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

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

Abstract

Background: Bloating is a bothersome symptom in irritable bowel syndrome with constipation (IBS-C). Aim: To evaluate plecanatide efficacy in patients with IBS-C stratified by bloating intensity. Methods: Pooled 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. Results: At 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]). Conclusion: Plecanatide treatment improved IBS-C abdominal and bowel symptoms, including in those who present with moderate-to-severe bloating. Graphical Abstract: (Figure presented.)

Original languageEnglish
Pages (from-to)1731-1738
Number of pages8
JournalDigestive diseases and sciences
Volume69
Issue number5
DOIs
StatePublished - May 2024

Keywords

  • Abdominal pain
  • Bloating
  • Constipation
  • Gastrointestinal motility
  • Guanylyl cyclase C agonists
  • Irritable bowel syndrome

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