title: Impact of the conversion of the immunosuppressive regimen from prograf to advagraf or to sirolimus in long-term stable liver transplant recipients: indications, safety, and outcome.
abstract: BACKGROUND
  Compliance problems have arisen due to the twice a day administration of calcineurin inhibitors (CNI). We examined the safety, indications, and efficacy in terms of graft and patient survivals after conversion from tacrolimus to sirolimus or advagraf.
  
  
  METHODS
  Between January 2006 and December 2009, 36 orthotopic liver transplantation patients underwent conversion of the immunosuppressive regimen from prograf to either sirolimus (group 1; n=10) or advagraf (group 2; n=26). A group of patients taking prograf was used as a control group (group 3; n=15). We identified 51 patients of mean age 57 years and male:female percentages of 57%:43% from a prospective database. Renal and liver graft functions, patient survival, as well as laboratory and clinical data over at least 12 months (mean, 38) were the investigated parameters.
  
  
  RESULTS
  Patients converted to sirolimus did not show significantly improved renal function at 12 months as evidenced by creatinine levels (1.31 mg/dL+/-0.47 vs 1.34 mg/dL+/-0.78) and glomerular filtration rate (GFR, 57+/-16 vs 56+/-16 mL/min). However, there were significant antiproliferative effects. Patients with a hepatocellular carcinoma in the pretransplantation phase remained without a recurrence. The side effects including ankle edema, aphthae, and tachyarrhythmia absoluta, required reconversion to the CNI. Patients prescribed advagraf reported a better life quality because of the single administration and a slight, insignificant improvement in renal function. An acute rejection episode was evidenced under either immunosuppresant.
  
  
  CONCLUSIONS
  Sirolimus is a safe immunosuppressive option in liver transplant recipients suffering from hepatocellular carcinoma. Advagraf showed a lower incidence of side effects than prograf and probably is not as harmful for renal function, offering better compliance and better life quality.
authors.affiliation: Department of Surgery, University of Erlangen-Nuremberg, Erlangen, Germany. aristotelis.perrakis@uk-erlangen.de
authors.forename: A
authors.initials: A
authors.lastname: Perrakis
authors.forename: K
authors.initials: K
authors.lastname: Schwarz
authors.forename: S
authors.initials: S
authors.lastname: Yedibela
authors.forename: R S
authors.initials: RS
authors.lastname: Croner
authors.forename: W
authors.initials: W
authors.lastname: Hohenberger
authors.forename: V
authors.initials: V
authors.lastname: Müller
mesh_terms: D000328:Adult; D000368:Aged; D015415:Biomarkers / Q000097:blood; D003404:Creatinine / Q000097:blood; D004334:Drug Administration Schedule; D057915:Drug Substitution; D005260:Female; D005858:Germany; D005919:Glomerular Filtration Rate / Q000187:drug effects; D006084:Graft Rejection / Q000276:immunology / Q000517:prevention & control*; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D007668:Kidney / Q000187:drug effects / Q000503:physiopathology; D016031:Liver Transplantation / Q000009:adverse effects / Q000276:immunology; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011788:Quality of Life; D020123:Sirolimus / Q000008:administration & dosage* / Q000009:adverse effects; D016559:Tacrolimus / Q000008:administration & dosage* / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D015415:Biomarkers; D007166:Immunosuppressive Agents; D003404:Creatinine; D020123:Sirolimus; D016559:Tacrolimus