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Mycophenolate Mofetil Therapeutic Drug Monitoring: Combined Multi-linear Regression and Bayesian Limited Sampling Area Under the Curve versus Standard Care

1 November 2010


Therapeutic drug monitoring (TDM) of mycophenolate mofetil (MMF) has been investigated using multiple linear regression (MLR) and bayesian pharmacokinetics (BAY) independently. We hypothesize that performing TDM using simultaneous MLR and BAY for guidance in MMF dose selection will decrease acute rejection and risk of toxicity. Twenty-nine renal transplant (RT) patients were prospectively enrolled into a study of CellCept® (MMF, Roche), having their mycophenolic acid (MPA) levels monitored and dose adjusted to achieve target area under the curve (AUC) level of 45 (range 40 – 50 This cohort is compared to 28 control patients prescribed standard of care, fixed dose MMF. MPA monitoring is associated with a non-significant decrease rate of acute rejection (AR) by 3 months. Increased rates of BK polyoma virus (BK) infection were observed by 3 months. The high frequency of MMF dose decreases on day 30 and 60 is consistent with literature that MPA AUC increases with time.


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