title: Once-daily prolonged-release tacrolimus in de novo liver transplantation: a single center cohort study.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
authors.affiliation: Department of Surgery, Osaka University, Osaka, Japan. smarubashi@gesurg.med.osaka-u.ac.jp
authors.forename: Shigeru
authors.initials: S
authors.lastname: Marubashi
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Wada
authors.forename: Shogo
authors.initials: S
authors.lastname: Kobayashi
authors.forename: Hidetoshi
authors.initials: H
authors.lastname: Eguchi
authors.forename: Masahiro
authors.initials: M
authors.lastname: Tanemura
authors.forename: Koji
authors.initials: K
authors.lastname: Umeshita
authors.forename: Yuichiro
authors.initials: Y
authors.lastname: Doki
authors.forename: Masaki
authors.initials: M
authors.lastname: Mori
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Nagano
mesh_terms: D000328:Adult; D000368:Aged; D015331:Cohort Studies; D003692:Delayed-Action Preparations; D004334:Drug Administration Schedule; D005260:Female; D006084:Graft Rejection / Q000453:epidemiology; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D016031:Liver Transplantation; D019520:Living Donors; D008297:Male; D008875:Middle Aged; D016559:Tacrolimus / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics
chemical_list: D003692:Delayed-Action Preparations; D007166:Immunosuppressive Agents; D016559:Tacrolimus