Randomized Clinical Trial: Crofelemer Treatment in Women With Diarrhea-Predominant Irritable Bowel Syndrome
| Autor: | Ha-Neul Lee, Vikram Rangan, Jesse Katon, Eve Takazawa, Thomas Sommers, Johanna Iturrino, Prashant Singh, Andrew Ludwig, Katherine Salley, Sarah Ballou, Sarah Duehren, Anthony Lembo, Judy Nee |
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| Rok vydání: | 2019 |
| Předmět: |
Adult
Diarrhea medicine.medical_specialty Abdominal pain Analgesic Placebo Article Drug Administration Schedule law.invention Irritable Bowel Syndrome 03 medical and health sciences 0302 clinical medicine Double-Blind Method Gastrointestinal Agents Randomized controlled trial law Internal medicine Clinical endpoint medicine Humans Proanthocyanidins Functional GI Disorders Antidiarrheals Irritable bowel syndrome Pain Measurement Gastrointestinal agent business.industry Gastroenterology Crofelemer Middle Aged medicine.disease United States Abdominal Pain Treatment Outcome 030220 oncology & carcinogenesis Female 030211 gastroenterology & hepatology medicine.symptom business Follow-Up Studies |
| Zdroj: | Clinical and Translational Gastroenterology |
| ISSN: | 2155-384X |
| Popis: | Introduction Crofelemer, the active compound purified from latex of Croton lechleri, has been shown to improve HIV and traveler's diarrhea and improve pain in women with irritable bowel syndrome-diarrhea (IBS-D). This trial evaluated the effect of crofelemer on abdominal pain in women with IBS-D. Methods Women with IBS-D were randomized to crofelemer (125 mg) or placebo twice daily for 12 weeks. The primary efficacy endpoint was overall change in percentage of abdominal pain/discomfort-free days. Post hoc analysis for Food and Drug Administration (FDA) monthly responders was performed for stool consistency, abdominal pain, and combined stool consistency and abdominal pain. Results A total of 240 women were enrolled. There was no significant difference in overall percentage of pain/discomfort-free day between the groups. In post hoc analysis, FDA abdominal pain monthly responders were significantly more likely during months 1 through 2 (58.3% vs 45.0%, P = 0.030) as well as during the entire 3 months (54.2% vs 42.5%, P = 0.037) in the crofelemer group when compared with placebo. However, there was no significant difference in the percentage of FDA stool consistency monthly responders or combined stool consistency and pain monthly responders between the groups. Crofelemer had a safety profile similar to placebo. Discussion Crofelemer did not significantly improve abdominal pain over placebo by the primary endpoint. However, it did based on the FDA abdominal pain monthly responder endpoint. This suggests that crofelemer may have a role in the treatment of abdominal pain associated with IBS-D. Further studies are warranted to evaluate the potential of crofelemer as a visceral analgesic. |
| Databáze: | OpenAIRE |
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