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

ABSTRACT:

Background

Treatment options for patients with opioid-induced constipation (OIC) and inadequate response to laxatives (LIR) are few.

Objective

Assess the efficacy and safety of orally administered naloxegol in patients with prospectively confirmed OIC and LIR.

Methods

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.

Results

OIC response rates for the naloxegol 25-mg (p < 0.001) and the 12.5-mg

SUBMITTER: Tack J 

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

REPOSITORIES: biostudies-literature