Use of mycophenolate sodium in stable renal transplant recipients in Spain: preliminary results of the MIDATA study.
BACKGROUND
The use of mycophenolate mofetil (MMF) is limited by gastrointestinal adverse events (GI-AEs). Enteric-coated mycophenolate sodium (EC-MPS) was developed to avoid these effects.


METHODS
This multicenter prospective study sought to analyze the clinical benefit of EC-MPS among 726 stable renal transplant recipients in Spain. The data collection included: doses and trough levels of mycophenolic acid (MPA) and calcineurin inhibitors (CNI), renal function, routine biochemical parameters (3-6 months preconversion, baseline, and 1, 3, 6, and 12 months of EC-MPS initiation), as well as graft and patient survivals and adverse events.


RESULTS
The main indication for EC-MPS introduction was GI-AEs associated with MMF (44.1%). Preliminary data showed that before introduction of EC-MPs there was a progressive deterioration of renal function, as demonstrated by a negative slope of the creatinine clearance (P < .005). However, after EC-MPS conversion, the slope became positive (P < .05), suggesting an improvement in renal function. Only in 4.8%, EC-MPS was stopped due to GI-AEs. There was an increase in MPA serum levels (P < .01) and a reduction in CNI doses. Interestingly, 80% of 85 patients without MMF treatment because of severe GI-AEs tolerated EC-MPS, including 43% who could be treated with adequate doses of EC-MPS (>or=720 mg/d).


CONCLUSIONS
There was a significant improvement in GI-AEs after conversion from MMF to EC-MPS. The use of lower doses of CNI and the better tolerability of EC-MPS could be the underlying causes of improvement in renal function.
Sánchez-Fructuoso
A
A
H Clínico San Carlos, Madrid, Spain. asanchez.hcsc@salud.madrid.org
Ruiz
J C
JC
Rengel
M
M
Andrés
A
A
Morales
J M
JM
Beneyto
I
I
Guirado
L I
LI
Cantarell
C
C
D000328:Adult; D003404:Creatinine / Q000378:metabolism; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use; D007668:Kidney / Q000187:drug effects; D007677:Kidney Function Tests; D016030:Kidney Transplantation / Q000276:immunology*; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use*; D013030:Spain; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; D003404:Creatinine; D009173:Mycophenolic Acid