Efﬁcacy and safety of steroid – free immunosuppression with tacrolimus and daclizumab in liver transplant recipients. Six years follow-up in a single centre
B Foroncewicz, K Mucha, E Ryszkowska, J Ziółkowski, M Krawczyk, L Pączek
Ann Transplant 2009; 14(1): 76-76
Background: Corticosteroid-free maintenance immunosuppression eliminates the well-known corticosteroid-related side effects and may help to improve long-term outcome.
Material/Methods: We investigated whether a corticosteroid-free tacrolimus
(Tac) in combination with daclizumab (Dac) induction therapy, provides an
adequate immunosuppression after liver transplantation (OLTx). This 6-years,
single centre, retrospective study involved 25 liver transplant recipients randomized to a Tac/Dac regimen (n=7) or a Tac/corticosteroids (Tac/CS)
regimen (n=18), according to the protocol of the MASTER study. Patient's and graft's survival, incidence of acute rejection and diabetes mellitus, liver and kidney function as well as BMI were compared between the groups. In order to quantify the therapy-related adverse events the total length of hospitalization was analysed.
Results: Demographic data including age, gender and ischemic time were similar in both groups. No signifi cant difference was found in patient and graft
survival in both treatment arms (71.5% in Tac/Dac and 94.5% in Tac/CS, p=NS). The incidence of biopsy-proven acute rejection was 16% in Tac/CS and 14% in Tac/Dac group (P=NS). Renal and liver function was also similar in both groups. However, compared with the Tac/CS regimen, a significantly reduced incidence of new-onset diabetes mellitus (DM) (14% vs. 22%, p<0.05) was found with steroid-free immunosuppression. Also the blood pressure (BP) and BMI were significantly lower in Tac/Dac patients (p<0.05). Total time of hospitalization did not differ significantly between the groups (46.1 days/person in Tac/CS vs. 55.1 in Tac/Dac, p=NS)
Conclusions: Corticosteroid-free immunosuppression with a Tac/Dac regimen
is as effective at yielding good patient and graft survival as a standard double
regimen of Tac/CS. The lower incidence of DM and better BP and BMI control in Tac/Dac group may indicate higher safety of Tac/Dac treatment.
Keywords: Immunosuppression, Liver Transplantation, clinical outcome