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Open Access Highly Accessed 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

Oliver Löwenstein1, Petra Leyendecker2*, Eberhard A Lux3, Mark Blagden4, Karen H Simpson5, Michael Hopp2, Björn Bosse2 and Karen Reimer26

Author Affiliations

1 Schmerzpraxis, Rheinstrasse, Mainz, Germany

2 Mundipharma Research GmbH & Co. KG, Hoehenstrasse, Limburg (Lahn), Germany

3 Klinik für Schmerz- und Palliativmedizin, Klinikum St. Marien-Hospital Lünen, Altstadtstrasse, Lünen, Germany

4 Avondale Surgery, Chesterfield, Avondale Road, Derbyshire, UK

5 Leeds Teaching Hospital, Glebe House, Scholes Lane, Leeds, UK

6 University Witten/Herdecke, Alfred-Herrhausen-Straße, Witten, Germany

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BMC Clinical Pharmacology 2010, 10:12  doi:10.1186/1472-6904-10-12

Published: 29 September 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