Eluxadoline Efficacy in IBS-D Patients Who Report Prior Loperamide Use
Autor: | Paul S. Covington, William D. Chey, Anthony Lembo, Brian E. Lacy, Brooks D. Cash, Leonard S. Dove |
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Rok vydání: | 2017 |
Předmět: |
Adult
Diarrhea Male Loperamide medicine.medical_specialty Eluxadoline Phenylalanine Gastroenterology law.invention Irritable Bowel Syndrome 03 medical and health sciences 0302 clinical medicine Double-Blind Method Gastrointestinal Agents Randomized controlled trial law Internal medicine medicine Humans In patient 030212 general & internal medicine Antidiarrheals Functional GI Disorders Irritable bowel syndrome Pain Measurement Hepatology business.industry Imidazoles Middle Aged medicine.disease Abdominal Pain Clinical trial Anesthesia Female 030211 gastroenterology & hepatology Symptom Assessment medicine.symptom business Previously treated medicine.drug |
Zdroj: | The American Journal of Gastroenterology |
ISSN: | 0002-9270 |
Popis: | Objectives: Irritable bowel syndrome with diarrhea (IBS-D) is often managed with over-the-counter therapies such as loperamide, though with limited success. This analysis evaluated the efficacy of eluxadoline in patients previously treated with loperamide in two phase 3 studies. Methods: Adults with IBS-D (Rome III criteria) were enrolled and randomized to placebo or eluxadoline (75 or 100 mg) twice daily for 26 (IBS-3002) or 52 (IBS-3001) weeks. Patients reported loperamide use over the previous year and recorded their rescue loperamide use during the studies. The primary efficacy end point was the proportion of patients with a composite response of simultaneous improvement in abdominal pain and reduction in diarrhea. Results: A total of 2,428 patients were enrolled; 36.0% reported prior loperamide use, of whom 61.8% reported prior inadequate IBS-D symptom control with loperamide. Among patients with prior loperamide use, a greater proportion treated with eluxadoline (75 and 100 mg) were composite responders vs. those treated with placebo with inadequate prior symptom control, over weeks 1–12 (26.3% (P=0.001) and 27.0% (P |
Databáze: | OpenAIRE |
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