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Large scale analysis of routine dose adjustments of mycophenolate mofetil based on global exposure in renal transplant patients.

Abstract：

BACKGROUND:We report a feasibility study based on our large-scale experience with mycophenolate mofetil dose adjustment based on mycophenolic acid interdose area under the curve (AUC) in renal transplant patients. METHODS:Between 2005 and 2010, 13,930 requests for 7090 different patients (outside any clinical trial) were posted by more than 30 different transplantation centers on a free, secure web site for mycophenolate mofetil dose recommendations using three plasma concentrations and Bayesian estimation. RESULTS:This retrospective study showed that 1) according to a consensually recommended 30- to 60-mg·h/L target, dose adjustment was needed for approximately 35% of the patients, 25% being underexposed with the highest proportion observed in the first weeks after transplantation; 2) when dose adjustment had been previously proposed, the subsequent AUC was significantly more often in the recommended range if the dose was applied than not at all posttransplantation periods (72-80% vs. 43-54%); and 3) the interindividual AUC variability in the "respected-dose" group was systematically lower than that in the "not respected-dose" group (depending on the posttransplantation periods; coefficient of variation %, 31-41% vs 49-70%, respectively). Further analysis suggested that mycophenolic acid AUC should best be monitored at least every 2 weeks during the first month, every 1 to 3 months between months 1 and 12, whereas in the stable phase, the odds to be still in the 30- to 60-mg·h/L range on the following visit was still 75% up to 1 year after the previous dose adjustment. CONCLUSION:This study showed that the monitoring of mycophenolate mofetil on the basis of AUC measurements is a clinically feasible approach, apparently acceptable by the patients, the nurses, and the physicians owing to its large use in routine clinics.

journal_name

Ther Drug Monit

journal_title

Therapeutic drug monitoring

authors

Saint-Marcoux F,Vandierdonck S,Prémaud A,Debord J,Rousseau A,Marquet P

doi

10.1097/FTD.0b013e31821633a6

subject

Has Abstract

pub_date

2011-06-01 00:00:00

pages

285-94

issue

eissn

0163-4356

issn

1536-3694

journal_volume

pub_type

杂志文章

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Large scale analysis of routine dose adjustments of mycophenolate mofetil based on global exposure in renal transplant patients.