Extended release versus immediate release tacrolimus in kidney transplant recipients: a systematic review and meta-analysis

Saengram, Warangkana; Vadcharavivad, Somratai; Poolsup, Nalinee; Chancharoenthana, Wiwat

doi:10.1007/s00228-018-2512-7

Cited by 19 publications

(14 citation statements)

References 35 publications

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“…Similar to the result of our previous meta-analysis [15], a significant difference in BPAR incidences within 6 months was not found in this current study. The impact of induction therapy, close monitoring during this high-risk period post-KT, and/or strategies of initiating ER-Tac therapy would at least in part explain the finding.…”

Section: Discussionsupporting

confidence: 91%

“…Our finding of significant lower BPAR in ER-Tac (5 studies, n = 659; RR 0.69, 95% CI 0.51–0.95; p = 0.02; I 2 = 0%) compared with IR-Tac at 12 months post-KT is inconsistent with our previous meta-analysis of RCTs, in which no significant difference in BPAR at 12 months post-transplant was found between the 2 groups among low-to-moderate risk KTRs (4 trials, n = 1738; RR 1.11; 95% CI 0.88–1.44; p = 0.40; I 2 = 0%) [15]. The difference in these findings may partly be explained by one or more of potential reasons, including a favorable impact of the ER-Tac formulation, a broader range of immunological risk, individualization in selection of induction therapy and pre-/peri-conditioning strategies, refinement in clinical and drug monitoring together with immunosuppressive drug dosage adjustment, and/or plausible bias in patient selection and uncontrolled confounders in the included observational studies.…”

Section: Discussioncontrasting

confidence: 57%

“…Based upon the evidence from randomized controlled trials (RCTs) comparing the efficacy and toxicity across different formulations in de novo KTRs, the impact on kidney allograft function appears to be comparable between ER-Tac and IR-Tac [15]. Of note, most of the studied KTRs were at low immunologic risk, possibly for ethical reasons.…”

Section: Introductionmentioning

confidence: 99%

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Once-Daily versus Twice-Daily Tacrolimus in Kidney Transplantation: A Systematic Review and Meta-analysis of Observational Studies

Vadcharavivad

Saengram

Phupradit

et al. 2019

Drugs

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Background Tacrolimus is the most commonly prescribed medication in initial immunosuppressive regimens to prevent acute rejection in kidney transplant recipients (KTRs). Tacrolimus was originally available as an immediate-release formulation (IR-Tac) given twice daily. Extended-release tacrolimus (ER-Tac) given once daily was later developed with the expectation of improved medication adherence. Data from observational studies, which compared outcomes between ER-Tac and IR-Tac in different populations of KTRs including those who are unlikely to be enrolled in randomized clinical trials, have been reported. Purpose To evaluate the incidence of biopsy-proven acute rejection (BPAR) at 12 months together with other outcomes reported in observational studies among adult KTRs who received ER-Tac compared to IR-Tac. Methods In accordance with the recommendations of the Cochrane Collaboration and the Meta-analysis of Observational Studies in Epidemiology, we systematically reviewed all observational studies that compared clinical outcomes between ER-Tac and IR-Tac in KTRs. The systematic searches were conducted on PubMed, EMBASE, Scopus, and Web of Science without language restriction. Reference lists were also searched and reviewed. Data were extracted for BPAR, graft survival, patient survival, estimated glomerular filtration rate (eGFR), serum creatinine (Scr), creatinine clearance (CrCl), at different times after kidney transplantation (KT). A meta-analysis was performed to integrate the results from the eligible studies. This study is registered with PROSPERO, number CRD42019135705. Results From the 1401 articles screened, 10 observational studies in KTRs who received tacrolimus were included. The pooled results showed significantly lower BPAR with ER-Tac than with IR-Tac at 12 months post-KT (5 studies, n = 659; RR, 0.69; 95% CI 0.51-0.95; p = 0.02; I 2 = 0%). No significant differences in BPAR at other time points after KT were found. Graft survival, patient survival, Scr, and eGFR were comparable between groups at different times over approximately 1 year after transplantation. Conclusions Based upon currently available evidence in observational studies, 30% lower risk of BPAR was observed in ER-Tac group compared with IR-Tac group at 12 months post-KT, while there was no significant difference in BPAR risk at any other studied time points. No differences in graft-and patient-survival rates and kidney function were found. Given the limitations of observational studies to make causal inference, as well as quality limitations among the included studies, caution should be exercised in interpreting these findings.

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Section: Discussionsupporting

confidence: 91%

Section: Discussioncontrasting

confidence: 57%

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Once-Daily versus Twice-Daily Tacrolimus in Kidney Transplantation: A Systematic Review and Meta-analysis of Observational Studies

Vadcharavivad

Saengram

Phupradit

et al. 2019

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“…Graft failure can be caused by acute rejection, glomerular disease, fibrosis/atrophy, and as an event secondary to separate medical or surgical conditions [56]. Recent pharmaceutical innovation has increased graft survival [43,[57][58][59][60]. While the current study is hypothetical in nature, the results of existing studies could be further translated into a broader range of real-world impacts by accounting for the spillover impact described in the present paper.…”

Section: Accepted Manuscriptmentioning

confidence: 95%

Quantifying spillover benefits in value assessment: a case study of increased graft survival on the US kidney transplant waitlist

Dennen¹,

Espinosa²,

Birch³

et al. 2021

Journal of Medical Economics

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Aim: To quantify the wider impacts of increased graft survival on the size of the kidney transplant waitlist and health and economic outcomes. Materials and Methods:The analysis employed steady-state solutions and a simulation version of a double-queuing model. Baseline input parameters were sourced from the Organ Procurement and Transplant Network and the United States Renal Data System. Three increased graft survival scenarios were modeled: decreases in repeat transplant candidates joining the waitlist of 25%, 50%, and 100%.Results: Under the three scenarios, we estimated that the US waitlist size would decrease from 91,822 to 85,461 (6.9% decrease), 80,073 (12.8% decrease), and 69,340 (24.4% decrease), respectively. Patient outcomes improved, with lifetime quality-adjusted life years (QALYs) for a one-year cohort of transplant recipients increasing by 10,010, 16,888, and 43,345 over the three scenarios.

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“…Nevertheless, to date, an insu cient number of studies have analyzed the difference in blood-concentration and dosing pro le of once-daily and twice-daily dosing tacrolimus at de novo kidney transplant patients [3,7,9].…”

Section: Introductionmentioning

confidence: 99%

A Comparative Analysis Of Once-Daily And Twice-Daily Formulation Of Tacrolimus In De Novo Kidney Transplant Recipients

Ferhatoglu

Kartal

Filiz

et al. 2020

Preprint

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Objectives: Once-daily formulation of tacrolimus has begun to find a place in daily clinical practice as similar efficacy and safety profile as the twice-daily formulation according to clinical trials. However, few numbers of un-sponsored, non-trial studies are issued centering on its usage in clinical practice. We compared once-daily and twice-daily formulation of tacrolimus in terms of the efficiency and effects on graft function in de novo kidney transplant patients.Methods: Twenty once-daily (TAC-OD) and twenty twice-daily (TAC-BID) tacrolimus administrated de novo kidney recipients who had received initial immunosuppressive therapy according to protocols at our institution (0.2 mg/kg of tacrolimus combined with 1000 milligrams of steroid taper plus 720 mg of mycophenolate and with 2,5mg/kg human immune globulin) assessed in terms of demographics, drug doses and blood concentration, and graft function. Results: The mean tacrolimus blood concentration measurements were higher in the TAC-OD group in the first sixty days after transplantation, and the TAC-OD group showed more blood concentration overshoots in the first 30 days of the treatment. The initial drug dose was significantly higher in the TAC-OD group compared to the TAC-BID group (p=0.04). There was no meaningful difference among groups according to graft function (creatinine measurements) (p>0.05).Conclusion: Between de novo kidney recipients, the new TAC-OD formulation presents a similar short-term efficacy profile as TAC-BID. However, a higher daily dosage of TAC-OD is needed to achieve similar blood concentrations in the early postoperative period.

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Extended release versus immediate release tacrolimus in kidney transplant recipients: a systematic review and meta-analysis

Abstract: Based upon currently available evidences in KTRs, the impact on kidney allograft function appears to be comparable between ER-Tac and IR-Tac.

Cited by 19 publications

References 35 publications

Once-Daily versus Twice-Daily Tacrolimus in Kidney Transplantation: A Systematic Review and Meta-analysis of Observational Studies

Once-Daily versus Twice-Daily Tacrolimus in Kidney Transplantation: A Systematic Review and Meta-analysis of Observational Studies

Quantifying spillover benefits in value assessment: a case study of increased graft survival on the US kidney transplant waitlist

A Comparative Analysis Of Once-Daily And Twice-Daily Formulation Of Tacrolimus In De Novo Kidney Transplant Recipients

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