Randomized Trial of 2 Delayed-Release Formulations of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation Article Swipe
William D. Chey
,
Gregory S. Sayuk
,
Wilmin Bartolini
,
David S. Reasner
,
Susan M. Fox
,
Wieslaw Bochenek
,
Ramesh Boinpally
,
Elizabeth P. Shea
,
Kenneth Tripp
,
Niels Borgstein
·
YOU?
·
· 2020
· Open Access
·
· DOI: https://doi.org/10.14309/ajg.0000000000000967
YOU?
·
· 2020
· Open Access
·
· DOI: https://doi.org/10.14309/ajg.0000000000000967
INTRODUCTION: Immediate-release (IR) formulation of linaclotide 290 μg improves abdominal pain and constipation (APC) in patients with irritable bowel syndrome (IBS) with constipation. Delayed-release (DR) formulations were developed on the premise that targeting the ileum (delayed-release formulation 1 [DR1]) or ileocecal junction and cecum (MD-7246, formerly DR2) would modulate linaclotide's secretory effects while preserving pain relief effects. METHODS: This phase 2b study randomized patients with IBS with constipation to placebo or 1 of 7 once-daily linaclotide doses (DR1 30, 100, or 300 μg; MD-7246 30, 100, or 300 μg; or IR 290 μg) for 12 weeks. Key efficacy endpoints were change from baseline in abdominal pain and complete spontaneous bowel movement frequency, and 6/12-week combined APC+1 responder rate. RESULTS: Overall, 532 patients were randomized; mean age was 45.1 years, and most were women (83.3%) and White (64.7%). All linaclotide DR1 and MD-7246 groups experienced greater improvements in abdominal pain from baseline and vs placebo throughout treatment. Linaclotide DR1 and IR led to numerically greater improvements from baseline in complete spontaneous bowel movement frequency and higher APC+1 responder rates compared with placebo; MD-7246 results were similar to placebo. Diarrhea was the most common adverse event with DR1 and IR; rates were similar between MD-7246 and placebo. DISCUSSION: Altering the site of drug delivery in the intestine might uncouple linaclotide's pain relief from secretory effects. Persistent, modest abdominal pain improvement with limited impact on bowel symptom parameters, as seen across MD-7246 doses, warrants further study of MD-7246 as a novel treatment for abdominal pain, regardless of IBS subtype.
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Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.14309/ajg.0000000000000967
- OA Status
- green
- Cited By
- 53
- References
- 27
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W3092931770
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
-
https://openalex.org/W3092931770Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.14309/ajg.0000000000000967Digital Object Identifier
- Title
-
Randomized Trial of 2 Delayed-Release Formulations of Linaclotide in Patients With Irritable Bowel Syndrome With ConstipationWork title
- Type
-
articleOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2020Year of publication
- Publication date
-
2020-10-15Full publication date if available
- Authors
-
William D. Chey, Gregory S. Sayuk, Wilmin Bartolini, David S. Reasner, Susan M. Fox, Wieslaw Bochenek, Ramesh Boinpally, Elizabeth P. Shea, Kenneth Tripp, Niels BorgsteinList of authors in order
- Landing page
-
https://doi.org/10.14309/ajg.0000000000000967Publisher landing page
- Open access
-
YesWhether a free full text is available
- OA status
-
greenOpen access status per OpenAlex
- OA URL
-
https://www.ncbi.nlm.nih.gov/pmc/articles/8279899Direct OA link when available
- Concepts
-
Medicine, Irritable bowel syndrome, Constipation, Randomized controlled trial, Internal medicine, Gastroenterology, Lubiprostone, Chronic constipationTop concepts (fields/topics) attached by OpenAlex
- Cited by
-
53Total citation count in OpenAlex
- Citations by year (recent)
-
2025: 3, 2024: 33, 2023: 1, 2022: 5, 2021: 9Per-year citation counts (last 5 years)
- References (count)
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27Number of works referenced by this work
- Related works (count)
-
10Other works algorithmically related by OpenAlex
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| sustainable_development_goals[0].score | 0.8399999737739563 |
| sustainable_development_goals[0].display_name | Good health and well-being |
| citation_normalized_percentile.value | 0.89859065 |
| citation_normalized_percentile.is_in_top_1_percent | False |
| citation_normalized_percentile.is_in_top_10_percent | True |