Colesevelam for the treatment of bile acid malabsorption-associated diarrhea in patients with Crohn's disease: A randomized,double-blind,placebo-controlled study |
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| Affiliation: | 1. Department of Medicine II, University Hospital Munich-Grosshadern, Ludwig-Maximilians-University Munich, Germany;2. Internal Practice, Leipzig, Germany;3. Internal Practice, Hamburg, Germany;4. Department of Medicine II, Saarland University Medical Center, Homburg, Germany;5. Department for Gastroenterology, Infectious Diseases and Rheumatology Charité-Berlin, Campus Benjamin Franklin, Berlin, Germany;6. Department of Medicine II, Krankenhaus Barmherzige Brüder, Munich, Germany;7. Isarmedizin Zentrum, Munich, Germany;1. IBD Center, Gastroenterology, Humanitas Research Hospital, Rozzano, Milan, Italy;2. IBD Center, Gastroenterology, La Source-Beaulieu, Lausanne, Switzerland;1. Department of Gastroenterology and Hepatology, University Hospital Basel, Basel, Switzerland;2. University of Applied Sciences Northwestern Switzerland (FHNW), Institute of Chemistry and Bioanalytics, Muttenz, Switzerland;1. Children''s Hospital Zagreb, University of Zagreb School of Medicine, Zagreb, Croatia;2. Hvidovre University Hospital, Copenhagen, Denmark;3. Department of Paediatrics, University Hospital Motol, Prague, Czech Republic;4. Children''s Hospital, University of Helsinki, Helsinki, Finland;5. Ospedale pediatrico Meyer, Florence, Italy;6. Department of Paediatric Surgery, University Hospital Motol, Prague, Czech Republic;1. Department of Gastroenterology, Sheba Medical Center, Sackler School of Medicine, Tel-Aviv University, Tel-Hashomer, Israel;2. Coagulation Unit, Hematology Department, Sheba Medical Center, Sackler School of Medicine, Tel-Aviv University, Tel-Hashomer, Israel;3. Radiology Department, Sheba Medical Center, Sackler School of Medicine, Tel-Aviv University, Tel-Hashomer, Israel;1. Department of Cardiovascular and Renal Research, Institute of Molecular Medicine, University of Southern Denmark, Odense, Denmark;2. Department of Pathology, Odense University Hospital, Denmark;3. Department of Gastroenterology, Hospital of Southwest Jutland, Esbjerg, Denmark;4. Department of Gastroenterology, Odense University Hospital, Denmark;5. Department of Pharmacology, University of CA, Davis, USA;6. Aragon Institute of Health Sciences & IIS and Fundación Agencia Aragonesa para la Investigación y Desarrollo (ARAID), 50009 Zaragoza, Spain;1. Department of Gastroenterology, Spital Tiefenau, Tiefenaustrasse 112, 3004 Bern, Switzerland;2. Department of Gastroenterology, Inselspital, University Hospital Bern, Switzerland;3. Department of Gastroenterology and Hepatology, University Hospital Lausanne, Lausanne, Switzerland;4. Department of Statistics, Faculty of Organizational Sciences, Belgrade, Serbia;5. Department of Gastroenterology, University Hospital Zvezdara, Belgrade, Serbia;6. Division of Clinical Pharmacology and Toxicology, University Hospital Zürich, Zürich, Switzerland;7. Department of Gastroenterology, Hospital Neuchâtel, Neuchâtel, Switzerland;8. Department of Gastroenterology, University Hospital Basel, Basel, Switzerland;9. Department of Gastroenterology and Hepatology, Stadtspital Triemli, Zürich, Switzerland;10. Department of Gastroenterology and Hepatology, University Hospital Zürich, Zürich, Switzerland;11. Department of Gastroenterology, See Spital, Horgen, Switzerland |
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| Abstract: | Background and AimsBile acid malabsorption (BAM)-associated diarrhea is an important clinical issue in patients with Crohn's disease (CD). We analyzed the efficacy and safety of the bile acid sequestrant colesevelam for treatment of BAM-associated diarrhea in CD patients in a randomized, double-blind, placebo-controlled study.MethodsThe primary endpoint was the proportion of patients with > 30% reduction of liquid stools/day from baseline to termination visit at week 4. Secondary endpoints were reduction of the number of liquid stools/day, improvement of stool consistency and quality of life.Results26 patients were analyzed in the intention-to-treat (ITT) analysis. The primary endpoint was reached by 10 patients (69.7%) in the colesevelam group compared to 3 patients (27.3%) in the placebo group (risk difference RD = .394, 95%CI:[− 0.012; 0.706]; P = .0566). In the per-protocol analysis (n = 22), the risk difference was statistically significant (RD = .470, 95%CI:[0.018; 0.788], P(H0: RD = 0) = 0.0364; 95% CI:[1.3;54.7]). Regarding secondary endpoints, in the ITT population colesevelam-treated patients had a significant reduction of liquid stools/day at week 4 (median 5.0 to 2.0; P = 0.01), while patients treated with placebo had no significant reduction (median 4.0 to 3.0; P = 0.42). Significantly more patients in the colesevelam group had improvement of stool consistency of at least one level in the Bristol stool chart, as compared to the placebo group (P = 0.003).ConclusionsWe found significant differences in favor for colesevelam treatment compared to placebo treatment for CD patients with BAM regarding the reduction of the number of liquid stools/day and stool consistency.ClinicalTrials.gov number: NCT01203254. |
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