One-Year Follow-Up of Treatment With Once-Daily Tacrolimus in De Novo Renal Transplant

Kitada, Hidehisa; Okabe, Yoshinobu; Nishiki, Takehiro; Miura, Yoshifumi; Kurihara, Kei; Terasaka, Soushi; Kawanami, S.; Tuchimoto, Akihiro; Masutani, Kohsuke; Tanaka, Masao

doi:10.6002/ect.2012.0087

Cited by 15 publications

(12 citation statements)

References 28 publications

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“…Several studies revealed that TAC-OD required higher daily doses up to six months after transplantation than those on TAC-BID [2,13,14]. Kitada et al showed that recipients on TAC-OD therapy have lower tacrolimus blood concentration and necessitate to be administered higher doses than those receiving TAC-BID in the early posttransplant phase [15]. Our outcomes on daily dosage were consistent with previous studies; recipients having TAC-OD immunosuppressive therapy needed higher doses than those receiving TAC-BID.…”

Section: Discussionsupporting

confidence: 89%

“…Tacrolimus is principally absorbed from the intestines. The inactive components inserted into the capsule covering the active drug form create disparity among once-daily and twice-daily forms [14,15]. This prolonged-release period may be linked with problems in optimizing the blood concentration in the target concentration through the initial post-transplant period.…”

Section: Discussionmentioning

confidence: 99%

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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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Section: Discussionsupporting

confidence: 89%

Section: Discussionmentioning

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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“…According to de novo studies on Tac-OD, excellent survival rates and comparable safety profiles have been achieved with both formulations [4,5].…”

mentioning

confidence: 86%

Pharmacogenetic-Based Strategy Using De Novo Tacrolimus Once Daily After Kidney Transplantation: Prospective Pilot Study

et al. 2016

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“…ration during 3-12 months aft er transplantation [23]. On the contrary, Kitada et al demonstrated signifi cant diff erences in Tac daily dose between examined preparations in the early period aft er Tx (up to three months), which was not followed by the same trend at the end of the fi rst year [24].…”

Section: Volume 6 • Number 2 • August 2019 • Hophmentioning

confidence: 92%

Influence of different formulations of tacrolimus on dosage regimen and drug exposure within the first year after kidney transplantation

Stefanović¹,

Cvetković²,

Dinić³

et al. 2019

Hosp Pharm Int Multi J

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Introduction: Two most common pharmaceutical formulation of tacrolimus (Tac) used after kidney transplantation (Tx) are immediate-release one, administered twice-daily (Tac-TD), and prolonged-release one, administered once-daily (Tac-OD). Aim: The aim of this study was to compare daily doses, trough concentrations (C 0 ) and dose-adjusted trough concentrations (C 0 /D) of Tac between patients who administered diff erent drug formulations, Tac-TD or Tac-OD, during the fi rst year after Tx. Additionally, the aim of the study was to compare the distribution of C 0 within and beyond the target therapeutic range (8-12 ng/mL for the fi rst 90 days and 6-10 ng/mL afterwards) after the administration of diff erent drug formulations. Subjects and Methods: A retrospective pharmacokinetic study included 84 patients (56 on Tac-TD and 28 on Tac-OD), with a follow-up period between the fi rst and twelfth month post-transplantation. Following pharmacokinetic data were used: daily dose, daily dose according to patient's body weight, concentration C 0 and C 0 /D of Tac. Results: Тhe results of the study showed that patients on Tac-OD formulation had higher daily doses and higher C 0 during 4-6 months (p<0.01) and 7-12 months (p<0.01) after Tx. Patients on Tac-OD had lower C 0 /D during 4-6 months (p<0.05) and 7-12 months (p<0.01) after Tx. C 0 in Tac-TD patients was signifi cantly more frequently below the target range, whereas in Tac-OD patients C 0 was more frequently above the target range, while both patient groups had equal distribution of C 0 within the target range of Tac in the period between 4 th and 12 th month post-transplantation (p<0.01). Conclusions:The conducted research suggests that patients on Tac-OD preparation may require higher daily doses of Tac compared to patients on Tac-TD preparation in order to maintain optimal immunosuppression in the late post-transplant period.

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One-Year Follow-Up of Treatment With Once-Daily Tacrolimus in De Novo Renal Transplant

Cited by 15 publications

References 28 publications

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

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

Pharmacogenetic-Based Strategy Using De Novo Tacrolimus Once Daily After Kidney Transplantation: Prospective Pilot Study

Influence of different formulations of tacrolimus on dosage regimen and drug exposure within the first year after kidney transplantation

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