Efficacy and Safety of Conversion from Twice-daily to Once-daily Tacrolimus in a Large Cohort of Stable Kidney Transplant Recipients

被引：73

作者：

Guirado, L. ^{[1
]}

Cantarell, C. ^{[2
]}

Franco, A. ^{[3
]}

Huertas, E. G. ^{[4
]}

Fructuoso, A. S. ^{[5
]}

Fernandez, A. ^{[6
]}

Gentil, M. A. ^{[7
]}

Rodriguez, A. ^{[8
,11
]}

Paul, J. ^{[9
]}

Torregrossa, J. V. ^{[10
]}

Rodriguez, A. ^{[8
,11
]}

Alonso, A. ^{[12
]}

Hernandez, D. ^{[13
]}

Burgos, D. ^{[13
]}

Jimenez, C. ^{[14
]}

Jimeno, L. ^{[15
]}

Lauzurica, R. ^{[16
]}

Mazuecos, A. ^{[17
]}

Osuna, A. ^{[18
]}

Plumed, J. S. ^{[19
]}

Ruiz, J. C. ^{[20
]}

Zarraga, S. ^{[21
]}

机构：

[1] Fundacio Puigvert, Renal Transplant Unit, Barcelona, Spain

[2] Hosp Univ Vall Hebron, Dept Nephrol, Barcelona, Spain

[3] Hosp Generalde Alicante, Dept Nephrol, Alicante, Spain

[4] Hosp Univ Cent Asturias, Dept Nephrol, Oviedo, Spain

[5] Hosp Clin San Carlos, Dept Nephrol, Madrid, Spain

[6] Hosp Ramon & Cajal, Dept Nephrol, Madrid, Spain

[7] Hosp Virgen del Rocio, Clin Nephrol & Urol Unit, Seville, Spain

[8] Hosp Univ Canarias, Dept Nephrol, Santa Cruz De Tenerife, Spain

[9] Hosp Univ Miguel Servet, Dept Nephrol, Zaragoza, Spain

[10] Hosp Clin Barcelona, Renal Transplant Unit, Barcelona, Spain

[11] Hosp Reina Sofia, Dept Nephrol, Cordoba, Spain

[12] Complejo Hosp A Coruna, Dept Nephrol, La Coruna, Spain

[13] Hosp Reg Univ Carlos Haya, Dept Nephrol, Malaga, Spain

[14] Hosp La Paz, Dept Nephrol, Madrid, Spain

[15] Hosp Virgen Arrixaca, Dept Nephrol, Murcia, Spain

[16] Hosp Badalona Germans Trias & Pujol, Dept Nephrol, Barcelona, Spain

[17] Hosp Puerta del Mar, Dept Nephrol, Cadiz, Spain

[18] Hosp Virgen de las Nieves, Dept Nephrol, Granada, Spain

[19] Hosp La Fe, Dept Nephrol, E-46009 Valencia, Spain

[20] Hosp Marques de Valdecilla, Dept Nephrol, Santander, Spain

[21] Hosp Cruces, Dept Nephrol, Bilbao, Spain

来源：

AMERICAN JOURNAL OF TRANSPLANTATION | 2011年 / 11卷 / 09期

关键词：

Kidney transplantation; once-daily; prolonged-release; renal function; routine clinical practice; tacrolimus; EXTENDED-RELEASE FORMULATION; PROGRAF-BASED REGIMEN; REJECTION; ADVAGRAF; LIVER;

D O I：

10.1111/j.1600-6143.2011.03571.x

中图分类号：

R61 [外科手术学];

学科分类号：

摘要：

Prolonged-release tacrolimus was developed to provide a more convenient once-daily dosing that could improve patient adherence. We conducted a multicenter, prospective, observational, 12-month study to describe the efficacy, safety and patient preference of conversion from tacrolimus twice-daily to once-daily formulation in stable kidney transplant recipients in routine clinical practice. Conversion was made on a 1 mg : 1 mg basis (1 mg : 1.1 mg in patients with trough levels <6 ng/mL). The study included 1832 patients (mean age (+/- SD): 50.0 +/- 13.4 years; 62.7% male). After conversion, a modest reduction in tacrolimus trough levels, necessitating an increase in daily dose, was observed (mean changes at 12 months of -9.1% and + 1.24%, respectively; p < 0.0001). Mean glomerular filtration rate did not change significantly (56.5 +/- 19.7 mL/min at conversion vs. 55.7 +/- 20.6 mL/min at 12 months). Proteinuria, blood pressure, lipid, hepatic and glucose parameters remained stable. Eight patients (0.4%) had acute rejection and 34 patients (1.85%) discontinued treatment. Almost all patients (99.4%) preferred the once-daily formulation, because of less frequent dosing (66%) and improved adherence (34%). In conclusion, at similar doses to twice-daily tacrolimus, once-daily formulation provided stable renal function, a low acute rejection rate, and good tolerability in stable kidney transplant recipients in the routine clinical practice setting.

引用

页码：1965 / 1971

页数：7

共 23 条

[1] Patient outcomes and economics of once-daily tacrolimus in renal transplant patients: Results of a modeling analysis [J].

Abecassis, M. M. ;

Seifeldin, R. ;

Riordan, M. E. .

TRANSPLANTATION PROCEEDINGS, 2008, 40 (05) :1443-1445

[2] 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

[3] 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

[4] Effect of low- and high-fat meals on tacrolimus absorption following 5 mg single oral doses to healthy human subjects [J].

Bekersky, I ;

Dressler, D ;

Mekki, QA .

JOURNAL OF CLINICAL PHARMACOLOGY, 2001, 41 (02) :176-182

[5] Modified-release tacrolimus [J].

Chisholm, MA ;

Middleton, MD .

ANNALS OF PHARMACOTHERAPY, 2006, 40 (02) :270-275

[6] 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

[7] 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

[8] 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

[9] Three-Month Experience With Tacrolimus Once-Daily Regimen in Stable Renal Allografts [J].

Diez Ojea, B. ;

Alonso Alvarez, M. ;

Aguado Fernandez, S. ;

Banos Gallardo, M. ;

Garcia Melendreras, S. ;

Gomez Huertas, E. .

TRANSPLANTATION PROCEEDINGS, 2009, 41 (06) :2323-2325

[10] Conversion to Tacrolimus Extended-Release Formulation: Short-term Clinical Results [J].

Gallego-Valcarce, E. ;

Ortega-Cerrato, A. ;

Llamas-Fuentes, F. ;

Martinez-Fernandez, G. ;

Perez-Martinez, J. ;

Gomez-Roldan, C. .

TRANSPLANTATION PROCEEDINGS, 2009, 41 (06) :2326-2327

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