A pharmacokinetic evaluation of tenapanor for the treatment of irritable bowel syndrome with constipation: an update of the literature

References

• Lacy BE, Mearin F, Chang L, et al. Bowel disorders. Gastroenterology. 2016;150(6):1393–1407.e5. doi: 10.1053/j.gastro.2016.02.031
   Web of Science ®Google Scholar
• Sperber AD. Review article: epidemiology of IBS and other bowel disorders of gut-brain interaction (DGBI). Aliment Pharmacol Ther. 2021;54(Suppl 1):S1–S11. doi: 10.1111/apt.16582
   PubMedGoogle 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.e3. doi: 10.1053/j.gastro.2020.04.014
   PubMed Web of Science ®Google Scholar
• Chang L, Sultan S, Lembo A, et al. AGA clinical 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
• Basilisco G, Italian Society of Neurogastroenterology Motility (SINGEM) Study Group. Patient dissatisfaction with medical therapy for chronic constipation or irritable bowel syndrome with constipation: analysis of N-of-1 prospective trials in 81 patients. Aliment Pharmacol Ther. 2020;51(6):629–636. doi: 10.1111/apt.15657
   PubMed Web of Science ®Google Scholar
• Fukudo S, Okumura T, Inamori M, et al. Evidence-based clinical practice guidelines for irritable bowel syndrome 2020. J Gastroenterol. 2021;56(3):193–217. doi: 10.1007/s00535-020-01746-z
   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
• 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
• 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
• Chapman RW, Stanghellini V, Geraint M, et al. Randomized clinical trial: macrogol/PEG 3350 plus electrolytes for treatment of patients with constipation associated with irritable bowel syndrome. Am J Gastroenterol. 2013;108(9):1508–1515. doi: 10.1038/ajg.2013.197
   PubMed Web of Science ®Google Scholar
• Brenner DM, Harris LA, Chang CH, et al. Real-world treatment strategies to improve outcomes in patients with chronic idiopathic constipation and irritable bowel syndrome with constipation. Am J Gastroenterol. 2022;117(4S):S21–S26. doi: 10.14309/ajg.0000000000001709
   PubMed Web of Science ®Google Scholar
• Markham A. Tenapanor: first approval. drugs. Drugs. 2019;79(17):1897–1903. doi: 10.1007/s40265-019-01215-9
   PubMed Web of Science ®Google Scholar
• Jacobs JW, Leadbetter MR, Bell N, et al. Discovery of tenapanor: a first-in-class minimally systemic inhibitor of intestinal Na+/H+ exchanger isoform 3. ACS Med Chem Lett. 2022;13(7):1043–1051. doi: 10.1021/acsmedchemlett.2c00037
   PubMedGoogle Scholar
• Xu H, Ghishan FK, Kiela PR. SLC9 gene family: function, expression, and regulation. Compr Physiol. 2018;8(2):555–583. doi: 10.1002/cphy.c170027
   PubMed Web of Science ®Google Scholar
• Pedersen SF, Counillon L. The SLC9A-C mammalian Na+/H+ exchanger family: molecules, mechanisms, and physiology. Physiol Rev. 2019;99(4):2015–2113. doi: 10.1152/physrev.00028.2018
   PubMed Web of Science ®Google Scholar
• King AJ, Siegel M, He Y, et al. Inhibition of sodium/hydrogen exchanger 3 in the gastrointestinal tract by tenapanor reduces paracellular phosphate permeability. Sci Transl Med. 2018;10(456):eaam6474. doi: 10.1126/scitranslmed.aam6474
   PubMed Web of Science ®Google Scholar
• Spencer AG, Labonte ED, Rosenbaum DP, et al. 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
• 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(4):341–351. doi: 10.1007/s40261-017-0614-0
   PubMed Web of Science ®Google Scholar
• Heitmann PT, Vollebregt PF, Knowles CH, et al. Understanding the physiology of human defaecation and disorders of continence and evacuation. Nat Rev Gastroenterol Hepatol. 2021;18(11):751–769. doi: 10.1038/s41575-021-00487-5
   PubMed Web of Science ®Google Scholar
• Johansson S, Rosenbaum DP, Knutsson M, et al. 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
• Johansson SA, Knutsson M, Leonsson-Zachrisson M, et al. Effect of food intake on the pharmacodynamics of tenapanor: a phase 1 study. Clin Pharmacol Drug Dev. 2017;6(5):457–465. doi: 10.1002/cpdd.341
   PubMed Web of Science ®Google Scholar
• Johansson S, Rosenbaum DP, Palm J, et al. Tenapanor administration and the activity of the H+ -coupled transporter PepT1 in healthy volunteers. Br J Clin Pharmacol. 2017;83(9):2008–2014. doi: 10.1111/bcp.13313
   PubMed Web of Science ®Google Scholar
• Johansson S, Rosenbaum DP, Ahlqvist M, et al. Effects of tenapanor on cytochrome P450-mediated drug-drug interactions. Clin Pharmacol Drug Dev. 2017;6(5):466–475. doi: 10.1002/cpdd.346
   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):763–774. doi: 10.1038/ajg.2017.41
   PubMed Web of Science ®Google Scholar
• Ardelyx. Inc. Ibsrela (tenapanor) [package insert]. U.S. Food and drug administration website. Revised Apr 2022Accessed Jun 27, 2023 https://www.Accessdata.fda.gov/drugsatfda_docs/label/2022/211801s004lbl.Pdf
   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, et al. Efficacy of tenapanor in treating patients with irritable bowel syndrome with constipation: a 26-week, placebo-controlled phase 3 trial (T3MPO-2). Am J Gastroenterol. 2021;116(6):1294–1303. doi: 10.14309/ajg.0000000000001056
   PubMed Web of Science ®Google Scholar
• Lembo AJ, Friedenberg KA, Fogel RP, et al. Long-term safety of tenapanor in patients with irritable bowel syndrome with constipation in the T3MPO-3 study. Neurogastroenterol Motil. 2023;35(11):e14658. doi: 10.1111/nmo.14658
   PubMedGoogle Scholar