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Open Access 01-12-2010 | Research article

Efficacy and safety of combined prolonged-release oxycodone and naloxone in the management of moderate/severe chronic non-malignant pain: results of a prospectively designed pooled analysis of two randomised, double-blind clinical trials

Authors: Oliver Löwenstein, Petra Leyendecker, Eberhard A Lux, Mark Blagden, Karen H Simpson, Michael Hopp, Björn Bosse, Karen Reimer

Published in: BMC Clinical Pharmacology | Issue 1/2010

Abstract

Background

Two randomised 12-week, double-blind, parallel-group, multicenter studies comparing oxycodone PR/naloxone PR and oxycodone PR alone on symptoms of opioid-induced bowel dysfunction in patients with moderate/severe non-malignant pain have been conducted.

Methods

These studies were prospectively designed to be pooled and the primary outcome measure of the pooled data analysis was to demonstrate non-inferiority in 12-week analgesic efficacy of oxycodone PR/naloxone PR versus oxycodone PR alone. Patients with opioid-induced constipation were switched to oxycodone PR and then randomised to fixed doses of oxycodone PR/naloxone PR (n = 292) or oxycodone PR (n = 295) for 12 weeks (20-80 mg/day).

Results

No statistically significant differences in analgesic efficacy were observed for the two treatments (p = 0.3197; non-inferiority p < 0.0001; 95% CI -0.07, 0.23) and there was no statistically significant difference in frequency of analgesic rescue medication use. Improvements in Bowel Function Index score were observed for oxycodone PR/naloxone PR by Week 1 and at every subsequent time point (-15.1; p < 0.0001; 95% CI -17.3, -13.0). AE incidence was similar for both groups (61.0% and 57.3% of patients with oxycodone PR/naloxone PR and oxycodone PR alone, respectively).

Conclusions

Results of this pooled analysis confirm that oxycodone PR/naloxone PR provides effective analgesia and suggest that oxycodone PR/naloxone PR improves bowel function without compromising analgesic efficacy.

Trial registration numbers

ClinicalTrials.gov identifier: NCT00412100 and NCT00412152

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The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1472-6904/10/12/prepub

Title: Efficacy and safety of combined prolonged-release oxycodone and naloxone in the management of moderate/severe chronic non-malignant pain: results of a prospectively designed pooled analysis of two randomised, double-blind clinical trials
Authors: Oliver Löwenstein
Petra Leyendecker
Eberhard A Lux
Mark Blagden
Karen H Simpson
Michael Hopp
Björn Bosse
Karen Reimer
Publication date: 01-12-2010
Publisher: BioMed Central
Published in: BMC Clinical Pharmacology / Issue 1/2010
Electronic ISSN: 1472-6904
DOI: https://doi.org/10.1186/1472-6904-10-12

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Efficacy and safety of combined prolonged-release oxycodone and naloxone in the management of moderate/severe chronic non-malignant pain: results of a prospectively designed pooled analysis of two randomised, double-blind clinical trials

Abstract

Background

Methods

Results

Conclusions

Trial registration numbers

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Results

Conclusions

Trial registration numbers

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