P2933 - Efficacy and Safety of Tenapanor in Irritable Bowel Syndrome With Constipation (IBS-C): A Systematic Review and Meta-Analysis

Ahmed Aref, MD¹, Mohamed A. Aldemerdash, ², Islam Mohamed, MD³, Abdallfatah Abdallfatah, ⁴, Hazem Abosheaishaa, MD⁵, Dushyant S. Dahiya, MD⁶, Hassan Ghoz, MD⁷, Nikki Duong, MD⁸
1Corewell Health William Beaumont University Hospital, Royal Oak, MI; 2Sohag University, Faculty of Medicine, Sohag, Suhaj, Egypt; 3University of Missouri Columbia, Columbia, MO; 4Faculty of Medicine, October 6 University, Giza, Al Jizah, Egypt; 5Mount Sinai West, Icahn School of Medicine at Mount Sinai, Queens, NY; 6University of Kansas School of Medicine, Kansas City, KS; 7University of Missouri Kansas City School of Medicine, Kansas City, MO; 8Stanford University, Stanford, CA

Introduction: Irritable bowel syndrome with constipation (IBS-C) is a common disorder of gut-brain interaction (DGBI) that significantly impacts quality of life. Among the emerging treatments, tenapanor, a sodium/hydrogen exchange inhibitor, shows promise in managing IBS-C. This systematic review and meta-analysis aims to evaluate the efficacy and safety of tenapanor 50 mg compared to placebo.

Methods: This systematic review and meta-analysis followed PRISMA guidelines. A literature search was conducted on October 7, 2024, across PubMed, Cochrane, Embase, Scopus, and Web of Science databases. We included randomized controlled trials (RCTs) focusing on adult patients with IBS-C aged 18-75. Quality assessment was performed using the RoB 2 tool. Primary outcomes included responder rates for abdominal symptoms (pain, discomfort, bloating, cramping, fullness) and complete spontaneous bowel movements (CSBM). Secondary outcomes comprised treatment-related adverse events (AEs) and those leading to treatment discontinuation. Data analysis was conducted using R software.

Results: Three RCTs were included in the analysis. Tenapanor significantly improved several symptoms in patients with IBS-C compared to placebo. It demonstrated higher response rates for abdominal bloating (RR = 1.32, 95% CI: [1.15, 1.51], p < 0.01), cramping (RR = 1.27, 95% CI: [1.13, 1.44], p < 0.01), discomfort (RR = 1.37, 95% CI: [1.21, 1.56], p < 0.01), fullness (RR = 1.37, 95% CI: [1.20, 1.58], p < 0.01), pain (RR = 1.37, 95% CI: [1.17, 1.49], p < 0.01), and complete spontaneous bowel movements (CSBM) (RR = 1.54, 95% CI: [1.24, 1.91], p < 0.01). However, in terms of safety, tenapanor was associated with a significantly higher incidence of treatment-related adverse events (RR = 2.3, 95% CI: [1.72, 3.06], p < 0.01) and adverse events leading to treatment discontinuation (RR = 9.08, 95% CI: [3.63, 22.71], p < 0.01) when compared to placebo. Diarrhea was a prominent adverse event, occurring significantly more often with tenapanor than placebo (RR = 5.75, 95% CI: [3.44, 9.6], p < 0.01).

Discussion: Tenapanor shows promise as a potential treatment for IBS-C, demonstrating superior efficacy in alleviating symptoms such as abdominal pain, bloating, and discomfort compared to placebo. However, it is associated with a higher incidence of treatment-related adverse events, including those leading to treatment discontinuation. Further prospective, randomized controlled trials are needed to address these safety concerns with diverse patient populations.

Disclosures:
Ahmed Aref indicated no relevant financial relationships.
Mohamed A. Aldemerdash indicated no relevant financial relationships.
Islam Mohamed indicated no relevant financial relationships.
Abdallfatah Abdallfatah indicated no relevant financial relationships.
Hazem Abosheaishaa indicated no relevant financial relationships.
Dushyant Dahiya indicated no relevant financial relationships.
Hassan Ghoz indicated no relevant financial relationships.
Nikki Duong indicated no relevant financial relationships.

Ahmed Aref, MD¹, Mohamed A. Aldemerdash, ², Islam Mohamed, MD³, Abdallfatah Abdallfatah, ⁴, Hazem Abosheaishaa, MD⁵, Dushyant S. Dahiya, MD⁶, Hassan Ghoz, MD⁷, Nikki Duong, MD⁸. P2933 - Efficacy and Safety of Tenapanor in Irritable Bowel Syndrome With Constipation (IBS-C): A Systematic Review and Meta-Analysis, ACG 2025 Annual Scientific Meeting Abstracts. Phoenix, AZ: American College of Gastroenterology.