title: Conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium in renal transplant recipients with gastrointestinal tract disorders.
abstract: OBJECTIVE
  The objective of this prospective study was to evaluate the effect of conversion from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPS) in renal transplant recipients with gastrointestinal tract (GI) reverse effects using patient-reported outcomes instrument.
  
  
  METHODS
  A multicenter, open-label, prospective study was undertaken in renal transplant recipients treated with MMF. In patients experiencing GI tract symptoms, treatment was changed to equimolar EC-MPS (myfortic). At baseline and visit 2 (4-6 weeks after baseline), patients completed the Gastrointestinal Symptom Rating Scale (GSRS) and Gastrointestinal Quality of Life Index (GIQLI), and physicians completed the Overall Treatment Effect (OTE) scale at visit 2. A difference of 0.5 or greater in the OTE score is indicative of clinical relevance.
  
  
  RESULTS
  Of 154 patients screened, 118 fulfilled the inclusion or exclusion criteria. Eighty-five men and 33 women with a mean age of 41.6 years participated in this study. Median time since transplantation was 12 months. Mean (SD) dose of MMF reported at baseline was 1209.4 (422.89) mg/d. More than 50% of patients reported MMF-associated nausea, dyspepsia, and abdominal pain. After conversion to an equimolar dose of EC-MPS, patients showed improvement in GI symptoms. This benefit was predominantly observed in patients with moderate to severe symptoms at baseline. On the GSRS, patients reported a significant (P < .05) reduction in symptom burden across all parameters (reflux, 36%; diarrhea, 38%; indigestion, 36%; constipation, 28%; and abdominal pain, 40%). On the GIQLI also, significant (P < .05) improvement was reported (symptoms, 18%; emotional status, 22%; physical functioning, 21%, and use of medical treatment, 18%). On the OTE scale, 84.7% of patients reported improvement in GI symptoms.
  
  
  CONCLUSIONS
  In patients with moderate to severe GI symptoms, changing treatment from MMF to EC-MPS significantly reduces GI-related symptom burden and improves GI-specific quality of life.
authors.affiliation: Gujarat Kidney Foundation, Ahmedabad, India. drprakash-darji@hotmail.com
authors.forename: P
authors.initials: P
authors.lastname: Darji
authors.forename: R
authors.initials: R
authors.lastname: Vijayaraghavan
authors.forename: C M
authors.initials: CM
authors.lastname: Thiagarajan
authors.forename: R K
authors.initials: RK
authors.lastname: Sharma
authors.forename: B
authors.initials: B
authors.lastname: Subbarao
authors.forename: R
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authors.lastname: Pishardy
authors.forename: K V
authors.initials: KV
authors.lastname: Dakshinamurthy
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authors.initials: R
authors.lastname: Vijaykumar
authors.forename: G
authors.initials: G
authors.lastname: Abraham
authors.forename: S
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authors.lastname: Bhaskar
authors.forename: L
authors.initials: L
authors.lastname: Agarwal
authors.forename: B
authors.initials: B
authors.lastname: Shah
authors.forename: A
authors.initials: A
authors.lastname: Abraham
authors.forename: M
authors.initials: M
authors.lastname: John
authors.forename: K
authors.initials: K
authors.lastname: Sampathkumar
authors.forename: T
authors.initials: T
authors.lastname: Das
authors.forename: L
authors.initials: L
authors.lastname: Umesh
authors.forename: S
authors.initials: S
authors.lastname: Sundar
authors.forename: H
authors.initials: H
authors.lastname: Ballal
authors.forename: S
authors.initials: S
authors.lastname: Jasuja
authors.forename: S
authors.initials: S
authors.lastname: Saxena
authors.forename: T K
authors.initials: TK
authors.lastname: Saha
mesh_terms: D000328:Adult; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced* / Q000145:classification / Q000188:drug therapy; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use; D016030:Kidney Transplantation / Q000276:immunology*; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D011446:Prospective Studies; D011795:Surveys and Questionnaires; D013608:Tablets, Enteric-Coated; D014019:Tissue Donors / Q000706:statistics & numerical data; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D013608:Tablets, Enteric-Coated; D009173:Mycophenolic Acid