2010 - TTS International Congress

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Clinical Immunosuppression Kidney late

19.4 - An enteric-coated formulation of mycophenolic acid reduces the risk of suffering gastrointestinal complications regardless of dose in renal transplant patients

Presenter: Ana, Sánchez-Fructuoso, Madrid, Spain
Authors: Ortega F., Sánchez-Fructuoso A., Cruzado J., Gómez-Alamillo J., Alarcón A., Pallardó L., Morales J., Oliver J., Mora S.



F. Ortega1, A. Sánchez-fructuoso2, J.M. Cruzado3, J.C. Gómez-alamillo4, A. Alarcón5, L. Pallardó6, J.M. Morales7, J. Oliver8, S. Mora9
1Nefrology, Hospital Universitario Central de Asturias, Oviedo/SPAIN, 2, Hospital San Carlos, Madrid/SPAIN, 3, Hospital de Bellvitge, Hospitalet de llobregat/SPAIN, 4, Hospital Marqués de Valdecilla, Santander/SPAIN, 5, Hospital Son Dureta, Mallorca/SPAIN, 6, Hospital Dr Peset, Valencia/SPAIN, 7, H 12 Octubre, Madrid/SPAIN, 8, Hospital Juan Canalejo, A Coruña/SPAIN, 9, Novartis Pharmeceuticals, Barcelona/SPAIN

Body: INTRODUCTION: The incidence of gastrointestinal (GI) complications in renal transplant pacients receiving mycophenolic acid (MPA) has been associated with the peak concentration of the drug, which is highly variable among individuals. The enteric-coated mycophenolate sodium (EC-MPS) formulation delays delivery of MPA, but results in similar exposure to that provided by mycophenolate mofetil (MMF). The objective of the present analysis was to predict the occurrence of GI adverse effects in renal transplant recipients receiving either EC-MPS or mycophenolate mofetil (MMF). METHODS: Using pooled data from all individuals (n=134) included in a multicenter, randomized, open-label, MMF-controlled, 12-weeks trial of conversion to EC-MPS in GI-sensitive patients, a multivariate logistic regression analysis was performed to predict the occurrence of GI complications during the study. The following variables were entered into the model: age, gender, weight, proton-pump inhibitors use, cyclosporine use, diabetes, MPA dose at the onset of GI complication, MPA formulation (MMF/EC-MPS), and glomerular filtration rate. RESULTS: Sixty-seven (50%) patients developed GI complications during the study. Patients receiving MMF suffered more complications (62.5% versus 38.6% with EC-MPS, p=0.006) despite a trend towards higher oral dose of MPA at the onset of GI complaints (67.2% of patients with MMF were receiving ≥1000 mg/day versus 81.4% of ≥720 mg/day –equimolar dose- in EC-MPS group, p=0.058). After extensive adjustment in the multivariate analysis, no significant association was observed between the administration of moderate or high MPA doses (≥1000 mg/day in MMF group or ≥720 mg/day –equimolar dose- in EC-MPS group) during the study and GI complications of any type (p=0.453). Regardless of dose, MMF treatment was associated with a three-fold increase in risk of GI complications (adjusted odds ratio [OR] of 3.3, 95% confidence interval [CI] 1.5 to 7.4, p=0.004), whereas higher glomerular filtration rate (GFR) protected against GI events (OR 0.98 for each additional ml/min, 95% CI 0.96 to 0.99, p=0.030). No significant differences were observed in Gastrointestinal Quality of Life Index (GIQLI) between patients achieving moderate or high MPA doses versus patients who did not tolerate a dose increase (mean scores of 103 [SD 22] and 106 [SD 22], respectively, p=0.639). CONCLUSIONS: The use of enteric-coated mycophenolate sodium reduces the risk of suffering GI complications regardless of dose in renal transplant patients. Oral doses of MPA are not predictive of GI complications, thus confirming the high interindividual variability in MPA pharmacokinetics. Higher GFR protected against GI events.

Disclosure: All authors have declared no conflicts of interest.

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