Evaluation of clinical safety of conversion to Advagraf therapy in liver transplant recipients: observational study

Transplant Proc. 2009 Jul-Aug;41(6):2184-6. doi: 10.1016/j.transproceed.2009.06.085.

Abstract

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.

Patients and 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.

Conclusion: Although tacrolimus levels decreased initially after conversion to Advagraf therapy, 1:1 conversion is safe for hepatorenal function in liver transplant recipients.

MeSH terms

  • Adult
  • Alanine Transaminase / blood
  • Alkaline Phosphatase / blood
  • Aspartate Aminotransferases / blood
  • Bilirubin / blood
  • Dose-Response Relationship, Drug
  • Follow-Up Studies
  • Humans
  • Liver Cirrhosis, Alcoholic / epidemiology
  • Liver Function Tests
  • Liver Transplantation / immunology*
  • Liver Transplantation / physiology
  • Middle Aged
  • Tacrolimus / administration & dosage
  • Tacrolimus / blood
  • Tacrolimus / therapeutic use*
  • Time Factors
  • Virus Diseases / epidemiology

Substances

  • Aspartate Aminotransferases
  • Alanine Transaminase
  • Alkaline Phosphatase
  • Bilirubin
  • Tacrolimus