Plecanatide Improves Abdominal Bloating and Bowel Symptoms of Irritable Bowel Syndrome with Constipation.
Dig Dis Sci
; 69(5): 1731-1738, 2024 May.
Article
in En
| MEDLINE
| ID: mdl-38594429
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.Key words
Full text:
1
Database:
MEDLINE
Main subject:
Abdominal Pain
/
Constipation
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Irritable Bowel Syndrome
/
Natriuretic Peptides
Limits:
Adult
/
Female
/
Humans
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Male
/
Middle aged
Language:
En
Journal:
Dig Dis Sci
Year:
2024
Type:
Article
Affiliation country:
United States