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Efficacy and Safety of Conversion from Twice‐daily to Once‐daily Tacrolimus in a Large Cohort of Stable Kidney Transplant Recipients
Author(s) -
Guirado L.,
Cantarell C.,
Franco A.,
Huertas E. G.,
Fructuoso A. S.,
Fernández A.,
Gentil M. A.,
Rodríguez A.,
Paul J.,
Torregrossa J. V.,
Rodríguez A.,
Alonso A.,
Hernández D.,
Burgos D.,
Jiménez C.,
Jimeno L.,
Lauzurica R.,
Mazuecos A.,
Osuna A.,
Plumed J. S.,
Ruiz J. C.,
Zárraga S.
Publication year - 2011
Publication title -
american journal of transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.89
H-Index - 188
eISSN - 1600-6143
pISSN - 1600-6135
DOI - 10.1111/j.1600-6143.2011.03571.x
Subject(s) - medicine , tacrolimus , tolerability , dosing , renal function , trough level , urology , kidney transplant , prospective cohort study , kidney transplantation , kidney , transplantation , surgery , adverse effect
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.