Once-daily tacrolimus extended release formulation: experience at 2 years postconversion from a Prograf-based regimen in stable liver transplant recipients.
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.
Florman
Sander
S
Department of Surgery, Tulane School of Medicine, New Orleans, LA, and Department of Surgery, University of Colorado Hospital, Denver, CO, USA.
Alloway
Rita
R
Kalayoglu
Munci
M
Punch
Jeffrey
J
Bak
Thomas
T
Melancon
Joseph
J
Klintmalm
Goran
G
Busque
Stephan
S
Charlton
Michael
M
Lake
John
J
Dhadda
Shobha
S
Wisemandle
Kathleen
K
Wirth
Mary
M
Fitzsimmons
William
W
Holman
John
J
First
M Roy
MR
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
D003692:Delayed-Action Preparations; D007166:Immunosuppressive Agents; D016559:Tacrolimus