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Evaluation of crofelemer in the treatment of diarrhea-predominant irritable bowel syndrome patients.

Authors :
Mangel AW
Chaturvedi P
Source :
Digestion [Digestion] 2008; Vol. 78 (4), pp. 180-6. Date of Electronic Publication: 2008 Dec 18.
Publication Year :
2008

Abstract

Background: Crofelemer improves bowel function in several conditions characterized by states of prominent secretory diarrhea.<br />Aim: This double-blind, randomized, placebo-controlled trial evaluated the effects of 3 dose levels of crofelemer in patients with diarrhea-predominant irritable bowel syndrome (D-IBS).<br />Methods: Male and female patients were randomly assigned to receive crofelemer 125, 250 or 500 mg or placebo twice daily for 12 weeks. The primary efficacy measure was a responder for improvement in stool consistency. In addition, abdominal pain- and discomfort-free days, pain and discomfort scores as well as other bowel function parameters (such as stool frequency and consistency, urgency, bloating) were evaluated.<br />Results: Two hundred and forty-two D-IBS patients were randomized. Crofelemer did not produce significant improvement in stool consistency (primary endpoint), stool frequency, urgency or adequate relief. However, female D-IBS patients showed improvement in the proportion of pain- and discomfort-free days during treatment with 500 mg crofelemer: month 1 (crofelemer vs. placebo: 17.7 vs. 10.2%, p = 0.098); month 2 (23.5 vs. 13.3%, p = 0.076); month 3 (26.1 vs. 10.6%, p = 0.0076). No benefit was seen in male D-IBS patients. Crofelemer was well tolerated.<br />Conclusions: Crofelelmer did not produce benefit on bowel function; an increase in the number of pain- and discomfort-free days in female D-IBS patients was seen. Further studies with crofelemer are warranted to evaluate it as a potential visceral analgesic.

Details

Language :
English
ISSN :
1421-9867
Volume :
78
Issue :
4
Database :
MEDLINE
Journal :
Digestion
Publication Type :
Academic Journal
Accession number :
19092244
Full Text :
https://doi.org/10.1159/000185719