Comparison of Low and High Initial Tacrolimus Dosing in Primary Heart Transplant Recipients: A Prospective European Multicenter Study

Abstract

Although low-dose and high-dose tacrolimus had similar efficacy, low-dose tacrolimus was associated with a more favorable safety profile. Therefore we recommend starting tacrolimus therapy after antibody induction at 0.075 mg/kg and adjust dose according to whole-blood trough levels.

Superior Prevention of Acute Rejection by Tacrolimus vs. Cyclosporine in Heart Transplant Recipients—A Large European Trial

“…An early pilot study suggested that antibody induction prior to oral Tac treatment resulted in superior control of acute rejection compared to oral administration of Tac from the first day of transplant without induction therapy (8). Dose finding studies (utilizing an initial oral Tac dose of 0.075 or 0.15 mg/kg/day) indicated that Tac could be given orally to cardiac recipients either following intravenous administration (9) or antibody induction (10). However, patients receiving antibody induction tended to experience fewer rejection episodes and showed better tolerability and fewer renal disorders.…”

“…However, patients receiving antibody induction tended to experience fewer rejection episodes and showed better tolerability and fewer renal disorders. In addition, the lower starting dose of Tac (0.075 mg/kg/day) was as effective as the higher dose in preventing acute rejection (10). Based on these findings, the present large multicenter Phase III study was carried out to assess the efficacy and safety of a Tac‐based regimen vs. a CyA‐microemulsion‐based therapy following cardiac transplantation.…”

Tacrolimus as an adjunct to autologous minced muscle grafts for the repair of a volumetric muscle loss injury

“…Herein we delivered systemic tacrolimus for 1 month following VML injury, during a period in which myogenesis is expected to be increased. The target dosage of systemic tacrolimus was selected as it has been previously used for successful cardiac transplant (Podesser et al 2005 ). While the circulating concentrations of tacrolimus were slightly below the expected range it is still expected that systemic delivery of tacrolimus presumably suppressed the immune response within the VML injured muscle.…”

“…Daily administration ranged from 3 to 4 mg during the treatment period to account for body weight; all treated and non-treated swine gained approximately the same amount of weight per week. The selected dosage is recommended for cardiac transplant surgery and has been shown to result in effective serum levels of tacrolimus of 10–20 ng/ml (Podesser et al 2005 ); notably whole blood concentrations can be variable as treatment begins. Evaluation of the whole blood concentrations of tacrolimus was completed by HPLC-tandem mass spec at day 3, 9, 14, 28, and 42 post-surgery, using blood collected in EDTA anti-coagulant coated tubes.…”

The ageing population – a challenge for cardiovascular surgery

“…The results of the surgery of the large vessels have improved from refined cerebro-and spinal protection techniques as well as from the development of endovascular stenting of the aneurysmatic part of the aorta [3][4][5]. In cardiac transplantation, new immunosuppressive drugs such as tacrolimus have become important alternatives to cyclosporine not only as back-up drug but also as primary regimen [6,7]. The widening of the spectrum of operations is mainly due to new technologies that have become available to cardiac surgeons.…”