title: Patient-reported gastrointestinal symptom burden and health-related quality of life following conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium.
abstract: BACKGROUND
  The benefit of converting renal transplant recipients with gastrointestinal (GI) complaints from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPS) has not been evaluated using patient-reported outcomes.
  
  
  METHODS
  A multicenter, open-label, prospective study was undertaken in MMF-treated renal transplant patients. Patients experiencing GI complaints were converted to equimolar EC-MPS (Cohort A). Patients without GI complaints remained on MMF (Cohort B). At baseline and Visit 2 (4-6 weeks postbaseline), patients completed the Gastrointestinal Symptom Rating Scale (GSRS), Gastrointestinal Quality of Life Index (GIQLI) and Psychological General Well-being Index (PGWBI). At Visit 2, patients and physicians completed the Overall Treatment Effect (OTE) scale for GI symptoms. Additionally, patients completed the OTE for health-related quality of life (HRQoL). Minimal important difference (MID) was calculated for GSRS and GIQLI based on patients' and physicians' OTE evaluation.
  
  
  RESULTS
  Of 328 patients enrolled (i.e. the intent-to-treat and safety populations), 278 formed the per-protocol population (Cohort A, n=177; Cohort B, n=101). At baseline, Cohort A had significantly worse scores on all GSRS, GIQLI and PGWBI subscales compared to Cohort B (all P<0.0001). All GSRS, GIQLI and PGWBI subscale scores improved significantly in Cohort A between baseline and Visit 2 (all P<0.0001). Mean improvements in all GSRS subscales and most GIQLI subscores exceeded the calculated MID. GSRS, GIQLI and PGWBI subscales remained stable in Cohort B.
  
  
  CONCLUSIONS
  This first exploratory study indicates that converting patients with mild, moderate or severe GI complaints from MMF to EC-MPS significantly reduces GI-related symptom burden and improves patient functioning and well-being.
authors.affiliation: University Colorado Health Sciences Center, Denver, CO 80262, USA, and Royal Melbourne Hospital, Parkville, Australia. larry.chan@uchsc.edu
authors.forename: Laurence
authors.initials: L
authors.lastname: Chan
authors.forename: Shamkant
authors.initials: S
authors.lastname: Mulgaonkar
authors.forename: Rowan
authors.initials: R
authors.lastname: Walker
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Arns
authors.forename: Patrice
authors.initials: P
authors.lastname: Ambühl
authors.forename: Ruben
authors.initials: R
authors.lastname: Schiavelli
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D001294:Attitude to Health; D015331:Cohort Studies; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced*; D006304:Health Status; D006801:Humans; D016030:Kidney Transplantation / Q000276:immunology / Q000502:physiology*; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011788:Quality of Life; D013608:Tablets, Enteric-Coated; D016896:Treatment Outcome
chemical_list: D013608:Tablets, Enteric-Coated; D009173:Mycophenolic Acid