What is the intrapatient variability of mycophenolic acid trough levels?

Pediatr Transplant. 2015 Nov;19(7):669-74. doi: 10.1111/petr.12559. Epub 2015 Jul 23.

Abstract

TDM of MPA, the active compound of MMF, is rarely used despite its substantial intra- and interpatient variability. Little is known about the utility of long-term MPA TDM. Data are expressed as mean (one standard deviation). All available data from 27 renal transplant recipients (mean age at transplantation: 7.7 [5.0] yr) with an average follow-up of 9.3 (4.6) yr were analyzed. MPA levels were measured using the EMIT. GFR was measured using cystatin C and eGFR was calculated using the Filler formula. Intrapatient CV of the trough level was calculated as the ratio of the mean divided by one standard deviation. Mean cystatin C eGFR was 56.9 (24.4) mL/min/1.73 m(2) . There was a weak but significant correlation between the MPA trough level and the AUC (Spearman r = 0.6592, p < 0.0001). A total of 1964 MPA trough levels (73 [45]/patient) were measured, as compared to 3462 Tac trough levels (144 [71]/patient). The average MPA trough level was 3.01 (1.26) mg/L and the average trough Tac level was 7.3 (1.8) ng/mL. Intrapatient CV was statistically higher (p = 0.00093) for MPA at 0.68 (0.29) when compared to Tac with a CV of 0.46 (0.12). CV did not correlate with eGFR. Intrapatient MPA trough level CV is significantly higher than for Tac, while CV for both MPA and Tac was high. MPA trough level monitoring may be a feasible monitoring option to improve patient exposure and possibly outcomes.

Keywords: kidney transplantation; mycophenolate mofetil; outcome; pediatric; therapeutic drug monitoring.

MeSH terms

  • Adolescent
  • Area Under Curve
  • Biomarkers / blood
  • Child
  • Child, Preschool
  • Drug Monitoring
  • Follow-Up Studies
  • Graft Rejection / prevention & control*
  • Humans
  • Immunosuppressive Agents / pharmacokinetics*
  • Immunosuppressive Agents / therapeutic use
  • Kidney Transplantation*
  • Mycophenolic Acid / analogs & derivatives*
  • Mycophenolic Acid / blood*
  • Mycophenolic Acid / pharmacokinetics
  • Mycophenolic Acid / therapeutic use
  • Retrospective Studies

Substances

  • Biomarkers
  • Immunosuppressive Agents
  • Mycophenolic Acid