title: Improvement in gastrointestinal and health-related quality of life outcomes after conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium in liver transplant recipients.
abstract: OBJECTIVE
  To evaluate improvement in gastrointestinal (GI) symptoms and health-related quality of life (HRQoL) in liver transplant recipients switched from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPS).
  
  
  METHODS
  A multicenter, open-label, single-arm study was undertaken in maintenance liver transplant recipients who reported GI complications with MMF therapy. The patients were switched to equimolar doses of EC-MPS at baseline. The primary end point was the change in the Gastrointestinal Symptom Rating Scale (GSRS) total score after 6 to 8 weeks of treatment with EC-MPS. Other key assessments for GI symptoms and HRQoL included the GSRS subscores, the Gastrointestinal Quality of Life Index (GIQLI), the Psychological General Well-Being Index, and the Overall Treatment Effect (OTE). Paired t-test was used to assess the difference in the mean score changes over time.
  
  
  RESULTS
  A total of 34 patients were enrolled and switched to equimolar doses of EC-MPS. After 6 to 8 weeks of EC-MPS treatment, mean GSRS total score improved significantly from 2.88 ± 0.66 to 2.10 ± 0.78. Mean improvement in GSRS total score (-0.77 score points; P = .001) exceeded the minimal clinically important difference. Significant improvements were observed in all GSRS subscales (P < .05), GIQLI total scores (P = .001), and GIQLI subscales "GI symptoms" (P < .001) and "physical function" (0.013). Patients who continued EC-MPS reported sustained benefits compared with patients who switched back to MMF after 6 to 8 weeks of treatment with EC-MPS. On the OTE scale, improvement in symptoms was reported in 76.5% and 61.8% of the patients as perceived by the physicians and the patients. Improvement in HRQoL was reported by 41.2% of the patients. No deaths, biopsy proven acute rejections, or graft losses were reported during the study.
  
  
  CONCLUSIONS
  Conversion from MMF to EC-MPS was associated with a significant improvement in GI symptoms and HRQoL in liver transplant recipients.
authors: Universitätsklinikum, Hamburg-Eppendorf, Hamburg, Germany. Electronic address: sterneck@uke.de.
authors: M
authors: M
authors: Sterneck
authors: Universitätsklinikum Jena, Lobeda, Jena, Germany.
authors: U
authors: U
authors: Settmacher
authors: Universitätsklinikum Heidelberg, Heidelberg, Germany.
authors: T
authors: T
authors: Ganten
authors: (d)Klinikum Joh.Wolfg.Goethe-UNI Zentrum d.Inneren Medizin Medizinische Klinik I, Frankfurt, Hessen, Deutschland, Germany.
authors: C
authors: C
authors: Sarrazin
authors: (e)Universitätsklinikum Bonn (AöR), Bonn, Germany.
authors: N
authors: N
authors: Speidel
authors: Klinik für Allgemeine Chirurgie und Thoraxchirurgie, Kiel, Germany.
authors: D
authors: D
authors: Broering
authors: Universitätsklinikum Tübingen, Medizinische Klinik IV, Sektion Nieren- und Hochdruckkrankheiten, Tübingen, Germany.
authors: N
authors: N
authors: Heyne
authors: Stefan Scheidl, Novartis Pharma GmbH, Nuernberg, Germany.
authors: E
authors: E
authors: Paulus
authors: Stefan Scheidl, Novartis Pharma GmbH, Nuernberg, Germany.
authors: M
authors: M
authors: Mertens
authors: Universitätsklinikum, Hamburg-Eppendorf, 20246 Hamburg, Germany.
authors: L
authors: L
authors: Fischer
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced* / Q000150:complications / Q000523:psychology; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects; D017093:Liver Failure / Q000150:complications / Q000523:psychology / Q000601:surgery*; D016031:Liver Transplantation; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000009:adverse effects / Q000031:analogs & derivatives*; D011788:Quality of Life; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D013608:Tablets, Enteric-Coated; D066027:Transplant Recipients; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D013608:Tablets, Enteric-Coated; D009173:Mycophenolic Acid