At a glance
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Determining Equivalence Dose for Oral Versus Sublingual Administration of Tacrolimus in Hepatic Receptors
In Brief
A clinical study evaluating Tacrolimus for Evidence of Liver Transplantation and Effects of Immunosuppressant Therapy. Completed, enrolled 20 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
compared oral administration versus sublingual administration of tacrolimus.