title: Reduction of gastrointestinal complications in renal graft recipients after conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium.
abstract: Gastrointestinal (GI) complications such as diarrhea or indigestion frequently occur in renal graft recipients treated with mycophenolate mofetil (MMF), requiring dose reductions to reduce side effects, thereby increasing the risk of rejection episodes and graft loss. In a prospective clinical trial, the immunosuppressive therapy of renal graft recipients was converted from MMF to enteric-coated mycophenolate sodium (EC-MPS) to identify a strategy to reduce GI symptoms without dose reduction. At baseline and 6-8 weeks later patients filled in 4 questionnaires related to GI symptoms and general and health-related quality of life. In 15 German study centers, 196 renal graft recipients (mean age 49.5 ± 13.5 years; male/female, 120/76) were included; 51.0% of patients suffered from GI complications at baseline. The Gastrointestinal Symptom Rating Scale score decreased significantly (P < .001) in patients with GI complications from 2.61 ± 0.86 at baseline to 2.14 ± 0.86 at visit 2. Health-related and general quality of life improved significantly. Fifty percent of patients with GI symptoms and 34% of the total per protocol population reported an improvement of their physical condition after converting the medication. In conclusion, conversion from MMF to EC-MPS reduces GI complications in renal graft recipients, reduces the patients' physical discomfort, and maintains their quality of life. (ClinicalTrials.gov number NCT00149968.).
authors.affiliation: Department of Nephrology, University Hospital Charité, Berlin, Germany.
authors.forename: P
authors.initials: P
authors.lastname: Reinke
authors.forename: K
authors.initials: K
authors.lastname: Budde
authors.forename: C
authors.initials: C
authors.lastname: Hugo
authors.forename: P
authors.initials: P
authors.lastname: Petersen
authors.forename: P
authors.initials: P
authors.lastname: Schnuelle
authors.forename: L
authors.initials: L
authors.lastname: Fricke
authors.forename: D
authors.initials: D
authors.lastname: Scholz
authors.forename: H
authors.initials: H
authors.lastname: Sperschneider
authors.forename: U
authors.initials: U
authors.lastname: Bahner
authors.forename: S
authors.initials: S
authors.lastname: Kramer
authors.forename: W
authors.initials: W
authors.lastname: Fischer
authors.forename: W
authors.initials: W
authors.lastname: Arns
mesh_terms: D004304:Dosage Forms; D041981:Gastrointestinal Tract / Q000503:physiopathology*; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects*; D016030:Kidney Transplantation / Q000009:adverse effects; D009173:Mycophenolic Acid / Q000009:adverse effects / Q000031:analogs & derivatives*; D011788:Quality of Life
chemical_list: D004304:Dosage Forms; D007166:Immunosuppressive Agents; D009173:Mycophenolic Acid