title: Differences in Peripheral Blood Lymphocytes between Brand-Name and Generic Tacrolimus Used in Stable Liver Transplant Recipients.
abstract: OBJECTIVE
  In this study, peripheral blood lymphocytes were compared between a brand-name and a generic tacrolimus group in stable liver transplant recipients.
  
  
  METHODS
  Sixteen patients who underwent ABO-compatible living donor liver transplants between 2012 and 2013 and had stable graft function were included in this study. Ten patients received brand-name tacrolimus and 6 patients received generic tacrolimus. CD3, CD4, CD8, γδ, CD4+FoxP3+, and CD3-CD56+ T cells were analyzed in peripheral blood obtained preoperatively and 4, 8, 12, and 24 weeks after liver transplantation. Categorical variables were compared using a χ2 test or Fisher exact test, and continuous variables were compared using the Mann-Whitney U test.
  
  
  RESULTS
  Regarding the baseline and perioperative characteristics, there were no statistically significant differences between the 2 groups. Immunosuppression also was not different. Subtype analysis of T-cell populations carried out in parallel showed similar levels of CD3, CD4, CD8, and γδT cells with brand-name tacrolimus and generic tacrolimus in stable liver transplant recipients. However, the levels of CD4+Foxp3+ and CD3-CD56+ T cells were higher in the brand-name tacrolimus group than in the generic tacrolimus group 8 weeks after transplantation (p < 0.05).
  
  
  CONCLUSIONS
  The level of CD4+Foxp3+ T cells was higher in the brand-name tacrolimus group than in the generic tacrolimus group after transplantation. This finding showed that brand-name tacrolimus could have more potential immunosuppressive activity than generic tacrolimus regarding the contribution of CD4+Foxp3+ T cells to graft tolerance in liver transplant recipients.
authors.affiliation: Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
authors.forename: Jong Man
authors.initials: JM
authors.lastname: Kim
authors.forename: Choon Hyuck David
authors.initials: CHD
authors.lastname: Kwon
authors.forename: Jae-Won
authors.initials: JW
authors.lastname: Joh
authors.forename: Dong Hyun
authors.initials: DH
authors.lastname: Sinn
authors.forename: Gyu-Seong
authors.initials: GS
authors.lastname: Choi
authors.forename: Jae Berm
authors.initials: JB
authors.lastname: Park
authors.forename: Eun-Suk
authors.initials: ES
authors.lastname: Kang
authors.forename: Suk-Koo
authors.initials: SK
authors.lastname: Lee
mesh_terms: D000328:Adult; D000368:Aged; D002985:Clinical Protocols; D016568:Drugs, Generic / Q000494:pharmacology* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000276:immunology* / Q000627:therapeutic use; D016031:Liver Transplantation / Q000379:methods*; D019520:Living Donors; D008297:Male; D008875:Middle Aged; D013601:T-Lymphocytes / Q000187:drug effects / Q000276:immunology*; D016559:Tacrolimus / Q000276:immunology* / Q000627:therapeutic use
chemical_list: D016568:Drugs, Generic; D007166:Immunosuppressive Agents; D016559:Tacrolimus
keywords: Liver transplantation; Living donors; Regulatory T cells; Stable graft function; γδT cells