Efficacy and tolerability of guanylate cyclase-C agonists for irritable bowel syndrome with constipation and chronic idiopathic constipation: A systematic review and meta-analysis

American Journal of Gastroenterology

Volumn 113, Issue 3, 2018, Pages 329-338

  Shah, Eric D ^a   Kim, Hyungjin Myra ^a   Schoenfeld, Philip ^a,b  

^a UNIVERSITY OF MICHIGAN   (United States)

^b VETERANS AFFAIRS MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

LINACLOTIDE; PLACEBO; PLECANATIDE; HEAT STABLE ENTEROTOXIN RECEPTOR AGONIST; NATRIURETIC FACTOR; PEPTIDE;

CHRONIC CONSTIPATION; CHRONIC IDIOPATHIC CONSTIPATION; CLINICAL OUTCOME; CONSTIPATION; DIARRHEA; DRUG EFFICACY; DRUG TOLERABILITY; FOOD AND DRUG ADMINISTRATION; HUMAN; IRRITABLE COLON; META ANALYSIS; PATIENT-REPORTED OUTCOME; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SYSTEMATIC REVIEW; UNITED STATES; CHEMICALLY INDUCED; CHRONIC DISEASE; COMPLICATION;

CHRONIC DISEASE; CONSTIPATION; DIARRHEA; GUANYLYL CYCLASE C AGONISTS; HUMANS; IRRITABLE BOWEL SYNDROME; NATRIURETIC PEPTIDES; PEPTIDES; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 85046144926     PISSN: 00029270     EISSN: 15720241     Source Type: Journal    
DOI: 10.1038/ajg.2017.495     Document Type: Review

References (32)

1. El-Serag HB, Olden K, Bjorkman D. Health-related quality of life among persons with irritable bowel syndrome: A systematic review. Aliment Pharmacol Ther 2002; 16: 1171-85.
2. Koloski NA, Talley NJ, Boyce PM. The impact of functional gastrointestinal disorders on quality of life. Am J Gastroenterol 2000; 95: 67-71.
3. Sun SX, Dibonaventura M, Purayidathil FW et al. Impact of chronic constipation on health-related quality of life, work productivity, and healthcare resource use: an analysis of the National Health and Wellness Survey. Dig Dis Sci 2011; 56: 2688-95.
4. Lovell RM, Ford AC. Global prevalence of and risk factors for irritable bowel syndrome: a meta-analysis. Clin Gastroenterol Hepatol 2012; 10: 712-721.e4.
5. Busby RW, Bryant AP, Bartolini WP et al. Linaclotide, through activation of guanylate cyclase C, acts locally in the gastrointestinal tract to elicit enhanced intestinal secretion and transit. Eur J Pharmacol 2010; 649: 328-35.
6. Linaclotide (Linzess) for constipation. Med Lett Drugs ther 2012; 54: 91-2.
7. Silos-Santiago I, Hannig G, Eutamene H et al. Gastrointestinal pain: unraveling a novel endogenous pathway through uroguanylin/guanylatecyclase-C/cGMP activation. Pain 2013; 154: 1820-30.
8. Hannig G, Tchernychev B, Kurtz CB et al. Guanylate cyclase-C/cGMP: an emerging pathway in the regulation of visceral pain. Front Mol Neurosci 2014; 7: 31.
9. Drugs@FDA. Label for New Drug Application 202811. US Food Drug Adm. 11 2017, https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202811s013lbl.pdf.
10. Drugs@FDA. Label for New Drug Application 208745. US Food Drug Adm. 6 2017, https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208745lbl.pdf.
11. Sonu I, Triadafilopoulos G, Gardner JD. Persistent constipation and abdominal adverse events with newer treatments for constipation. BMJ Open Gastroenterol 2016; 3: e000094.
12. Patwa V, Joshi A, Thadi A et al. 967 plecanatide, like uroguanylin, activates guanylate cyclase-C signaling in a pH-dependent manner in T84 cells, and in murine intestinal epithelial cells and tissues. Gastroenterology 2016; 150: S193-S194.
13. Brancale A, Shailubhai K, Ferla S et al. Mo1316 structural and dynamic features of plecanatide: insights from molecular dynamics simulations. Gastroenterology 2016; 150: S695.
14. Miner PB Jr, Koltun WD, Wiener GJ et al. A randomized phase III clinical trial of plecanatide, a uroguanylin analog, in patients with chronic idiopathic constipation. Am J Gastroenterol 2017; 112: 613-21.
15. Hanes LS. Clinical review (Application Number 208745Orig1s000). US Food Drug Adm 2016; 140: 140.
16. Wynn EL. Clinical review (Application Number 202811Orig1s000). US Food Drug Adm 2012; 169: 169.
17. Higgins JPT, Altman DG, Gotzsche PC et al. the Cochrane Collaboration’s tool for assessing risk of bias in randomised trials. BMJ 2011; 343: d5928.
18. Sweeting MJ, Sutton AJ, Lambert PC. What to add to nothing? Use and avoidance of continuity corrections in meta-analysis of sparse data. Stat Med 2004; 23: 1351-75.
19. Lembo AJ, Kurtz CB, Macdougall JE et al. Efficacy of linaclotide for patients with chronic constipation. Gastroenterology 2010; 138: 886-895.e1.
20. Lembo AJ, Schneier HA, ShiffSJ et al. Two randomized trials of linaclotide for chronic constipation. N Engl J Med 2011; 365: 527-36.
21. Lacy BE, Schey R, ShiffSJ et al. Linaclotide in chronic idiopathic constipation patients with moderate to severe abdominal bloating: a randomized, controlled trial. PloS ONE 2015; 10: e0134349.
22. 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: 1877-1886.e2.
23. 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: 1702-12.
24. Rao S, Lembo AJ, ShiffSJ 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: 1714-24. quiz p.1725.
25. Schoenfeld P, Lacy BE, Chey WD et al. Low-dose linaclotide (72 μg) for chronic idiopathic constipation: a 12-week, randomized, double-blind, placebo-controlled trial. Am J Gastroenterol 2018; 113: 105-14.
26. Shailubhai K et al. plecanatide, a guanylate cyclase C agonist, improves bowel habits and symptoms associated with chronic constipation in a phase IIa clinical study. Am J Gastroenterol 2011; 106: S502.
27. Miner PB et al. 925g plecanatide, a novel guanylate cyclase-C (GC-C) receptor agonist, is efficacious and safe in patients with chronic idiopathic constipation (CIC): results from a 951 patient, 12 week, multi-center trial. Gastroenterology 2013; 144: S-163.
28. Miner P et al. Plecanatide, a novel uroguanylin analog: a 12-week, randomized, double-blind, placebo-controlled, dose-ranging trial to evaluate efficacy and safety in patients with irritable bowel syndrome with constipation (IBS-C). Am J Gastroenterol 2014; 109: S541.
29. Synergy Pharmaceuticals Announces Positive Results in First Phase 3 Trial of Plecanatide in Patients with Irritable Bowel Syndrome with Constipation (IBS-C). Form 8-K, Exhibit 99.1. Accession No. 0001104659-16-1614112016.
30. Synergy Pharmaceuticals Announces Positive Results in Second Phase 3 Trial of Plecanatide in Patients with Irritable Bowel Syndrome with Constipation (IBS-C). Form 8-K, Exhibit 99.1. Accession No. 0001104659-16-163508 2016.
31. Synergy Pharmaceuticals Announces Positive Results in the Second Phase 3 Trial of Plecanatide in Patients with Chronic Idiopathic Constipation (CIC). Form 8-K, Exhibit 99.1. Accession No. 0001104659-15-054706 2015.
32. Johnston JM, Kurtz CB, Drossman DA et al. Pilot study on the effect of linaclotide in patients with chronic constipation. Am J Gastroenterol 2009; 104: 125-32.