title: Mycophenolate mofetil monotherapy in liver transplantation: 5-year follow-up of a prospective randomized trial.
abstract: BACKGROUND
  Calcineurin inhibitors (CNIs) play the key role in immunosuppressive protocols yet are often associated with numerous side effects. Renal insufficiency, hypertension, hyperglycemia, and increased risk of secondary malignancy are major problems in short- and long-term follow-up of liver transplant patients. Mycophenolate mofetil (MMF) has proved to be a potent immunosuppressive agent free of the CNI-associated side effects.
  
  
  METHODS
  One hundred fifty patients who received liver transplantation at our institution (1998-2003) were prospectively randomized: 75 patients continued CNI standard therapy, 75 patients were switched to MMF monotherapy, and follow-up was 5 years. Incidence of rejection, renal complication, cardiovascular, neurological and gastrointestinal adverse effects, and diabetes and malignancy development was recorded. Graft biopsies were performed every 2 to 3 years.
  
  
  RESULTS
  No significant difference regarding the incidence of acute rejection was detected. A trend to higher rejection frequency was apparent in the MMF monotherapy group. Chronic rejection was absent; organ and patient survival were identical in the two groups. No significant difference occurred concerning the incidence of cardiovascular, gastrointestinal or neurological adverse effects, or the development of malignancies. Renal function improved significantly in patients with renal insufficiency when patients treated with CNI were switched to MMF monotherapy.
  
  
  CONCLUSIONS
  MMF monotherapy may serve as safe long-term immunosuppression after liver transplantation for a subgroup of patients. Especially for patients with renal insufficiency MMF offers immunosuppression without the risk of nephrotoxicity.
authors.affiliation: Department of General and Transplantation Surgery, University Hospital Aachen, RWTH Aachen, Germany. mschmeding@ukaachen.de
authors.forename: Maximilian
authors.initials: M
authors.lastname: Schmeding
authors.forename: Anja
authors.initials: A
authors.lastname: Kiessling
authors.forename: Ruth
authors.initials: R
authors.lastname: Neuhaus
authors.forename: Christoph
authors.initials: C
authors.lastname: Heidenhain
authors.forename: Marcus
authors.initials: M
authors.lastname: Bahra
authors.forename: Peter
authors.initials: P
authors.lastname: Neuhaus
authors.forename: Ulf P
authors.initials: UP
authors.lastname: Neumann
mesh_terms: D000328:Adult; D005260:Female; D005355:Fibrosis; D005500:Follow-Up Studies; D005919:Glomerular Filtration Rate; D006084:Graft Rejection; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007668:Kidney / Q000473:pathology; D016031:Liver Transplantation / Q000009:adverse effects / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011446:Prospective Studies; D017211:Treatment Failure
chemical_list: D007166:Immunosuppressive Agents; D009173:Mycophenolic Acid