Determining Equivalence Dose for Oral Versus Sublingual Administration of Tacrolimus in Hepatic Receptors
Status:
Completed
Trial end date:
2016-03-01
Target enrollment:
Participant gender:
Summary
After liver transplantation one of the most important cost, for both patients and their
health insurance system, is immunosuppressive drug therapy. Tacrolimus (FK 506) is considered
the cornerstone of immunosuppressive therapy in solid organ transplantation. Oral
administration is the usual route, however, sublingual (SL) administration has been recently
reported. This method of administration avoids first pass metabolism and allows an
alternative route after transplant surgery, particularly in those patients who should extend
the period of fasting (prolonged intubation, ileus, etc). Interestingly, in some studies, the
dose of tacrolimus SL required to maintain similar plasma concentrations compared with oral
administration, is significantly lower, even up to 50%, which can result in considerable
savings in short and long term. Among these studies, only one was conducted in liver
recipients. This study suggest that SL administration of tacrolimus could allow to obtain
similar concentrations compared with oral administration. The design of this study did not
assess the existence of differences in the dose required and only included six patients.