title: The effect of 2-gram versus 1-gram concentration controlled mycophenolate mofetil on renal transplant outcomes using sirolimus-based calcineurin inhibitor drug-free immunosuppression.
abstract: BACKGROUND
  We performed a sequential study to determine the efficacy and side effects of low-dose (1 g) mycophenolate mofetil (MMF) in a CNI drug avoidance regimen including sirolimus/steroids.
  
  
  METHODS
  A total of 260 kidney-only recipients were given basiliximab (232) or thymoglobulin (28) induction, and sirolimus/steroids. In addition, 160 recipients were begun on standard MMF 1 g twice daily (2-g group), while 100 recipients were begun on low-dose MMF 500 mg twice daily (1-g group). The 1-g recipients were concentration controlled to keep mycophenolic acid (MPA) C0 levels at 1.8-4 microg/ml.
  
  
  RESULTS
  There were no statistically significant differences in demographics between the groups. At 6 months there were no significant differences between the 2-g and 1-g MMF groups in patient survival (96.8% vs. 96%), graft survival (92.5% vs. 95%), biopsy-confirmed and treated acute rejection (8.8% vs. 13%), or mean creatinine mg/dL (1.41+/-0.52 vs. 1.47+/-0.67), respectively. Mean MPA C0 levels microg/ml were (4.7 vs. 2.3) at 1 month, (4.1 vs. 3.1) at 3 months, and (3.9 vs. 2.4) at 6 months. There were no significant differences at 1, 3, or 6 months in mean WBC, HgB, or platelets, or wound complications. There were significant reductions in the number of patients reporting nausea-vomiting-dyspepsia (20.6% vs. 8%, P=0.007), diarrhea (34.3% vs. 20%, P=0.01), and abdominal pains (10.6% vs. 4%, P=0.05), between the 2-g and 1-g MMF groups, respectively.
  
  
  CONCLUSIONS
  The use of concentration-controlled 1-g MMF results in comparable transplant outcomes with less GI toxicity during the first 6 months posttransplant in a CNI drug-free sirolimus based immunosuppressive regimen.
authors.affiliation: Section of Renal Transplantation, Transplant Center/Glickman Urological Institute, Cleveland Clinic Foundation, Cleveland, Ohio 44195, USA. flechns@ccf.org
authors.forename: Stuart M
authors.initials: SM
authors.lastname: Flechner
authors.forename: Jing
authors.initials: J
authors.lastname: Feng
authors.forename: Barbara
authors.initials: B
authors.lastname: Mastroianni
authors.forename: Kathy
authors.initials: K
authors.lastname: Savas
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Arnovitz
authors.forename: Hazem
authors.initials: H
authors.lastname: Moneim
authors.forename: Charles S
authors.initials: CS
authors.lastname: Modlin
authors.forename: David
authors.initials: D
authors.lastname: Goldfarb
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Cook
authors.forename: Andrew C
authors.initials: AC
authors.lastname: Novick
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D065095:Calcineurin Inhibitors; D005260:Female; D005500:Follow-Up Studies; D006085:Graft Survival; D006801:Humans; D007165:Immunosuppression Therapy / Q000379:methods*; D016030:Kidney Transplantation / Q000276:immunology; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D012189:Retrospective Studies; D020123:Sirolimus / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D014945:Wound Healing / Q000187:drug effects
chemical_list: D065095:Calcineurin Inhibitors; D009173:Mycophenolic Acid; D020123:Sirolimus