No dose-dependent tubulotoxicity of 5-aminosalicylic acid: a prospective study in patients with inflammatory bowel diseases |
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Authors: | Carsten?Dehmer,Roland?Greinwald,Juergen?L?ffler,Wolfgang?Grotz,Lothar?Wolf,Hans-Burkhardt?Hagmann,Werner?Schneider,Wolfgang?Kreisel author-information" > author-information__contact u-icon-before" > mailto:kreisel@med.ukl.uni-freiburg.de" title=" kreisel@med.ukl.uni-freiburg.de" itemprop=" email" data-track=" click" data-track-action=" Email author" data-track-label=" " >Email author,and the German Salofalk? Study Group |
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Affiliation: | Department of Gastroenterology, Hepatology and Endocrinology, Medical Clinic, University of Freiburg, Hugstetter Strasse 55, 79106 Freiburg, Germany. |
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Abstract: | 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. |
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