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

Abstract

BACKGROUND:

Crofelemer improves bowel function in several conditions characterized by states of prominent secretory diarrhea.

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).

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.

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.

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.

• Authors: Allen W Mangel, Pravin Chaturvedi
• Journal: Digestion (Digestion) Vol. 78 Issue 4 Pg. 180-6 ( 2008) ISSN: 1421-9867 [Electronic] Switzerland
• PMID: 19092244 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Plant Extracts
• Proanthocyanidins
• crofelemer

Topics

• Adult
• Croton (chemistry)
• Diarrhea (etiology)
• Double-Blind Method
• Female
• Gastrointestinal Diseases (chemically induced)
• Humans
• Irritable Bowel Syndrome (complications, drug therapy)
• Male
• Middle Aged
• Pain (etiology, physiopathology)
• Plant Extracts (adverse effects, therapeutic use)
• Proanthocyanidins (adverse effects, therapeutic use)
• Sex Factors
• Treatment Outcome