title: Everolimus is safe within the first month after liver transplantation.
abstract: OBJECTIVE
  Sirolimus should not be started within the first month after liver transplantation (LT) because of an increased risk of adverse outcomes. The evidence regarding everolimus is lacking but the manufacturer transposed the same warning. We aimed to evaluate the safety of everolimus started within the first month after LT.
  
  
  METHODS
  A consecutive cohort 187 LT patients (2009-2013) with a tacrolimus-based immunosuppression was evaluated. Patients starting everolimus within the first month after LT (n = 33; 17.6%) were compared with those starting everolimus thereafter (n = 25; 13.4%) or not receiving everolimus (n = 129; 69%). The median follow-up after LT was 21 months (IQR 7-36). Prospective outcomes were evaluated by using Kaplan-Meier curves and Cox's regression.
  
  
  RESULTS
  The incidence of hepatic artery thrombosis was not significantly different in patients early treated with everolimus when compared with the remaining cohort (0% vs 9.1%; p = 0.12). Other vascular complications occurred in 9.1% of patients with early everolimus vs 7.3% in the remaining cohort (p = 0.72). No wound healing complications were detected with early everolimus. There were similar rates of incisional hernia (p = 0.31), infections (p = 0.15), renal impairment (p = 0.37), and histologically-proven acute rejection (p = 0.24) between groups. The rates of hyperlipidemia were increased with early everolimus (29.9% vs 16.5% at 3 years; p = 0.018). Graft loss and mortality rates were similar between groups (p = 0.34 and p = 0.94 respectively), after adjusting for possible confounding factors.
  
  
  CONCLUSIONS
  Everolimus combined with reduced tacrolimus proved to be safe within the first month after LT. Future trials may be allowed to implement everolimus early after LT.
authors.affiliation: Department of Hepatology and Liver Transplantation, Reina Sofía University Hospital, IMIBIC. CIBERehd, Córdoba, Spain. Electronic address: ropeml@hotmail.com.
authors.forename: Manuel
authors.initials: M
authors.lastname: Rodríguez-Perálvarez
authors.affiliation: Department of Hepatology and Liver Transplantation, Reina Sofía University Hospital, IMIBIC. CIBERehd, Córdoba, Spain. Electronic address: dra.perezmedrano@gmail.com.
authors.forename: Indhira
authors.initials: I
authors.lastname: Pérez-Medrano
authors.affiliation: Department of Hepatology and Liver Transplantation, Reina Sofía University Hospital, IMIBIC. CIBERehd, Córdoba, Spain. Electronic address: martagmisas1987@hotmail.com.
authors.forename: Marta
authors.initials: M
authors.lastname: Guerrero-Misas
authors.affiliation: Department of Hepatology and Liver Transplantation, Reina Sofía University Hospital, IMIBIC. CIBERehd, Córdoba, Spain. Electronic address: victormanglezcosano@gmail.com.
authors.forename: Víctor
authors.initials: V
authors.lastname: González
authors.affiliation: Department of Hepatology and Liver Transplantation, Reina Sofía University Hospital, IMIBIC. CIBERehd, Córdoba, Spain. Electronic address: poyato.antonio@gmail.com.
authors.forename: Antonio
authors.initials: A
authors.lastname: Poyato
authors.affiliation: Department of Hepatology and Liver Transplantation, Reina Sofía University Hospital, IMIBIC. CIBERehd, Córdoba, Spain. Electronic address: pbarrerabaena@gmail.com.
authors.forename: Pilar
authors.initials: P
authors.lastname: Barrera
authors.affiliation: Department of Hepatology and Liver Transplantation, Reina Sofía University Hospital, IMIBIC. CIBERehd, Córdoba, Spain.
authors.forename: Gustavo
authors.initials: G
authors.lastname: Ferrín
authors.affiliation: Intensive Care Unit, Reina Sofía University Hospital, Córdoba, Spain. Electronic address: juanc.pozo.sspa@juntadeandalucia.es.
authors.forename: Juan C
authors.initials: JC
authors.lastname: Pozo
authors.affiliation: Histology Department, Reina Sofía University Hospital, Córdoba, Spain. Electronic address: marinasanchezfrias@telefonica.net.
authors.forename: Marina
authors.initials: M
authors.lastname: Sánchez-Frías
authors.affiliation: Department of General Surgery and Abdominal Transplantation, Reina Sofía University Hospital, Córdoba, Spain. Electronic address: rubenciria@hotmail.com.
authors.forename: Rubén
authors.initials: R
authors.lastname: Ciria
authors.affiliation: Department of General Surgery and Abdominal Transplantation, Reina Sofía University Hospital, Córdoba, Spain. Electronic address: javibriceno@hotmail.com.
authors.forename: Javier
authors.initials: J
authors.lastname: Briceño
authors.affiliation: Department of Hepatology and Liver Transplantation, Reina Sofía University Hospital, IMIBIC. CIBERehd, Córdoba, Spain. Electronic address: jlm14005623@gmail.com.
authors.forename: José L
authors.initials: JL
authors.lastname: Montero
authors.affiliation: Department of Hepatology and Liver Transplantation, Reina Sofía University Hospital, IMIBIC. CIBERehd, Córdoba, Spain. Electronic address: mdelamatagarcia@gmail.com.
authors.forename: Manuel
authors.initials: M
authors.lastname: De la Mata
mesh_terms: D000368:Aged; D015331:Cohort Studies; D042783:Endothelial Cells / Q000187:drug effects* / Q000502:physiology; D000068338:Everolimus / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006084:Graft Rejection / Q000276:immunology / Q000517:prevention & control*; D006499:Hepatic Artery / Q000473:pathology*; D006801:Humans; D016031:Liver Transplantation; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016019:Survival Analysis; D016559:Tacrolimus / Q000008:administration & dosage* / Q000009:adverse effects; D013927:Thrombosis; D016896:Treatment Outcome
chemical_list: D000068338:Everolimus; D016559:Tacrolimus
keywords: Everolimus; Hepatic artery thrombosis; Immunosuppression; Liver transplantation; Safety; mTOR