63166
document
Similar MPA exposure on modified release and regular tacrolimus . Concomitant immunosuppression may affect the mycophenolate mofetil exposure . Astellas developed a once-daily modified release formulation of tacrolimus ( TacMR ) with the potential to reduce the likelihood of nonadherence . It is unknown whether mycophenolic acid ( MPA ) area under the concentration-time curve ( AUC ) differs between the 2 tacrolimus ( Tac ) formulations . In a 2-by-2 crossover design , 20 stable renal transplant recipients on twice-daily Tac either continued their usual Tac therapy ( n = 10 , group 1 ) or switched to TacMR for a 12-week period ( n = 10 , group 2 ) , after which the patients crossed over to the other formulation for another 12-week period . Pharmacokinetic profiles using limited sampling strategies were obtained before randomization ( visit 1 ) , and at 12 ( visit 2 ) and 24 weeks ( visit 3 ) at steady state . MPA AUC was calculated using the Pawinski formula . When analyzing visits on Tac , TacMR , and back on Tac combined , the MPA AUC for all 20 patients at baseline was 42.24 ( 16.98 ) , 37.18 ( 13.75 ) , and 40.09 ( 16.69 ) mg·h·L ( -1 ) , respectively , which was not statistically significant using repeated measures ( P = 0.1327 , R ( 2 ) = 0.1109 ) . We conclude that MPA pharmacokinetic profiles are not altered when converting patients from Tac to TacMR .
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Intervention_Pharmacological
tacrolimus
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Intervention_Pharmacological
mycophenolic acid ( MPA )
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Intervention_Pharmacological
Tac therapy
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Intervention_Pharmacological
or switched to TacMR for
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Intervention_Pharmacological
Tac
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Intervention_Pharmacological
TacMR
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Intervention_Pharmacological
Tac
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Intervention_Pharmacological
MPA AUC
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Participant_Condition
regular tacrolimus .
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Participant_Sample-size
20
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Participant_Condition
renal transplant recipients
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Participant_Sample-size
20