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| |  Renal Transplant Recipients Underexposed to Mycophenolic Acid Can Reach a Therapeutic Window: Presented at ATC By Cheryl Lathrop BOSTON -- June 2, 2009 -- Most renal transplant recipients underexposed to mycophenolic acid (MPA) can reach a therapeutic window by either increasing their mycophenolate mofetil (MMF) dose or switching to enteric coated-mycophenolate sodium (EC-MPS) with similar safety results, according to a study presented here at the 2009 American Transplant Congress (ATC). Carlucci Gualberto Ventura, Renal Transplant Unit, Division of Urology, University of São Paulo, São Paulo, Brazil, presented the results of a prospective, randomised trial in a poster presentation on May 31. The researchers investigated whether stable renal transplant patients on a low dose of MMF (due to adverse events or other causes) were underexposed to MPA and, if so, could increasing MMF dose, or switching to EC-MPS, result in a different MPA exposure. The study included 96 patients who had dose reductions of MMF (<=1.5 g/day). Their MMF dose at screening was 21.3 +- 5.8 mg/kg/day; serum creatinine was 1.4 +- 0.77 mg/dL. Patient age ranged from 29 to 56 years; time after transplant ranged from 20 to 102 months (stable); and the population was evenly divided into male and female. Causes of their MMF dose reduction were diarrhoea (n = 46), leucopenia (n = 20), and other (n = 30). Screening according to MPA-AUC (defined by a C2-based abbreviated area under the curve equation) found 57 patients in the therapeutic window (>=40 mcg/mL) and 38 patients underexposed to MPA (<40 mcg/mL). After excluding 4 patients, 17 of the underexposed patients were randomised into the EC-MPS 1,440 mg/day group and 17 into the MMF 2,000 mg/day group. After 3 months, the mean MPA-AUC (mcg.h/mL) 0-12 h did not differ between the 2 groups: MMF 59.72 +- 25.5 versus EC-MPS 73.54 +- 32.0 (P = NS). The number of patients who continued underexposed to MPA, despite a maximal dose of MMF or EC-MPS, was similar (4 vs 3, respectively). The incidence of adverse events was not different between the 2 study groups. [Presentation title: Are Patients With Low MMF Dose Underexposed to Mycophenolic Acid (MPA)? Can We Change This by Increasing the Dose or Switching to MPS? Abstract 1106]
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