Impact of Diabetic Status on Mycophenolic Acid (MPA) Exposure Using Mycophenolate Mofetil (MMF) in De Novo Renal Transplant Patients.

O281 Aims: Individualization of MMF therapy has been advocated to minimize the incidence of acute rejection. Pre-existing disease state may contribute to the variability in MPA exposure. This is a retrospective analysis of the impact of pre-existing diabetes on MPA exposure in kidney transplant patients. Methods: 141 kidney transplant patients had three full MPA pharmacokinetics (PK) profiles (0 to 12 hours) on days 3, 7, and 11; and five abbreviated (0 to 2 hours) PK profiles on Weeks 3, 4, 8, 12, and 20. Diabetic status was determined based on medical history and / or reported use of anti-diabetics at study entry. Diabetics and non-diabetics were compared using repeated measures in a linear mixed effects model. Log transformed AUC0-12 and Cmax were compared adjusting for treatment group, sex, age, donor age, and average daily dose of MMF, cyclosporine, and corticosteroids. The ratio of the least squares of the means (LSM) and the 90% confidence interval (C.I.) were compared to the (0.8, 1.25) equivalency range. Individual time concentration points were also compared. Results: AUC0-12 increased over time in both diabetic and non-diabetic patients, almost doubling by Week 12. MPA exposure during 20 weeks of therapy, expressed as MPA AUC0-12, was not significantly different in the diabetic and non-diabetic groups. Selected MPA AUC0-12 (mg.h/L) by Diabetic StatusFigureCmax was not significantly different for all periods except for days 7 and 11. However, AUC0-12 was not significantly different for all periods. Conclusion: The data suggest that pre-existing diabetic status does not influence MPA exposure as measured by AUC0-12 after MMF administration to kidney transplant patients. MPA AUC’s were similar in all groups including days 7 and 11.