| Improvement in 3-month patient-reported gastrointestinal symptoms after conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium in renal transplant patients. | |
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MedLine Citation:
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PMID: 18091520 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: The benefit of conversion from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPS) in terms of gastrointestinal symptom burden has been evaluated previously using patient-reported outcomes. However, data are lacking concerning the sustained effect of conversion over time, and the potential impact of concomitant calcineurin inhibitor. METHODS: In this 3-month, prospective, multicenter, longitudinal, open-label trial, MMF-treated renal transplant patients with gastrointestinal symptoms receiving cyclosporine or tacrolimus were converted to equimolar doses of EC-MPS. Change in gastrointestinal symptom burden was evaluated using a validated Gastrointestinal Symptom Rating Scale (GSRS). RESULTS: A significant improvement in GSRS score was observed from baseline (2.61, 95% CI 2.54-2.68) to month 1 (1.87, 95% CI 1.81-1.93) after conversion to EC-MPS and was sustained to month 3 (1.81, 95% CI 1.74-188; both P<0.0001 versus baseline). The mean change in overall GSRS score from baseline to month 1 was -0.74 overall (cyclosporine: -0.73 and tacrolimus: -0.74; all P<0.0001 versus baseline), with a slight further improvement (-0.79) at month 3 (cyclosporine: -0.82 and tacrolimus: -0.78; all P<0.0001 versus baseline). A significant improvement in GSRS subscale scores was also observed in the total population regardless of calcineurin inhibitor at month 1, sustained to month 3 (all P<0.0001 versus baseline). The improvement in GSRS score postconversion was similar in African-American and non-African-American patients, and in diabetic and nondiabetic patients. CONCLUSIONS: This exploratory study in 728 patients demonstrates that following conversion from MMF to EC-MPS, regardless of concomitant calcineurin inhibitor, GSRS is improved and sustained over 3 months. |
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Authors:
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Paul Bolin; Bekir Tanriover; Gazi B Zibari; Melissa L Lynn; John D Pirsch; Laurence Chan; Matthew Cooper; Anthony J Langone; Stephen J Tomlanovich |
Publication Detail:
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Type: Clinical Trial; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Transplantation Volume: 84 ISSN: 0041-1337 ISO Abbreviation: Transplantation Publication Date: 2007 Dec |
Date Detail:
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Created Date: 2007-12-19 Completed Date: 2008-01-29 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0132144 Medline TA: Transplantation Country: United States |
Other Details:
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Languages: eng Pagination: 1443-51 Citation Subset: IM |
Affiliation:
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Division of Nephrology and Hypertension, Brody School of Medicine at East Carolina University, Greenville, NC 27834, USA. bolinp@ecu.edu |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00150020 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adolescent Adult Aged Female Gastrointestinal Tract / drug effects* Humans Immune Tolerance / drug effects, immunology Kidney Transplantation* / immunology Male Middle Aged Mycophenolic Acid / administration & dosage, adverse effects, analogs & derivatives*, chemistry, pharmacology Questionnaires Sensitivity and Specificity Time Factors |
| Chemical | |
Reg. No./Substance:
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128794-94-5/mycophenolate mofetil; 24280-93-1/Mycophenolic Acid |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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