Efficacy and safety of tenapanor in the management of irritable bowel syndrome with constipation: a systematic review and meta-analysis

Introduction Irritable bowel syndrome with constipation (IBS-C) is a common gastrointestinal disorder that significantly impacts quality of life. Tenapanor, a sodium/hydrogen exchanger inhibitor, shows promise in managing IBS-C. This systematic review and meta-analysis aim to evaluate the efficacy and safety of tenapanor 50 mg compared with placebo. Methods This systematic review and meta-analysis followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A literature search was conducted on 7 October 2024 across PubMed, Cochrane, Embase, Scopus , and Web of Science databases. We included randomized controlled trials (RCTs) focusing on adult IBS-C patients aged 18–75. Quality assessment was performed using the risk of bias 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 involving 1378 patients were included. Tenapanor significantly improved symptoms versus placebo, including bloating [relative risk (RR) = 1.32; 95% confidence interval (CI), 1.15–1.51], cramping (RR = 1.27; CI, 1.13–1.44), discomfort (RR = 1.37; CI, 1.21–1.56), fullness (RR = 1.37; CI, 1.20–1.58), pain (RR = 1.37; CI, 1.17–1.49), and CSBM (RR = 1.54; CI, 1.24–1.91). However, tenapanor was associated with higher rates of treatment-related AEs (RR = 2.3; CI, 1.72–3.06) and AEs leading to discontinuation (RR = 9.08; CI, 3.63–22.71). Conclusion Tenapanor is effective in improving IBS-C symptoms but has a higher incidence of treatment-related AEs. Further studies are needed to evaluate its long-term safety.