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Evaluation of crofelemer in the treatment of diarrhea-predominant irritable bowel syndrome patients.
- 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.
- Subjects :
- Adult
Double-Blind Method
Female
Gastrointestinal Diseases chemically induced
Humans
Male
Middle Aged
Pain etiology
Pain physiopathology
Plant Extracts adverse effects
Proanthocyanidins adverse effects
Sex Factors
Treatment Outcome
Croton chemistry
Diarrhea etiology
Irritable Bowel Syndrome complications
Irritable Bowel Syndrome drug therapy
Plant Extracts therapeutic use
Proanthocyanidins therapeutic use
Subjects
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