title: Twelve-month efficacy and safety of the conversion to everolimus in maintenance heart transplant recipients.
abstract: OBJECTIVE
  To determine the clinical reasons for conversion to everolimus (EVL) and long-term outcomes in heart transplant (HT) recipients.
  
  
  METHODS
  A retrospective 12-mo study has been carried out in 14 Spanish centres to assess the efficacy and safety of conversion to EVL in maintenance HT recipients.
  
  
  RESULTS
  Two hundred and twenty-two patients were included (mean age: 53 ± 10.5 years; mean time from HT: 8.1 ± 4.5 years). The most common reasons for conversion were nephrotoxicity (30%), chronic allograft vasculopathy (20%) and neoplasms (17%). The doses and mean levels of EVL at baseline (conversion to EVL) and after one year were 1.3 ± 0.3 and 1.2 ± 0.6 mg/d and 6.4 ± 3.4 and 5.6 ± 2.5 ng/mL, respectively. The percentage of patients receiving calcineurin inhibitors (CNIs) at baseline and on the final visit was 95% and 65%, respectively. The doses and mean levels of CNIs decreased between baseline and month 12 from 142.2 ± 51.6 to 98.0 ± 39.4 mg/d (P < 0.001) and from 126.1 ± 50.9 to 89.2 ± 47.7 ng/mL (P < 0.001), respectively, for cyclosporine, and from 2.9 ± 1.8 to 2.6 ± 1.9 mg/d and from 8.3 ± 4.0 to 6.5 ± 2.7 ng/mL (P = 0.011) for tacrolimus. In the subgroup of patients converted because of nephrotoxicity, creatinine clearance increased from 34.9 ± 10.1 to 40.4 ± 14.4 mL/min (P < 0.001). There were 37 episodes of acute rejection in 24 patients (11%). The most frequent adverse events were oedemas (12%), infections (9%) and gastrointestinal problems (6%). EVL was suspended in 44 patients (20%). Since the database was closed at the end of the study, no further follow-up data is available.
  
  
  CONCLUSIONS
  Conversion to EVL in maintenance HT recipients allowed minimisation or suspension of the CNIs, with improved kidney function in the patients with nephrotoxicity, after 12 mo.
authors.affiliation: Nicolás Manito, Heart Failure and Transplant Unit, Department of Cardiology, Hospital de Bellvitge, 08907 Barcelona, Spain.
authors.forename: Nicolás
authors.initials: N
authors.lastname: Manito
authors.affiliation: Nicolás Manito, Heart Failure and Transplant Unit, Department of Cardiology, Hospital de Bellvitge, 08907 Barcelona, Spain.
authors.forename: Juan F
authors.initials: JF
authors.lastname: Delgado
authors.affiliation: Nicolás Manito, Heart Failure and Transplant Unit, Department of Cardiology, Hospital de Bellvitge, 08907 Barcelona, Spain.
authors.forename: María G
authors.initials: MG
authors.lastname: Crespo-Leiro
authors.affiliation: Nicolás Manito, Heart Failure and Transplant Unit, Department of Cardiology, Hospital de Bellvitge, 08907 Barcelona, Spain.
authors.forename: José María
authors.initials: JM
authors.lastname: Arizón
authors.affiliation: Nicolás Manito, Heart Failure and Transplant Unit, Department of Cardiology, Hospital de Bellvitge, 08907 Barcelona, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Segovia
authors.affiliation: Nicolás Manito, Heart Failure and Transplant Unit, Department of Cardiology, Hospital de Bellvitge, 08907 Barcelona, Spain.
authors.forename: Francisco
authors.initials: F
authors.lastname: González-Vílchez
authors.affiliation: Nicolás Manito, Heart Failure and Transplant Unit, Department of Cardiology, Hospital de Bellvitge, 08907 Barcelona, Spain.
authors.forename: Sònia
authors.initials: S
authors.lastname: Mirabet
authors.affiliation: Nicolás Manito, Heart Failure and Transplant Unit, Department of Cardiology, Hospital de Bellvitge, 08907 Barcelona, Spain.
authors.forename: Ernesto
authors.initials: E
authors.lastname: Lage
authors.affiliation: Nicolás Manito, Heart Failure and Transplant Unit, Department of Cardiology, Hospital de Bellvitge, 08907 Barcelona, Spain.
authors.forename: Domingo
authors.initials: D
authors.lastname: Pascual-Figal
authors.affiliation: Nicolás Manito, Heart Failure and Transplant Unit, Department of Cardiology, Hospital de Bellvitge, 08907 Barcelona, Spain.
authors.forename: Beatriz
authors.initials: B
authors.lastname: Díaz
authors.affiliation: Nicolás Manito, Heart Failure and Transplant Unit, Department of Cardiology, Hospital de Bellvitge, 08907 Barcelona, Spain.
authors.forename: Jesús
authors.initials: J
authors.lastname: Palomo
authors.affiliation: Nicolás Manito, Heart Failure and Transplant Unit, Department of Cardiology, Hospital de Bellvitge, 08907 Barcelona, Spain.
authors.forename: Gregorio
authors.initials: G
authors.lastname: Rábago
authors.affiliation: Nicolás Manito, Heart Failure and Transplant Unit, Department of Cardiology, Hospital de Bellvitge, 08907 Barcelona, Spain.
authors.forename: Marisa
authors.initials: M
authors.lastname: Sanz
authors.affiliation: Nicolás Manito, Heart Failure and Transplant Unit, Department of Cardiology, Hospital de Bellvitge, 08907 Barcelona, Spain.
authors.forename: Teresa
authors.initials: T
authors.lastname: Blasco
authors.affiliation: Nicolás Manito, Heart Failure and Transplant Unit, Department of Cardiology, Hospital de Bellvitge, 08907 Barcelona, Spain.
authors.forename: Eulàlia
authors.initials: E
authors.lastname: Roig
keywords: Everolimus; Heart transplantation; Mammalian target of rapamycin inhibitors; Nephrotoxicity; Renal failure