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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Pharmacokinetics in stable kidney transplant recipients after conversion from twice-daily to once-daily tacrolimus formulations
Therapeutic Drug Monitoring, Volume 34, No. 1, Year 2012
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Description
Background: A prolonged-release formulation of tacrolimus for once-daily administration (Tacrolimus QD) has been developed to offer potential improvements in patient adherence. This study compared the pharmacokinetics (PK) of tacrolimus in stable kidney transplant recipients before and after conversion from twice-daily tacrolimus (Tacrolimus BID) to Tacrolimus QD. Methods: This was an open-label, multicenter replicate design study in stable adult kidney transplant recipients (≥6 months posttransplantation) maintained on Tacrolimus BID. Patients underwent four sequential 14-day treatment periods of alternating Tacrolimus BID and QD (mg:mg conversion). Four 24-hour PK profiles were collected, one on the last day of each treatment period. Adverse events were also reported. Results: A total of 60 of 69 patients completed all 4 PK profiles. Steady-state tacrolimus area under the curve from 0 to 24 hours and Cmin were comparable for both formulations, with treatment ratio means (90% confidence intervals) of 92.9% (89.8%-96.0%) and 90.9% (87.3%-94.6%), respectively (acceptance interval: 80%-125%). Both formulations were well tolerated, with renal function remaining stable over the 8-week period. There was a good correlation between area under the curve from 0 to 24 hours and Cmin for Tacrolimus QD and BID (r = 0.88 and 0.82, respectively). The relationship between these two parameters was also similar. Conclusions: The results of this study provide evidence for safe conversion from Tacrolimus BID to QD with appropriate trough concentration monitoring. Copyright © 2012 by LippincottWilliams & Wilkins.
Authors & Co-Authors
van Hooff, Johannnes P.
Netherlands, Maastricht
Maastricht Universitair Medisch Centrum+
Van Der Walt, Isak
South Africa, Pretoria
Jacaranda Hospital
Kallmeyer, Jeffrey C.
South Africa, Durban
St. Augustine's Hospital
Miller, Derek
South Africa, Cape Town
Christiaan Barnard Memorial Hospital
Dawood, Shabbir
South Africa, Durban
St. Augustine's Hospital
Moosa, Mohammed Rafique E.
South Africa, Tygerberg
Tygerberg Hospital
Christiaans, Maarten H.L.
Netherlands, Maastricht
Maastricht Universitair Medisch Centrum+
Karpf, Carmen
Germany, Munich
Astellas Gmbh
Undre, Nasrullah A.
United Kingdom, Addlestone
Astellas Pharma Ltd
Statistics
Citations: 47
Authors: 9
Affiliations: 7
Identifiers
Doi:
10.1097/FTD.0b013e318244a7fd
ISSN:
01634356
e-ISSN:
15363694
Research Areas
Health System And Policy