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Efficacy and safety of naloxegol in patients with opioid-induced constipation and laxative-inadequate response.

ABSTRACT: Treatment options for patients with opioid-induced constipation (OIC) and inadequate response to laxatives (LIR) are few.Assess the efficacy and safety of orally administered naloxegol in patients with prospectively confirmed OIC and LIR.We analyzed pooled data from two identical randomized, double-blind, placebo-controlled, Phase 3 trials of naloxegol in patients with non-cancer pain, OIC and LIR in which naloxegol (12.5?mg, n?=?240; 25?mg, n?=?241) or placebo (n?=?239) were administered daily. We assessed the response rates, time to first post-dose laxation, spontaneous bowel movements (SBMs), OIC symptoms and patient-reported outcomes over 12 weeks.OIC response rates for the naloxegol 25-mg (p?

SUBMITTER: Tack J 

PROVIDER: S-EPMC4625753 | biostudies-literature | 2015 Oct

REPOSITORIES: biostudies-literature

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Efficacy and safety of naloxegol in patients with opioid-induced constipation and laxative-inadequate response.

Tack Jan J   Lappalainen Jaakko J   Diva Ulysses U   Tummala Raj R   Sostek Mark M  

United European gastroenterology journal 20151001 5

<h4>Background</h4>Treatment options for patients with opioid-induced constipation (OIC) and inadequate response to laxatives (LIR) are few.<h4>Objective</h4>Assess the efficacy and safety of orally administered naloxegol in patients with prospectively confirmed OIC and LIR.<h4>Methods</h4>We analyzed pooled data from two identical randomized, double-blind, placebo-controlled, Phase 3 trials of naloxegol in patients with non-cancer pain, OIC and LIR in which naloxegol (12.5 mg, n = 240; 25 mg, n  ...[more]

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