Elsevier

Transplantation Proceedings

Volume 38, Issue 8, October 2006, Pages 2396-2397
Transplantation Proceedings

Kidney transplantation
Outcome
Renal Transplant Patients With Gastrointestinal Intolerability to Mycophenolate Mofetil: Conversion to Enteric-Coated Mycophenolate Sodium

https://doi.org/10.1016/j.transproceed.2006.08.085Get rights and content

Abstract

The introduction of mycophenolate mofetil (MMF) was an important advance in immunosuppressive therapy, although its use is limited by adverse gastrointestinal events. Enteric-coated mycophenolate sodium (EC-MPS; myfortic) has been developed to avoid these side effects. Recent clinical trials have demonstrated that EC-MPS is a safe drug in both de novo and maintenance renal transplant patients. In this prospective study, therapeutically equivalent doses of EC-MPS were administered to 39 stable kidney transplant patients receiving MMF. After 3 months of treatment with EC-MPS the incidence of adverse gastrointestinal events was lower (15.8% of the patients). There were higher levels of mycophenolic acid after conversion to EC-MPS, probably due to better absorption. These factors allowed decreased doses and levels of calcineurin inhibitors without increasing the risk of graft rejection. At 3 months postconversion, serum creatinine improved from the mean baseline value of 1.83 ± 0.12 mg/dL to 1.70 ± 0.10 mg/dL. In conclusion, EC-MPS was well tolerated in maintenance renal transplant patients with adverse gastrointestinal events secondary to MMF.

Section snippets

Materials and methods

We performed a prospective study of 39 stable kidney transplant patients (median time posttransplantation = 44 months) who were receiving MMF and maintenance immunosuppressive therapy (24 patients with tacrolimus, 10 with cyclosporine, and five with sirolimus). These patients displayed GI intolerance to MMF and were therefore converted to equipotent doses of EC-MPS.

Results

Table 1 shows the most important results. The median preconversion dose of MMF was 750 mg (range = 0 to 1000 mg) and the median postconversion dose of EC-MPS was 720 mg (range = 180 to 1080 mg). The serum creatinine fell after 3 months from 1.83 ± 0.12 mg/dL to 1.70 ± 0.10 mg/dL (P < .03). At 3 months levels of mycophenolic acid had increased from 1.46 μg/mL to 2.56 μg/mL (P < .01) and those of calcineurin inhibitors were decreased: Tacrolimus levels preconversion were 10.8 ± 0.8 ng/mL and at 3

Discussion

The new formulation for delivering mycophenolic acid, EC-MPS, was developed with the aim of improving mycophenolic acid–related GI AEs. The present study showed a significant improvement in GI AEs after conversion from MMF to EC-MPS. There was also an increase in mycophenolic acid serum levels. This might be explained because of better GI absorption with EC-MPS. This more suitable immunosuppression therapy permits use of lower doses of calcineurin inhibitors, with both factors contributing to

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