A Critical Analysis of Equations for MPA Exposure in Patients Under EC-MPS and Tacrolimus.
Hospital das Clinicas FMUSP, Sao Paulo, Brazil
Meeting: 2017 American Transplant Congress
Abstract number: D104
Keywords: Pharmacokinetics
Session Information
Session Name: Poster Session D: Kidney Immunosuppression: Novel Regimens and Drug Minimization
Session Type: Poster Session
Date: Tuesday, May 2, 2017
Session Time: 6:00pm-7:00pm
Presentation Time: 6:00pm-7:00pm
Location: Hall D1
Mycophenolic acid(MPA) PK, from enteric-coated mycophenolate sodium(EC-MPS) has a broad range of Tmax avoiding the use a single concentration to calculate the area-under-the-time-concentration curve(AUC). Either for research or for clinical MPA monitoring, a complete AUC is troublesome for the patients(pts). We have developed abbreviated equations in 59 adult(54±16y) pts (29males,43whites) with 171 complete MPA-AUC0-12h, under TAC/EC-MPS using 59 curves measured at mean of 31±4days after transplant, to develop the equations, and the remaining 112 performed at a mean of 109±59d for validation. We also compared our results with 5 other equations(4 with EMIT) available in the literature, comparing estimated AUC(eAUC) with measured AUC(mAUC), bias and 10%/30% accuracy. MPA was measured by UPLC MS-MS. EMIT data was transformed using Emit=1.012HPLC+0.244. The eAUCs that measure MPA up to 6hours, had an acceptable low bias with more results in the 10-30% range than those up to 4h. A highly adequate eAUC is obtained with 8h of blood collection. This analysis offers blood sampling alternatives depending on the precision needed.
Equations | eAUC | p | Bias | 30% | 10% | |
Emit (MPA) | mAUC= 56±36 [micro]g*hr/mL | |||||
Sanchez Ther Drug Monit, 2012 | 11.15+0.68xC1+0.45xC1.5+0.57xC2+8.16xC4 | 57±35 | NS | +1±19 | 74 | 29 |
Yao Ther Drug Monit, 2015 | 10.44+0.7xC1+1.22xC2+1.75xC4+4.36xC6 | 55±29 | 0.026 | -2.5±14 | 79 | 40 |
Sommerer Br J Clin Pharmacol, 2010 | 11.5+0.99xC0+1.56xC1+0.74xC2+0.87xC3+2.09xC4 | 49±25 | 0.000 | -7±16 | 78 | 29 |
Huang Int J Clin Pharmacol Ther, 2016 | 22.13+1.7xC0.5+0.61xC1.5+0.78xC2+1.83xC4 | 52±21 | 0.025 | -3±19 | 67 | 23 |
(UPLC MS-MS) (MPA) | mAUC = 53±34 [micro]g*hr/mL | eAUC | p | Bias | 30% | 10% |
HC –FMUSP8h | 0,081+0,661xC0+0,564xC1.5+0,768xC2+1,600xC3+1,560xC4+2,421xC6 +3,590xC8 | 53±34 | NS | 0±14 | 96 | 56 |
HC –FMUSP6h | 1,044+2,150xC0.33+0,601xC1.5+0,836xC2+1,107xC3+2,337xC4+3,454xC6 | 55±36 | NS | +2.2±16 | 90 | 44 |
HC –FMUSP4h | -1,844+1,683xC0+1,836xC0,66+0,752xC1.5+0,924xC2+0,380xC3+5,852xC4 | 60±42 | 0.002 | +6.6±22 | 73 | 36 |
Li Am J Nephrol, 2013 | -3.63+8.35xC4+17.04xC7+13.74xC12 | 121±94 | 0.000 | 69±68 | 11 | 4 |
CITATION INFORMATION: David-Neto E, Triboni A, Ramos F, Agena F, Romano P, Freitas G. A Critical Analysis of Equations for MPA Exposure in Patients Under EC-MPS and Tacrolimus. Am J Transplant. 2017;17 (suppl 3).
To cite this abstract in AMA style:
David-Neto E, Triboni A, Ramos F, Agena F, Romano P, Freitas G. A Critical Analysis of Equations for MPA Exposure in Patients Under EC-MPS and Tacrolimus. [abstract]. Am J Transplant. 2017; 17 (suppl 3). https://atcmeetingabstracts.com/abstract/a-critical-analysis-of-equations-for-mpa-exposure-in-patients-under-ec-mps-and-tacrolimus/. Accessed November 9, 2024.« Back to 2017 American Transplant Congress