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

• Published in: Digestive diseases and sciences 2024-05, Vol.69 (5), p.1731-1738
• Main Authors: Brenner, Darren M., Sharma, Amol, Rao, Satish S. C., Laitman, Adam P., Heimanson, Zeev, Allen, Christopher, Sayuk, Gregory S.
• Format: Article
• Language: English
• Subjects: Abdomen; Abdominal Pain - drug therapy; Abdominal Pain - etiology; Adult; Biochemistry; Constipation; Constipation - drug therapy; Defecation - drug effects; Double-Blind Method; Female; Gastroenterology; Gastrointestinal Agents - therapeutic use; Hepatology; Humans; Irritable bowel syndrome; Irritable Bowel Syndrome - complications; Irritable Bowel Syndrome - drug therapy; Male; Medicine; Medicine & Public Health; Middle Aged; Natriuretic Peptides - therapeutic use; Oncology; Original; Original Article; Pain; Severity of Illness Index; Transplant Surgery; Treatment Outcome
• ISSN: 0163-2116; 1573-2568; 1573-2568
• DOI: 10.1007/s10620-024-08330-y

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