title: Gastrointestinal quality of life improvement of renal transplant recipients converted from mycophenolate mofetil to enteric-coated mycophenolate sodium drugs or agents: mycophenolate mofetil and enteric-coated mycophenolate sodium.
abstract: BACKGROUND
  In renal transplant (RT) recipients, treatment with enteric-coated mycophenolate sodium (EC-MPS) improves gastrointestinal (GI) tolerability compared with mycophenolate mofetil (MMF). The impact of conversion from MMF to EC-MPS on patient's health-related quality of life (HRQoL) using GI-specific instruments has been scarcely evaluated in randomized trials.
  
  
  METHODS
  The present randomized, multicenter, open-labeled, 12-week study included RT recipients experiencing GI adverse events due to MMF treatment. Patients were randomized to continue with MMF (n=54) or change to EC-MPS (n=59). Patients were converted at equimolar doses, and dose was optimized between weeks 2 and 6 to achieve maximum tolerated dose.
  
  
  RESULTS
  Incidence of GI complications (particularly diarrhea) was significantly lower in the EC-MPS group (67.8% vs. 87.0%, P=0.015). The baseline-adjusted mean global scores at 12 weeks in GI quality of life index were significantly higher in the EC-MPS group versus MMF (P=0.014). Results at 12 weeks for all secondary scales indicated better HRQoL in the EC-MPS group compared with the MMF group (Gastrointestinal Symptom Rating Scale, Psychological General Well-Being Index, and overall treatment effect). In the EC-MPS group, a higher percentage of patients were receiving intermediate doses of mycophenolic acid (720 mg/day) at 12 weeks compared with MMF (55.4% vs. 27.4%, P=0.003), whereas no differences were observed for high doses (>720 mg/day).
  
  
  CONCLUSIONS
  In RT patients with GI undesirable effects due to MMF, switching from MMF to EC-MPS may enable an increase in the maximum tolerated dose of mycophenolic acid and reduce GI complications, thus enhancing patients' GI HRQoL.
authors.affiliation: H U Central de Asturias, Nephrology Department, Oviedo, Spain. fortega@hca.es
authors.forename: Francisco
authors.initials: F
authors.lastname: Ortega
authors.forename: Ana
authors.initials: A
authors.lastname: Sánchez-Fructuoso
authors.forename: José María
authors.initials: JM
authors.lastname: Cruzado
authors.forename: Juan Carlos
authors.initials: JC
authors.lastname: Gómez-Alamillo
authors.forename: Antonio
authors.initials: A
authors.lastname: Alarcón
authors.forename: Lluís
authors.initials: L
authors.lastname: Pallardó
authors.forename: José María
authors.initials: JM
authors.lastname: Morales
authors.forename: Juan
authors.initials: J
authors.lastname: Oliver
authors.forename: Guillermo
authors.initials: G
authors.lastname: Guinea
mesh_terms: D000328:Adult; D003967:Diarrhea / Q000139:chemically induced / Q000517:prevention & control; D005260:Female; D041981:Gastrointestinal Tract / Q000187:drug effects*; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D016030:Kidney Transplantation / Q000009:adverse effects* / Q000276:immunology; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives*; D011788:Quality of Life; D013608:Tablets, Enteric-Coated
chemical_list: D007166:Immunosuppressive Agents; D013608:Tablets, Enteric-Coated; D009173:Mycophenolic Acid