scholarly journals Bioavailability of once‐daily tacrolimus formulations used in clinical practice in the management of De Novo kidney transplant recipients: the better study

2021 ◽  
Author(s):  
Constantino Fernandez Rivera ◽  
María Calvo Rodríguez ◽  
José Luís Poveda ◽  
Julio Pascual ◽  
Marta Crespo ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Kidney Transplant ◽  
De Novo ◽  
Transplant Recipients ◽  
Kidney Transplant Recipients ◽  
Once Daily

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

2020 ◽  
Author(s):  
Murat Ferhat Ferhatoglu ◽  
Abdulcabbar Kartal ◽  
Ali Ilker Filiz ◽  
Gursel Yildiz ◽  
Alp Gurkan
Keyword(s):  
Clinical Practice ◽  
Kidney Transplant ◽  
Blood Concentration ◽  
De Novo ◽  
Graft Function ◽  
Early Postoperative Period ◽  
Kidney Transplant Recipients ◽  
Blood Concentrations ◽  
Once Daily ◽  
Kidney Recipients

Abstract 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.

scholarly journals P1779NOVEL ONCE-DAILY EXTENDED-RELEASE TACROLIMUS VERSUS TWICE -DAILY TACROLIMUS IN DE NOVO KIDNEY TRANSPLANT RECIPIENTS DURING THE EARLY POSTTRANSPLANT PERIOD

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Volkan Polatkan ◽  
Ebru Ozdemir ◽  
Turker Erturk ◽  
Emel Tatli ◽  
Ibrahim Berber ◽  
...  
Keyword(s):  
Acute Rejection ◽  
Serum Creatinine ◽  
Kidney Transplant ◽  
Whole Blood ◽  
De Novo ◽  
Prolonged Release ◽  
Transplant Recipients ◽  
Kidney Transplant Recipients ◽  
Once Daily ◽  
Group Ii

Abstract Background and Aims Both under and over-dosing of tacrolimus may compromise clinical outcomes by exposing patients to either the risks of graft rejection or adverse events (AEs) associated with immunosuppressive therapy. This study is designed to compare the clinical follow-up of our kidney transplant recipients receiving once-daily, prolonged-release (PR-T; Advagraf) and twice-daily, immediate-release (IR-T; Prograf) tacrolimus in the early posttransplant period. Method This randomized study included 78 de novo, adult kidney transplant recipients to PR-T 0.15 mg/kg/day (Group I=39) and IR-T 0.15 mg/kg/day (Group II=39) for seven days in the posttransplant period. Demographic features and clinical parameters regarding levels of whole blood tacrolimus and serum creatinine were compared between the two groups. Presence of acute rejection and AEs were investigated. Dose adjustments were permitted to target a pre-defined therapeutic range based on measured trough blood concentrations in all patients. SPSS 15 for Windows was used for statistical analysis. Results None of the patients suffered from acute rejection and there were no AEs in the early posttransplant period. However, Group II patients were found to have higher whole blood tacrolimus levels on the posttransplant 1st, 4th and 7th days (p=0.02, p=0.009 and p=0.013 respectively). Also serum creatinine levels were significantly increased in Group II patients on the posttransplant 7th day (p=0.02). Conclusion Prolonged release tacrolimus seems promising in preventing acute transplant rejection with adequate blood levels, as well as making it possible to avoid the interindividual variation in absorption and early calcineurin inhibitor toxicity.

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