Document Detail


Improvement in 3-month patient-reported gastrointestinal symptoms after conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium in renal transplant patients.
MedLine Citation:
PMID:  18091520     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
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:
Type:  Clinical Trial; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Transplantation     Volume:  84     ISSN:  0041-1337     ISO Abbreviation:  Transplantation     Publication Date:  2007 Dec 
Date Detail:
Created Date:  2007-12-19     Completed Date:  2008-01-29     Revised Date:  2013-05-29    
Medline Journal Info:
Nlm Unique ID:  0132144     Medline TA:  Transplantation     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1443-51     Citation Subset:  IM    
Affiliation:
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.:
ClinicalTrials.gov/NCT00150020
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MeSH Terms
Descriptor/Qualifier:
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:
24280-93-1/Mycophenolic Acid; 9242ECW6R0/mycophenolate mofetil

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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