Date: Monday, June 4, 2018
Session Name: Poster Session C: Liver: Immunosuppression and Rejection
Session Time: 6:00pm-7:00pm
Presentation Time: 6:00pm-7:00pm
Location: Hall 4EF
Introduction: Immunosuppression after OLT has reached a quite high standard with an excellent evidence base. However, there is still a lack of data for the de-novo use of Meltdose tacrolimus (EnvarsusR, extended release) which has not only significant different pharmacodynamics but is also almost exclusively resorbed in the right colon compared to all other tacrolimus formulation that are uptaken in the small bowel.
Methods: In a single center pair-matched study we analysed 114 pts. early after OLT who either received EnvarsusR (n=57), prolonged released Tacrolimus (AdvagrafR, n=29) or immediate released Tacrolimus (n=28) twice daily after induction therapy with ATG (1,5mg/kgBW) together with steroids. Prolonged and immediate released Tac showed no difference in any outcome parameter so the controls were summed up for further analyses to an enteric resorbtion group compared to colonic resorbtion study group. Study endpoints where therapy failure (death, graft loss , rejection), complication rates and Tac trough levels within the targeted range.
Results: As the patients were matched for Age, Sex and underlying disease there was no difference is these parameters. One year patient and graft survival was 94% vs 85% (n.s.)and 89% vs 83% (n.s.) for the study group and the control group respectively. Rejection free survival was 95% vs. 88% at one year (n.s.) Bile duct insufficiency were found in 21% and vascular complications in 5% in both groups. Systemic infection episodes were diagnosed in 26% after OLT again equally in both group. Tacrolimus trough levels and seruem creatinine at 1 week, 1 month, 3 and 6 month as well as 12 month after OLT showed no significant difference at any time. No change of immunosuppression was induced by severe side effects.
Conclusion: Tacrolimus in its extended release formulation is a potent and easy to use immunosuppressant also denovo after OLT that is well tolerated by the patients. The outcome is not different to other tacrolimus formulations. So obviously the colonic resorption of Meltdose tacrolimus (EnvarsusR, extended release) does neither impair the immunosuppressive potential nor does it have negative influence on complication rates. It might even be the tacrolimus formulation of first choice for patients with any kind of intestinal malfunction (small bowel syndrome, bariatric surgery etc.).
CITATION INFORMATION: Soliman T., Györi G., Hofmann M., Salat A., Rockenschaub S., Berlakovich G. De Novo Use of Extended Released Tacrolimus (Meltdose, EnvasusR)) after OLT – Does the Colonic Resorption Influences the Outcome? Am J Transplant. 2017;17 (suppl 3).
To cite this abstract in AMA style:Soliman T, Györi G, Hofmann M, Salat A, Rockenschaub S, Berlakovich G. De Novo Use of Extended Released Tacrolimus (Meltdose, EnvasusR)) after OLT – Does the Colonic Resorption Influences the Outcome? [abstract]. https://atcmeetingabstracts.com/abstract/de-novo-use-of-extended-released-tacrolimus-meltdose-envasusr-after-olt-does-the-colonic-resorption-influences-the-outcome/. Accessed January 25, 2021.
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