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Evaluation of Plecanatide for the Treatment of Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation in Patients 65 Years or Older.

Abstract：

PURPOSE:Chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C) are common functional gastrointestinal disorders. The prevalence of constipation-related issues tends to increase with age. This analysis pooled data from Phase III trials in CIC and IBS-C to assess the safety and efficacy of plecanatide in patients aged ≥65 years. METHODS:Patients randomized to receive plecanatide (3 or 6 mg) or placebo from two CIC and two IBS-C trials were pooled. Efficacy end points common to all trials included changes in stool consistency (Bristol Stool Form Scale), changes in weekly frequency of complete spontaneous bowel movements (CSBMs) and spontaneous bowel movements (SBMs), and time to first CSBM and SBM. Efficacy and safety profile results are reported per age group (≥65 and <65 years of age). FINDINGS:The pooled intention-to-treat population comprised 451 patients aged ≥65 years (mean age, 70 years) and 4364 patients aged <65 years (mean age, 41.9 years), of whom 287 and 2914, respectively, were randomized to receive plecanatide. Compared with placebo, plecanatide produced statistically significant improvements in stool consistency from baseline at week 12 (both age groups), CSBM and SBM frequency from baseline at week 12 (plecanatide 3 mg group aged ≥65 years and both plecanatide groups aged <65 years), and time from start of therapy to first CSBM (both age groups) and SBM (plecanatide 6 mg group aged ≥65 years and both plecanatide groups aged <65 years). No new safety issues were observed. IMPLICATIONS:Plecanatide is a well-tolerated and effective treatment option for patients aged ≥65 years with CIC or IBS-C. CLINICALTRIALS. GOV IDENTIFIERS:NCT01982240, NCT02122471, NCT02387359, and NCT02493452.

journal_name

Clin Ther

journal_title

Clinical therapeutics

authors

Menees SB,Franklin H,Chey WD

doi

10.1016/j.clinthera.2020.05.012

subject

Has Abstract

pub_date

2020-07-01 00:00:00

pages

1406-1414.e4

issue

eissn

0149-2918

issn

1879-114X

pii

S0149-2918(20)30246-0

journal_volume

pub_type

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Evaluation of Plecanatide for the Treatment of Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation in Patients 65 Years or Older.