediately after transplantation have comparable efficacy and safety with those recipients who received twice-daily tacrolimus. Therefore, once-daily tacrolimus medication can be an alternative for de novo renal transplantation recipients. Keywords: De novo renal transplantation; Immunosuppressive agents; Once-daily; Twice-daily; Tacrolimus 1. INTRODUCTION End-stage renal disease (ESRD) occurs when chronic kidney disease, the progressive loss of renal function, reaches an advanced * Address correspondence. Prof. Yuan-Hung Wang, Graduate Institute of Clinical Medicine, College of Medicine, Taipei Medical University, 250, Wu-Hsing Street, Taipei 110, Taiwan, [ROC. E-mail address: d508091002@tmu.edu.tw](ROC. E-mail address: d508091002@tmu.edu.tw) (Y-H Wang). Author contributions: Dr. Tair-Shin Wang and Dr. Kuan-Hua Huang contributed equally to this work. Conflicts of interest: The authors declare that they have no conflicts of interest related to the subject matter or mat

FAQs

What clinical question does this study address?

It compares efficacy and safety between once-daily and twice-daily prolonged-release tacrolimus in de novo kidney transplant recipients.

How were studies selected and effects estimated?

Randomized controlled trials evaluating once-daily versus twice-daily tacrolimus in de novo renal transplantation were identified up to July 2022, with pooled risk ratios and standardized mean differences calculated using a random-effects model.

What were the main efficacy and safety findings?

Across nine included RCTs, biopsy-confirmed acute rejection and renal function showed no significant differences, and risks of graft failure, death, and adverse events in the first year were similar between dosing strategies.

Sep 29, 2026

Uploaded by Sarah