598
Views
9
CrossRef citations to date
0
Altmetric
Reviews

New pharmacological treatment options for irritable bowel syndrome with constipation

&

Bibliography

  • Saito YA, Schoenfeld P, Locke III GR. The epidemiology of irritable bowel syndrome in North America: a systematic review. Am J Gastroenterol. 2002;97(8):1910–1915.
  • Quigley EM, Abdel-Hamid H, Barbara G, et al. A global perspective on irritable bowel syndrome: a consensus statement of the World Gastroenterology Organisation Summit Task Force on irritable bowel syndrome. J Clin Gastroenterol. 2012;46(5):356–366.
  • Brandt LJ, Chey WD, Foxx-Orenstein AE, et al. An evidence-based position statement on the management of irritable bowel syndrome. Am J Gastroenterol. 2009;104:S1–35.
  • Siegfried W, Rao SS. Advances in the management of constipation-predominant irritable bowel syndrome: the role of linaclotide. Therap Adv Gastroenterol. 2014;7(5):193–205.
  • Longstreth GF, Thompson WG, Chey WD, et al. Functional bowel disorders. Gastroenterology. 2006;130(5):1480–1491.
  • Cash B, Sullivan S, Barghout V. Total costs of IBS: employer and managed care perspective. Am J Manag Care. 2005;11(1 suppl):S7–S16.
  • Paré P, Gray J, Lam S, et al. Health-related quality of life, work productivity, and health care resource utilization of subjects with irritable bowel syndrome: baseline results from LOGIC (longitudinal outcomes study of gastrointestinal symptoms in Canada), a naturalistic study. Clin Ther. 2006;28(10):1726–1735.
  • Mayer EA, Tillisch K. The brain-gut axis in abdominal pain syndromes. Annu Rev Med. 2011;62:381–396.
  • Feng B, La JH, Schwartz ES, et al. Irritable bowel syndrome: methods, mechanisms, and pathophysiology. Neural and neuro-immune mechanisms of visceral hypersensitivity in irritable bowel syndrome. Am J Physiology-Gastrointestinal Liver Physiol. 2012;302(10):G1085–G98.
  • Camilleri M, Kerstens R, Rykx A, et al. A placebo-controlled trial of prucalopride for severe chronic constipation. New Engl J Med. 2008;358(22):2344–2354.
  • Quigley E, Vandeplassche L, Kerstens R, et al. Clinical trial: the efficacy, impact on quality of life, and safety and tolerability of prucalopride in severe chronic constipation–a 12‐week, randomized, double‐blind, placebo‐controlled study. Aliment Pharmacol Ther. 2009;29(3):315–328.
  • Tack J, Van Outryve M, Beyens G, et al. Prucalopride (Resolor) in the treatment of severe chronic constipation in patients dissatisfied with laxatives. Gut. 2009;58(3):357–365.
  • Ambizas EM, Ginzburg R. Lubiprostone: a chloride channel activator for treatment of chronic constipation. Ann Pharmacother. 2007;41(6):957–964.
  • Drossman D, Chey W, Johanson J, et al. Clinical trial: lubiprostone in patients with constipation‐associated irritable bowel syndrome–results of two randomized, placebo‐controlled studies. Aliment Pharmacol Ther. 2009;29(3):329–341.
  • Camilleri M, Gorman H. Intestinal permeability and irritable bowel syndrome. Neurogastroenterol Motil. 2007;19(7):545–552.
  • Moeser AJ, Nighot PK, Engelke KJ, et al. Recovery of mucosal barrier function in ischemic porcine ileum and colon is stimulated by a novel agonist of the ClC-2 chloride channel, lubiprostone. Am J Physiology-Gastrointestinal Liver Physiol. 2007;292(2):G647–G56.
  • Castro J, Harrington AM, Hughes PA, et al. Linaclotide inhibits colonic nociceptors and relieves abdominal pain via guanylate cyclase-C and extracellular cyclic guanosine 3′, 5′-monophosphate. Gastroenterology. 2013;145(6):1334–46. e11.
  • Bryant AP, Busby RW, Bartolini WP, et al. Linaclotide is a potent and selective guanylate cyclase C agonist that elicits pharmacological effects locally in the gastrointestinal tract. Life Sci. 2010;86(19):760–765.
  • Kurtz C, Fitch D, Busby RW, et al., editors. Effects of multidose administration of MD-1100 on safety, tolerability, exposure, and pharmacodynamics in healthy subjects. Gastroenterology. 2006;130:A26.
  • Currie M, Kurtz C, Mahajan-Miklos S, et al., editors. Effects of single dose administration of MD-1100 on safety, tolerability, exposure, and stool consistency in healthy subjects. Am J Gastroenterol. 2005;100:S328.
  • Andresen V, Camilleri M, Busciglio IA, et al. Effect of 5 days linaclotide on transit and bowel function in females with constipation-predominant irritable bowel syndrome. Gastroenterology. 2007;133(3):761–768.
  • Johnston JM, Kurtz CB, MacDougall JE, et al. Linaclotide improves abdominal pain and bowel habits in a phase IIb study of patients with irritable bowel syndrome with constipation. Gastroenterology. 2010;139(6):1877–86. e2.
  • Rao S, Lembo AJ, Shiff SJ, et al. A 12-week, randomized, controlled trial with a 4-week randomized withdrawal period to evaluate the efficacy and safety of linaclotide in irritable bowel syndrome with constipation. Am J Gastroenterol. 2012;107(11):1714–1724.
  • Chey WD, Lembo AJ, Lavins BJ, et al. Linaclotide for irritable bowel syndrome with constipation: a 26-week, randomized, double-blind, placebo-controlled trial to evaluate efficacy and safety. Am J Gastroenterol. 2012;107(11):1702–1712.
  • Faure C, Patey N, Gauthier C, et al. Serotonin signaling is altered in irritable bowel syndrome with diarrhea but not in functional dyspepsia in pediatric age patients. Gastroenterology. 2010;139(1):249–258.
  • Hoffman JM, Tyler K, MacEachern SJ, et al. Activation of colonic mucosal 5-HT< sub> 4</sub> receptors accelerates propulsive motility and inhibits visceral hypersensitivity. Gastroenterology. 2012;142(4):844–54. e4.
  • Gershon MD, Tack J. The serotonin signaling system: from basic understanding to drug development for functional GI disorders. Gastroenterology. 2007;132(1):397–414.
  • Ford AP, Clarke DE. The 5‐HT4 receptor. Med Res Rev. 1993;13(6):633–662.
  • Bockaert J, Fagni L, Sebben M, et al. Pharmacological characterization of brain 5-HT4 receptors: relationship between the effects of indole, benzamide and azabicycloalkybenzimidazolone derivatives. In: Fozard JR and Saxena PR, editors. Serotonin: molecular biology, receptors and functional effects. Basel: Birkhäuser; 1991. p. 220–231.
  • Novick J, Miner P, Krause R, et al. A randomized, double‐blind, placebo‐controlled trial of tegaserod in female patients suffering from irritable bowel syndrome with constipation. Aliment Pharmacol Ther. 2002;16(11):1877–1888.
  • Kamm M. The complexity of drug development for irritable bowel syndrome. Aliment Pharmacol Ther. 2002;16(3):343–351.
  • Grider JR. Role of cholecystokinin in the regulation of gastrointestinal motility. J Nutr. 1994;124(8 Suppl):1334S–9S.
  • Meyer B, Beglinger C, Jansen JM, et al. Role of cholecystokinin in regulation of gastrointestinal motor functions. Lancet. 1989;334(8653):12–15.
  • Lal S, McLaughlin J, Barlow J, et al. Cholecystokinin pathways modulate sensations induced by gastric distension in humans. Am J Physiology-Gastrointestinal Liver Physiol. 2004;287(1):G72–G9.
  • Wank SA, Pisegna JR, De Weerth A. Brain and gastrointestinal cholecystokinin receptor family: structure and functional expression. Proc Natl Acad Sci USA. 1992;89(18):8691–8695.
  • Sjölund K, Ekman R, Lindgren S, et al. Disturbed motilin and cholecystokinin release in the irritable bowel syndrome. Scand J Gastroenterol. 1996;31(11):1110–1114.
  • Schulz S, Green CK, Yuen PS, et al. Guanylyl cyclase is a heat-stable enterotoxin receptor. Cell. 1990;63(5):941–948.
  • Bharucha AE, Linden DR. Linaclotide–a secretagogue and antihyperalgesic agent–what next? Neurogastroenterol Motil. 2010;22(3):227–231.
  • Lin JE, Valentino M, Marszalowicz G, et al. Bacterial heat-stable enterotoxins: translation of pathogenic peptides into novel targeted diagnostics and therapeutics. Toxins. 2010;2(8):2028–2054.
  • Vaandrager AB, Smolenski A, Tilly BC, et al. Membrane targeting of cGMP-dependent protein kinase is required for cystic fibrosis transmembrane conductance regulator Cl− channel activation. Proc Natl Acad Sci USA. 1998;95(4):1466–1471.
  • Feng B, Kiyatkin ME, La J-H, et al. Activation of guanylate cyclase-C attenuates stretch responses and sensitization of mouse colorectal afferents. J Neurosci. 2013;33(23):9831–9839.
  • Blaustein M. Sodium ions, calcium ions, blood pressure regulation, and hypertension: a reassessment and a hypothesis. Am J Physiology-Cell Physiol. 1977;232(5):C165–C73.
  • Donaldson SH, Hirsh A, Li DC, et al. Regulation of the epithelial sodium channel by serine proteases in human airways. J Biol Chem. 2002;277(10):8338–8345.
  • Blaufox MD, Lewis EJ, Jagger P, et al. Physiologic responses of the transplanted human kidney: sodium regulation and renin secretion. New Engl J Med. 1969;280(2):62–66.
  • Greig E, Sandle GI. Diarrhea in ulcerative colitis: the role of altered colonic sodium transport. Ann N Y Acad Sci. 2000;915(1):327–332.
  • Brett CL, Donowitz M, Rao R. Evolutionary origins of eukaryotic sodium/proton exchangers. Am J Physiology-Cell Physiol. 2005;288(2):C223–C39.
  • Binder HJ, Stange G, Murer H, et al. Sodium-proton exchange in colon brush-border membranes. Am J Physiol. 1986;251(3 Pt 1):G382–90.
  • Zachos NC, Tse M, Donowitz M. Molecular physiology of intestinal N+/H+ exchange. Annu Rev Physiol. 2005;67:411–443.
  • Linz D, Wirth K, Linz W, et al. Antihypertensive and laxative effects by pharmacological inhibition of sodium-proton-exchanger subtype 3–mediated sodium absorption in the gut. Hypertension. 2012;60(6):1560–1567.
  • Thaysen EH, Pedersen L. Idiopathic bile acid catharsis. Gut. 1976;17(12):965–970.
  • Taylor I, Basu P, Hammond P, et al. Effect of bile acid perfusion on colonic motor function in patients with the irritable colon syndrome. Gut. 1980;21(10):843–847.
  • Gelbmann CM, Schteingart CD, Thompson SM, et al. Mast cells and histamine contribute to bile acid-stimulated secretion in the mouse colon. J Clin Investig. 1995;95(6):2831–2839.
  • Business-Wire. SK Biopharmaceuticals drug program is granted funding support from Korean government [Internet]. 2012 [ cited 2014 Sep 19]. Available from: http://www.businesswire.com/news/home/20121213006033/en/SK-Biopharmaceuticals-Drug-Program-Granted-Funding-Support#.VEWII410xeU
  • Shin A, Acosta A, Boldingh A, et al. Tu2037 effects of YKP10811, a selective 5-HT4 receptor agonist, in patients with functional constipation: a randomized, controlled, phase II study. Gastroenterology. 2014;146(5):S-902-S-3.
  • clinicaltrial.gov. Efficacy and Safety of YKP10811 in subjects with irritable bowel syndrome with constipation [Internet]. 2014 [ cited 2014 Sep 19]. Available from: http://clinicaltrials.gov/ct2/show/NCT02082457?term=ykp&rank=1
  • Clinicaltrials.jp. A randomized, placebo-controlled, double-blind, parallel-group, exploratory study of DSP-6952 in patients with irritable bowel syndrome with constipation (early phase 2 study) [Internet]. 2013 [cited 2015 Jan 6]. Available from: http://www.clinicaltrials.jp/user/showCteDetailE.jsp?japicId=JapicCTI-122041
  • Scarpignato C, Kisfalvi I, D’Amato M, et al. Effect of dexloxiglumide and spiroglumide, two new CCK‐receptor antagonists, on gastric emptying and secretion in the rat: evaluation of their receptor selectivity in vivo. Aliment Pharmacol Ther. 1996;10(3):411–419.
  • Cilexetil C. Information update. Drugs Future. 2001;26(7):695–722.
  • Varga G. Dexloxiglumide Rotta Research Lab. Current Opin Investigational Drugs. 2002;3(4):621–626.
  • Persiani S, D’Amato M, Jakate A, et al. Pharmacokinetic profile of dexloxiglumide. Clin Pharmacokinet. 2006;45(12):1177–1188.
  • Persiani S, D’Amato M, Makovec F, et al. Pharmacokinetics of dexloxiglumide after administration of single and repeat oral escalating doses in healthy young males. Int J Clin Pharmacol Ther. 2002;40(5):198–206.
  • Cremonini F, Camilleri M, McKinzie S, et al. Effect of CCK-1 antagonist, dexloxiglumide, in female patients with irritable bowel syndrome: a pharmacodynamic and pharmacogenomic study. Am J Gastroenterol. 2005;100(3): 652–663.
  • D’Amato M, Whorwell P, Thompson D, et al. The efficacy and safety of the CCKA-receptor antagonist dexloxiglumide in IBS. Gut. 1999;45(Suppl V):A258.
  • Whorwell PJ, Pace F, D’Amato M, et al. 1051 A phase III, 6-month, double-blind, placebo-controlled, randomized withdrawal trial of the selective CCK-1 antagonist dexloxiglumide in constipation-predominant IBS: the Darwin study. Gastroenterology. 2008;134(4):A–157.
  • Pharmabiz. Forest to discontinue development in U.S. of dexloxiglumide for irritable bowel syndrome [Internet]. 2003 [cited 2015 Jan 6]. Available from: http://www.pharmabiz.com/article/detnews.asp?articleid=18255&sectionid=14
  • Solinga R, Kessler M, Busby R, et al., editors. A comparison of the physical and pharmacological properties of plecanatide (SP-304) and the human hormone uroguanylin. ACJ. 2011;11(S2):332.
  • Shailubhai K, Comiskey S, Foss JA, et al. Plecanatide, an oral guanylate cyclase C agonist acting locally in the gastrointestinal tract, is safe and well-tolerated in single doses. Dig Dis Sci. 2013;58(9):2580–2586.
  • Shailubhai K, Barrow L, Talluto C, et al. Plecanatide, a guanylate cyclase-C agonist, improves bowel habits and symptoms associated with chronic constipation in a phase IIa clinical study P1174. Am J Gastroenterol. 2011;106:(Suppl 2s):S502.
  • Pharmaceuticals S. Plecanatide for IBS-C [Internet]. 2015 [cited 2015 Oct 20]. Available from: www.synergypharma.com/our-pipeline/clinical-trials
  • 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–ra36.
  • Spencer AG, Jacobs JW, Leadbetter MR, et al. RDX5791, a first-in-class minimally systemic NHE3 inhibitor in clinical development for CIC and IBS-C, increases intestinal sodium leading to enhanced intestinal fluid volume and transit. Gastroenterology. 2011;140(5):S–99.
  • Trinkley KE, `ata MC. Medication management of irritable bowel syndrome. Digestion. 2014;89(4):253–267.
  • Ardelyx. Tenapanor [Internet]. 2014 [cited 2015 Jan 6]. Available from: http://www.ardelyx.com/tenapanor/
  • Ardelyx. Tenapanor for IBS-C [Internet]. 2014 [cited 2015 Jan 3]. Available from: http://www.ardelyx.com/tenapanor-for-ibs-c/
  • Ardelyx. Tenapanor generally well tolerated [Internet]. 2014 [cited 2015 Jan 3]. Available from: http://files.shareholder.com/downloads/AMDA-2XKMMX/0x0xS1193125-14-296774/1437402/filing.pdf
  • Ardelyx. Tenapanor diverts dietry sodium to the feces in healthy adults and ESRD patients [Internet]. 2014 [cited 2015 Jan 3]. Available from: http://files.shareholder.com/downloads/AMDA-2XKMMX/0x0xS1193125-14-296774/1437402/filing.pdf
  • Ardelyx. News: Ardelyx’s Products & Technologies [Internet]. 2011 [cited 2015 Jan 3]. Available from: http://www.ardelyx.com/news/ardelyx-inc-closes-30m-series-b-financing/
  • Ardelyx. Ardelyx reports positive results from its phase 2b clinical trial evaluating tenapanor in IBS-C patients [Internet]. 2014 [cited 2015 Jan 2]. Available from: http://ir.ardelyx.com/releasedetail.cfm?releaseid=873924
  • Tack J, Corsetti M. Elobixibat. Ileal sodium-dependent bile acid transporter (IBAT) inhibitor, agent for constipation. Drugs Future. 2012;37(7):475.
  • Simren M, Bajor A, Gillberg PG, et al. Randomised clinical trial: the ileal bile acid transporter inhibitor A3309 vs. placebo in patients with chronic idiopathic constipation–a double‐blind study. Aliment Pharmacol Ther. 2011;34(1):41–50.
  • Wong BS, Camilleri M, McKinzie S, et al. Effects of A3309, an ileal bile acid transporter inhibitor, on colonic transit and symptoms in females with functional constipation. Am J Gastroenterol. 2011;106(12):2154–2164.
  • Chey WD, Camilleri M, Chang L, et al. A randomized placebo-controlled phase IIb trial of a3309, a bile acid transporter inhibitor, for chronic idiopathic constipation. Am J Gastroenterol. 2011;106(10):1803–1812.
  • Song X, Chen BN, Zagorodnyuk VP, et al. Identification of medium/high-threshold extrinsic mechanosensitive afferent nerves to the gastrointestinal tract. Gastroenterology. 2009;137(1):274–284. e1.
  • Jones RCW, Xu L, Gebhart G. The mechanosensitivity of mouse colon afferent fibers and their sensitization by inflammatory mediators require transient receptor potential vanilloid 1 and acid-sensing ion channel 3. J Neuroscience. 2005;25(47):10981–10989.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.