title: Efficacy, safety, and immunosuppressant adherence in stable liver transplant patients converted from a twice-daily tacrolimus-based regimen to once-daily tacrolimus extended-release formulation.
abstract: The aim of this study was to determine the efficacy, safety, and immunosuppressant adherence in 125 stable liver transplant (LT) patients converted from twice-daily tacrolimus (TAC BID) to once-daily TAC (TAC OD). Tacrolimus trough levels, laboratory parameters, metabolic disorders, selected patient reported outcomes, and adverse events were assessed. Mean TAC trough level concentration was 6.1 ± 2.3 ng/ml at study entry, decreased to 5.5 ± 2.1 ng/ml (P = 0.016) and 5.5 ± 2.2 ng/ml (P = 0.019) after 1 and 2 weeks, respectively, and tended to equal the baseline value during further follow-up. At week 1, TAC concentrations were lower in 62.4% of patients and higher in 36.0% when compared with baseline. Renal and cardiovascular risk factors remained stable and no rejection episodes occurred over 12 months. Adverse events were consistent with the safety profile known from previous studies with TAC BID. Nonadherence measured by the "Basel Assessment of Adherence Scale to Immunosuppressives" was evident in 66.4% at study entry and decreased to 30.9% postconversion (P < 0.0001). Prevalence of nonadherence at baseline was significantly higher in patients converted >2 years after LT and in those ≤60 years of age. Conversion to TAC OD is safe, enhances immunosuppressant adherence and should be accompanied by a close TAC level monitoring during the initial period.
authors.affiliation: Department of Gastroenterology and Hepatology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany. susanne.beckebaum@uni-due.de
authors.forename: Susanne
authors.initials: S
authors.lastname: Beckebaum
authors.forename: Speranta
authors.initials: S
authors.lastname: Iacob
authors.forename: Dani
authors.initials: D
authors.lastname: Sweid
authors.forename: Georgios C
authors.initials: GC
authors.lastname: Sotiropoulos
authors.forename: Fuat
authors.initials: F
authors.lastname: Saner
authors.forename: Gernot
authors.initials: G
authors.lastname: Kaiser
authors.forename: Arnold
authors.initials: A
authors.lastname: Radtke
authors.forename: Christian G
authors.initials: CG
authors.lastname: Klein
authors.forename: Yesim
authors.initials: Y
authors.lastname: Erim
authors.forename: Sabina
authors.initials: S
authors.lastname: de Geest
authors.forename: Andreas
authors.initials: A
authors.lastname: Paul
authors.forename: Guido
authors.initials: G
authors.lastname: Gerken
authors.forename: Vito R
authors.initials: VR
authors.lastname: Cicinnati
mesh_terms: D000328:Adult; D003692:Delayed-Action Preparations / Q000009:adverse effects; D004334:Drug Administration Schedule; D005260:Female; D006085:Graft Survival; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D016031:Liver Transplantation; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D016559:Tacrolimus / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D003692:Delayed-Action Preparations; D007166:Immunosuppressive Agents; D016559:Tacrolimus