Limited sampling strategy for the estimation of mycophenolic acid area under the curve in Tunisian renal transplant patients.

Abstract:

:Mycophenolate mofetil is a prodrug widely used in renal transplantation to prevent organ rejection. It is hydrolyzed to its active compound mycophenolic acid (MPA). MPA area under the curve (AUC0-12h) is considered the best pharmacokinetic parameter for the estimation of MPA exposition and for prediction of rejection. MPA-AUC requires several blood samples, making it impractical for clinical practice. Therefore, development of a limited sampling strategy (LSS) to estimate MPA AUC0-12h using three blood samples is very helpful for MPA individual dose adjustment. Results of LSS differ according to the patient background and to the drug formulation. Therefore, the purpose of this study was to develop a LSS for the estimation of MPA AUC0-12h in Tunisian renal transplant patients treated with the generic formulation of mycophenolate mofetil (MMF®, MEDIS). The best correlation was achieved by a profile based on three time points C0.5h, C1.5h, and C4h after drug intake: AUC0-12h = 0.414 + 1.210 × C0.5 + 2.256 × C1.5 + 4.134 × C4 (mei = 1.65% and rmse = 5.81%). The correlation between full AUC0-12h and abbreviated AUC0-12h was 0.917. In conclusion, this model provides a reliable and simple equation to estimate MPA AUC0-12h for the generic formulation of mycophenolate mofetil (MMF®).

journal_name

Nephrol Ther

authors

Gaies E,Ben Sassi M,El Jebari H,Jebabli N,Charfi R,Chokri I,Salouage I,Klouz A,Trabelsi S

doi

10.1016/j.nephro.2017.02.010

subject

Has Abstract

pub_date

2017-11-01 00:00:00

pages

460-462

issue

6

eissn

1769-7255

issn

1872-9177

pii

S1769-7255(17)30171-2

journal_volume

13

pub_type

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