title: Safety and Efficacy of Early Everolimus When Calcineurin Inhibitors Are Not Recommended in Orthotopic Liver Transplantation.
abstract: Our aim was to study the safety and efficacy of immunosuppression with everolimus (EVL) within the 1st month after orthotopic liver transplantation (LT) when calcineurin inhibitors are not recommended. For this purpose, 28 recipients who had been treated with EVL within the 1st month after adult LT were eligible to enter in a retrospective multicenter study. Patients were followed up for 12 months after LT. EVL therapy was initiated at a median of 14 days (range, 4-24) after LT. The reason for early EVL was neurotoxicity in 14 cases, renal dysfunction in 12, and acute cellular rejection combined with renal impairment in 2. In 23 patients, immunosuppression was EVL + mycophenolate mofetil/mycophenolate sodium + steroids, and EVL + tacrolimus + steroids/mycophenolate sodium was used in 4 cases. Neurotoxicity disappeared in all patients. Renal function in patients with renal impairment improved from a median of 32 mL/min/1.73 m2at the moment of implementation of EVL to 62 mL/min/1.73 m2at 1 year. Four patients (14.3%) developed acute cellular rejection. We observed incisional hernia in 4 patients (14.3%), hematologic complications in 6 (21.4%), proteinuria in 2 (7.1%), edema and/or effusions in 8 (28.6%), and dyslipidemia in 12 (42.8%). No arterial complications were observed. EVL was withdrawn in 5 patients during the 1st year after LT. One-year patient survival was 92.7%. In conclusion, use of EVL within the 1st month after LT when calcineurin inhibitors are not recommended seems to be an effective therapeutic option with an acceptable safety profile.
authors.affiliation: Hepatobiliary Surgery and Liver Transplantation Unit, Cruces University Hospital. University of the Basque Country, Bilbao, Spain. Electronic address: mikelgastaca@gmail.com.
authors.forename: M
authors.initials: M
authors.lastname: Gastaca
authors.affiliation: Hepatobiliopancreatic Surgery and Liver Transplant Unit, Hospital Universitario Vall d'Hebron, Barcelona, Spain.
authors.forename: I
authors.initials: I
authors.lastname: Bilbao
authors.affiliation: Unidad de Hepatología-Trasplante Hepático, Hospital Regional Universitario de Malaga, Malaga, Spain.
authors.forename: M
authors.initials: M
authors.lastname: Jimenez
authors.affiliation: Hepatology Unit, Cruces University Hospital, University of the Basque Country, Bilbao, Spain.
authors.forename: J
authors.initials: J
authors.lastname: Bustamante
authors.affiliation: Hepatobiliopancreatic Surgery and Liver Transplant Unit, Hospital Universitario Vall d'Hebron, Barcelona, Spain.
authors.forename: C
authors.initials: C
authors.lastname: Dopazo
authors.affiliation: Unidad de Hepatología-Trasplante Hepático, Hospital Regional Universitario de Malaga, Malaga, Spain.
authors.forename: R
authors.initials: R
authors.lastname: Gonzalez
authors.affiliation: Hepatobiliopancreatic Surgery and Liver Transplant Unit, Hospital Universitario Vall d'Hebron, Barcelona, Spain.
authors.forename: R
authors.initials: R
authors.lastname: Charco
authors.affiliation: Unidad de Cirugía Hepatobiliar-Trasplante Hepático, Hospital Regional Universitario de Malaga, Malaga, Spain.
authors.forename: J
authors.initials: J
authors.lastname: Santoyo
authors.affiliation: Hepatobiliary Surgery and Liver Transplantation Unit, Cruces University Hospital. University of the Basque Country, Bilbao, Spain.
authors.forename: J
authors.initials: J
authors.lastname: Ortiz de Urbina
mesh_terms: D000328:Adult; D000368:Aged; D065095:Calcineurin Inhibitors / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D000068338:Everolimus / Q000627:therapeutic use*; D005260:Female; D006084:Graft Rejection / Q000517:prevention & control; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D016031:Liver Transplantation; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies
chemical_list: D065095:Calcineurin Inhibitors; D007166:Immunosuppressive Agents; D000068338:Everolimus