Evaluation of limited sampling strategies for tacrolimus.
OBJECTIVE
In literature, a great diversity of limited sampling strategies (LSS) have been recommended for tacrolimus monitoring, however proper validation of these strategies to accurately predict the area under the time concentration curve (AUC0-12) is limited. The aim of this study was to determine whether these LSS might be useful for AUC prediction of other patient populations.


METHODS
The LSS from literature studied were based on regression equations or on Bayesian fitting using MWPHARM 3.50 (Mediware, Groningen, the Netherlands). The performance was evaluated on 24 of these LSS in our population of 37 renal transplant patients with known AUCs. The results were also compared with the predictability of the regression equation based on the trough concentrations C0 and C12 of these 37 patients. Criterion was an absolute prediction error (APE) that differed less than 15% from the complete AUC0-12 calculated by the trapezoidal rule.


RESULTS
Thirteen of the 18 (72%) LSS based on regression analysis were capable of predicting at least 90% of the 37 individual AUC0-12 within an APE of 15%. Additionally, all but three LSS examined gave a better prediction of the complete AUC0-12 in comparison with the trough concentrations C0 or C12 (mean 62%). All six LSS based on Bayesian fitting predicted <90% of the 37 complete AUC0-12 correctly (mean 67%).


CONCLUSIONS
The present study indicated that implementation of LSS based on regression analysis could produce satisfactory predictions although careful evaluation is necessary.
Op den Buijsch
Robert A M
RA
Department of Clinical Chemistry, University Hospital Maastricht, P.O. Box 5800, 6202 AZ, Maastricht, The Netherlands. RBUY@klinchem.azm.nl
van de Plas
Afke
A
Stolk
Leo M L
LM
Christiaans
Maarten H L
MH
van Hooff
Johannes P
JP
Undre
Nas A
NA
van Dieijen-Visser
Marja P
MP
Bekers
Otto
O
D000328:Adult; D019540:Area Under Curve; D001499:Bayes Theorem; D002986:Clinical Trials as Topic; D016903:Drug Monitoring / Q000379:methods*; D005260:Female; D005544:Forecasting; D006801:Humans; D007166:Immunosuppressive Agents / Q000493:pharmacokinetics*; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D012044:Regression Analysis; D016559:Tacrolimus / Q000493:pharmacokinetics*; D013997:Time Factors
D007166:Immunosuppressive Agents; D016559:Tacrolimus
Clin Pharmacokinet. 2004;43(10):623-53
15244495
Transplant Proc. 2003 Nov;35(7):2445-8
14611982
J Pharmacokinet Biopharm. 1981 Aug;9(4):503-12
7310648
Transplant Proc. 1994 Jun;26(3):1804
7518160
Transplant Proc. 1994 Aug;26(4):2106-8
7520623
Transpl Int. 1994 Aug;7(5):329-33
7527638
Drug Saf. 1995 May;12(5):348-57
7545405
Ther Drug Monit. 1995 Dec;17(6):602-5
8588228
Clin Pharmacokinet. 2004;43(11):741-62
15301578
Transplant Proc. 2003 Aug;35(5):1988-91
12962871
Transplant Proc. 2002 Dec;34(8):3173-5
12493410
Transplant Proc. 2002 Feb;34(1):142-3
11959225
Transplant Proc. 2001 May;33(3):2127-8
11377473
Ther Drug Monit. 2001 Apr;23(2):100-14
11294509
Ann Transplant. 2000;5(2):14-23
11217202
J Heart Lung Transplant. 2005 Sep;24(9):1315-9
16143250
Ther Drug Monit. 2005 Aug;27(4):431-4
16044098
Ther Drug Monit. 2002 Aug;24(4):573; author reply 573-4
12142646
Ther Drug Monit. 2006 Jun;28(3):419-30
16778729
Kidney Int. 2005 Jun;67(6):2440-7
15882290
Transplant Proc. 1999 Feb-Mar;31(1-2):296-8
10083114
Ther Drug Monit. 1998 Aug;20(4):401-7
9712465
Ther Drug Monit. 1998 Apr;20(2):219-23
9558138
Transplantation. 1996 Oct 15;62(7):920-6
8878385
Transplantation. 1996 Oct 15;62(7):900-5
8878381
Am J Kidney Dis. 2000 Apr;35(4):660-6
10739787