Once-daily prolonged-release tacrolimus in de novo liver transplantation: a single center cohort study.

BACKGROUND/AIMS: The feasibility of oral administration of once-daily prolonged-release tacrolimus (TAC-PR) in de novo liver transplantation is not clear and therefore was investigated further.

METHODOLOGY

The clinical profiles of 16 consecutive primary living donor liver transplantation (LDLT) recipients, who received oral TAC-PR once daily (TAC-PR group) between January 2009 and August 2010, were compared with those of 14 consecutive liver transplantation recipients given twice-daily tacrolimus (TAC; TAC group) between August 2006 and January 2009. Of the 14 patients in the TAC group, 9 received LDLT (TAC-L subgroup).

RESULTS

Patient characteristics were similar between groups. Trough levels of TAC during the first 3 months after liver transplantation were well-adjusted in both groups. Dose adjustment was more frequently required (31.3%) in the TAC-PR group and the total amount of TAC was significantly higher in the TAC-PR group (181.1±75.3mg) than in the TAC-L group (100.2±53.8mg, p=0.014). The incidence of biopsy-proven acute cellular rejection, renal dysfunction, other morbidities and hospital stay length were similar between groups.

CONCLUSIONS

Oral administration of TAC-PR for de novo liver transplantation recipients was well tolerated with similar safety and efficacy profiles as traditional twice-daily TAC with closely controlled adjustment of the TAC-PR dose.