title: Enteric-coated mycophenolate sodium containing GvHD prophylaxis reduces GvHD rate after allogeneic HSCT.
abstract: OBJECTIVE
  The aim of this study was to evaluate whether cyclosporine A (CsA)-based Graft vs. Host Disease (GvHD) prophylaxis with enteric-coated mycophenolate sodium (EC-MPS) instead of mycophenolate mofetil (MMF) or methotrexate (MTX) reduces the GvHD incidence and lowers gastrointestinal (GI-) toxicities.
  
  
  METHODS
  In a retrospective analysis of 102 allogeneic hematopoietic stem cell transplant (HSCT) patients, incidences of overall and severe aGvHD (>II°), cGvHD as well as overall and severe (CTC >II°) GI-toxicities were compared between GvHD prophylaxis containing EC-MPS vs. MMF or MTX (control group).
  
  
  RESULTS
  The overall aGvHD rate was significantly lower in the EC-MPS group compared to the control (47% vs. 72%, P = 0.022) with lower rates of severe aGvHD (10% vs. 25%, P = 0.088) and cGvHD (20% vs. 39%, P = 0.065). Prophylaxis with EC-MPS remained significantly associated with a lower aGvHD rate in a multiple logistic regression model. GI-toxicities did not differ between both groups except for severe abdominal pain for which the incidence was increased in the EC-MPS group (17% vs. 3%, P = 0.022).
  
  
  CONCLUSIONS
  This data support the hypothesis that replacement of MMF or MTX by EC-MPS reduces GvHD rates after HSCT. This appears not to be due to a reduced GI-toxicity of EC-MPS.
authors.affiliation: Department of Hematology and Oncology, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Weber
authors.affiliation: Department of Hematology and Oncology, Germany.
authors.forename: Jonas
authors.initials: J
authors.lastname: Niestadtkötter
authors.affiliation: Institute of Medical Epidemiology, Biostatistics and Informatics, Martin-Luther-University Halle-Wittenberg, Halle (Saale), Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Wienke
authors.affiliation: Department of Hematology and Oncology, Germany.
authors.forename: Carsten
authors.initials: C
authors.lastname: Müller-Tidow
authors.affiliation: Department of Hematology and Oncology, Germany.
authors.forename: Lutz P
authors.initials: LP
authors.lastname: Müller
mesh_terms: D000328:Adult; D000368:Aged; D004339:Drug Compounding; D004347:Drug Interactions; D004359:Drug Therapy, Combination; D005260:Female; D006086:Graft vs Host Disease / Q000175:diagnosis / Q000209:etiology* / Q000401:mortality / Q000517:prevention & control*; D018380:Hematopoietic Stem Cell Transplantation / Q000009:adverse effects*; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000737:chemistry; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000008:administration & dosage* / Q000009:adverse effects / Q000737:chemistry; D011292:Premedication; D054328:Proton Pump Inhibitors / Q000627:therapeutic use; D012189:Retrospective Studies; D014019:Tissue Donors; D019172:Transplantation Conditioning; D014184:Transplantation, Homologous; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D054328:Proton Pump Inhibitors; D009173:Mycophenolic Acid; D008727:Methotrexate
keywords: GvHD; allogeneic; enteric-coated; hematopoietic stem cell transplantation; methotrexate; mycophenolate; prophylaxis