title: Once-daily tacrolimus extended release formulation: experience at 2 years postconversion from a Prograf-based regimen in stable liver transplant recipients.
abstract: Compliance with complex immunosuppressant drug therapies in transplant recipients might be improved with regimens that require less frequent dosing. A once-daily extended release (XL) formulation of tacrolimus has been developed that allows a 1:1 conversion from the twice-a-day tacrolimus (TAC) formulation and has a good exposure to trough concentration correlation. In an open-label, multicenter study, stable liver transplant recipients (n=69) were converted from twice-a-day TAC to XL once-daily in the morning, and were maintained for at least 2 years postconversion using the same therapeutic monitoring and patient care techniques employed with TAC. Two years after conversion, the incidence of biopsy-confirmed acute rejection was 5.8% (4 of 69); patient and graft survival was 98.6% (68 of 69). The safety profile of XL was consistent with that previously reported for TAC. Liver transplant recipients can be converted from twice-a-day TAC to once-daily XL and maintained for at least 2 years postconversion with neither unique efficacy nor safety concerns.
authors.affiliation: Department of Surgery, Tulane School of Medicine, New Orleans, LA, and Department of Surgery, University of Colorado Hospital, Denver, CO, USA.
authors.forename: Sander
authors.initials: S
authors.lastname: Florman
authors.forename: Rita
authors.initials: R
authors.lastname: Alloway
authors.forename: Munci
authors.initials: M
authors.lastname: Kalayoglu
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Punch
authors.forename: Thomas
authors.initials: T
authors.lastname: Bak
authors.forename: Joseph
authors.initials: J
authors.lastname: Melancon
authors.forename: Goran
authors.initials: G
authors.lastname: Klintmalm
authors.forename: Stephan
authors.initials: S
authors.lastname: Busque
authors.forename: Michael
authors.initials: M
authors.lastname: Charlton
authors.forename: John
authors.initials: J
authors.lastname: Lake
authors.forename: Shobha
authors.initials: S
authors.lastname: Dhadda
authors.forename: Kathleen
authors.initials: K
authors.lastname: Wisemandle
authors.forename: Mary
authors.initials: M
authors.lastname: Wirth
authors.forename: William
authors.initials: W
authors.lastname: Fitzsimmons
authors.forename: John
authors.initials: J
authors.lastname: Holman
authors.forename: M Roy
authors.initials: MR
authors.lastname: First
mesh_terms: D000328:Adult; D000368:Aged; D003692:Delayed-Action Preparations; D005260:Female; D005500:Follow-Up Studies; D006084:Graft Rejection / Q000453:epidemiology; D006085:Graft Survival / Q000187:drug effects; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000627:therapeutic use; D016031:Liver Transplantation / Q000276:immunology* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D012449:Safety; D016019:Survival Analysis; D016559:Tacrolimus / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000627:therapeutic use*; D013997:Time Factors
chemical_list: D003692:Delayed-Action Preparations; D007166:Immunosuppressive Agents; D016559:Tacrolimus