Efficacy
In the full analysis set (FAS), the incidence of liver dysfunction after
the conversion to once-daily extended-release tacrolimus was 17.9% in
the expressor group (n = 5) versus 3.1% (n = 1) in the non-expressor
group (P = 0.088). In the per-protocol (PP) set, the incidence of liver
dysfunction in the expressor group was higher than in the non-expressor
group (12.0% vs. 0%, P = 0.088). The conversion to once-daily
extended-release tacrolimus was not associated with acute rejection,
graft failure, and mortality. The expressor and non-expressor groups did
not differ significantly in terms of serum creatinine levels and liver
parameters, such as AST, ALT, total bilirubin, and alkaline phosphatase
(ALP) during the follow-up (Figure 2).