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Efficacy of linaclotide for patients with chronic constipation.

Abstract：

BACKGROUND & AIMS:Linaclotide is a minimally absorbed peptide agonist of the guanylate cyclase-C receptor that stimulates intestinal fluid secretion and transit and reduces pain in animal models. We assessed the safety and efficacy of a range of linaclotide doses in patients with chronic constipation. METHODS:We performed a multicenter, double-blind, placebo-controlled, parallel-group study of 310 patients with chronic constipation. Patients were randomly assigned to groups given 75, 150, 300, or 600 microg oral linaclotide or placebo once daily for 4 weeks. Symptom assessments included spontaneous bowel movements (SBMs), complete SBMs, stool consistency, straining, abdominal discomfort, and bloating. Severity of constipation, adequate relief of constipation, global relief of constipation, treatment satisfaction, quality of life, adverse events, clinical laboratory data, and electrocardiogram results were assessed. RESULTS:All doses of linaclotide improved the weekly rate of SBM (primary end point) compared with placebo; the increases in overall weekly number of SBMs from baseline were 2.6, 3.3, 3.6, and 4.3 for linaclotide doses of 75, 150, 300, and 600 microg, respectively, compared with 1.5 for placebo (P < or = .05 for each pair-wise comparison of a linaclotide dose to placebo). Likewise, linaclotide significantly improved the weekly rate of complete SBM, stool consistency, straining, abdominal discomfort, bloating, global assessments, and quality of life. The most common and only dose-related adverse event was diarrhea (only 6 patients discontinued treatment because of diarrhea). CONCLUSIONS:Linaclotide therapy was associated with few adverse events and produced rapid and sustained improvement of bowel habits, abdominal symptoms, global relief, and quality of life in patients with chronic constipation.

journal_name

Gastroenterology

journal_title

Gastroenterology

authors

Lembo AJ,Kurtz CB,Macdougall JE,Lavins BJ,Currie MG,Fitch DA,Jeglinski BI,Johnston JM

doi

10.1053/j.gastro.2009.12.050

subject

Has Abstract

pub_date

2010-03-01 00:00:00

pages

886-95.e1

issue

eissn

0016-5085

issn

1528-0012

pii

S0016-5085(09)02247-1

journal_volume

138

pub_type

杂志文章,多中心研究,随机对照试验

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Efficacy of linaclotide for patients with chronic constipation.