Tenapanor in the Treatment of Irritable Bowel Syndrome with Constipation: Discovery, Efficacy, and Role in Management

References

• Drossman DA, Hasler WL. Rome IV-functional GI disorders: disorders of gut-brain interaction. Gastroenterology. 2016;150(6):1257–1261. doi:10.1053/j.gastro.2016.03.035
   PubMed Web of Science ®Google Scholar
• Sperber AD, Bangdiwala SI, Drossman DA, et al. Worldwide prevalence and burden of functional gastrointestinal disorders, results of Rome Foundation Global Study. Gastroenterology. 2021;160(1):99–114. doi:10.1053/j.gastro.2020.04.014
   PubMed Web of Science ®Google Scholar
• Frändemark Å, Törnblom H, Jakobsson S, Simrén M. Work productivity and activity impairment in irritable bowel syndrome (IBS): a multifaceted problem. Am J Gastroenterol. 2018;113(10):1540–1549. doi:10.1038/s41395-018-0262-x
   PubMed Web of Science ®Google Scholar
• Nellesen D, Yee K, Chawla A, Lewis BE, Carson RT. A systematic review of the economic and humanistic burden of illness in irritable bowel syndrome and chronic constipation. J Manag Care Pharm. 2013;19(9):755–764. doi:10.18553/jmcp.2013.19.9.755
   PubMed Web of Science ®Google Scholar
• Palsson OS, Whitehead W, Tornblom H, et al. Prevalence of Rome IV functional bowel disorders among adults in the United States, Canada and United Kingdom. Gastroenterology. 2020;158(5):1262–1273. doi:10.1053/j.gastro.2019.12.021
   PubMed Web of Science ®Google Scholar
• Lacy BE, Pimentel M, Brenner DM, et al. ACG clinical guideline: management of irritable bowel syndrome. Am J Gastroenterol. 2021;116(1):17–44. doi:10.14309/ajg.0000000000001036
   PubMed Web of Science ®Google Scholar
• Spencer AG, Labonte ED, Rosenbaum DP. Intestinal inhibition of the Na+/H+ exchanger 3 prevents cardiorenal damage in rats and inhibits Na+ uptake in humans. Sci Transl Med. 2014;6(227):227ra36. doi:10.1126/scitranslmed.3007790
   PubMed Web of Science ®Google Scholar
• Block GA, Rosenbaum DP, Korner P, Yan A, Chertow GM. Gastrointestinal tolerability of tenapanor to treat hyperphosphatemia in patients on hemodialysis. J Am Soc Nephrol. 2017;28:373.
   Google Scholar
• Johansson S, Rosenbaum DP, Knutsson M, Leonsson-Zachrisson M. A phase 1 study of the safety, tolerability, pharmacodynamics, and pharmacokinetics of tenapanor in healthy Japanese volunteers. Clin Exp Nephrol. 2017;21(3):407–416. doi:10.1007/s10157-016-1302-8
   PubMed Web of Science ®Google Scholar
• Li Q, King A, Liu L, Zhu Y, Caldwell J, Pasricha PJ. Tenapanor reduces IBS pain through inhibition of TRPV1-dependent neuronal hyperexcitability in vivo. Off J Am Coll Gastroenterol. 2017;112:S255. doi:10.14309/00000434-201710001-00484
   Web of Science ®Google Scholar
• Wang J, Larauche M, Siegel M, et al. Tenapanor attenuates increased macromolecule permeability in human colon monolayer cultures induced by inflammatory cytokines and human fecal supernatants. Gastroenterology. 2018;154(Suppl 1):S326. doi:10.1016/S0016-5085(18)31424-0
   Google Scholar
• Rosenbaum DP, Yan A, Jacobs JW. Pharmacodynamics, safety, and tolerability of the NHE3 inhibitor tenapanor: two trials in healthy volunteers. Clin Drug Investig. 2018;38:341–351. doi:10.1007/s40261-017-0614-0
   PubMed Web of Science ®Google Scholar
• Chey WD, Lembo AJ, Rosenbaum DP. Tenapanor treatment of patients with constipation-predominant irritable bowel syndrome: a phase 2, randomized, placebo-controlled efficacy and safety trial. Am J Gastroenterol. 2017;112(5):763. doi:10.1038/ajg.2017.41
   PubMed Web of Science ®Google Scholar
• Chey WD, Lembo AJ, Rosenbaum DP. Efficacy of tenapanor in treating patients with irritable bowel syndrome with constipation: a 12-week, placebo-controlled phase 3 trial (T3MPO-1). Am J Gastroenterol. 2020;115(2):281–293. doi:10.14309/ajg.0000000000000516
   PubMed Web of Science ®Google Scholar
• Chey WD, Lembo AJ, Yang Y, Rosenbaum DP. Efficacy of tenapanor in treating patients with irritable bowel syndrome with constipation: a 26-week, placebo-controlled phase 3 trial (T3MPO-2). AmJGastroenterol. 2021;116(6):1294–1303.
   PubMed Web of Science ®Google Scholar
• Fogel RP, Edelstein S, Yang Y, Rosenbaum DP. Tu1375: tenapanor has early onset of action in treating symptoms of irritable bowel syndrome with constipation (IBS-C) (T3MPO-1 AND T3MPO-2 TRIALS). Gastroenterology. 2022;162(7):S–940. doi:10.1016/S0016-5085(22)62229-7
   Web of Science ®Google Scholar
• Lembo A, Edelstein S, Yang Y, Rosenbaum DP. Mo1396: long term treatment with Tenapanor improves abdominal pain and other abdominal symptoms associated with IBS-C. Gastroenterology. 2022;162(7):S–757. doi:10.1016/S0016-5085(22)61788-8
   Web of Science ®Google Scholar
• Chey WD, Edelstein S, Yang Y, Rosenbaum DP. Mo1394: effect of Tenapanor on treatment satisfaction, degrees of relief, and quality of life for patients with irritable bowel syndrome with constipation (IBS C). Gastroenterology. 2022;162(7):S–756. doi:10.1016/S0016-5085(22)61786-4
   Web of Science ®Google Scholar
• Ladabaum U, Boyd E, Zhao WK, et al. Diagnosis, comorbidities, and management of irritable bowel syndrome in patients in a large health maintenance organization. Clin Gastroenterol Hepatol. 2012;10(1):37–45. doi:10.1016/j.cgh.2011.08.015
   PubMed Web of Science ®Google Scholar
• Sharma A, Rao SS, Kearns K, Orleck KD, Waldman SA. Diagnosis, management and patient perspectives of the spectrum of constipation disorders. Aliment Pharmacol Ther. 2001;53(12):1250–1267. doi:10.1111/apt.16369
   Google Scholar
• Sharma A, Herekar A, Yan Y, Karunaratne T, Rao SS. Dyssynergic defecation and other evacuation disorders. Gastroenterol Clin. 2022;51(1):55–69. doi:10.1016/j.gtc.2021.10.004
   Google Scholar
• Vasant DH, Paine PA, Black CJ, et al. British Society of Gastroenterology guidelines on the management of irritable bowel syndrome. Gut. 2021;70(7):1214–1240. doi:10.1136/gutjnl-2021-324598
   PubMed Web of Science ®Google Scholar
• Ringel Y, Williams RE, Kalilani L, Cook SF. Prevalence, characteristics, and impact of bloating symptoms in patients with irritable bowel syndrome. Clin Gastroenterol hepatol. 2009;7(1):68–72. doi:10.1016/j.cgh.2008.07.008
   PubMed Web of Science ®Google Scholar
• Nelson AD, Black CJ, Houghton LA, Lugo‐Fagundo NS, Lacy BE, Ford AC. Systematic review and network meta‐analysis: efficacy of licensed drugs for abdominal bloating in irritable bowel syndrome with constipation. Aliment Pharmacol Ther. 2021;54(2):98–108. doi:10.1111/apt.16437
   PubMed Web of Science ®Google Scholar
• Barberio B, Savarino EV, Black CJ, Ford AC. Adverse events in trials of licensed drugs for irritable bowel syndrome with constipation or diarrhea: systematic review and meta‐analysis. Neurogastroenterol Motil. 2022;34(6):e14279. doi:10.1111/nmo.14279
   PubMed Web of Science ®Google Scholar
• Barbara G, Cremon C, Bellini M, et al. Italian guidelines for the management of irritable bowel syndrome: joint consensus from the Italian societies of: gastroenterology and endoscopy (SIGE), neurogastroenterology and motility (SINGEM), Hospital Gastroenterologists and Endoscopists (AIGO), Digestive Endoscopy (SIED), general medicine (simg), gastroenterology, hepatology and pediatric nutrition (SIGENP) and Pediatrics (SIP). Dig Liver Dis. 2023;55(2):187–207. doi:10.1016/j.dld.2022.11.015
   PubMedGoogle Scholar
• Chang L, Sultan S, Lembo A, Verne GN, Smalley W, Heidelbaugh JJ. AGAclinical practice guideline on the pharmacological management of irritable bowel syndrome with constipation. Gastroenterology. 2022;163(1):118–136. doi:10.1053/j.gastro.2022.04.016
   PubMed Web of Science ®Google Scholar