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A review of the clinical efficacy of linaclotide in irritable bowel syndrome with constipation.
Curr Med Res Opin 2013; 29(2):149-60CM

Abstract

OBJECTIVES

The aims were: firstly, to review the definition and diagnosis of irritable bowel syndrome with constipation (IBS-C, a subtype of IBS); secondly, to critically assess current therapies for IBS-C with a focus on effectiveness for abdominal pain; and thirdly, to review clinical studies evaluating the efficacy of linaclotide, a therapy recently approved by the US Food and Drug Administration for the treatment of adults with IBS-C and chronic idiopathic constipation and the European Medicines Agency for the symptomatic treatment of moderate to severe IBS-C in adults, and in development for treatment of IBS-C worldwide.

METHODS

A comprehensive literature review was performed to summarize IBS-C and current treatments. MEDLINE and gastrointestinal society congress proceedings were searched to identify data from linaclotide clinical studies in adults with IBS-C published between January 2010 and August 2012.

RESULTS

IBS-C patients have chronic, relapsing symptoms. Rome III diagnostic criteria define the presence of chronic abdominal pain that improves with defecation and has onset associated with changes in stool frequency or form as a key element of IBS-C and other IBS subtypes. IBS-C patients generally are not completely satisfied with existing therapies. A therapy that treats bowel and abdominal symptoms effectively and can be taken safely on a chronic basis is a current unmet need for IBS-C patients. The guanylate cyclase-C agonist linaclotide has been shown to reduce visceral hypersensitivity in preclinical studies and to improve abdominal pain and constipation symptoms in phase 2 and 3 clinical trials of IBS-C patients.

CONCLUSIONS

IBS-C is a functional gastrointestinal disorder with chronic, relapsing abdominal and constipation symptoms. By virtue of its effects in relieving abdominal pain by reducing visceral hypersensitivity and improving constipation symptoms by increasing intestinal secretion and accelerating transit, linaclotide may be uniquely positioned for a role in the management of IBS-C patients.

Authors+Show Affiliations

Ironwood Pharmaceuticals, Inc., Cambridge, MA, USA. jjohnston@ironwoodpharma.comNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't
Review

Language

eng

PubMed ID

23198977

Citation

Johnston, Jeffrey M., et al. "A Review of the Clinical Efficacy of Linaclotide in Irritable Bowel Syndrome With Constipation." Current Medical Research and Opinion, vol. 29, no. 2, 2013, pp. 149-60.
Johnston JM, Shiff SJ, Quigley EM. A review of the clinical efficacy of linaclotide in irritable bowel syndrome with constipation. Curr Med Res Opin. 2013;29(2):149-60.
Johnston, J. M., Shiff, S. J., & Quigley, E. M. (2013). A review of the clinical efficacy of linaclotide in irritable bowel syndrome with constipation. Current Medical Research and Opinion, 29(2), pp. 149-60. doi:10.1185/03007995.2012.754743.
Johnston JM, Shiff SJ, Quigley EM. A Review of the Clinical Efficacy of Linaclotide in Irritable Bowel Syndrome With Constipation. Curr Med Res Opin. 2013;29(2):149-60. PubMed PMID: 23198977.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A review of the clinical efficacy of linaclotide in irritable bowel syndrome with constipation. AU - Johnston,Jeffrey M, AU - Shiff,Steven J, AU - Quigley,Eamonn M M, Y1 - 2012/12/20/ PY - 2012/12/4/entrez PY - 2012/12/4/pubmed PY - 2013/6/12/medline SP - 149 EP - 60 JF - Current medical research and opinion JO - Curr Med Res Opin VL - 29 IS - 2 N2 - OBJECTIVES: The aims were: firstly, to review the definition and diagnosis of irritable bowel syndrome with constipation (IBS-C, a subtype of IBS); secondly, to critically assess current therapies for IBS-C with a focus on effectiveness for abdominal pain; and thirdly, to review clinical studies evaluating the efficacy of linaclotide, a therapy recently approved by the US Food and Drug Administration for the treatment of adults with IBS-C and chronic idiopathic constipation and the European Medicines Agency for the symptomatic treatment of moderate to severe IBS-C in adults, and in development for treatment of IBS-C worldwide. METHODS: A comprehensive literature review was performed to summarize IBS-C and current treatments. MEDLINE and gastrointestinal society congress proceedings were searched to identify data from linaclotide clinical studies in adults with IBS-C published between January 2010 and August 2012. RESULTS: IBS-C patients have chronic, relapsing symptoms. Rome III diagnostic criteria define the presence of chronic abdominal pain that improves with defecation and has onset associated with changes in stool frequency or form as a key element of IBS-C and other IBS subtypes. IBS-C patients generally are not completely satisfied with existing therapies. A therapy that treats bowel and abdominal symptoms effectively and can be taken safely on a chronic basis is a current unmet need for IBS-C patients. The guanylate cyclase-C agonist linaclotide has been shown to reduce visceral hypersensitivity in preclinical studies and to improve abdominal pain and constipation symptoms in phase 2 and 3 clinical trials of IBS-C patients. CONCLUSIONS: IBS-C is a functional gastrointestinal disorder with chronic, relapsing abdominal and constipation symptoms. By virtue of its effects in relieving abdominal pain by reducing visceral hypersensitivity and improving constipation symptoms by increasing intestinal secretion and accelerating transit, linaclotide may be uniquely positioned for a role in the management of IBS-C patients. SN - 1473-4877 UR - https://www.unboundmedicine.com/medline/citation/23198977/A_review_of_the_clinical_efficacy_of_linaclotide_in_irritable_bowel_syndrome_with_constipation_ L2 - http://www.tandfonline.com/doi/full/10.1185/03007995.2012.754743 DB - PRIME DP - Unbound Medicine ER -