title: Favorable longterm outcomes of liver transplant recipients treated de novo with once-daily tacrolimus: Results of a single-center cohort.
abstract: The once-daily prolonged-release formulation of tacrolimus has been recently related with significant graft and patient mid-term survival advantages; however, practical information on the de novo administration after liver transplantation and longterm outcomes is currently lacking. This study is a 5-year retrospective analysis of a single-center cohort of liver transplant recipients treated de novo with once-daily tacrolimus (April 2008/August 2011). The study cohort consisted of 160 patients, including 23 with pretransplant renal dysfunction, with a median follow-up of 57.6 months (interquartile range, 46.6-69.0). Tacrolimus target trough levels were 5-10 ng/mL during the first 3 months after transplant, reducing progressively to <7 ng/mL after the first posttransplant year. Once-daily tacrolimus was withdrawn in 35 (21.8%) patients during follow-up, mostly due to renal dysfunction and/or metabolic syndrome. The biopsy-proven acute rejection rate was 12.5% with no cases of steroid-resistant rejection. The cumulative incidence of de novo diabetes, hypertension, and dyslipidemia were 16.9%, 31.2%, and 6.5%, respectively. Hepatocellular carcinoma recurrence rate was 2.8%. Renal function remained stable after the sixth month after transplant with a mean estimated glomerular filtration rate of 77.7 ± 19.6 mL/minute/1.73 m(2) at 5 years. None of our patients developed chronic kidney disease stage 4 or 5. Patient survival at 1, 3, and 5 years was 96.3%, 91.9%, and 88.3%, respectively. Overall survival of patients with Model for End-Stage Liver Disease (MELD) score > 25 points was not significantly different. In conclusion, our study suggests that immunosuppression based on de novo once-daily tacrolimus is feasible in routine clinical practice, showing favorable outcomes and outstanding longterm survival even in patients with high MELD scores. Liver Transplantation 22 1391-1400 2016 AASLD.
authors.affiliation: Hepatobiliary Surgery and Liver Transplantation Unit, Cruces University Hospital, Bilbao, Spain. mikelgastaca@gmail.com.|University of the Basque Country, Leioa, Spain. mikelgastaca@gmail.com.
authors.forename: Mikel
authors.initials: M
authors.lastname: Gastaca
authors.affiliation: Hepatobiliary Surgery and Liver Transplantation Unit, Cruces University Hospital, Bilbao, Spain.|University of the Basque Country, Leioa, Spain.
authors.forename: Andrés
authors.initials: A
authors.lastname: Valdivieso
authors.affiliation: Liver Diseases Unit, Cruces University Hospital, Bilbao, Spain.|University of the Basque Country, Leioa, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Bustamante
authors.affiliation: Liver Diseases Unit, Cruces University Hospital, Bilbao, Spain.
authors.forename: José R
authors.initials: JR
authors.lastname: Fernández
authors.affiliation: Hepatobiliary Surgery and Liver Transplantation Unit, Cruces University Hospital, Bilbao, Spain.
authors.forename: Patricia
authors.initials: P
authors.lastname: Ruiz
authors.affiliation: Hepatobiliary Surgery and Liver Transplantation Unit, Cruces University Hospital, Bilbao, Spain.
authors.forename: Alberto
authors.initials: A
authors.lastname: Ventoso
authors.affiliation: Liver Diseases Unit, Cruces University Hospital, Bilbao, Spain.
authors.forename: Milagros
authors.initials: M
authors.lastname: Testillano
authors.affiliation: Hepatobiliary Surgery and Liver Transplantation Unit, Cruces University Hospital, Bilbao, Spain.
authors.forename: Ibone
authors.initials: I
authors.lastname: Palomares
authors.affiliation: Liver Diseases Unit, Cruces University Hospital, Bilbao, Spain.
authors.forename: Patricia
authors.initials: P
authors.lastname: Salvador
authors.affiliation: Hepatobiliary Surgery and Liver Transplantation Unit, Cruces University Hospital, Bilbao, Spain.
authors.forename: Mikel
authors.initials: M
authors.lastname: Prieto
authors.affiliation: Infectious Diseases Unit, Cruces University Hospital, Bilbao, Spain.|University of the Basque Country, Leioa, Spain.
authors.forename: Miguel
authors.initials: M
authors.lastname: Montejo
authors.affiliation: Liver Diseases Unit, Cruces University Hospital, Bilbao, Spain.
authors.forename: María J
authors.initials: MJ
authors.lastname: Suárez
authors.affiliation: Hepatobiliary Surgery and Liver Transplantation Unit, Cruces University Hospital, Bilbao, Spain.
authors.forename: Jorge Ortiz
authors.initials: JO
authors.lastname: de Urbina
mesh_terms: D000328:Adult; D000368:Aged; D001706:Biopsy; D006528:Carcinoma, Hepatocellular / Q000601:surgery; D004334:Drug Administration Schedule; D058625:End Stage Liver Disease / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D006084:Graft Rejection; D006801:Humans; D007166:Immunosuppressive Agents / Q000276:immunology; D053208:Kaplan-Meier Estimate; D008113:Liver Neoplasms / Q000601:surgery; D016031:Liver Transplantation; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012189:Retrospective Studies; D016559:Tacrolimus / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D016559:Tacrolimus