Enteric-coated mycophenolate sodium given in combination with tacrolimus has a lower incidence of serious infections in Asian renal-transplant recipients compared with mycophenolate mofetil.

To compare the characteristics of the enteric-coated formulation of mycophenolate sodium (EC-MPS, myfortic) and mycophenolate mofetil (MMF, CellCept) given in combination with tacrolimus in Asian renal-transplant recipients. In a 24-month, single-centre, randomized, open-label, prospective study, 101 live-donor kidney transplant recipients were randomized to the EC-MPS (n = 50) or MMF (n = 51) group. The incidence of infection, therapeutic effect and adverse events were monitored. The incidences of infection were 40% and 49% for the EC-MPS and MMF groups, respectively (p = 0.362). However, serious infection was only observed in the MMF group (11.8%; p = 0.027). The incidences of gastro-intestinal adverse events (GI AEs) were 24% and 41.2% for EC-MPS and MMF, respectively (p = 0.066). However, serious diarrhoea only occurred in the MMF group (9.8%; p = 0.056). The trough level of FK 506 at the time of diarrhoea (13.22 ± 3.66 ng/ml) was significantly higher than the level within 1 month before (9.18 ± 1.12 ng/ml; p < 0.05) and 1 month after diarrhoea (9.13 ± 0.85 ng/ml; p < 0.05). The infection rate of patients with diarrhoea was significantly higher than those without diarrhoea (68%, 39%, p = 0.024). The serum creatinine level was 698 ± 60 μmol/l for EC-MPS and 673 ± 68 μmol/l for MMF from baseline (p > 0.05), and it decreased to 66 ± 6 μmol/l for EC-MPS and 69 ± 8 μmol/l for MMF at 24 months (p > 0.05). The incidences of biopsy proven acute rejection (BPAR) were 20% and 25.5% for EC-MPS and MMF, respectively (p = 0.511). Enteric-coated formulation of mycophenolate sodium, given in combination with tacrolimus, has a lower incidence of serious infection in Asian renal-transplant recipients compared with MMF, and the therapeutic effect of EC-MPS is similar to MMF. The clinical trial registration number is ChiCTR-IPR-14005509. The registry name is 'Effect of Enteric-coated mycophenolate sodium on posttransplant infection rate after renal transplantation compared with Mycophenolate mofetil'.

Feng JJ ，Zhang LW ，Zhao P ，Bow LM ，Tian J ... -  《-》

Long-term dosing patterns of enteric-coated mycophenolate sodium or mycophenolate mofetil with tacrolimus after renal transplantation.

MORE was a four-yr, prospective, observational study at 40 transplant centers in the US. Data were analyzed to evaluate changes in mycophenolic acid (MPA) dosing over time in 904 de novo kidney transplant recipients receiving enteric-coated mycophenolate sodium (EC-MPS, n = 616) or mycophenolate mofetil (MMF, n = 288) with tacrolimus. Induction therapy and steroid treatment were similar in the two subpopulations. The proportion of patients receiving the maximal recommended MPA dose was 80.5%, 43.9%, 39.2%, 34.6%, and 30.1% at baseline and years 1, 2, 3, and 4, respectively. More patients received the maximal recommended MPA dose with EC-MPS vs. MMF at month 1 (79.2% vs. 71.7%, p = 0.016), month 3 (68.5% vs. 56.9%, p = 0.001), and month 6 (52.9% vs. 44.0%, p = 0.028). Multivariate analysis showed the risk of biopsy-proven acute rejection, graft loss or death to be similar for EC-MPS vs. MMF. Estimated glomerular filtration rate (GFR) was similar with EC-MPS vs. MMF at all time points. There were no significant differences in any category of adverse event between the EC-MPS and MMF cohorts during follow-up, including gastrointestinal events. In conclusion, MPA dose was maintained more effectively in the first six months after kidney transplantation using EC-MPS vs. MMF, without an increase in adverse events.

Langone A ，Shihab F ，Pankewycz O ，Doria C ，Wiland A ，McCague K ，Chan L ... -  《-》

Randomized trial of mycophenolate mofetil versus enteric-coated mycophenolate sodium in primary renal transplant recipients given tacrolimus and daclizumab/thymoglobulin: one year follow-up.

Ciancio G ，Burke GW ，Gaynor JJ ，Roth D ，Sageshima J ，Kupin W ，Tueros L ，Hanson L ，Rosen A ，Ruiz P ，Miller J ... -  《TRANSPLANTATION》

Comparing outcomes associated with dose manipulations of enteric-coated mycophenolate sodium versus mycophenolate mofetil in renal transplant recipients.

Cooper M ，Deering KL ，Slakey DP ，Harshaw Q ，Arcona S ，McCann EL ，Rasetto FA ，Florman SS ... -  《-》

Conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium in maintenance renal transplant recipients receiving tacrolimus: clinical, pharmacokinetic, and pharmacodynamic outcomes.

Budde K ，Glander P ，Krämer BK ，Fischer W ，Hoffmann U ，Bauer S ，Grohmann J ，Neumayer HH ，Arns W ... -  《TRANSPLANTATION》