Safety and Efficacy of Conversion from Twice-Daily Tacrolimus to Once-Daily Tacrolimus One Month after Transplantation: Randomized Controlled Trial in Adult Renal Transplantation

被引：10
作者：
Oh, Chang-Kwon [1 ]
Huh, Kyu Ha [2 ]
Lee, Jong Soo [3 ]
Cho, Hong Rae [4 ]
Kim, Yu Seun [2 ]
机构：
[1] Ajou Univ Sch Med, Dept Surg, Suwon, South Korea
[2] Yonsei Univ Hlth Syst, Severance Hosp, Dept Transplantat Surg, Seoul, South Korea
[3] Univ Ulsan Coll Med, Dept Nephrol, Ulsan, South Korea
[4] Univ Ulsan Coll Med, Dept Surg, Ulsan, South Korea
来源：
YONSEI MEDICAL JOURNAL | 2014年 / 55卷 / 05期
关键词：
Acute rejection; efficacy; extended-release tacrolimus; kidney transplantation; safety; MODIFIED RELEASE TACROLIMUS; PROGRAF-BASED REGIMEN; RECIPIENTS; FORMULATION; FREQUENCY; ADHERENCE; ADVAGRAF;
D O I：
10.3349/ymj.2014.55.5.1341
中图分类号：
R5 [内科学];
学科分类号：
1002 ; 100201 ;
摘要：
Purpose: The purpose of this study was to compare once-daily tacrolimus with twice-daily tacrolimus in terms of safety, efficacy, and patient satisfaction. Materials and Methods: This prospective, randomized, open-label, multicenter study was conducted at three institutes. Patients in the investigational group were converted from tacrolimus twice daily to the same dose of extended-release tacrolimus once daily at 1 month post-transplantation, while patients in file control group were maintained on tacrolimus twice daily. The efficacies, safeties, and patient satisfaction for the two drugs at 6 months post-transplantation were compared. Results: Sixty patients were enrolled and randomized to the investigational group (28 of 29 patients completed the study) or the control group (26 of 31 patients completed the study). At 6 months post-transplantation, composite efficacy failure rates including the incidences of biopsy-confirmed acute rejection in the investigational and control groups were 0% and 10.7%, respectively; patient survival was 100% in each group. No difference in estimated glomerular filtration rate values were observed at 6 months post-transplantation (p=0.97). The safety and satisfaction profile (immunosuppressant therapy barrier scale) of once-daily tacrolimus was comparable with that of twice-daily tacrolimus (p=0.35). Conclusion: Conversion from twice-daily tacrolimus to once-daily tacrolimus one month after transplantation is safe and effective.
引用
收藏
页码：1341 / 1347
页数：7
相关论文
共 19 条
[1]   Conversion of stable kidney transplant recipients from a twice daily Prograf-based regimen to a once daily modified release tacrolimus-based regimen [J].
Alloway, R ;
Steinberg, S ;
Khalil, K ;
Gourishankar, S ;
Miller, J ;
Norman, D ;
Hariharan, S ;
Pirsch, J ;
Matas, A ;
Zaltzman, J ;
Wisemandle, K ;
Fitzsimmons, W ;
First, MR .
TRANSPLANTATION PROCEEDINGS, 2005, 37 (02) :867-870
[2]   Two years postconversion from a Prograf-based regimen to a once-daily tacrolimus extended-release formulation in stable kidney transplant recipients [J].
Alloway, Rita ;
Steinberg, Steven ;
Khalil, Kassem ;
Gourishankar, Sita ;
Miller, Joshua ;
Norman, Douglas ;
Hariharan, Sundaram ;
Pirsch, John ;
Matas, Arthur ;
Zaltzman, Jeffrey ;
Wisemandle, Kathleen ;
Fitzsimmons, William ;
First, M. Roy .
TRANSPLANTATION, 2007, 83 (12) :1648-1651
[3]   Frequency and impact of nonadherence to immunosuppressants after renal transplantation: A systematic review [J].
Butler, JA ;
Roderick, P ;
Mullee, M ;
Mason, JC ;
Peveler, RC .
TRANSPLANTATION, 2004, 77 (05) :769-776
[4]   Development and validation of an immunosuppressant therapy adherence barrier instrument [J].
Chisholm, MA ;
Lance, CE ;
Williamson, GM ;
Mulloy, LL .
NEPHROLOGY DIALYSIS TRANSPLANTATION, 2005, 20 (01) :181-188
[5]   De Novo Kidney Transplant Recipients Need Higher Doses of Advagraf Compared With Prograf to Get Therapeutic Levels [J].
Crespo, M. ;
Mir, M. ;
Marin, M. ;
Hurtado, S. ;
Estadella, C. ;
Guri, X. ;
Rap, O. ;
Moral, R. ;
Puig, J. M. ;
Lloveras, J. .
TRANSPLANTATION PROCEEDINGS, 2009, 41 (06) :2115-2117
[6]   Tacrolimus once-daily formulation - In the prophylaxis of transplant rejection in renal or liver allograft recipients [J].
Cross, Sarah A. ;
Perry, Caroline M. .
DRUGS, 2007, 67 (13) :1931-1943
[7]   Reduced C0 Concentrations and Increased Dose Requirements in Renal Allograft Recipients Converted to the Novel Once-Daily Tacrolimus Formulation [J].
de Jonge, Hylke ;
Kuypers, Dirk R. ;
Verbeke, Kristin ;
Vanrenterghem, Yves .
TRANSPLANTATION, 2010, 90 (05) :523-529
[8]   THE EFFECT OF PRESCRIBED DAILY DOSE FREQUENCY ON PATIENT MEDICATION COMPLIANCE [J].
EISEN, SA ;
MILLER, DK ;
WOODWARD, RS ;
SPITZNAGEL, E ;
PRZYBECK, TR .
ARCHIVES OF INTERNAL MEDICINE, 1990, 150 (09) :1881-1884
[9]   Modified release tacrolimus [J].
First, MR ;
Fitzsimmons, WE .
YONSEI MEDICAL JOURNAL, 2004, 45 (06) :1127-1131
[10]   Efficacy and Safety of Conversion from Twice-daily to Once-daily Tacrolimus in a Large Cohort of Stable Kidney Transplant Recipients [J].
Guirado, L. ;
Cantarell, C. ;
Franco, A. ;
Huertas, E. G. ;
Fructuoso, A. S. ;
Fernandez, A. ;
Gentil, M. A. ;
Rodriguez, A. ;
Paul, J. ;
Torregrossa, J. V. ;
Rodriguez, A. ;
Alonso, A. ;
Hernandez, D. ;
Burgos, D. ;
Jimenez, C. ;
Jimeno, L. ;
Lauzurica, R. ;
Mazuecos, A. ;
Osuna, A. ;
Plumed, J. S. ;
Ruiz, J. C. ;
Zarraga, S. .
AMERICAN JOURNAL OF TRANSPLANTATION, 2011, 11 (09) :1965-1971
12