One-year follow-up of treatment with once-daily tacrolimus in de novo renal transplant.
OBJECTIVE
The once-daily prolonged-release formulation of tacrolimus (tacrolimus QD) is expected to demonstrate equivalent efficacy and safety to the twice-daily formulation (tacrolimus BID). We reviewed the 1-year outcomes of tacrolimus QD in de novo renal transplant.


METHODS
We reviewed 50 de novo renal transplant patients assigned in a nonrandomized fashion to either tacrolimus QD (n=23, historic control group) or tacrolimus BID (n=27). Other immunosuppressive drugs used in both groups included mycophenolate mofetil, basiliximab, and steroids. We evaluated trough levels, required dosages, renal function, rejection rates, and episodes of infection within 1 year after transplant.


RESULTS
Trough levels of both drugs varied during the perioperative periods, but subsequently stabilized in both groups. There was a tendency toward a slow elevation and a higher dosage requirement in the tacrolimus QD group, compared with the tacrolimus BID group in the early stages, though the required dosages decreased steadily. The rejection rate in the tacrolimus QD group was low, and only 1 patient experienced subclinical rejection. No severe infectious adverse events were observed.


CONCLUSIONS
Patients taking tacrolimus QD tended to have lower trough levels and require higher dosages than those taking tacrolimus BID during the early posttransplant period, though the differences decreased with increasing time after transplant. Tacrolimus QD can be administered with excellent efficacy and safety in de novo renal transplant recipients.
Department of Surgery and Oncology, Graduate School of Medical Sciences, Fukuoka, Japan. hide@surg1.med.kyushu-u.ac.jp
Hidehisa
H
Kitada
Yasuhiro
Y
Okabe
Takehiro
T
Nishiki
Yoshifumi
Y
Miura
Kei
K
Kurihara
Soushi
S
Terasaka
Sayako
S
Kawanami
Akihiro
A
Tuchimoto
Kohsuke
K
Masutani
Masao
M
Tanaka
D003692:Delayed-Action Preparations; D005500:Follow-Up Studies; D006084:Graft Rejection; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000493:pharmacokinetics; D016030:Kidney Transplantation; D012189:Retrospective Studies; D016559:Tacrolimus / Q000008:administration & dosage* / Q000493:pharmacokinetics; D016896:Treatment Outcome
D003692:Delayed-Action Preparations; D007166:Immunosuppressive Agents; D016559:Tacrolimus