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Volumn 26, Issue 4, 2014, Pages 499-509

Effect of linaclotide in irritable bowel syndrome with constipation (IBS-C): A systematic review and meta-analysis

Author keywords

GRADE; IBS C; IBS QOL; Linaclotide; Meta analysis

Indexed keywords

LINACLOTIDE; PLACEBO; PEPTIDE;

EID: 84896387978     PISSN: 13501925     EISSN: 13652982     Source Type: Journal    
DOI: 10.1111/nmo.12292     Document Type: Article
Times cited : (55)

References (34)
  • 1
    • 0037357895 scopus 로고    scopus 로고
    • The prevalence, patterns and impact of irritable bowel syndrome: an international survey of 40,000 subjects
    • Hungin AP, Whorwell PJ, Tack J, Mearin F. The prevalence, patterns and impact of irritable bowel syndrome: an international survey of 40, 000 subjects. Aliment Pharmacol Ther 2003; 17: 643-50.
    • (2003) Aliment Pharmacol Ther , vol.17 , pp. 643-650
    • Hungin, A.P.1    Whorwell, P.J.2    Tack, J.3    Mearin, F.4
  • 2
    • 33748561834 scopus 로고    scopus 로고
    • Irritable bowel syndrome: the burden and unmet needs in Europe
    • Quigley EM, Bytzer P, Jones R, Mearin F. Irritable bowel syndrome: the burden and unmet needs in Europe. Dig Liver Dis 2006; 38: 717-23.
    • (2006) Dig Liver Dis , vol.38 , pp. 717-723
    • Quigley, E.M.1    Bytzer, P.2    Jones, R.3    Mearin, F.4
  • 3
    • 0035999159 scopus 로고    scopus 로고
    • Health-related quality of life among persons with irritable bowel syndrome: a systematic review
    • 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.
    • (2002) Aliment Pharmacol Ther , vol.16 , pp. 1171-1185
    • El-Serag, H.B.1    Olden, K.2    Bjorkman, D.3
  • 4
    • 33751574668 scopus 로고    scopus 로고
    • 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
    • Pare 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: 1726-35.
    • (2006) Clin Ther , vol.28 , pp. 1726-1735
    • Pare, P.1    Gray, J.2    Lam, S.3
  • 6
    • 77249162216 scopus 로고    scopus 로고
    • Taking a lesson from microbial diarrheagenesis in the management of chronic constipation
    • Bharucha AE, Waldman SA. Taking a lesson from microbial diarrheagenesis in the management of chronic constipation. Gastroenterology 2010; 138: 813-7.
    • (2010) Gastroenterology , vol.138 , pp. 813-817
    • Bharucha, A.E.1    Waldman, S.A.2
  • 7
    • 76349111067 scopus 로고    scopus 로고
    • Linaclotide - a secretagogue and antihyperalgesic agent - what next?
    • Bharucha AE, Linden DR. Linaclotide - a secretagogue and antihyperalgesic agent - what next? Neurogastroenterol Motil 2010; 22: 227-31.
    • (2010) Neurogastroenterol Motil , vol.22 , pp. 227-231
    • Bharucha, A.E.1    Linden, D.R.2
  • 8
    • 80051640525 scopus 로고    scopus 로고
    • Two randomized trials of linaclotide for chronic constipation
    • Lembo AJ, Schneier HA, Shiff SJ et al. Two randomized trials of linaclotide for chronic constipation. N Engl J Med 2011; 365: 527-36.
    • (2011) N Engl J Med , vol.365 , pp. 527-536
    • Lembo, A.J.1    Schneier, H.A.2    Shiff, S.J.3
  • 9
    • 78649690668 scopus 로고    scopus 로고
    • Linaclotide improves abdominal pain and bowel habits in a phase IIb study of patients with irritable bowel syndrome with constipation
    • e2
    • 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: 1877-86, e2.
    • (2010) Gastroenterology , vol.139 , pp. 1877-1886
    • Johnston, J.M.1    Kurtz, C.B.2    MacDougall, J.E.3
  • 10
    • 84869491248 scopus 로고    scopus 로고
    • Linaclotide for irritable bowel syndrome with constipation: a 26-week, randomized, double-blind, placebo-controlled trial to evaluate efficacy and safety
    • 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.
    • (2012) Am J Gastroenterol , vol.107 , pp. 1702-1712
    • Chey, W.D.1    Lembo, A.J.2    Lavins, B.J.3
  • 11
    • 84869493876 scopus 로고    scopus 로고
    • 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
    • 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: 1714-24.
    • (2012) Am J Gastroenterol , vol.107 , pp. 1714-1724
    • Rao, S.1    Lembo, A.J.2    Shiff, S.J.3
  • 12
    • 84869436279 scopus 로고    scopus 로고
    • Linaclotide: promising IBS-C efficacy in an era of provisional study endpoints
    • Sayuk GS. Linaclotide: promising IBS-C efficacy in an era of provisional study endpoints. Am J Gastroenterol 2012; 107: 1726-9.
    • (2012) Am J Gastroenterol , vol.107 , pp. 1726-1729
    • Sayuk, G.S.1
  • 13
    • 84871330788 scopus 로고    scopus 로고
    • AGA practice guideline on constipation: technical review
    • Bharucha AE, Pemberton JH, Locke GR. AGA practice guideline on constipation: technical review. Gastroenterology 2013; 144: 218-38.
    • (2013) Gastroenterology , vol.144 , pp. 218-238
    • Bharucha, A.E.1    Pemberton, J.H.2    Locke, G.R.3
  • 15
    • 84871944403 scopus 로고    scopus 로고
    • Irritable bowel syndrome
    • Jan 6 [cited 2013 Sep 20]; pii: 0410. Available at
    • Ford AC, Vandvik PO. Irritable bowel syndrome. Clin Evid (Online) 2012 Jan 6 [cited 2013 Sep 20]; pii: 0410. Available at: http://clinicalevidence.bmj.com/x/pdf/clinical-evidence/en-gb/systematic-review/0410.pdf.
    • (2012) Clin Evid (Online)
    • Ford, A.C.1    Vandvik, P.O.2
  • 16
    • 84896404905 scopus 로고    scopus 로고
    • Postmarket Drug Safety Information for Patients and Providers: Zelnorm (tegaserod maleate) Information [Internet]. Silver Spring, MD: U.S. Food and Drug Administration; [date unknown] [updated 2012 May 11; cited 2013 Sep 20]. Available at
    • Postmarket Drug Safety Information for Patients and Providers: Zelnorm (tegaserod maleate) Information [Internet]. Silver Spring, MD: U.S. Food and Drug Administration; [date unknown] [updated 2012 May 11; cited 2013 Sep 20]. Available at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103223.htm
  • 17
    • 58149103805 scopus 로고    scopus 로고
    • Clinical trial: lubiprostone in patients with constipation-associated irritable bowel syndrome-results of two randomized, placebo-controlled studies
    • Drossman DA, Chey WD, Johanson JF 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: 329-41.
    • (2009) Aliment Pharmacol Ther , vol.29 , pp. 329-341
    • Drossman, D.A.1    Chey, W.D.2    Johanson, J.F.3
  • 18
    • 84896393729 scopus 로고    scopus 로고
    • Lubiprostone prescribing information [Internet]. Silver Spring, MD: U.S. Food and Drug Administration; [date unknown] [updated 2012 Nov; cited 2013 Sep 20]. Available at
    • Lubiprostone prescribing information [Internet]. Silver Spring, MD: U.S. Food and Drug Administration; [date unknown] [updated 2012 Nov; cited 2013 Sep 20]. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021908s010lbl.pdf
  • 19
    • 84896402379 scopus 로고    scopus 로고
    • Guidance for Industry: Irritable Bowel Syndrome - Clinical Evaluation of Drugs for Treatment [Internet]. Silver Spring, MD: U.S. Food and Drug Administration; 2012 May [cited 2013 Sep 20]. Available at
    • Guidance for Industry: Irritable Bowel Syndrome - Clinical Evaluation of Drugs for Treatment [Internet]. Silver Spring, MD: U.S. Food and Drug Administration; 2012 May [cited 2013 Sep 20]. Available at: http://www.fda.gov/downloads/Drugs/Guidances/UCM205269.pdf
  • 20
    • 84896399710 scopus 로고    scopus 로고
    • Concept paper on the revision of the CHMP points to consider on the evaluation of medicinal products for the treatment of irritable bowel syndrome [Internet]. London, UK: European Medicines Agency; [cited 2013 Sep 20]; Available at
    • Concept paper on the revision of the CHMP points to consider on the evaluation of medicinal products for the treatment of irritable bowel syndrome [Internet]. London, UK: European Medicines Agency; 2012 [cited 2013 Sep 20]; Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500128217.pdf
    • (2012)
  • 21
    • 34250798707 scopus 로고    scopus 로고
    • Characterization of health related quality of life (HRQOL) for patients with functional bowel disorder (FBD) and its response to treatment
    • Drossman D, Morris CB, Hu Y et al. Characterization of health related quality of life (HRQOL) for patients with functional bowel disorder (FBD) and its response to treatment. Am J Gastroenterol 2007; 102: 1442-53.
    • (2007) Am J Gastroenterol , vol.102 , pp. 1442-1453
    • Drossman, D.1    Morris, C.B.2    Hu, Y.3
  • 22
    • 0034072849 scopus 로고    scopus 로고
    • Further validation of the IBS-QOL: a disease-specific quality-of-life questionnaire
    • Drossman DA, Patrick DL, Whitehead WE et al. Further validation of the IBS-QOL: a disease-specific quality-of-life questionnaire. Am J Gastroenterol 2000; 95: 999-1007.
    • (2000) Am J Gastroenterol , vol.95 , pp. 999-1007
    • Drossman, D.A.1    Patrick, D.L.2    Whitehead, W.E.3
  • 26
    • 43049113533 scopus 로고    scopus 로고
    • GRADE: an emerging consensus on rating quality of evidence and strength of recommendations
    • Guyatt GH, Oxman AD, Vist GE et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 2008; 336: 924-6.
    • (2008) BMJ , vol.336 , pp. 924-926
    • Guyatt, G.H.1    Oxman, A.D.2    Vist, G.E.3
  • 28
    • 83155177485 scopus 로고    scopus 로고
    • Effect of linaclotide on quality of life in adults with irritable bowel syndrome with constipation: pooled results from two randomized, double-blind, placebo-controlled Phase 3 trials
    • Carson R, Tourkodimitris S, Lewis BE, Johnston JM. Effect of linaclotide on quality of life in adults with irritable bowel syndrome with constipation: pooled results from two randomized, double-blind, placebo-controlled Phase 3 trials. Gastroenterology 2011; 140(5 Suppl. 1): S-51.
    • (2011) Gastroenterology , vol.140 , Issue.5 SUPPL. 1
    • Carson, R.1    Tourkodimitris, S.2    Lewis, B.E.3    Johnston, J.M.4
  • 29
    • 84896082720 scopus 로고    scopus 로고
    • Effect of linaclotide on severe abdominal symptoms in patients with irritable bowel syndrome with constipation
    • piiL S1542-3565(13)01427-4. doi: 10.1016/j.cgh.2013.09.022
    • Rao SS, Quigley EM, Shiff SJ et al. Effect of linaclotide on severe abdominal symptoms in patients with irritable bowel syndrome with constipation. Clin Gastroenterol Hepatol 2013; pii: S1542-3565(13)01427-4. doi: 10.1016/j.cgh.2013.09.022.
    • (2013) Clin Gastroenterol Hepatol
    • Rao, S.S.1    Quigley, E.M.2    Shiff, S.J.3
  • 30
    • 84877097873 scopus 로고    scopus 로고
    • Efficacy and safety of once-daily linaclotide administered orally for 12 weeks to patients with IBS-C: pooled results from two randomized, double-blind, placebo-controlled Phase 3 trials
    • Chey W, Rao S, Lembo A et al. Efficacy and safety of once-daily linaclotide administered orally for 12 weeks to patients with IBS-C: pooled results from two randomized, double-blind, placebo-controlled Phase 3 trials. Am J Gastroenterol 2011; 106(Suppl. 2): S504-6.
    • (2011) Am J Gastroenterol , vol.106 , Issue.SUPPL. 2
    • Chey, W.1    Rao, S.2    Lembo, A.3
  • 31
    • 84870601331 scopus 로고    scopus 로고
    • Randomised clinical trials: linaclotide phase 3 studies in IBS-C - a prespecified further analysis based on European Medicines Agency-specified endpoints
    • Quigley EM, Tack J, Chey WD et al. Randomised clinical trials: linaclotide phase 3 studies in IBS-C - a prespecified further analysis based on European Medicines Agency-specified endpoints. Aliment Pharmacol Ther 2013; 37: 49-61.
    • (2013) Aliment Pharmacol Ther , vol.37 , pp. 49-61
    • Quigley, E.M.1    Tack, J.2    Chey, W.D.3
  • 32
    • 84878015362 scopus 로고    scopus 로고
    • An evaluation of the FDA Responder Endpoint for IBS-C clinical trials: analysis of data from linaclotide Phase 3 clinical trials
    • Macdougall JE, Johnston JM, Lavins BJ et al. An evaluation of the FDA Responder Endpoint for IBS-C clinical trials: analysis of data from linaclotide Phase 3 clinical trials. Neurogastroenterol Motil 2013; 25: 481-6.
    • (2013) Neurogastroenterol Motil , vol.25 , pp. 481-486
    • Macdougall, J.E.1    Johnston, J.M.2    Lavins, B.J.3
  • 33
    • 84877968957 scopus 로고    scopus 로고
    • FDA and EMA end points: which outcome end points should we use in clinical trials in patients with irritable bowel syndrome?
    • Corsetti M, Tack J. FDA and EMA end points: which outcome end points should we use in clinical trials in patients with irritable bowel syndrome? Neurogastroenterol Motil 2013; 25: 453-7.
    • (2013) Neurogastroenterol Motil , vol.25 , pp. 453-457
    • Corsetti, M.1    Tack, J.2
  • 34
    • 84882775844 scopus 로고    scopus 로고
    • Effects of linaclotide in patients with irritable bowel syndrome with constipation or chronic constipation: a meta-analysis
    • Videlock EJ, Cheng V, Cremonini F. Effects of linaclotide in patients with irritable bowel syndrome with constipation or chronic constipation: a meta-analysis. Clin Gastroenterol Hepatol 2013; 11: 1084-92.
    • (2013) Clin Gastroenterol Hepatol , vol.11 , pp. 1084-1092
    • Videlock, E.J.1    Cheng, V.2    Cremonini, F.3


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