Evaluation of clinical safety of conversion to Advagraf therapy in liver transplant recipients: observational study.
OBJECTIVE
To present the correlation between dosage and plasma concentration of tacrolimus and the consequences for short-term hepatorenal function of conversion to Advagraf (tacrolimus extended-release capsules) in liver transplant recipients.


METHODS
This observational study on adult liver transplant recipients examined tacrolimus levels after conversion to Advagraf therapy. Mean (SD) patient age was 51 (44-59) years. Conversion occurred at 43 (19-85) months posttransplantation, and follow-up was 193 (106.5-243.25) days. Dosage was adjusted milligram for milligram. Levels of tacrolimus, total bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transferase, alkaline phosphatase, and creatinine were recorded on the day before conversion to Advagraf and 1, 3, 6, and months afterward.


RESULTS
Of the 79 patients in whom therapy was converted to Advagraf, 31 (39.2%) had alcoholic cirrhosis, 19 (24.1%) had viral disease, 10 (12.7) had mixed disease, 8 (10.1%) had cholestatic disease, 4 (5.1%) had metabolic disease, and 7 (8.8%) had other diseases. Despite no modification of Advagraf dosage during follow-up in most patients, mean tacrolimus levels decreased from the first month after conversion; however, at 6 months after conversion, they tended to equal the initial value. Renal function and liver biochemistry values demonstrated no significant change during follow-up.


CONCLUSIONS
Although tacrolimus levels decreased initially after conversion to Advagraf therapy, 1:1 conversion is safe for hepatorenal function in liver transplant recipients.
Marin-Gomez
L M
LM
Liver Transplantation Unit, Digestive Surgery Department, Virgen del Rocio University Hospital, Seville, Spain. marinlm@hotmail.com
Gomez-Bravo
M A
MA
Alamo-Martinez
J A
JA
Barrera-Pulido
L
L
Bernal Bellido
C
C
Suárez Artacho
G
G
Pascasio
J M
JM
D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000469:Alkaline Phosphatase / Q000097:blood; D001219:Aspartate Aminotransferases / Q000097:blood; D001663:Bilirubin / Q000097:blood; D004305:Dose-Response Relationship, Drug; D005500:Follow-Up Studies; D006801:Humans; D008104:Liver Cirrhosis, Alcoholic / Q000453:epidemiology; D008111:Liver Function Tests; D016031:Liver Transplantation / Q000276:immunology* / Q000502:physiology; D008875:Middle Aged; D016559:Tacrolimus / Q000008:administration & dosage / Q000097:blood / Q000627:therapeutic use*; D013997:Time Factors; D014777:Virus Diseases / Q000453:epidemiology
D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase; D000469:Alkaline Phosphatase; D001663:Bilirubin; D016559:Tacrolimus