Conversion from twice-daily to once-daily tacrolimus does not reduce intrapatient variability in tacrolimus exposure.
Ther Drug Monit
; 37(2): 262-9, 2015 Apr.
Article
em En
| MEDLINE
| ID: mdl-25265255
ABSTRACT
BACKGROUND:
Intrapatient variability (IPV) in tacrolimus exposure is associated with renal allograft failure. The aim of this study was to investigate whether conversion from the twice-daily tacrolimus formulation (Tac-TD) to a once-daily formulation (Tac-OD) leads to a lower IPV in tacrolimus exposure.METHODS:
Two hundred forty-seven stable renal transplant recipients were converted from Tac-TD to Tac-OD (Advagraf) on a 11-mg total daily dose basis. After conversion, patients were followed for 12 months and tacrolimus predose whole-blood concentrations (C0), serum creatinine, estimated glomerular filtration rate, and proteinuria were measured. These parameters were compared with those collected at all outpatient visits in the 12-month period (±3 months) before conversion (Tac-TD period). The IPV was calculated based on the dose-adjusted tacrolimus C0.RESULTS:
The Tac-OD formulation provided an excellent graft survival (100%), a low acute rejection rate (0.8%), and good tolerability. Renal function remained stable estimated glomerular filtration rate 48 (16-90) versus 46 (12-90) mL/min (P = 0.15) before and after conversion, respectively. After conversion to Tac-OD, mean C0 was significantly lower, decreasing from 5.7 ± 1.5 to 5.0 ± 1.5 ng/mL, corresponding to a 12% reduction (P < 0.01). Both drugs had similar IPVs (Tac-TD 17.3% ± 1.6% versus Tac-OD 16.4% ± 1.6%, P = 0.31).CONCLUSIONS:
Although conversion from Tac-TD to Tac-OD significantly reduces tacrolimus exposure as measured by C0 and seems safe, it does not reduce IPV in tacrolimus exposure.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Transplante de Rim
/
Tacrolimo
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Sobrevivência de Enxerto
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Imunossupressores
Tipo de estudo:
Clinical_trials
Limite:
Adolescent
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Adult
/
Aged
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Aged80
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Female
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Humans
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Male
/
Middle aged
Idioma:
En
Revista:
Ther Drug Monit
Ano de publicação:
2015
Tipo de documento:
Article
País de afiliação:
Holanda