Initial experience with EC-MPA (myfortic) in heart transplant recipients after gastrointestinal intolerance to mycophenolate mofetil (cellcept)

Objective: We analyzed the safety, tolerability and efficacy of enteric coated mucophenolic acid post heart transplantation in patients that did not tolerate mucophenolate mofetil due to gastrointestinal complications.

Material and Methods: Between 8/2003 and 9/2004 14 patients transplanted between 1997 and 2004 had to stop MMF due to gastrointestinal complications 34.6±34.5 months post transplantation. All of those were started on EC-MPA 14–21 days after discontinuation of MMF, i.e. cessation of symptons. Starting dose was 720mg BID. Daily doses were adapted to achieve a target through level of 2–4mg/l. Concomittant immunosuppression was neoral (n=4), tacrolimus (n=10) and 8/14 are off steroids.

Results: Average follow-up of EC-MPA intake is 8.69±4.58 months. Only 4 patients showed again gastrointestinal symptoms after 1, 3, 7 & 8 weeks respectively, requiring to stop medication. Average daily dose to achieve target levels was 1157.1±568mg on EC-MPA compared to 2111.1±858mg on MMF normalized to dose equivalent 3.21±1.58 tabs vs. 4.22±1.72 tabs, respectively (p=n.s.). No acute rejection requiring treatment (ISHLT>II) or clinically relevant new infections were diagnosed in any patient after switch to EC-MPA.

Conclusions: In this study cohort 71.4% of patients tolerated treatment with EC-MPA after a mid-term follow-up after previous intolerance of MMF. There were no significant differences in dosing neccessities to achieve comparable target levels. We conclude that switch from MMF to EC-MPA in case of gastrointestinal intolerance is a worthwhile strategy.