Impact of dose reductions on efficacy outcome in heart transplant patients receiving enteric-coated mycophenolate sodium or mycophenolate mofetil at 12 months post-transplantation

: Mycophenolic acid (MPA) dose reduction is associated with increased risk of rejection and graft loss in renal transplantation. This analysis investigated the impact of MPA dose changes with enteric‐coated mycophenolate sodium (EC‐MPS) or mycophenolate mofetil (MMF) in de novo heart transplant recipients. In a 12‐month, single‐blind trial, 154 patients (EC‐MPS, 78; MMF, 76) were randomized to either EC‐MPS (1080 mg bid) or MMF (1500 mg bid) in combination with cyclosporine and steroids. The primary efficacy variable was the incidence of treatment failure, comprising a composite of biopsy‐proven (BPAR) and treated acute rejection, graft loss or death. Significantly fewer patients receiving EC‐MPS required ≥2 dose reductions than patients on MMF (26.9% vs. 42.1% of patients, p = 0.048). Accordingly, the average daily dose of EC‐MPS as a percentage of the recommended dose was significantly higher than for MMF (88.4% vs. 79.0%, p = 0.016). Among patients requiring ≥1 dose reduction, the incidence of treated BPAR grade ≥3A was significantly lower with EC‐MPS compared with MMF (23.4% vs. 44.0%, p = 0.032). These data suggest that EC‐MPS‐treated heart transplant patients are less likely to require multiple dose reductions than those on MMF which may be associated with a significantly lower risk of treated BPAR ≥3A.