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Cited by 114Gastrointestinal motility and disordersDrug Transport and Resistance MechanismsDrug Solubulity and Delivery Systems

The DOI matches its Crossref record; 20 of the 20 references it cites were found in a registry or an index.

Randomised clinical trial: the ileal bile acid transporter inhibitor A3309 vs. placebo in patients with chronic idiopathic constipation - a double-blind study: Randomised clinical trial: the ASBT/IBAT inhibitor A3309 in constipation

Simrén, M., Bajor, A., Gillberg, P.-G., Rudling, M., Abrahamsson, H.·2011·Alimentary Pharmacology & Therapeutics
DOI 10.1111/j.1365-2036.2011.04675.x
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Abstract

BACKGROUND: One half of patients with constipation are not satisfied with available therapies, hence there is a need for more effective and well-tolerated drugs. AIM: To evaluate the effects of a specific inhibitor of the Ileal Bile Acid Transporter (IBAT; syn apical sodium-dependent bile acid transporter; ASBT) in patients with chronic idiopathic constipation (CIC) with focus on safety, colonic transit and efficacy signals. METHODS: This was a single-centre, prospective, randomised, double-blind, placebo-controlled study with a dose-escalating design in patients with CIC. In addition to evaluation of conventional safety and tolerability parameters, (i) colonic transit time (CTT) was measured using radio-opaque markers, (ii) metabolic parameters [lipid profile, C4 (7α-hydroxy-4-cholesten-3-one) and FGF19 (Fibroblast Growth Factor 19)] were evaluated, and (iii) constipation parameters, such as changes in stool frequency and consistency, were analysed. RESULTS: Thirty patients were randomised into five dose-levels (range: 0.1-10 mg/day) or to placebo. All patients completed a 14-day treatment period, and the safety/tolerability analysis was favourable. A3309, present in picomolar concentrations in plasma, induced up to a three-fold increase in bile acid synthesis (C4) and a reduction of plasma FGF19, as well as reduction in total and LDL cholesterol. CTT was reduced in the highest dose groups; the main acceleration was identified in the left colon. Efficacy parameters showed trends for increased number of spontaneous bowel movements and improved stool consistency. CONCLUSIONS: Ileal Bile Acid Transporter inhibition is a novel mechanism for treatment of patients with chronic idiopathic constipation and has additional benefits of improving metabolic parameters (EudraCT 2008-003255-72).

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Crossref · 10.1111/j.1365-2036.2011.04675.x

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Metadata

Authors
Simrén, M., Bajor, A., Gillberg, P.-G., Rudling, M., & Abrahamsson, H.
Affiliations
  • University of Gothenburg (SE)
  • Albireo (Sweden) (SE)
  • Karolinska University Hospital (SE)
Corresponding author
Simrén, M.
ORCID
Venue
Alimentary Pharmacology & Therapeutics
Publisher
Wiley
Published
2011-05-05
Volume
34
Issue
1
Pages
41-50
ISSN
0269-2813 (ISSN-L)
DOI
10.1111/j.1365-2036.2011.04675.x
OpenAlex
W1826937932
Cited by
114
References
20
Citations by year
2026: 2 · 2025: 1 · 2024: 2 · 2023: 3 · 2022: 4 · 2021: 9 · 2020: 10 · 2019: 3 · 2018: 12 · 2017: 8 · 2016: 12 · 2015: 12 · 2014: 12 · 2013: 6 · 2012: 10
FWCI
11.49
Type
journal article
Language
en
Open access
closed
Licence
doi.wiley.com/10.1002/tdm_license_1 (tdm, 1580 d)
Locations
  • Alimentary Pharmacology & Therapeutics (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • AstraZeneca
  • Danone
  • Kommunfullmäktige, Stockholms Stad
  • Karolinska Institutet
  • Vetenskapsrådet
  • Sahlgrenska Universitetssjukhuset
Topics
  • Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
  • Health Sciences › Medicine › Oncology › Drug Transport and Resistance Mechanisms
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmaceutical Science › Drug Solubulity and Delivery Systems
Keywords
chronic idiopathic constipation, colonic transit time, bile acid synthesis, C4, FGF19, LDL cholesterol, stool frequency, stool consistency, drug safety and tolerability
MeSH terms
Adult, Aged, Chronic Disease, Colon, Constipation, Defecation, Double-Blind Method, Female, Gastrointestinal Transit, Humans, Cholesterol, LDL, Male, Middle Aged, Placebo Effect, Treatment Outcome, Patient Satisfaction, Symporters, Organic Anion Transporters, Sodium-Dependent

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