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Eluxadoline for Irritable Bowel Syndrome with Diarrhea
Open accessAbstract
Background Effective and safe treatments are needed for patients who have irritable bowel syndrome (IBS) with diarrhea. We conducted two phase 3 trials to assess the efficacy and safety of eluxadoline, a new oral agent with mixed opioid effects (μ- and κ-opioid receptor agonist and δ-opioid receptor antagonist), in patients with IBS with diarrhea. Methods We randomly assigned 2427 adults who had IBS with diarrhea to eluxadoline (at a dose of 75 mg or 100 mg) or placebo twice daily for 26 weeks (IBS-3002 trial) or 52 weeks (IBS-3001 trial). The primary end point was the proportion of patients who had a composite response of decrease in abdominal pain and improvement in stool consistency on the same day for at least 50% of the days from weeks 1 through 12 and from weeks 1 through 26. Results For weeks 1 through 12, more patients in the eluxadoline groups (75 mg and 100 mg) than in the placebo group reached the primary end point (IBS-3001 trial, 23.9% with the 75-mg dose and 25.1% with the 100-mg dose vs. 17.1% with placebo; P=0.01 and P=0.004, respectively; IBS-3002 trial, 28.9% and 29.6%, respectively, vs. 16.2%; P<0.001 for both comparisons). For weeks 1 through 26, the corresponding rates in IBS-3001 were 23.4% and 29.3% versus 19.0% (P=0.11 and P<0.001, respectively), and the corresponding rates in IBS-3002 were 30.4% and 32.7% versus 20.2% (P=0.001 and P<0.001, respectively). The most common adverse events associated with 75 mg of eluxadoline and 100 mg of eluxadoline, as compared with placebo, were nausea (8.1% and 7.5% vs. 5.1%), constipation (7.4% and 8.6% vs. 2.5%), and abdominal pain (5.8% and 7.2% vs. 4.1%). Pancreatitis developed in 5 (2 in the 75-mg group and 3 in the 100-mg group) of the 1666 patients in the safety population (0.3%). Conclusions Eluxadoline is a new therapeutic agent that reduced symptoms of IBS with diarrhea in men and women, with sustained efficacy over 6 months in patients who received the 100-mg dose twice daily. (Funded by Furiex Pharmaceuticals, an affiliate of Allergan; IBS-3001 and IBS-3002 ClinicalTrials.gov numbers, NCT01553591 and NCT01553747 , respectively.).
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“…was able to have a signi fi cant effect in terms of FDA and EMA endpoints, while the 75 mg formulation reached ef fi cacy only for FDA criteria, 85 other than ameliorating stool consistency, frequency, urgency, adequate relief of IBS symptoms, global symptom scores, and scores on IBS-quality…”
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“So wurde zum Beispiel für den bei Reizdarmbeschwerden vom DiarrhöTyp zugelassenen Wirkstoff Eluxadolin eine zwar schwache, aber immerhin statistisch signifikante Überlegenheit gegenüber Placebo nachgewiesen, dafür aber auch das Auftreten von Pankreatitis in 0,3 % der behandelten Patienten [4].”
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Diagnosis dan Tatalaksana Irritable Bowel Syndrome
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افزایش سطوح سایتوکاین های التهابی IL-6 و TNF-α در سرم بیماران مبتلا به سندرم روده تحریک پذیر
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Letter: eluxadoline‐associated acute pancreatitis—myth or reality? Authors’ reply
Harinstein, L., Wu, E., & Brinker, A. (2018) · Alimentary Pharmacology and Therapeutics · doi:10.1111/apt.14851
“Importantly, in the two phase 3 trials, five cases of pancreatitis and eight of sphincter of Oddi spasm (SOS) occurred in the eluxadoline treatment groups (N = 1666); more events occurred with the eluxadoline 100 mg dose (n = 10) than the 75 mg dose (n = 3) to suggest a drug-associated effect.(3,5) No cases of pancrea…”
BackgroundResultNeue Optionen gegen Reizdarm in Sicht
Wettstein, M. (2017) · MMW - Fortschritte der Medizin · doi:10.1007/s15006-017-9582-9
Snyder, L. M., Omori, Y., Hachisuka, J., Adelman, P., Hu, Z., Fulton, S., Sypeck, E., Huang, H.-Z., Cai, X., Scherrer, G., et al. (2017) · Journal of Pain · doi:10.1016/j.jpain.2017.02.369
Behandlung des Reizdarmsyndroms
Loeliger, B. (2017) · pharma-kritik · doi:10.37667/pk.2016.1009
Neue Hoffnung für Reizdarmpatienten
Füessl, H. (2016) · MMW - Fortschritte der Medizin · doi:10.1007/s15006-016-8770-3
Dietary therapy for irritable bowel syndrome
Lebwohl, B., & Green, P. (2016) · British medical journal · doi:10.1136/bmj.i3902
IBS: Treating IBS with diarrhoea
Dickson, I. (2016) · Nature Reviews Gastroenterology &Hepatology · doi:10.1038/nrgastro.2016.15
Louwies, T., & Meerveld, B. (2021) · Reference Module in Biomedical Sciences · doi:10.1016/b978-0-12-820472-6.00037-2
Vanderberg, R., Lu, A. D., & Hashash, J. G. (2020) · Sex- and Gender-Based Women's Health · doi:10.1007/978-3-030-50695-7_27
Kingsley, M. J., & Moshiree, B. (2019) · Elsevier eBooks · doi:10.1016/b978-0-12-813037-7.00030-3 · Cited by 1
Assouline-Dayan, Y. (2018) · Springer eBooks · doi:10.1007/978-3-319-59352-4_38
Metadata
- Authors
- Lembo, A. J., Lacy, B. E., Zuckerman, M. J., Schey, R., Dove, L. S., Andrae, D. A., Davenport, J. M., McIntyre, G., Lopez, R., Turner, L., & Covington, P. S.
- Affiliations
- Dartmouth College (US)
- Texas Tech University Health Sciences Center (US)
- Temple University (US)
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2016-01-21
- Volume
- 374
- Issue
- 3
- Pages
- 242-253
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2330377679
- Cited by
- 334
- References
- 0
- Citations by year
- 2026: 21 · 2025: 23 · 2024: 23 · 2023: 19 · 2022: 27 · 2021: 40 · 2020: 31 · 2019: 31 · 2018: 41 · 2017: 49 · 2016: 27
- FWCI
- 54.37
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Infant Health and Development
- Health Sciences › Medicine › Gastroenterology › Inflammatory Bowel Disease
- Keywords
- eluxadoline, irritable bowel syndrome with diarrhea, mu-opioid receptor agonists, kappa opioid receptor agonists, delta-opioid receptor antagonists, abdominal pain, stool consistency, drug safety and efficacy, nausea, constipation, adverse events, dose comparison
- MeSH terms
- Adult, Aged, Diarrhea, Dose-Response Relationship, Drug, Female, Humans, Imidazoles, Male, Middle Aged, Pancreatitis, Phenylalanine, Abdominal Pain, Irritable Bowel Syndrome
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