Evidence map›Paper›PMID 38594429›Full record

Trial reportDigestive diseases and sciences2024

Plecanatide Improves Abdominal Bloating and Bowel Symptoms of Irritable Bowel Syndrome with Constipation.

Darren M Brenner, Amol Sharma, Satish S C Rao, Adam P Laitman, Zeev Heimanson, Christopher Allen, Gregory S Sayuk

Open access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Digestive diseases and sciences, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
4.6field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 10 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Review
  5. Review
  6. Parkinson Disease and the Gut: A Primer for Gastroenterologists.The American journal of gastroenterology · 2025
    Review
  7. Article
  8. Article
  9. Patient-Centered Approach in IBS-C Management.Gastroenterology & hepatology · 2025
    Article
  10. Raising Expectations in IBS-C Management.Gastroenterology & hepatology · 2025
    Article
  11. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 1 country.

Darren M BrennerDepartment of Medicine, Division of Gastroenterology and Hepatology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA. Darren.brenner@nm.org.ORCID http://orcid.org/0000-0002-8732-3632
Amol SharmaDivision of Gastroenterology and Hepatology, Digestive Health Center, Augusta University, Augusta, GA, USA.
Satish S C RaoDivision of Gastroenterology and Hepatology, Digestive Health Center, Augusta University, Augusta, GA, USA.
Adam P LaitmanSalix Pharmaceuticals, Bridgewater, NJ, USA.
Zeev HeimansonSalix Pharmaceuticals, Bridgewater, NJ, USA.
Christopher AllenSalix Pharmaceuticals, Bridgewater, NJ, USA.
Gregory S SayukDivision of Gastroenterology and Department of Psychiatry, Washington University School of Medicine, St. Louis, MO, USA.
Augusta University Health · USNorthwestern University · USWashington University in St. Louis · US

Funding

Salix Pharmaceuticals analysesSalix Pharmaceuticals studySalix Pharmaceuticals technical editorial assistance
6 · The paper itself

Abstract

backgroundBloating is a bothersome symptom in irritable bowel syndrome with constipation (IBS-C).

aimTo evaluate plecanatide efficacy in patients with IBS-C stratified by bloating intensity.

methodsPooled phase 3 data (2 randomized, controlled IBS-C trials) from adults treated with plecanatide 3 mg or placebo for 12 weeks were analyzed. Patients were stratified post-hoc by baseline bloating severity (11-point scale: mild [≤ 5] and moderate-to-severe [> 5]). Assessments included change from baseline in bloating, abdominal pain, and complete spontaneous bowel movement (CSBM) frequency. Abdominal pain and bloating composite responders were defined as patients with ≥ 30% improvement from baseline in both bloating and abdominal pain at Week 12.

resultsAt baseline, 1104/1436 patients with IBS-C (76.9%) reported moderate-to-severe bloating. In the moderate-to-severe bloating subgroup, plecanatide significantly reduced bloating severity versus placebo (least-squares mean change [LSMC]: - 1.7 vs - 1.3; P = 0.002), reduced abdominal pain (- 1.7 vs - 1.3; P = 0.006), and increased CSBM frequency (1.4 vs 0.8; P < 0.0001). In the mild bloating subgroup, significant improvements were observed with plecanatide versus placebo for abdominal pain (LSMC: - 1.3 vs - 1.0; P = 0.046) and CSBM frequency (2.0 vs 1.2; P = 0.003) but not bloating (- 0.9 vs - 0.8; P = 0.28). A significantly greater percentage of patients were abdominal pain and bloating composite responders with plecanatide versus placebo (moderate-to-severe bloating: 33.6% vs 26.8% [P = 0.02]; mild bloating: 38.4% vs 27.2% [P = 0.03]).

conclusionPlecanatide treatment improved IBS-C abdominal and bowel symptoms, including in those who present with moderate-to-severe bloating.

Indexed as

Abdominal PainConstipationIrritable Bowel SyndromeNatriuretic PeptidesAdultDefecationDouble-Blind MethodFemaleGastrointestinal AgentsHumansMaleMiddle AgedSeverity of Illness IndexTreatment OutcomeGastrointestinal AgentsNatriuretic PeptidesplecanatideAbdominal painBloatingConstipationGastrointestinal motilityGuanylyl cyclase C agonistsIrritable bowel syndrome

Identifiers

PMID38594429
PMCPMC11098865
OpenAlexW4394596456

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.