The use of tacrolimus (FK506) in adult kidney-transplant recipients has bee
n the subject of a number of single- and multi-center studies. This review
article focuses on those studies in which tacrolimus was used either as res
cue therapy in patients who developed refractory rejection on cyclosporine
(CyA)-based regimens or as primary immunosuppression in adult renal-allogra
ft recipients. Twenty-five prospective and retrospective studies conducted
in the US, Japan and Europe, including single- and multi-center experiences
, were identified in the medical literature. Of these studies, most show a
74-98% initial success rate for tacrolimus rescue therapy. Comparative stud
ies reviewed herein demonstrate comparable patient- and graft-survival rate
s between tacrolimus- and CyA-treated patients. Many studies have shown tha
t rejection episodes occur with similar or lower frequency among patients t
reated with tacrolimus than among those given CyA as primary immunosuppress
ion. The major toxicities associated with tacrolimus are nephrotoxicity, ne
urotoxicity and diabetogenicity. Results from several studies have also dem
onstrated an association between these tacrolimus side effects and high who
le-blood trough levels of tacrolimus. In many cases, a reduction in dosage
can reverse these adverse effects. In summary, based on both single- and mu
lti-center data, tacrolimus has been demonstrated to be efficacious when us
ed for either primary immunosuppression or as rescue therapy for refractory
acute rejection in adult renal-allograft recipients.