title: Efficacy and safety of conversion from twice-daily to once-daily tacrolimus in a large cohort of stable kidney transplant recipients.
abstract: Prolonged-release tacrolimus was developed to provide a more convenient once-daily dosing that could improve patient adherence. We conducted a multicenter, prospective, observational, 12-month study to describe the efficacy, safety and patient preference of conversion from tacrolimus twice-daily to once-daily formulation in stable kidney transplant recipients in routine clinical practice. Conversion was made on a 1 mg: 1 mg basis (1 mg: 1.1 mg in patients with trough levels <6 ng/mL). The study included 1832 patients (mean age (± SD): 50.0 ± 13.4 years; 62.7% male). After conversion, a modest reduction in tacrolimus trough levels, necessitating an increase in daily dose, was observed (mean changes at 12 months of -9.1% and +1.24%, respectively; p < 0.0001). Mean glomerular filtration rate did not change significantly (56.5 ± 19.7 mL/min at conversion vs. 55.7 ± 20.6 mL/min at 12 months). Proteinuria, blood pressure, lipid, hepatic and glucose parameters remained stable. Eight patients (0.4%) had acute rejection and 34 patients (1.85%) discontinued treatment. Almost all patients (99.4%) preferred the once-daily formulation, because of less frequent dosing (66%) and improved adherence (34%). In conclusion, at similar doses to twice-daily tacrolimus, once-daily formulation provided stable renal function, a low acute rejection rate, and good tolerability in stable kidney transplant recipients in the routine clinical practice setting.
authors.affiliation: Renal Transplant Unit, Fundació Puigvert, Barcelona, Spain. lguirado@fundacio-puigvert.es
authors.forename: L
authors.initials: L
authors.lastname: Guirado
authors.forename: C
authors.initials: C
authors.lastname: Cantarell
authors.forename: A
authors.initials: A
authors.lastname: Franco
authors.forename: E G
authors.initials: EG
authors.lastname: Huertas
authors.forename: A S
authors.initials: AS
authors.lastname: Fructuoso
authors.forename: A
authors.initials: A
authors.lastname: Fernández
authors.forename: M A
authors.initials: MA
authors.lastname: Gentil
authors.forename: A
authors.initials: A
authors.lastname: Rodríguez
authors.forename: J
authors.initials: J
authors.lastname: Paul
authors.forename: J V
authors.initials: JV
authors.lastname: Torregrossa
authors.forename: A
authors.initials: A
authors.lastname: Rodríguez
authors.forename: A
authors.initials: A
authors.lastname: Alonso
authors.forename: D
authors.initials: D
authors.lastname: Hernández
authors.forename: D
authors.initials: D
authors.lastname: Burgos
authors.forename: C
authors.initials: C
authors.lastname: Jiménez
authors.forename: L
authors.initials: L
authors.lastname: Jimeno
authors.forename: R
authors.initials: R
authors.lastname: Lauzurica
authors.forename: A
authors.initials: A
authors.lastname: Mazuecos
authors.forename: A
authors.initials: A
authors.lastname: Osuna
authors.forename: J S
authors.initials: JS
authors.lastname: Plumed
authors.forename: J C
authors.initials: JC
authors.lastname: Ruiz
authors.forename: S
authors.initials: S
authors.lastname: Zárraga
mesh_terms: D000328:Adult; D015331:Cohort Studies; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D016559:Tacrolimus / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D007166:Immunosuppressive Agents; D016559:Tacrolimus