Document Detail

No dose-dependent tubulotoxicity of 5-aminosalicylic acid: a prospective study in patients with inflammatory bowel diseases.
MedLine Citation:
PMID:  12904998     Owner:  NLM     Status:  MEDLINE    
BACKGROUND AND AIMS: Elevated levels of renal tubular markers in the urine are found in 20-30% of patients with chronic inflammatory bowel diseases. We investigated whether this reflects a dose-dependent tubulotoxicity of 5-aminosalicylic acid (5-ASA). PATIENTS AND METHODS: In an open, prospective, multicenter study 18 patients with Crohn's disease and 29 with ulcerative colitis were treated with 3 g 5-ASA or more daily as the sole drug for 6 weeks. Clinical activity (CDAI, CAI) and renal tubular markers [beta-N-acetyl-D-glucosaminidase (beta-NAG) and other proteins in urine] were monitored. We examined whether the proportion of patients with elevated beta-NAG is more than 15% higher (absolute difference) than that prior to treatment. RESULTS: The proportion decreased from 19.2% to 12.8% in the intention-to-treat analysis (n=47) and from 24.3% to 13.5% in the per-protocol analysis (n=37), which was not more than 15% higher than at baseline. Mean CDAI decreased from 222 to 146 and mean CAI from 7.3 to 3.1 (intention-to-treat analysis). Response to therapy was shown by 61% of patients with Crohn's disease and 66% of patients with ulcerative colitis. The cumulative dose of 5-ASA was not correlated with beta-NAG level in the urine. CONCLUSION: This study largely rules out that 5-ASA at 3 g or higher per day for 6 weeks induces renal tubular damage. Elevated renal tubular markers reflect inflammatory activity or an extraintestinal manifestation of inflammatory bowel diseases.
Carsten Dehmer; Roland Greinwald; Juergen Löffler; Wolfgang Grotz; Lothar Wolf; Hans-Burkhardt Hagmann; Werner Schneider; Wolfgang Kreisel;
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Publication Detail:
Type:  Clinical Trial; Clinical Trial, Phase III; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't     Date:  2003-02-08
Journal Detail:
Title:  International journal of colorectal disease     Volume:  18     ISSN:  0179-1958     ISO Abbreviation:  Int J Colorectal Dis     Publication Date:  2003 Sep 
Date Detail:
Created Date:  2003-08-07     Completed Date:  2004-03-31     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  8607899     Medline TA:  Int J Colorectal Dis     Country:  Germany    
Other Details:
Languages:  eng     Pagination:  406-12     Citation Subset:  IM    
Department of Gastroenterology, Hepatology and Endocrinology, Medical Clinic, University of Freiburg, Hugstetter Strasse 55, 79106 Freiburg, Germany.
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MeSH Terms
Anti-Inflammatory Agents, Non-Steroidal / administration & dosage*
Biological Markers / blood,  urine
Crohn Disease / drug therapy*,  enzymology,  immunology
Dose-Response Relationship, Drug
Drug Administration Schedule
Hexosaminidases / urine*
Kidney Tubules / drug effects*
Mesalamine / administration & dosage*
Prospective Studies
Receptors, Interleukin-2 / blood
Receptors, Tumor Necrosis Factor / blood
Reg. No./Substance:
0/Anti-Inflammatory Agents, Non-Steroidal; 0/Biological Markers; 0/Receptors, Interleukin-2; 0/Receptors, Tumor Necrosis Factor; 89-57-6/Mesalamine; EC 3.2.1.-/Hexosaminidases; EC

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