Prograf Concentrations in Liver Transplantation: Correlation With Headache and Other Neurotoxic Complications?

Abstract

Background: Immunosuppressive tacrolimus is widely used in liver transplantation but could be potentially neurotoxic if blood levels increase to more than 15 mg/L. Objectives: The aim of this study was to investigate the drug levels that might be related to the neurotoxic effects of tacrolimus. Patients and Methods: Based on a cross-sectional method, preliminary data was obtained from fifty patients after liver transplantation. To determine the effectiveness or side effects, evidence-based results were obtained using Prograf therapy. Further data was obtained by reviewing the patients’ medical records. Trough levels of tacrolimus were determined by microparticle enzyme immunoassay. Statistical analysis was performed using SPSS. Results: There was no correlation between the dose and the trough level in the population (n = 45) studied (P = 0.270, r = 0.168). In 80% of patients, the tacrolimus dose was 5 mg and trough levels of tacrolimus showed as highly variable. The mean trough level was 13.2 mg/L (range: 0.1 - 41.4 mg/L). In 35% of patients, the level of tacrolimus C0 was more than 15 mg/L, which appeared to indicate a neurotoxic side effect. Conclusions: In the Iranian population of organ transplantation polypharmacy should be based on a rational basis of scheduled therapeutic drug monitoring. To confirm the presence of a correlation between Prograf levels with early or late rejection, nephrotoxicity or neurotoxicity, further studies in a greater number of liver recipients are recommended.