Safety and Efficacy of Conversion from Twice-Daily Tacrolimus (Prograf) to Once-Daily Prolonged-Release Tacrolimus (Graceptor) in Stable Kidney Transplant Recipients

被引：12

作者：

Nakamura, Y. ^{[1
]}

Hama, K. ^{[1
]}

Katayama, H. ^{[3
]}

Soga, A. ^{[3
]}

Toraishi, T. ^{[2
]}

Yokoyama, T. ^{[1
]}

Kihara, Y. ^{[1
]}

Jojima, Y. ^{[1
]}

Konno, O. ^{[1
]}

Iwamoto, H. ^{[1
]}

Takeuchi, H. ^{[3
]}

Hirano, T. ^{[3
]}

Shimazu, M. ^{[1
]}

机构：

[1] Tokyo Med Univ, Hachioji Med Ctr, Div Organ Transplantat, Dept Surg, Tokyo, Japan

[2] Tokyo Med Univ, Hachioji Med Ctr, Dept Pharmaceut, Tokyo, Japan

[3] Tokyo Univ Pharm & Life Sci, Dept Pract Pharm, Tokyo, Japan

来源：

TRANSPLANTATION PROCEEDINGS | 2012年 / 44卷 / 01期

关键词：

ADVAGRAF;

D O I：

10.1016/j.transproceed.2011.11.051

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

Background. Graceptor is a new modified-release once-daily formulation of tacrolimus with an efficacy and safety profile similar to twice-daily tacrolimus (Prograf), as identified by clinical trials, offering a more convenient dosing regimen to improve adherence. The aim of this study was to analyze the safety of a 1:1 dose conversion from twice-daily Prograf to once-daily Graceptor in stable kidney transplant recipients. Methods. We switched 33 Japanese patients who had undergone kidney transplantation >= 1 years before from twice-daily Prograf to once-daily Graceptor. The dose conversion ratio between Prograf and Graceptor was 1:1. We compared the following parameters: minimum tacrolimus concentration (C-min); concentration dose per weight (CDW); serum creatinine (sCr); blood urea nitrogen (BUN); total cholesterol (TC); high-density lipoprotein cholesterol (HDL-C); uric acid (UA); fasting blood sugar (FBS). Time points for measurements were 1 month before study start and 1 and 2 months afterward. Results. The mean age of the subjects in this study was 46.5 +/- 13.1 years. Mean C-min decreased from 4.55 +/- 1.79 to 3.20 +/- 1.22 ng/dL. The mean CDW also decreased, from 99.8 +/- 69.5 to 75.0 +/- 55.1 mg/dL/kg over the 2 months. There were no significant changes in sCR, BUN, UA, and FBS. Mean TC increased from 187.5 +/- 51.4 to 194.3 +/- 43.4 mg/dL, and mean HDL-C changed from 53.7 +/- 12.0 to 56.1 +/- 11 mg/dL. There were no episodes of rejection or infection. Conclusions. We conclude that switching from Prograf to Graceptor is safe and has the advantage of improving adherence. It could also have a beneficial effect in controlling glycemic levels and the adverse effects of tacrolimus. In many cases (25%-30%), the minimum concentration of tacrolimus decreased after changing tablets. With Graceptor, the ratio of area under trough level to area under the curve (AUC) is low compared with Prograf, resulting in low C-min values of 1-2 ng/mL, and the AUC for Graceptor is very similar to that for Prograf.

引用

页码：124 / 127

页数：4

共 9 条

[1]

Benkali K, 2010, CLIN PHARMACOKINET, V683

[2] 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

[3] Conversion From Prograf to Advagraf Among Kidney Transplant Recipients Results in Sustained Decrease in Tacrolimus Exposure [J].

Hougardy, Jean-Michel ;

Broeders, Nilufer ;

Kianda, Mireille ;

Massart, Annick ;

Madhoun, Phillippe ;

Le Moine, Alain ;

Hoang, Anh-Dung ;

Mikhalski, Dimitri ;

Wissing, Karl M. ;

Abramowicz, Daniel .

TRANSPLANTATION, 2011, 91 (05) :566-569

[4] Switch from Twice-Daily Tacrolimus (Prograf) to Once-Daily Prolonged-Release Tacrolimus (Advagraf) in Kidney Transplantation [J].

Iaria, G. ;

Sforza, D. ;

Angelico, R. ;

Toti, L. ;

de Luca, L. ;

Manuelli, M. ;

Bellini, I. ;

Manzia, T. M. ;

Anselmo, A. ;

Tisone, G. .

TRANSPLANTATION PROCEEDINGS, 2011, 43 (04) :1028-1029

[5] Therapeutic Drug Monitoring in De Novo Kidney Transplant Receiving the Modified-Release Once-Daily Tacrolimus [J].

Jelassi, M. L. ;

Lefeuvre, S. ;

Karras, A. ;

Moulonguet, L. ;

Billaud, E. M. .

TRANSPLANTATION PROCEEDINGS, 2011, 43 (02) :491-494

[6] Tacrolimus Once Daily (ADVAGRAF) Versus Twice Daily (PROGRAF) in De Novo Renal Transplantation: A Randomized Phase III Study [J].

Kraemer, B. K. ;

Charpentier, B. ;

Backman, L. ;

Silva, H. Tedesco, Jr. ;

Mondragon-Ramirez, G. ;

Cassuto-Viguier, E. ;

Mourad, G. ;

Sola, R. ;

Rigotti, P. ;

Ortuno Mirete, J. .

AMERICAN JOURNAL OF TRANSPLANTATION, 2010, 10 (12) :2632-2643

[7] Once Daily Tacrolimus Formulation: Monitoring of Plasma Levels, Graft Function, and Cardiovascular Risk Factors [J].

Mecule, A. ;

Poli, L. ;

Nofroni, I. ;

Bachetoni, A. ;

Tinti, F. ;

Umbro, I. ;

Barile, M. ;

Berloco, P. B. ;

Mitterhofer, A. P. .

TRANSPLANTATION PROCEEDINGS, 2010, 42 (04) :1317-1319

[8] Improvement of Graft Function after Conversion to Once Daily Tacrolimus of Stable Kidney Transplant Patients [J].

Tinti, F. ;

Mecule, A. ;

Poli, L. ;

Bachetoni, A. ;

Umbro, I. ;

Brunini, F. ;

Barile, M. ;

Nofroni, I. ;

Berloco, P. B. ;

Mitterhofer, A. P. .

TRANSPLANTATION PROCEEDINGS, 2010, 42 (10) :4047-4048

[9] Once-Daily Prolonged-Release Tacrolimus (ADVAGRAF) Versus Twice-Daily Tacrolimus (PROGRAF) in Liver Transplantation [J].

Trunecka, P. ;

Boillot, O. ;

Seehofer, D. ;

Pinna, A. D. ;

Fischer, L. ;

Ericzon, B-G ;

Trois, R. I. ;

Baccarani, U. ;

Ortiz de Urbina, J. ;

Wall, W. .

AMERICAN JOURNAL OF TRANSPLANTATION, 2010, 10 (10) :2313-2323

← 1 →