A Prospective, Observational Study of Conversion From Immediate- to Prolonged-Release Tacrolimus in Renal Transplant Recipients in France: The OPALE Study

Moal, Valérie; Grimbert, Philippe; Beauvais, Adrien; Dubel, Laurence; Meur, Yann Le

doi:10.12659/aot.916043

Cited by 3 publications

(2 citation statements)

References 21 publications

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“…The results of observational studies comparing adherence in KTRs treated with IR-TAC capsules versus ER-TAC formulations have been mixed; some studies found greater self-reported adherence with ER-TAC formulations in select KTRs, [13][14][15][16][17][18][19][20] while others found no improvements with these newer formulations. [21][22][23][24][25] In addition to studies comparing adherence, there have been several randomized trials that have compared the safety and efficacy of IR-TAC and ER-TAC formulations in KTRs.…”

Section: Introductionmentioning

confidence: 99%

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Outcomes in kidney transplant recipients treated with immediate‐release tacrolimus capsules versus extended‐release tacrolimus capsules: A cohort study

Divard

Mitra

et al. 2022

Clinical Transplantation

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Introduction Prior randomized trials and observational studies have generally reported similar outcomes in kidney transplant recipients (KTRs) treated with immediate‐release tacrolimus (IR‐TAC) versus extended‐release tacrolimus (ER‐TAC). However, many of these previous studies focused on patients with low immunological risks, had small sample sizes and brief follow‐up periods, and excluded outcomes associated with graft loss, such as chronic rejection. Methods To address these limitations, we conducted a cohort study of 848 KTRs at a single transplantation center who had generally high immunological risks and were treated with either IR‐TAC capsules (589 patients, 65.9%) or ER‐TAC capsules (289 patients, 34.1%). All patients received their designated maintenance immunosuppressive regimen for at least 3 months post‐transplantation. Afterwards, tacrolimus formulation was at the discretion of each patient's transplant nephrologist. For the two treatment groups, we compared the hazards of experiencing a composite outcome of acute or chronic antibody‐mediated rejection (AMR), acute or chronic T‐cell‐mediated rejection, de novo DSA, and/or graft loss over a 3‐year period starting at 3 months post‐transplantation. Results In a multivariable Cox proportional hazards regression model, KTRs treated with IR‐TAC capsules had an increased hazard of experiencing the composite outcome when compared to patients treated with ER‐TAC capsules; however, this result was not significant (adj HR 1.24, 95% CI .92–1.68, p = .163). Similar results were obtained with inverse probability of treatment weighting (IPTW) using a propensity score (adj HR 1.25, 95% CI .93–1.68, p = .146). Conclusion These findings suggest that when compared to IR‐TAC capsules, ER‐TAC capsules do not reduce the hazard of poor outcomes in KTRs with generally high immunological risks.

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Section: Introductionmentioning

confidence: 99%

“…The results of observational studies comparing adherence in KTRs treated with IR‐TAC capsules versus ER‐TAC formulations have been mixed; some studies found greater self‐reported adherence with ER‐TAC formulations in select KTRs, 13–20 while others found no improvements with these newer formulations 21–25 …”

Section: Introductionmentioning

confidence: 99%

Outcomes in kidney transplant recipients treated with immediate‐release tacrolimus capsules versus extended‐release tacrolimus capsules: A cohort study

Divard

Mitra

et al. 2022

Clinical Transplantation

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Novel management of diabetes in kidney transplantation

Ong

Rhee

2021

Current Opinion in Nephrology &Amp; Hypertension

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Purpose of review Posttransplant diabetes mellitus (PTDM) is a prevalent complication in kidney transplant recipients, and has been associated with worse short-term and long-term outcomes. Recent findings While hyperglycemia is frequently seen in the early posttransplant period because of surgical stress, infection, and use of high-dose steroids, the diagnosis of PTDM should be established after patients are clinically stable and on stable maintenance immunosuppression. In the early posttransplant period, hyperglycemia is typically treated with insulin, and pilot data have suggested potential benefit of lower vs. higher glycemic targets in this setting. Growing data indicate lifestyle modifications, including dietary interventions, physical activity, and mitigation of obesity, are associated with improved posttransplant outcomes. While there are limited data to support a first-line antidiabetic medication for PTDM, more established pharmacotherapies such as sulfonylureas, meglitinides, and dipetidyl peptidase IV inhibitors are commonly used. Given recent trials showing the benefits of sodium–glucose cotransporter 2 inhibitors and glucagon-like peptide 1 receptor agonists upon kidney outcomes in nontransplant patients, further study of these agents specifically in kidney transplant recipients are urgently needed. Summary Increasing evidence supports a multidisciplinary approach, including lifestyle modification, obesity treatment, judicious immunosuppression selection, and careful utilization of novel antidiabetic therapies in PTDM patients.

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Thirty Years of Tacrolimus in Clinical Practice

Ong

Gaston

2020

Transplantation

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Tacrolimus was discovered in 1984 and entered clinical use shortly thereafter, contributing to successful solid organ transplantation across the globe. In this review, we cover development of tacrolimus, its evolving clinical utility, and issues affecting its current usage. Since earliest use of this class of immunosuppressant, concerns for calcineurin-inhibitor toxicity have led to efforts to minimize or eliminate these agents in clinical regimens but with limited success. Current understanding of the role of tacrolimus focuses more on its efficacy in preventing graft rejection and graft loss. As we enter the fourth decade of tacrolimus use, newer studies utilizing novel combinations (as with the mammalian target of rapamycin inhibitor, everolimus, and T-cell costimulation blockade with belatacept) offer potential for enhanced benefits.

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A Prospective, Observational Study of Conversion From Immediate- to Prolonged-Release Tacrolimus in Renal Transplant Recipients in France: The OPALE Study

Cited by 3 publications

References 21 publications

Outcomes in kidney transplant recipients treated with immediate‐release tacrolimus capsules versus extended‐release tacrolimus capsules: A cohort study

Outcomes in kidney transplant recipients treated with immediate‐release tacrolimus capsules versus extended‐release tacrolimus capsules: A cohort study

Novel management of diabetes in kidney transplantation

Thirty Years of Tacrolimus in Clinical Practice

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