Conversion from twice-daily to once-daily tacrolimus administration in liver transplant patient.
BACKGROUND
Compliance to immunosuppressive therapy is critical to prevent organ rejection and possible graft loss. A once-daily Tacrolimus formulation that may improve adherence-to-therapy while allowing the same patient care strategies, total daily dose and monitoring techniques that have been recently approved. The present study was sought to evaluate the feasibility of this formulation among liver transplantation patients (OLT).


METHODS
Patients transplanted for at least 6 months were enrolled if they had stable doses of Tacrolimus over the last 3 months. Conversion from a twice to a once-daily regimen was based on a 1 mg:1 mg proportion. Tacrolimus blood levels were assessed at 0, 15, 30, 60, 90 days as well and 6 months after conversion. We recorded liver and renal function as well as adverse events.


RESULTS
Among twenty-eight patients enrolled in the study including 23 males and 5 females the overall mean age was 59 +/- 8 years and the mean distance from OLT was 39 +/- 22. 32% of patients did not require any dose adjustment. In contrast, 43% required an increase (+0.6 +/- 0.3 mg/d), while 25%, a decrease (-0.5 +/- 0.0 mg/d) in the drug dose to maintain the same tacrolimus blood concentrations as at baseline. Ninety percent of patients stabilized blood levels within 45 days. None of the patients experienced adverse events or alterations in liver function.


CONCLUSIONS
Our study confirmed that once-daily Tacrolimus is a useful therapeutic option for OLT patients; however dose adjustments are frequently needed in the short term. The drug is safe and may improve patient compliance.
Centro Trapianti Policlinico Umberto I La Sapienza, Roma. manuela.merli@uniroma1.it
M
M
Merli
S
S
Di Menna
M
M
Giusto
V
V
Giannelli
C
C
Lucidi
I
I
Loria
S
S
Ginanni Corradini
G
G
Mennini
M
M
Rossi
D000368:Aged; D000410:Alanine Transaminase / Q000097:blood; D001219:Aspartate Aminotransferases / Q000097:blood; D003404:Creatinine / Q000097:blood; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics / Q000627:therapeutic use; D016031:Liver Transplantation / Q000276:immunology*; D008297:Male; D008875:Middle Aged; D016559:Tacrolimus / Q000008:administration & dosage* / Q000097:blood / Q000493:pharmacokinetics / Q000627:therapeutic use
D007166:Immunosuppressive Agents; D003404:Creatinine; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase; D016559:Tacrolimus