PMID- 25891697
OWN - NLM
STAT- MEDLINE
DCOM- 20151117
LR  - 20221207
IS  - 1873-2623 (Electronic)
IS  - 0041-1345 (Linking)
VI  - 47
IP  - 3
DP  - 2015 Apr
TI  - A single center, open-label, randomized pilot study to evaluate the safety and 
      efficacy of tacrolimus modified release, Advagraf, versus tacrolimus twice daily, 
      Prograf, in stable renal recipients (single).
PG  - 617-21
LID - S0041-1345(15)00123-2 [pii]
LID - 10.1016/j.transproceed.2014.12.042 [doi]
AB  - BACKGROUND: Compliance with immunosuppressive regimens may affect clinical 
      outcomes in renal transplant recipients. The aim of this study was to assess the 
      safety and efficacy of standard-dose tacrolimus modified-release (TAC-MR) once 
      daily versus tacrolimus (TAC) twice daily in stable renal transplant recipients. 
      METHODS: Ninety-nine stable renal transplant recipients were randomized to 
      receive standard-dose tacrolimus twice daily or standard-dose modified-release 
      tacrolimus once daily on a 1:1 (mg:mg) basis. The primary end point was the 
      incidence of adverse events (AEs) in both groups. Secondary end points included 
      biopsy-proven acute rejection, graft survival, patient survival, clinical 
      indicators, and change in score of questionnaire. RESULTS: The incidence of AEs 
      was not different between the TAC and TAC-MR groups (56.0% vs 53.1%, P > .05). 
      There were no significant differences in mean calculated glomerular filtration 
      rate, blood pressure, glycosylated hemoglobulin (HbA1c), blood concentration of 
      tacrolimus, and drug compliance. The scores of all items in the 36-item short 
      form health survey (SF-36) were not different between groups, except for 
      vitality. With respect to the subject questionnaire, there was no difference in 
      question scores between the two treatment groups. CONCLUSION: A regimen of TAC-MR 
      once daily can be considered as an effective and safe alternative formulation of 
      tacrolimus in stable renal transplant patients.
CI  - Copyright (c) 2015. Published by Elsevier Inc.
FAU - Yang, S-S
AU  - Yang SS
AD  - Department of Surgery, Chungnam National University Hospital, Daejeon, Korea.
FAU - Choi, J-Y
AU  - Choi JY
AD  - Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of 
      Medicine, Seoul, Korea.
FAU - Cho, W-T
AU  - Cho WT
AD  - Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of 
      Medicine, Seoul, Korea.
FAU - Park, J B
AU  - Park JB
AD  - Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of 
      Medicine, Seoul, Korea.
FAU - Kim, S J
AU  - Kim SJ
AD  - Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of 
      Medicine, Seoul, Korea. Electronic address: kmhyj111@skku.edu.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Transplant Proc
JT  - Transplantation proceedings
JID - 0243532
RN  - 0 (Delayed-Action Preparations)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Immunosuppressive Agents)
RN  - 0 (hemoglobin A1c protein, human)
RN  - WM0HAQ4WNM (Tacrolimus)
SB  - IM
MH  - Adult
MH  - Blood Pressure/drug effects
MH  - Delayed-Action Preparations
MH  - Drug Administration Schedule
MH  - Drug-Related Side Effects and Adverse Reactions/epidemiology
MH  - Female
MH  - Glomerular Filtration Rate/drug effects
MH  - Glycated Hemoglobin/drug effects
MH  - Graft Survival/*drug effects
MH  - Humans
MH  - Immunosuppressive Agents/*administration & dosage/adverse effects/blood
MH  - *Kidney Transplantation
MH  - Male
MH  - Middle Aged
MH  - Pilot Projects
MH  - Research Design
MH  - Surveys and Questionnaires
MH  - Tacrolimus/*administration & dosage/adverse effects/blood
EDAT- 2015/04/22 06:00
MHDA- 2015/11/18 06:00
CRDT- 2015/04/21 06:00
PHST- 2014/11/24 00:00 [received]
PHST- 2014/12/31 00:00 [accepted]
PHST- 2015/04/21 06:00 [entrez]
PHST- 2015/04/22 06:00 [pubmed]
PHST- 2015/11/18 06:00 [medline]
AID - S0041-1345(15)00123-2 [pii]
AID - 10.1016/j.transproceed.2014.12.042 [doi]
PST - ppublish
SO  - Transplant Proc. 2015 Apr;47(3):617-21. doi: 10.1016/j.transproceed.2014.12.042.