title: Results of a phase 4 trial of Tacrobell® in liver transplantation patients: a multicenter study in South Korea.
abstract: OBJECTIVE
  This 26-week pilot study was performed in de novo liver transplant recipients to evaluate the efficacy of tacrobell capsule as an immunosuppressant drug after living donor liver transplant patients by determining the rate of acute cellular rejection after its use and evaluating its safety after transplantation.
  
  
  METHODS
  From October 2005 to July 2007, 57 patients from four major medical centers in Seoul, South Korea were enrolled in the study. This open-label, noncomparative, multicenter pilot study lasted 26 weeks and assigned patients to receive tacrobell and corticosteroid after liver transplantation. Tacrobell (0.05mg/ kg/day, bid) and methylprednisolone were injected either on the day of the operation or on postoperative day one. A retrospective matched control group consisting of living donor liver transplant recipients at one center (Asan medical center) was used for comparison.
  
  
  RESULTS
  The rate of acute cellular rejection with Tacrobell after 26 weeks of administration was 0.0% (95% CI, 0.0%-6.27%), which was below our hypothesized 36%. The most common drug-related adverse events included endocrine/nutritional disorders followed by gastrointestinal and hepatobiliary disorders. No patients died during the study period. The side effect profile of this drug was no different than other tacrolimus based immunosuppressants.
  
  
  CONCLUSIONS
  Although our study was based on a low risk population and had a shortterm follow up, we conclude that tacrobell, as a generic tacrolimus, can be considered safe and effective in liver transplant patients.
authors.affiliation: Department of Surgery, Asian Medical Center, Seoul, Korea.
authors.forename: Young-Dong
authors.initials: YD
authors.lastname: Yu
authors.forename: Sung-Gyu
authors.initials: SG
authors.lastname: Lee
authors.forename: Jae-Won
authors.initials: JW
authors.lastname: Joh
authors.forename: Choon-Hyuck
authors.initials: CH
authors.lastname: Kwon
authors.forename: Dong-Gu
authors.initials: DG
authors.lastname: Kim
authors.forename: Kyung-Suk
authors.initials: KS
authors.lastname: Suh
authors.forename: Nam-Jun
authors.initials: NJ
authors.lastname: Lee
authors.forename: Shin
authors.initials: S
authors.lastname: Hwang
authors.forename: Chul-Soo
authors.initials: CS
authors.lastname: Ahn
authors.forename: Ki-Hun
authors.initials: KH
authors.lastname: Kim
authors.forename: Deok-Bog
authors.initials: DB
authors.lastname: Moon
authors.forename: Tae-Yong
authors.initials: TY
authors.lastname: Ha
authors.forename: Gi-Won
authors.initials: GW
authors.lastname: Song
authors.forename: Dong-Hwan
authors.initials: DH
authors.lastname: Jung
mesh_terms: D000284:Administration, Oral; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D000328:Adult; D002214:Capsules; D016009:Chi-Square Distribution; D004359:Drug Therapy, Combination; D005260:Female; D006084:Graft Rejection / Q000175:diagnosis / Q000276:immunology / Q000517:prevention & control*; D006085:Graft Survival / Q000187:drug effects*; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008111:Liver Function Tests; D016031:Liver Transplantation / Q000009:adverse effects / Q000276:immunology; D019520:Living Donors; D008297:Male; D008775:Methylprednisolone / Q000627:therapeutic use; D008875:Middle Aged; D010865:Pilot Projects; D056910:Republic of Korea; D016559:Tacrolimus / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000305:Adrenal Cortex Hormones; D002214:Capsules; D007166:Immunosuppressive Agents; D016559:Tacrolimus; D008775:Methylprednisolone