title: Conversion to everolimus monotherapy in maintenance liver transplantation: feasibility, safety, and impact on renal function.
abstract: We present the 12-month results of a prospective trial of conversion from calcineurin inhibitors (CNI) to everolimus (EVL) in maintenance liver transplant (LT) recipients. Forty (M:F = 28:12; 54.9 +/- 11 years) patients were enrolled at a mean interval of 45.5 +/- 31.2 months from transplantation. Conversion was with EVL at a dosage of 0.75 mg b.i.d., withdrawal of antimetabolites, and a 50%-per-week reduction of CNI to a complete stop within 4 weeks. The treatment success was conversion to EVL monotherapy at 12 months while failure was presence of CNI, death, and graft loss. Indication to conversion was deteriorating renal function in 36 (90%). At 12 months, patient- and graft survival were 100% and the success rate was 75% (30/40). Ten patients (25%) were failures: four (10%) for acute rejection; three hepatitis C virus-RNA positive patients (7.5%) for hypertransaminasemia; one (2.5%) for acute cholangitis; and two (5%) due to persistent pruritus and oral ulcers. In patients on EVL monotherapy, at 12 months the mean change of calculated creatinine clearance (cCrCl) was 4.03 +/- 12.6 mL/min and the only variable correlated with the probability of improvement was baseline cCrCl (P < 0.0001). Conversion from CNI to EVL is feasible in 75% of the cases and associated with improvement in renal function for patients with higher baseline cCrCl.
authors.affiliation: Unità Operativa Chirurgia Generale e Trapianti di Fegato, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: De Simone
authors.forename: Paola
authors.initials: P
authors.lastname: Carrai
authors.forename: Arianna
authors.initials: A
authors.lastname: Precisi
authors.forename: Stefania
authors.initials: S
authors.lastname: Petruccelli
authors.forename: Lidiana
authors.initials: L
authors.lastname: Baldoni
authors.forename: Emanuele
authors.initials: E
authors.lastname: Balzano
authors.forename: Juri
authors.initials: J
authors.lastname: Ducci
authors.forename: Francesco
authors.initials: F
authors.lastname: Caneschi
authors.forename: Laura
authors.initials: L
authors.lastname: Coletti
authors.forename: Daniela
authors.initials: D
authors.lastname: Campani
authors.forename: Franco
authors.initials: F
authors.lastname: Filipponi
mesh_terms: D000208:Acute Disease; D000328:Adult; D000368:Aged; D000963:Antimetabolites / Q000008:administration & dosage; D000068338:Everolimus; D005260:Female; D005500:Follow-Up Studies; D006084:Graft Rejection / Q000628:therapy*; D006085:Graft Survival / Q000187:drug effects; D006526:Hepatitis C / Q000175:diagnosis; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D007668:Kidney / Q000187:drug effects* / Q000502:physiology; D016031:Liver Transplantation; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D020123:Sirolimus / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*
chemical_list: D000963:Antimetabolites; D007166:Immunosuppressive Agents; D000068338:Everolimus; D020123:Sirolimus